Quixidar

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 1.5 mg/0.3 ml solution for injection, pre-filled syringe.  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium. 
 
Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially 
sodium free.  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
The solution is a clear and colourless liquid.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic 
surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who 
are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal 
cancer surgery (see section 5.1). 
 
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high 
risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute 
respiratory disorders, and/or acute infectious or inflammatory disease.  
 
4.2 Posology and method of administration  
 
Patients undergoing major orthopaedic or abdominal surgery 
The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by 
subcutaneous injection.  
 
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been 
established.  
 
Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually 
until the patient is ambulant, at least 5 to 9 days after surgery. Experience shows that in patients 
undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. In these 
patients the use of prolonged prophylaxis with fondaparinux should be considered for up to an 
additional 24 days (see section 5.1). 
 
Medical patients who are at high risk for thromboembolic complications based on an individual risk 
assessment 
The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection. 
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).  
 



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Special populations  
In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in 
patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine 
clearance ranging between 20 to 50 ml/min. 
 
The first fondaparinux administration should be given not earlier than 6 hours following surgical 
closure. The injection should not be given unless haemostasis has been established (see section 4.4). 
 
Renal impairment - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min 
(see section 4.3). The dose should be reduced to 1.5 mg once daily in patients with creatinine 
clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2). No dosage reduction is required 
for patients with mild renal impairment (creatinine clearance >50 ml/min). 
 
Hepatic impairment - No dosing adjustment is necessary. In patients with severe hepatic impairment, 
fondaparinux should be used with care (see section 4.4).  
 
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age 
due to a lack of data on safety and efficacy. 
 
Method of administration  
Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. Sites of 
administration should alternate between the left and the right anterolateral and left and right 
posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled 
syringe do not expel the air bubble from the syringe before the injection. The whole length of the 
needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; 
the skin fold should be held throughout the injection. 
 
For additional instructions for use and handling and disposal see section 6.6. 
 
4.3 Contraindications  
 
- hypersensitivity to the active substance or to any of the excipients  
- active clinically significant bleeding  
- acute bacterial endocarditis  
- severe renal impairment defined by creatinine clearance < 20 ml/min. 
 
4.4 Special warnings and precautions for use 
 
Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. 
 
Haemorrhage  
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, 
such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active 
ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or 
ophthalmic surgery and in special patient groups as outlined below. 
 
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with 
fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, 
heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). When required, concomitant 
therapy with vitamin K antagonist should be administered in accordance with the information of 
Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, 
ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, 
close monitoring is necessary. 
 
Spinal / Epidural anaesthesia  
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in 
long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and 



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spinal/epidural anaesthesia or spinal puncture. The risk of these rare events may be higher with post-
operative use of indwelling epidural catheters or the concomitant use of other medicinal products 
affecting haemostasis.  
 
Elderly patients  
The elderly population is at increased risk of bleeding. As renal function is generally decreasing with 
age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see 
section 5.2). Fondaparinux should be used with caution in elderly patients (see section 4.2).  
 
Low body weight  
Patients with body weight <50 kg are at increased risk of bleeding. Elimination of fondaparinux 
decreases with weight. Fondaparinux should be used with caution in these patients (see section 4.2). 
 
Renal impairment  
Fondaparinux is known to be mainly excreted by the kidney. Patients with creatinine clearance <50 
ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 
4.3 and 5.2). There are limited clinical data available from patients with creatinine clearance less than 
30 ml/min. 
 
Severe hepatic impairment  
Dosing adjustment of fondaparinux is not necessary. However, the use of fondaparinux should be 
considered with caution because of an increased risk of bleeding due to a deficiency of coagulation 
factors in patients with severe hepatic impairment (see section 4.2). 
 
Patients with Heparin Induced Thrombocytopenia 
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with 
Heparin Induced Thrombocytopenia (HIT) type II. The efficacy and safety of fondaparinux have not 
been formally studied in patients with HIT type II. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may 
enhance the risk of haemorrhage (see section 4.4). 
 
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and 
digoxin did not interact with the pharmacokinetics of fondaparinux. The fondaparinux dose (10 mg) in 
the interaction studies was higher than the dose recommended for the present indications. 
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under 
acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state. 
 
Follow-up therapy with another anticoagulant medicinal product 
If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general 
rule, be given one day after the last fondaparinux injection. 
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be 
continued until the target INR value has been reached. 
 
4.6 Pregnancy and lactation 
 
There are no adequate data from the use of fondaparinux in pregnant women. Animal studies are 
insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal 
development because of limited exposure. Fondaparinux should not be prescribed to pregnant women 
unless clearly necessary.  
 
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human 
milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the 
child is however unlikely. 
 



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4.7 Effects on ability to drive and use machines  
 
No studies on the effect on the ability to drive and to use machines have been performed. 
 
4.8 Undesirable effects  
 
The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic 
surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated 
for 3 weeks following an initial prophylaxis of 1 week, 1407 patients undergoing abdominal surgery 
treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications 
treated up to 14 days. 
 
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are 
presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; 
uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ 
class by decreasing order of seriousness; these adverse reactions should be interpreted within the 
surgical and medical context.  
 

System organ class 

MedDRA 

Undesirable effects in patients 
undergoing major orthopaedic 
surgery of lower limbs and/or 
abdominal surgery 

 

Undesirable effects in medical 
patients 

Infections and 
infestations 
 

Rare: post-operative wound 
infection 

 

Blood and lymphatic 
system disorders 

 

Common: post-operative 
haemorrhage, anaemia 
Uncommon: bleeding (epistaxis, 
gastrointestinal, haemoptysis, 
haematuria, haematoma) 
thrombocytopenia, purpura, 
thrombocythaemia, platelet 
abnormal, coagulation disorder 

 

Common: bleeding 
(haematoma, haematuria, 
haemoptysis, gingival bleeding) 
Uncommon: anaemia 

Immune system disorders Rare: allergic reaction 
 

 

Metabolism and nutrition 
disorders 
 

Rare: hypokalaemia  

Nervous system disorders Rare: anxiety, somnolence, 
vertigo, dizziness, headache, 
confusion 
 

 

Vascular disorders Rare: hypotension 
 

 

Respiratory, thoracic and 
mediastinal disorders 
 

Rare: dyspnoea, coughing Uncommon: dyspnoea 



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Gastrointestinal 
disorders 
 

Uncommon: nausea, vomiting 
Rare: abdominal pain, dyspepsia, 
gastritis, constipation, diarrhoea 
 

 

Hepatobiliary disorders  Uncommon: hepatic enzymes 
increased, hepatic function 
abnormal 
Rare: bilirubinaemia 
 

 

Skin and subcutaneous 
tissue disorders 
 

Uncommon: rash, pruritus Uncommon: rash, pruritus 

General disorders and 
administration site 
conditions 

Uncommon: oedema, oedema 
peripheral, fever, wound 
secretion 
Rare: chest pain, fatigue, hot 
flushes, leg pain, oedema genital, 
flushing, syncope 
 

Uncommon: chest pain 

 
In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and 
retroperitoneal bleedings have been reported. 
 
4.9 Overdose  
 
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. There 
is no known antidote to fondaparinux. 
 
Overdose associated with bleeding complications should lead to treatment discontinuation and search 
for the primary cause. Initiation of appropriate therapy such as surgical haemostasis, blood 
replacements, fresh plasma transfusion, plasmapheresis should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antithrombotic agents.  
ATC code: B01AX05 
 
Pharmacodynamic effects  
 
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic 
activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of 
Factor Xa. By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate 
neutralization of Factor Xa by ATIII. Neutralisation of Factor Xa interrupts the blood coagulation 
cascade and inhibits both thrombin formation and thrombus development. Fondaparinux does not 
inactivate thrombin (activated Factor II) and has no effects on platelets.  
 
At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial 
thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International 
Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity. 
 
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.  
 



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Clinical studies 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic 
surgery of the lower limbs treated up to 9 days 
The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the 
prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis 
(DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower 
limbs such as hip fracture, major knee surgery or hip replacement surgery. Over 8,000 patients (hip 
fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled 
Phase II and III clinical studies. Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was 
compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily 
started 12-24 hours after surgery. 
 
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus 
enoxaparin was associated with a significant decrease (54% - 95% CI, 44 %; 63%) in the rate of VTE 
evaluated up to day 11 after surgery, irrespective of the type of surgery performed. The majority of 
endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, 
but the incidence of proximal DVT was also significantly reduced. The incidence of symptomatic 
VTE, including PE was not significantly different between treatment groups. 
 
In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was 
observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% 
with enoxaparin. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture 
surgery treated for up to 24 days following an initial prophylaxis of 1 week 
In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once 
daily for 7 +/- 1 days following hip fracture surgery. At the end of this period, 656 patients were 
randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/- 2 days. 
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 
patients (1.4%) vs 77 patients (35%), respectively]. The majority (70/80) of the recorded VTE events 
were venographically detected non-symptomatic cases of DVT. Fondaparinux also provided a 
significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) 
patients, respectively] including two fatal PE reported in the placebo group. Major bleedings, all at 
surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg 
compared to 2 (0.6%) with placebo. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery 
who are judged to be at high risk of thromboembolic complications, such as patients undergoing 
abdominal cancer surgery 
In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once 
daily or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU 
post-operative injection, for 7+2 days. The main sites of surgery were colonic/rectal, gastric, hepatic, 
cholecystectomy or other biliary. Sixty-nine percent of the patients underwent surgery for cancer. 
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or 
vascular surgery were not included in the study. 
 
In this study, the incidence of total VTE was 4.6% (47/1027) with fondaparinux, versus 6.1%: 
(62/1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].  The difference in 
total VTE rates between the treatment groups, which was not statistically significant, was mainly due 
to a reduction of asymptomatic distal DVT. The incidence of symptomatic DVT was similar between 
treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin 
group. In the large subgroup of patients undergoing cancer surgery (69% of the patient population), 
the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.   
 
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the 
dalteparin group.  



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Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk 
for thromboembolic complications due to restricted mobility during acute illness 
In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once 
daily or placebo for 6 to 14 days. This study included acutely ill medical patients, aged ≥ 60 years, 
expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA 
class III/IV and/or acute respiratory illness and/or acute infectious or inflammatory disease. 
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) 
vs 34 patients (10.5%), respectively]. The majority of events were asymptomatic distal DVT. 
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 
patients (1.2%), respectively]. Major bleedings were observed in 1 patient (0.2%) of each group.  
 
5.2 Pharmacokinetic properties 
 
Absorption  
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 
100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 
peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing. Plasma 
concentrations of half the mean Cmax values are reached 25 minutes post-dosing. 
 
In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by 
subcutaneous route. Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 
days with a 1.3-fold increase in Cmax and AUC. 
 
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients 
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 
(31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). In hip fracture patients, associated with their 
increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), 
Cmin (mg/l) - 0.19 (58%). 
 
Distribution  
The distribution volume of fondaparinux is limited (7-11 litres). In vitro, fondaparinux is highly and 
specifically bound to antithrombin protein with a dose-dependant plasma concentration binding 
(98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l). Fondaparinux does not bind 
significantly to other plasma proteins, including platelet factor 4 (PF4). 
 
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction 
with other medicinal products by protein binding displacement are expected. 
 
Metabolism 
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no 
evidence for the formation of active metabolites. 
 
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, 
CYP2E1 or CYP3A4) in vitro. Thus, fondaparinux is not expected to interact with other medicinal 
products in vivo by inhibition of CYP-mediated metabolism.  
 
Excretion/Elimination  
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy 
elderly subjects. Fondaparinux is excreted to 64 – 77 % by the kidney as unchanged compound. 
 
Special populations  
 
Paediatric patients - Fondaparinux has not been investigated in this population.  
 



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Elderly patients - Renal function may decrease with age and thus, the elimination capacity for 
fondaparinux may be reduced in elderly. In patients >75 years undergoing orthopaedic surgery, the 
estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years. 
 
Renal impairment - Compared with patients with normal renal function (creatinine 
clearance > 80 ml/min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal 
impairment (creatinine clearance 50 to 80 ml/min) and on average 2 times lower in patients with 
moderate renal impairment (creatinine clearance 30 to 50 ml/min). In severe renal impairment 
(creatinine clearance < 30 ml/min), plasma clearance is approximately 5 times lower than in normal 
renal function. Associated terminal half-life values were 29 h in moderate and 72 h in patients with 
severe renal impairment. 
 
Gender - No gender differences were observed after adjustment for body weight. 
 
Race - Pharmacokinetic differences due to race have not been studied prospectively. However, studies 
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile 
compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed 
between black and Caucasian patients undergoing orthopaedic surgery. 
 
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). 
 
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.  
 
5.3 Preclinical safety data  
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, and genotoxicity. Animal studies are insufficient with respect to 
effects on toxicity to reproduction because of limited exposure.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Water for injections 
Hydrochloric acid 
Sodium hydroxide 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not freeze. 
 



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6.5 Nature and contents of container  
 
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl 
or chlorobutyl elastomer plunger stopper.  
 
Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a yellow automatic safety 
system. Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The subcutaneous injection is administered in the same way as with a classical syringe. 
 
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to 
administration. 
 
Instruction for self-administration is mentioned in the Package Leaflet. 
 
The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic 
safety system to protect from needle stick injuries following injection. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/02/207/005-008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 March 2002 
Date of latest renewal: 21 March 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMEA) http://www.emea.europa.eu 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 2.5 mg/0.5 ml solution for injection, pre-filled syringe.  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium. 
 
Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially 
sodium free.  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
The solution is a clear and colourless liquid.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic 
surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who 
are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal 
cancer surgery (see section 5.1). 
 
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high 
risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute 
respiratory disorders, and/or acute infectious or inflammatory disease.  
 
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in 
patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 
and 5.1). 
 
Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with 
thrombolytics or who initially are to receive no other form of reperfusion therapy.  
 
4.2 Posology and method of administration  
 
Patients undergoing major orthopaedic or abdominal surgery 
The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by 
subcutaneous injection.  
 
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been 
established.  
 
Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually 
until the patient is ambulant, at least 5 to 9 days after surgery. Experience shows that in patients 
undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. In these 
patients the use of prolonged prophylaxis with fondaparinux should be considered for up to an 
additional 24 days (see section 5.1). 



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Medical patients who are at high risk for thromboembolic complications based on an individual risk 
assessment 
The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection. 
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).  
 
Treatment of unstable angina/non- ST segment elevation myocardial infarction (UA/NSTEMI) 
The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection. 
Treatment should be initiated as soon as possible following diagnosis and continued for up to a 
maximum of 8 days or until hospital discharge if that occurs earlier. 
 
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as 
per local practice should be administered during PCI, taking into account the patient’s potential risk of 
bleeding, including the time since the last dose of fondaparinux (see section 4.4). The timing of 
restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment. In 
the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 
hours after sheath removal.  
 
Treatment of ST segment elevation myocardial infarction (STEMI) 
The recommended dose of fondaparinux is 2.5 mg once daily. The first dose of fondaparinux is 
administered intravenously and subsequent doses are administered by subcutaneous injection. 
Treatment should be initiated as soon as possible following diagnosis and continued for up to a 
maximum of 8 days or until hospital discharge if that occurs earlier. 
 
If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should 
be administered during PCI, taking into account the patient’s potential risk of bleeding, including the 
time since the last dose of fondaparinux (see section 4.4). The timing of restarting subcutaneous 
fondaparinux after sheath removal should be based on clinical judgment. In the pivotal STEMI clinical 
trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.  
 
In STEMI or UA/NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, 
fondaparinux where possible, should not be given during the 24 hours before surgery and may be 
restarted 48 hours post-operatively. 
 
Special populations  
 
Prevention of VTE following Surgery 
In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in 
patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine 
clearance ranging between 20 to 50 ml/min. 
 
The first fondaparinux administration should be given not earlier than 6 hours following surgical 
closure. The injection should not be given unless haemostasis has been established (see section 4.4). 
 
Renal impairment 
• Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine 

clearance <20 ml/min (see section 4.3). The dose should be reduced to 1.5 mg once daily in 
patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2). 
No dosage reduction is required for patients with mild renal impairment (creatinine clearance 
>50 ml/min). 

 
•    Treatment of UA/NSTEMI and STEMI - fondaparinux should not be used in patients with 

creatinine clearance < 20 ml/min (see section 4.3). No dosage reduction is required for 
patients with creatinine clearance > 20 ml/min. 

 
Hepatic impairment - No dosing adjustment is necessary. In patients with severe hepatic impairment, 
fondaparinux should be used with care (see section 4.4).  



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Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age 
due to a lack of data on safety and efficacy. 
 
Method of administration  
• Subcutaneous administration 

Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. 
Sites of administration should alternate between the left and the right anterolateral and left and 
right posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-
filled syringe do not expel the air bubble from the syringe before the injection. The whole length 
of the needle should be inserted perpendicularly into a skin fold held between the thumb and the 
forefinger; the skin fold should be held throughout the injection. 

 
• Intravenous administration (first dose in patients with STEMI only) 

Intravenous administration should be through an existing intravenous line either directly or using a 
small volume (25 or 50ml) 0.9% saline minibag. To avoid the loss of medicinal product when 
using the pre-filled syringe do not expel the air bubble from the syringe before the injection. The 
intravenous tubing should be well flushed with saline after injection to ensure that all of the 
medicinal product is administered.  If administered via a minibag, the infusion should be given 
over 1 to 2 minutes. 

 
For additional instructions for use and handling and disposal see section 6.6. 
 
4.3 Contraindications  
 
- hypersensitivity to the active substance or to any of the excipients  
- active clinically significant bleeding  
- acute bacterial endocarditis  
- severe renal impairment defined by creatinine clearance < 20 ml/min. 
 
4.4 Special warnings and precautions for use 
 
Fondaparinux must not be administered intramuscularly. 
 
Haemorrhage  
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, 
such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active 
ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or 
ophthalmic surgery and in special patient groups as outlined below. 
 
For prevention of VTE, agents that may enhance the risk of haemorrhage should not be administered 
concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa 
receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). When 
required, concomitant therapy with vitamin K antagonist should be administered in accordance with 
the information of section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, 
dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If 
co-administration is essential, close monitoring is necessary. 
 
For treatment of UA/NSTEMI and STEMI, fondaparinux should be used with caution in patients who 
are being treated concomitantly with other agents that increase the risk of haemorrhage (such as 
GPIIb/IIIa inhibitors or thrombolytics). 
 
PCI and risk of guiding catheter thrombus   
In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not 
recommended.  Similarly, in UA/NSTEMI patients with life threatening conditions that require urgent 
revascularisation, the use of fondaparinux prior to and during PCI is not recommended. These are 



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patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life-
threatening arrhythmias or haemodynamic instability. 
 
In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole 
anticoagulant during PCI is not recommended, therefore UFH should be used according to local 
practice (see section 4.2).  
 
There are limited data on the use of UFH during non-primary PCI in patients treated with 
fondaparinux (see section 5.1).  In those patients who underwent non-primary PCI 6-24 hours after the 
last dose of fondaparinux, the median dose of UFH was 8000 IU and the incidence of major bleeding 
was 2% (2/98).  In those patients who underwent non-primary PCI <6 hours after the last dose of 
fondaparinux, the median dose of UFH was 5000 IU and the incidence of major bleeding was 4.1% 
(2/49). 
 
Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated 
with fondaparinux for anticoagulation during PCI compared to control. Incidences in non-primary PCI 
in UA/NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 
1.2% vs 0% (fondaparinux vs. control). 
 
Spinal / Epidural anaesthesia  
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in 
long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and 
spinal/epidural anaesthesia or spinal puncture. The risk of these rare events may be higher with post-
operative use of indwelling epidural catheters or the concomitant use of other medicinal products 
affecting haemostasis.  
 
Elderly patients  
The elderly population is at increased risk of bleeding. As renal function is generally decreasing with 
age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see 
section 5.2). Fondaparinux should be used with caution in elderly patients (see section 4.2).  
 
Low body weight  
Patients with body weight <50 kg are at increased risk of bleeding. Elimination of fondaparinux 
decreases with weight. Fondaparinux should be used with caution in these patients (see section 4.2). 
 
Renal impairment  
Fondaparinux is known to be mainly excreted by the kidney.  
 
• Prophylaxis of VTE - Patients with creatinine clearance <50 ml/min are at increased risk of 

bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).  There are 
limited clinical data available from patients with creatinine clearance less than 30 ml/min. 

 
• Treatment of UA/NSTEMI and STEMI - For the treatment of UA/NSTEMI and STEMI, there are 

limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with 
creatinine clearance between 20 and 30 ml/min. Therefore the physician should determine if the 
benefit of treatment outweighs the risk (see sections 4.2 and 4.3). 

 
Severe hepatic impairment  
Dosing adjustment of fondaparinux is not necessary. However, the use of fondaparinux should be 
considered with caution because of an increased risk of bleeding due to a deficiency of coagulation 
factors in patients with severe hepatic impairment (see section 4.2). 
 
Patients with Heparin Induced Thrombocytopenia 
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with 
Heparin Induced Thrombocytopenia (HIT) type II. The efficacy and safety of fondaparinux have not 
been formally studied in patients with HIT type II. 
 



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4.5 Interaction with other medicinal products and other forms of interaction  
 
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may 
enhance the risk of haemorrhage (see section 4.4). 
 
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and 
digoxin did not interact with the pharmacokinetics of fondaparinux. The fondaparinux dose (10 mg) in 
the interaction studies was higher than the dose recommended for the present indications. 
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under 
acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state. 
 
Follow-up therapy with another anticoagulant medicinal product 
If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general 
rule, be given one day after the last fondaparinux injection. 
 
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be 
continued until the target INR value has been reached. 
 
4.6 Pregnancy and lactation 
 
There are no adequate data from the use of fondaparinux in pregnant women. Animal studies are 
insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal 
development because of limited exposure. Fondaparinux should not be prescribed to pregnant women 
unless clearly necessary.  
 
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human 
milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the 
child is however unlikely. 
 
4.7 Effects on ability to drive and use machines  
 
No studies on the effect on the ability to drive and to use machines have been performed. 
 
4.8 Undesirable effects  
 
The safety of fondaparinux 2.5 mg has been evaluated in:  
- 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days 
- 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis 

of 1 week 
- 1407 patients undergoing abdominal surgery treated up to 9 days 
- 425 medical patients who are at risk for thromboembolic complications treated up to 14 days 
- 10,057 patients undergoing treatment of UA or NSTEMI ACS 
- 6,036 patients undergoing treatment of STEMI ACS. 
 



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For the prevention of VTE, the adverse reactions reported by the investigator as at least possibly 
related to fondaparinux are presented within each frequency grouping (very common ≥ 1/10; common: 
≥1/100 to < 1/10; uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) 
and system organ class by decreasing order of seriousness; these adverse reactions should be 
interpreted within the surgical and medical context.  
 

System organ class 

MedDRA 

Undesirable effects in patients 
undergoing major orthopaedic 
surgery of lower limbs and/or 
abdominal surgery 

 

Undesirable effects in medical 
patients 

Infections and 
infestations 
 

Rare: post-operative wound 
infection 

 

Blood and lymphatic 
system disorders 

 

Common: post-operative 
haemorrhage, anaemia 
Uncommon: bleeding (epistaxis, 
gastrointestinal, haemoptysis, 
haematuria, haematoma) 
thrombocytopenia, purpura, 
thrombocythaemia, platelet 
abnormal, coagulation disorder 

 

Common: bleeding 
(haematoma, haematuria, 
haemoptysis, gingival bleeding) 
Uncommon: anaemia 

Immune system disorders Rare: allergic reaction 
 

 

Metabolism and nutrition 
disorders 
 

Rare: hypokalaemia  

Nervous system disorders Rare: anxiety, somnolence, 
vertigo, dizziness, headache, 
confusion 
 

 

Vascular disorders Rare: hypotension 
 

 

Respiratory, thoracic and 
mediastinal disorders 
 

Rare: dyspnoea, coughing Uncommon: dyspnoea 

Gastrointestinal 
disorders 
 

Uncommon: nausea, vomiting 
Rare: abdominal pain, dyspepsia, 
gastritis, constipation, diarrhoea 
 

 

Hepatobiliary disorders  Uncommon: hepatic enzymes 
increased, hepatic function 
abnormal 
Rare: bilirubinaemia 
 

 



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Skin and subcutaneous 
tissue disorders 
 

Uncommon: rash, pruritus Uncommon: rash, pruritus 

General disorders and 
administration site 
conditions 

Uncommon: oedema, oedema 
peripheral, fever, wound 
secretion 
Rare: chest pain, fatigue, hot 
flushes, leg pain, oedema genital, 
flushing, syncope 
 

Uncommon: chest pain 

 
In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and 
retroperitoneal bleedings have been reported. 
 
The adverse event profile reported in the ACS program is consistent with the adverse drug reactions 
identified for VTE prophylaxis.     
 
Bleeding was a commonly reported event in patients with UA/NSTEMI and STEMI. The incidence of 
adjudicated major bleeding was 2.1% (fondaparinux) vs. 4.1% (enoxaparin) up to and including Day 9 
in the Phase III UA/NSTEMI study, and the incidence of adjudicated severe hemorrhage by modified 
TIMI criteria was 1.1% (fondaparinux) vs. 1.4% (control [UFH/placebo]) up to and including Day 9 in 
the Phase III STEMI study. 
 
In the Phase III UA/NSTEMI study, the most commonly reported non-bleeding adverse events 
(reported in at least 1% of subjects on fondaparinux) were headache, chest pain and atrial fibrillation. 
   
In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events 
(reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, 
headache, ventricular tachycardia, vomiting, and hypotension. 
 
4.9 Overdose  
 
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. There 
is no known antidote to fondaparinux. 
 
Overdose associated with bleeding complications should lead to treatment discontinuation and search 
for the primary cause. Initiation of appropriate therapy such as surgical haemostasis, blood 
replacements, fresh plasma transfusion, plasmapheresis should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antithrombotic agents.  
ATC code: B01AX05 
 
Pharmacodynamic effects  
 
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic 
activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of 
Factor Xa. By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate 
neutralization of Factor Xa by ATIII. Neutralisation of Factor Xa interrupts the blood coagulation 
cascade and inhibits both thrombin formation and thrombus development. Fondaparinux does not 
inactivate thrombin (activated Factor II) and has no effects on platelets.  
 



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At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial 
thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International 
Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity. 
 
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.  
 
Clinical studies 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic 
surgery of the lower limbs treated up to 9 days 
The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the 
prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis 
(DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower 
limbs such as hip fracture, major knee surgery or hip replacement surgery. Over 8,000 patients (hip 
fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled 
Phase II and III clinical studies. Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was 
compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily 
started 12-24 hours after surgery. 
 
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus 
enoxaparin was associated with a significant decrease (54% - 95% CI, 44 %; 63%) in the rate of VTE 
evaluated up to day 11 after surgery, irrespective of the type of surgery performed. The majority of 
endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, 
but the incidence of proximal DVT was also significantly reduced. The incidence of symptomatic 
VTE, including PE was not significantly different between treatment groups. 
 
In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was 
observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% 
with enoxaparin. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture 
surgery treated for up to 24 days following an initial prophylaxis of 1 week 
In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once 
daily for 7 +/- 1 days following hip fracture surgery. At the end of this period, 656 patients were 
randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/- 2 days. 
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 
patients (1.4%) vs 77 patients (35%), respectively]. The majority (70/80) of the recorded VTE events 
were venographically detected non-symptomatic cases of DVT. Fondaparinux also provided a 
significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) 
patients, respectively] including two fatal PE reported in the placebo group. Major bleedings, all at 
surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg 
compared to 2 (0.6%) with placebo. 
 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery 
who are judged to be at high risk of thromboembolic complications, such as patients undergoing 
abdominal cancer surgery 
In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once 
daily or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU 
post-operative injection, for 7+2 days. The main sites of surgery were colonic/rectal, gastric, hepatic, 
cholecystectomy or other biliary. Sixty-nine percent of the patients underwent surgery for cancer. 
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or 
vascular surgery were not included in the study. 
 
In this study, the incidence of total VTE was 4.6% (47/1027) with fondaparinux, versus 6.1%: 
(62/1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].  The difference in 
total VTE rates between the treatment groups, which was not statistically significant, was mainly due 
to a reduction of asymptomatic distal DVT. The incidence of symptomatic DVT was similar between 



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treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin 
group. In the large subgroup of patients undergoing cancer surgery (69% of the patient population), 
the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.   
 
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the 
dalteparin group.  
 
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk 
for thromboembolic complications due to restricted mobility during acute illness 
In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once 
daily or placebo for 6 to 14 days. This study included acutely ill medical patients, aged ≥ 60 years, 
expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA 
class III/IV and/or acute respiratory illness and/or acute infectious or inflammatory disease. 
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) 
vs 34 patients (10.5%), respectively]. The majority of events were asymptomatic distal DVT. 
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 
patients (1.2%), respectively]. Major bleedings were observed in 1 patient (0.2%) of each group.  
 
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI)  
OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg 
subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 
20,000 patients with UA/NSTEMI. All patients received standard medical treatment for UA/NSTEMI, 
with 34% of patients undergoing PCI and 9% undergoing CABG. The mean treatment duration was 
5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group. If PCI was performed, 
patients received either intravenous fondaparinux (fondaparinux patients) or weight adjusted 
intravenous UFH (enoxaparin patients) as adjunctive therapy, dependent on the timing of the last 
subcutaneous dose and planned use of GP IIb/IIIa inhibitor. The mean age of the patients was 67 
years, and approximately 60% were at least 65 years old. Approximately 40% and 17% of patients had 
mild (creatinine clearance ≥50 to <80 ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) 
renal impairment, respectively. 
 
The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory 
ischaemia (RI) within 9 days of randomisation. Of the patients in the fondaparinux group, 5.8% 
experienced an event by Day 9 compared to 5.7% for enoxaparin-treated patients (hazard ratio 1.01, 
95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003).  
 
By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 
2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02). The effects on the incidence of 
MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.    
 
At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, 
respectively (hazard ratio 0.52, 95% CI, 0.44;0.61, p < 0.001).  
 
The efficacy findings and results on major bleeding were consistent across prespecified subgroups 
such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, 
thienopyridines or GP IIb/IIIa inhibitors). 
 
In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 
8.2% of patients respectively, experience death/MI/RI within 9 days of randomisation (hazard ratio 
1.08, 95% CI, 0.92;1.27). In this subgroup, the incidence of major bleeding on fondaparinux and 
enoxaparin at Day 9 was 2.2% and 5.0% respectively (hazard ratio 0.43, 95% CI, 0.33;0.57). 
 
Treatment of ST segment elevation myocardial infarction (STEMI) 
OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 
mg once daily, versus usual care (placebo (47%) or UFH (53%)) in approximately 12000 patients with 
STEMI. All patients received standard treatments for STEMI, including primary PCI (31%), 
thrombolytics (45%) or no reperfusion (24%). Of the patients treated with a thrombolytic, 84% were 



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treated with a non-fibrin specific agent (primarily streptokinase).  The mean treatment duration was 
6.2 days on fondaparinux. The mean age of the patients was 61 years, and approximately 40% were at 
least 65 years old. Approximately 40% and 14% of patients had mild (creatinine clearance ≥50 to <80 
ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment, respectively. 
 
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days 
of randomisation. The incidence of death/re-MI at Day 30 was significantly reduced from 11.1% for 
the control group to 9.7% for the fondaparinux group (hazard ratio 0.86, 95% CI, 0.77, 0.96, p = 
0.008). In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with non-
fibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%)), 
the incidence of death/re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% 
(hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003). In the predefined stratum comparing fondaparinux 
to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific 
lytics (2.6%) and no reperfusion (25.9%)), the effects of fondaparinux and UFH on the incidence of 
death/re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 
95% CI, 0.79, 1.11 p = 0.460). However, in this stratum, in the subgroup of indicated population 
undergoing thrombolysis or no reperfusion (i.e patients not undergoing primary PCI), the incidence of 
death/re-MI at Day 30 was significantly reduced from 14.3% on UFH to 11.5% with fondaparinux 
(hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03). 
  
The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the 
control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77;0.98, p = 0.02). The 
difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in 
stratum 2 (UFH comparator). The mortality benefit shown in the fondaparinux group was maintained 
until the end of follow-up at Day 180. 
 
In patients who were revascularised with a thrombolytic, fondaparinux significantly reduced the 
incidence of death/re-MI at Day 30 from 13.6% for the control group to 10.9% (hazard ratio 0.79, 
95%CI, 0.68;0.93, p = 0.003). Among patients initially not reperfused, the incidence of death/re-MI at 
Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group 
(hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023). In patients treated with primary PCI, the incidence 
of death/re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux 
group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66)]. 
 
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a 
severe haemorrhage.  In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the 
fondaparinux patients and in 2.0% of controls. In patients initially not reperfused, the incidence of 
severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls. For patients receiving primary 
PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls. 
 
The efficacy findings and results on severe haemorrhage were consistent across prespecified 
subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation 
inhibitors (aspirin, thienopyridines). 
 
5.2 Pharmacokinetic properties 
 
Absorption  
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 
100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 
peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing. Plasma 
concentrations of half the mean Cmax values are reached 25 minutes post-dosing. 
 
In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by 
subcutaneous route. Following once daily subcutaneous dosing, steady state of plasma levels is 
obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC. 
 



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Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients 
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 
(31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). In hip fracture patients, associated with their 
increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), 
Cmin (mg/l) - 0.19 (58%). 
 
Distribution  
The distribution volume of fondaparinux is limited (7-11 litres). In vitro, fondaparinux is highly and 
specifically bound to antithrombin protein with a dose-dependant plasma concentration binding 
(98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l). Fondaparinux does not bind 
significantly to other plasma proteins, including platelet factor 4 (PF4). 
 
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction 
with other medicinal products by protein binding displacement are expected. 
 
Metabolism 
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no 
evidence for the formation of active metabolites. 
 
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, 
CYP2E1 or CYP3A4) in vitro. Thus, fondaparinux is not expected to interact with other medicinal 
products in vivo by inhibition of CYP-mediated metabolism.  
 
Excretion/Elimination  
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy 
elderly subjects. Fondaparinux is excreted to 64 – 77 % by the kidney as unchanged compound. 
 
Special populations  
 
Paediatric patients - Fondaparinux has not been investigated in this population.  
 
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for 
fondaparinux may be reduced in elderly. In patients >75 years undergoing orthopaedic surgery, the 
estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years. 
 
Renal impairment - Compared with patients with normal renal function (creatinine 
clearance > 80 ml/min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal 
impairment (creatinine clearance 50 to 80 ml/min) and on average 2 times lower in patients with 
moderate renal impairment (creatinine clearance 30 to 50 ml/min). In severe renal impairment 
(creatinine clearance < 30 ml/min), plasma clearance is approximately 5 times lower than in normal 
renal function. Associated terminal half-life values were 29 h in moderate and 72 h in patients with 
severe renal impairment. 
 
Gender - No gender differences were observed after adjustment for body weight. 
 
Race - Pharmacokinetic differences due to race have not been studied prospectively. However, studies 
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile 
compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed 
between black and Caucasian patients undergoing orthopaedic surgery. 
 
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). 
 
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.  
 



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5.3 Preclinical safety data  
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, and genotoxicity. Animal studies are insufficient with respect to 
effects on toxicity to reproduction because of limited exposure. 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Water for injections 
Hydrochloric acid 
Sodium hydroxide 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years.  
 
If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, 
but can be stored at room temperature for up to 24 hours. 
 
6.4 Special precautions for storage 
 
Do not freeze. 
 
6.5 Nature and contents of container  
 
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl 
or chlorobutyl elastomer plunger stopper.  
 
Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a blue automatic safety 
system. Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The subcutaneous injection is administered in the same way as with a classical syringe. Intravenous 
administration should be through an existing intravenous line either directly or using a small volume 
(25 or 50ml) 0.9% saline minibag. 
 
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to 
administration. 
 
Instruction on self-administration by subcutaneous injection is included in the Package Leaflet. 
 
The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic 
safety system to protect from needle stick injuries following injection. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 



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7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/02/207/001-004  
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 March 2002 
Date of latest renewal: 21 March 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMEA) http://www.emea.europa.eu 
 
 



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1. NAME OF THE MEDICINAL PRODUCT  
 
Quixidar 5 mg/0.4 ml solution for injection, pre-filled syringe.  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection. 
 
Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially 
sodium free.  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Solution for injection.  
The solution is a clear and colourless to slightly yellow liquid.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), 
except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary 
embolectomy. 
 
4.2 Posology and method of administration 
 
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once 
daily administered by subcutaneous injection. For patients with body weight < 50 kg, the 
recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg. 
 
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established 
(International Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment should be initiated 
as soon as possible and usually within 72 hours. The average duration of administration in clinical 
trials was 7 days and the clinical experience from treatment beyond 10 days is limited.  
 
Special populations 
 
Elderly patients - No dosing adjustment is necessary. In patients ≥75 years, fondaparinux should be 
used with care, as renal function decreases with age (see section 4.4). 
 
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal 
impairment (see section 4.4).  
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). In this subgroup, after an initial 10 mg daily 
dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling 
(see section 4.4). 
 
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 
ml/min) (see section 4.3). 
 



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Hepatic impairment - No dosing adjustment is necessary. In patients with severe hepatic impairment, 
fondaparinux should be used with care (see section 4.4).  
 
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age 
due to a lack of data on safety and efficacy. 
 
Method of administration  
Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. Sites of 
administration should alternate between the left and the right anterolateral and left and right 
posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled 
syringe do not expel the air bubble from the syringe before the injection. The whole length of the 
needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; 
the skin fold should be held throughout the injection. 
 
For additional instructions for use and handling and disposal see section 6.6. 
 
4.3 Contraindications  
 
- hypersensitivity to the active substance or to any of the excipients  
- active clinically significant bleeding  
- acute bacterial endocarditis  
- severe renal impairment defined by creatinine clearance < 30 ml/min. 
 
4.4 Special warnings and precautions for use 
 
Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. 
 
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients 
and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. 
 
Haemorrhage  
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, 
such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active 
ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or 
ophthalmic surgery and in special patient groups as outlined below. 
 
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone 
recent surgery (<3 days) and only once surgical haemostasis has been established. 
 
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with 
fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, 
heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, 
concomitant therapy with vitamin K antagonist should be administered in accordance with the 
information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, 
sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-
administration is essential, close monitoring is necessary. 
 
Spinal / Epidural anaesthesia 
In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural 
anaesthesia in case of surgical procedures should not be used.  
 
Elderly patients  
The elderly population is at increased risk of bleeding. As renal function generally decreases with age, 
elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 
5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of 
DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 
corresponding incidences in patients receiving the recommended regimen of enoxaparin in the 



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treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving 
the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. 
Fondaparinux should be used with caution in elderly patients (see section 4.2). 
 
Low body weight  
Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with 
caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2). 
 
Renal impairment  
The risk of bleeding increases with increasing renal impairment. Fondaparinux is known to be 
excreted mainly by the kidney. Incidences of bleeding events in patients receiving the recommended 
regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate 
renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), 
and 14.5 % (8/55) respectively. The corresponding incidences in patients receiving the recommended 
regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) 
and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated 
heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), 
respectively.  
 
Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance <30 ml/min) and 
should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 
ml/min). The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) 
(see sections 4.2, 4.3 and 5.2). 
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). Fondaparinux should be used with care in these 
patients. After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, 
based on pharmacokinetic modelling (see section 4.2).  
 
Severe hepatic impairment  
The use of fondaparinux should be considered with caution because of an increased risk of bleeding 
due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2). 
 
Patients with Heparin Induced Thrombocytopenia  
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with 
Heparin Induced Thrombocytopenia (HIT) type II. The efficacy and safety of fondaparinux have not 
been formally studied in patients with HIT type II. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may 
enhance the risk of haemorrhage (see section 4.4). 
 
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with 
the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux 
did not influence the anticoagulation monitoring (INR) activity of warfarin. 
 
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the 
pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did 
not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the 
pharmacokinetics of digoxin at steady state. 
 



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4.6 Pregnancy and lactation  
 
No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to 
effects on pregnancy, embryo/foetal development, parturition and postnatal development because of 
limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary.  
 
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human 
milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the 
child is however unlikely. 
 
4.7 Effects on ability to drive and use machines  
 
No studies on the effect on the ability to drive and to use machines have been performed. 
 
4.8 Undesirable effects   
 
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo-
Embolism and treated with fondaparinux for an average of 7 days. The most common adverse 
reactions were bleeding complications (see section 4.4). 
 
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are 
presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; 
uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ 
class by decreasing order of seriousness. 



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System organ class 
MedDRA 
 

Undesirable effects in patients treated for VTE1 
 

Blood and lymphatic 
system disorders 

 

Common: bleeding (gastrointestinal, haematuria, 
haematoma, epistaxis, haemoptysis, utero-vaginal 
haemorrhage, haemarthrosis, ocular, purpura, 
bruise) 

Uncommon: anaemia, thrombocytopaenia 

Rare: other bleeding (hepatic, retroperitoneal, 
intracranial/intracerebral), thrombocythaemia 

Immune system 
disorders 

Rare: allergic reaction 
 

Metabolism and 
nutrition disorders 

Rare: non-protein-nitrogen (Npn) 2 increased 

Nervous system 
disorders 

Uncommon: headache 

Rare: dizziness 

Gastrointestinal 
disorders 

Uncommon: nausea, vomiting 

Hepatobiliary disorders  Uncommon: abnormal liver function 

Skin and subcutaneous 
tissue disorders 

Rare: rash erythematous 

General disorders and 
administration site 
conditions 

Uncommon: pain, oedema, 

Rare: reaction at injection site 
 

 
 (1) Isolated AEs have not been considered except if they were medically relevant. 
 (2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. 
 
4.9 Overdose  
 
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. There 
is no known antidote to fondaparinux. 
 
Overdose associated with bleeding complications should lead to treatment discontinuation and search 
for the primary cause. Initiation of appropriate therapy such as surgical haemostasis, blood 
replacements, fresh plasma transfusion, plasmapheresis should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties  
 
Pharmacotherapeutic group: antithrombotic agents. 
ATC code: B01AX05 
 



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Pharmacodynamic effects  
 
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic 
activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition 
of Factor Xa. By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the 
innate neutralization of Factor Xa by antithrombin. Neutralisation of Factor Xa interrupts the blood 
coagulation cascade and inhibits both thrombin formation and thrombus development. Fondaparinux 
does not inactivate thrombin (activated Factor II) and has no effects on platelets.  
 
At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine 
coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) 
or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or 
fibrinolytic activity. At higher doses, moderate changes in aPTT can occur. At the 10 mg dose used in 
interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of 
warfarin. 
 
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia. 
 
Clinical studies 
 
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to 
demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and 
pulmonary embolism (PE). Over 4874 patients were studied in controlled Phase II and III clinical 
studies. 
 
Treatment of Deep Venous Thrombosis 
In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute 
symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 
kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC 
twice daily. A total of 2192 patients were treated; for both groups, patients were treated for at least 5 
days and up to 26 days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy 
usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 
days, with regular dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the 
composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. 
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 
4.1%, respectively). 
 
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, 
compared to 1.2% with enoxaparin. 
 
Treatment of Pulmonary Embolism 
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE. The 
diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan). 
Patients who required thrombolysis or embolectomy or vena cava filter were excluded. Randomised 
patients could have been pre-treated with UFH during the screening phase but patients treated for 
more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were 
excluded. Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 
mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5000 IU) 
followed by a continuous IV infusion adjusted to maintain 1.5–2.5 times aPTT control value.. A total 
of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 
days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy usually initiated 
within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular 
dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the composite of 
confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. Treatment with 
fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 
5.0%, respectively). 
 



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Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, 
compared to 1.1% with unfractionated heparin. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations 
quantified via anti factor Xa activity. Only fondaparinux can be used to calibrate the anti-Xa assay (the 
international standards of heparin or LMWH are not appropriate for this use). As a result, the 
concentration of fondaparinux is expressed as milligrams (mg). 
 
Absorption  
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 
100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 
peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing. Plasma 
concentrations of half the mean Cmax values are reached 25 minutes post-dosing. 
 
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by 
subcutaneous route. Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 
days with a 1.3-fold increase in Cmax and AUC. 
 
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients 
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 
(31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). In hip fracture patients, associated with their 
increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), 
Cmin (mg/l) - 0.19 (58%). 
 
In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body 
weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted 
doses provide similar exposure across all body weight categories. The mean (CV%) steady state 
pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the 
fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) – 2.4 (8%) and 
Cmin (mg/l) -0.52 (45 %). The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for 
Cmax (mg/l), and 0.24 and 0.95 for Cmin (mg/l). 
 
Distribution  
The distribution volume of fondaparinux is limited (7-11 litres). In vitro, fondaparinux is highly and 
specifically bound to antithrombin protein with a dose-dependant plasma concentration binding 
(98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l). Fondaparinux does not bind 
significantly to other plasma proteins, including platelet factor 4 (PF4). 
 
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no 
interaction with other medicinal products by protein binding displacement are expected. 
 
Metabolism  
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no 
evidence for the formation of active metabolites. 
 
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, 
CYP2E1 or CYP3A4) in vitro. Thus, fondaparinux is not expected to interact with other medicinal 
products in vivo by inhibition of CYP-mediated metabolism.  
 
Excretion/Elimination  
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy 
elderly subjects. Fondaparinux is excreted to 64 – 77 % by the kidney as unchanged compound. 
 



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Special populations  
 
Paediatric patients - Fondaparinux has not been investigated in this population.  
 
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for 
fondaparinux may be reduced in elderly. In patients >75 years undergoing orthopaedic surgery and 
receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower 
than in patients <65 years. A similar pattern is observed in DVT and PE treatment patients. 
 
Renal impairment - Compared with patients with normal renal function (creatinine clearance 
> 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma 
clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 
80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine 
clearance 30 to 50 ml/min). In severe renal impairment (creatinine clearance <30 ml/min), plasma 
clearance is approximately 5 times lower than in normal renal function. Associated terminal half-life 
values were 29 h in moderate and 72 h in patients with severe renal impairment. A similar pattern is 
observed in DVT and PE treatment patients. 
 
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). 
 
Gender - No gender differences were observed after adjustment for body weight.  
 
Race - Pharmacokinetic differences due to race have not been studied prospectively. However, studies 
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile 
compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed 
between black and Caucasian patients undergoing orthopaedic surgery. 
 
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.  
 
5.3 Preclinical safety data  
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety  
pharmacology and genotoxicity. The repeated dose and reproduction toxicity studies did not reveal 
any special risk but did not provide adequate documentation of safety margins due to limited exposure 
in the animal species. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Sodium chloride 
Water for injections 
Hydrochloric acid 
Sodium hydroxide 
 
6.2 Incompatibilities  
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years  
 



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6.4 Special precautions for storage  
 
Do not freeze. 
 
6.5 Nature and contents of container  
 
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl 
elastomer plunger stopper.  
 
Quixidar 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with an orange 
automatic safety system. Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The subcutaneous injection is administered in the same way as with a classical syringe. 
 
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to 
administration. 
 
Instruction for self-administration is mentioned in the Package Leaflet. 
 
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to 
prevent needle stick injuries following injection. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
This medicinal product is for single use only. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/02/207/009-011, 018 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 21 March 2002 
Date of latest renewal: 21 March 2007 
 
10. DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMEA) http://www.emea.europa.eu 



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1. NAME OF THE MEDICINAL PRODUCT  
 
Quixidar 7.5 mg/0.6 ml solution for injection, pre-filled syringe.  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection. 
Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially 
sodium free.  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Solution for injection.  
The solution is a clear and colourless to slightly yellow liquid.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), 
except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary 
embolectomy. 
 
4.2 Posology and method of administration 
 
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once 
daily administered by subcutaneous injection. For patients with body weight < 50 kg, the 
recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg. 
 
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established 
(International Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment should be initiated 
as soon as possible and usually within 72 hours. The average duration of administration in clinical 
trials was 7 days and the clinical experience from treatment beyond 10 days is limited.  
 
Special populations 
 
Elderly patients - No dosing adjustment is necessary. In patients ≥75 years, fondaparinux should be 
used with care, as renal function decreases with age (see section 4.4). 
 
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal 
impairment (see section 4.4).  
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). In this subgroup, after an initial 10 mg daily 
dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling 
(see section 4.4). 
 
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 
ml/min) (see section 4.3). 
 
Hepatic impairment - No dosing adjustment is necessary. In patients with severe hepatic impairment, 
fondaparinux should be used with care (see section 4.4).  



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Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age 
due to a lack of data on safety and efficacy. 
 
Method of administration  
Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. Sites of 
administration should alternate between the left and the right anterolateral and left and right 
posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled 
syringe do not expel the air bubble from the syringe before the injection. The whole length of the 
needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; 
the skin fold should be held throughout the injection. 
 
For additional instructions for use and handling and disposal see section 6.6. 
 
4.3 Contraindications  
 
- hypersensitivity to the active substance or to any of the excipients  
- active clinically significant bleeding  
- acute bacterial endocarditis  
- severe renal impairment defined by creatinine clearance < 30 ml/min. 
 
4.4 Special warnings and precautions for use  
 
Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. 
 
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients 
and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. 
 
Haemorrhage  
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, 
such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active 
ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or 
ophthalmic surgery and in special patient groups as outlined below. 
 
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone 
recent surgery (<3 days) and only once surgical haemostasis has been established. 
 
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with 
fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, 
heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, 
concomitant therapy with vitamin K antagonist should be administered in accordance with the 
information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, 
sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-
administration is essential, close monitoring is necessary. 
 
Spinal / Epidural anaesthesia 
In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural 
anaesthesia in case of surgical procedures should not be used.  
 
Elderly patients  
The elderly population is at increased risk of bleeding. As renal function generally decreases with age, 
elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 
5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of 
DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 
corresponding incidences in patients receiving the recommended regimen of enoxaparin in the 
treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving 



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the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. 
Fondaparinux should be used with caution in elderly patients (see section 4.2). 
 
Low body weight 
Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with 
caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2). 
 
Renal impairment 
The risk of bleeding increases with increasing renal impairment. Fondaparinux is known to be 
excreted mainly by the kidney. Incidences of bleeding events in patients receiving the recommended 
regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate 
renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), 
and 14.5 % (8/55) respectively. The corresponding incidences in patients receiving the recommended 
regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) 
and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated 
heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), 
respectively.  
 
Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance <30 ml/min) and 
should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 
ml/min). The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) 
(see sections 4.2, 4.3 and 5.2). 
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). Fondaparinux should be used with care in these 
patients. After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, 
based on pharmacokinetic modelling (see section 4.2).  
 
Severe hepatic impairment  
The use of fondaparinux should be considered with caution because of an increased risk of bleeding 
due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2). 
 
Patients with Heparin Induced Thrombocytopenia  
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with 
Heparin Induced Thrombocytopenia (HIT) type II. The efficacy and safety of fondaparinux have not 
been formally studied in patients with HIT type II. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may 
enhance the risk of haemorrhage (see section 4.4). 
 
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with 
the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux 
did not influence the anticoagulation monitoring (INR) activity of warfarin. 
 
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the 
pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did 
not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the 
pharmacokinetics of digoxin at steady state. 
 
4.6 Pregnancy and lactation  
 
No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to 
effects on pregnancy, embryo/foetal development, parturition and postnatal development because of 
limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary.  
 



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Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human 
milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the 
child is however unlikely. 
 
4.7 Effects on ability to drive and use machines  
 
No studies on the effect on the ability to drive and to use machines have been performed. 
 
4.8 Undesirable effects   
 
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo-
Embolism and treated with fondaparinux for an average of 7 days. The most common adverse 
reactions were bleeding complications (see section 4.4). 
 
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are 
presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; 
uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ 
class by decreasing order of seriousness. 
 

System organ class 
MedDRA 
 

Undesirable effects in patients treated for VTE1 
 

Blood and lymphatic 
system disorders 

 

Common: bleeding (gastrointestinal, haematuria, 
haematoma, epistaxis, haemoptysis, utero-vaginal 
haemorrhage, haemarthrosis, ocular, purpura, 
bruise) 

Uncommon: anaemia, thrombocytopaenia 

Rare: other bleeding (hepatic, retroperitoneal, 
intracranial/intracerebral), thrombocythaemia 

Immune system 
disorders 

Rare: allergic reaction 
 

Metabolism and 
nutrition disorders 

Rare: non-protein-nitrogen (Npn) 2 increased 

Nervous system 
disorders 

Uncommon: headache 

Rare: dizziness 

Gastrointestinal 
disorders 

Uncommon: nausea, vomiting 
 

Hepatobiliary disorders  Uncommon: abnormal liver function 

Skin and subcutaneous 
tissue disorders 

Rare: rash erythematous 

General disorders and 
administration site 
conditions 

Uncommon: pain, oedema, 

Rare: reaction at injection site 
 

 
 (1) Isolated AEs have not been considered except if they were medically relevant. 
 (2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. 
 



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4.9 Overdose  
 
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. 
There is no known antidote to fondaparinux. 
 
Overdose associated with bleeding complications should lead to treatment discontinuation and search 
for the primary cause. Initiation of appropriate therapy such as surgical haemostasis, blood 
replacements, fresh plasma transfusion, plasmapheresis should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties  
 
Pharmacotherapeutic group: antithrombotic agents. 
ATC code: B01AX05 
 
Pharmacodynamic effects  
 
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic 
activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition 
of Factor Xa. By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the 
innate neutralization of Factor Xa by antithrombin. Neutralisation of Factor Xa interrupts the blood 
coagulation cascade and inhibits both thrombin formation and thrombus development. Fondaparinux 
does not inactivate thrombin (activated Factor II) and has no effects on platelets.  
 
At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine 
coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) 
or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or 
fibrinolytic activity. At higher doses, moderate changes in aPTT can occur. At the 10 mg dose used in 
interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of 
warfarin. 
 
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia. 
 
Clinical studies 
 
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to 
demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and 
pulmonary embolism (PE). Over 4874 patients were studied in controlled Phase II and III clinical 
studies. 
 
Treatment of Deep Venous Thrombosis 
In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute 
symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 
kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC 
twice daily. A total of 2192 patients were treated; for both groups, patients were treated for at least 5 
days and up to 26 days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy 
usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 
days, with regular dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the 
composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. 
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 
4.1%, respectively). 
 
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, 
compared to 1.2% with enoxaparin. 
 



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Treatment of Pulmonary Embolism 
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE. The 
diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan). 
Patients who required thrombolysis or embolectomy or vena cava filter were excluded. Randomised 
patients could have been pre-treated with UFH during the screening phase but patients treated for 
more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were 
excluded. Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 
mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5000 IU) 
followed by a continuous IV infusion adjusted to maintain 1.5–2.5 times aPTT control value.. A total 
of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 
days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy usually initiated 
within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular 
dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the composite of 
confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. Treatment with 
fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 
5.0%, respectively). 
 
Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, 
compared to 1.1% with unfractionated heparin. 
 
5.2 Pharmacokinetic properties  
 
The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations 
quantified via anti factor Xa activity. Only fondaparinux can be used to calibrate the anti-Xa assay (the 
international standards of heparin or LMWH are not appropriate for this use). As a result, the 
concentration of fondaparinux is expressed as milligrams (mg). 
 
Absorption  
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 
100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 
peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing. Plasma 
concentrations of half the mean Cmax values are reached 25 minutes post-dosing. 
 
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by 
subcutaneous route. Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 
days with a 1.3-fold increase in Cmax and AUC. 
 
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients 
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 
(31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). In hip fracture patients, associated with their 
increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), 
Cmin (mg/l) - 0.19 (58%). 
 
In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body 
weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted 
doses provide similar exposure across all body weight categories. The mean (CV%) steady state 
pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the 
fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) – 2.4 (8%) and 
Cmin (mg/l) -0.52 (45 %). The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for 
Cmax (mg/l), and 0.24 and 0.95 for Cmin (mg/l). 
 
Distribution  
The distribution volume of fondaparinux is limited (7-11 litres). In vitro, fondaparinux is highly and 
specifically bound to antithrombin protein with a dose-dependant plasma concentration binding 
(98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l). Fondaparinux does not bind 
significantly to other plasma proteins, including platelet factor 4 (PF4). 
 



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Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no 
interaction with other medicinal products by protein binding displacement are expected. 
 
Metabolism  
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no 
evidence for the formation of active metabolites. 
 
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, 
CYP2E1 or CYP3A4) in vitro. Thus, fondaparinux is not expected to interact with other medicinal 
products in vivo by inhibition of CYP-mediated metabolism.  
 
Excretion/Elimination  
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy 
elderly subjects. Fondaparinux is excreted to 64 – 77 % by the kidney as unchanged compound. 
 
Special populations  
 
Paediatric patients - Fondaparinux has not been investigated in this population.  
 
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for 
fondaparinux may be reduced in elderly. In patients >75 years undergoing orthopaedic surgery and 
receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower 
than in patients <65 years. A similar pattern is observed in DVT and PE treatment patients. 
 
Renal impairment - Compared with patients with normal renal function (creatinine clearance 
> 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma 
clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 
80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine 
clearance 30 to 50 ml/min). In severe renal impairment (creatinine clearance <30 ml/min), plasma 
clearance is approximately 5 times lower than in normal renal function. Associated terminal half-life 
values were 29 h in moderate and 72 h in patients with severe renal impairment. A similar pattern is 
observed in DVT and PE treatment patients. 
 
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). 
 
Gender - No gender differences were observed after adjustment for body weight.  
 
Race - Pharmacokinetic differences due to race have not been studied prospectively. However, studies 
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile 
compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed 
between black and Caucasian patients undergoing orthopaedic surgery. 
 
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.  
 
5.3 Preclinical safety data  
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology and genotoxicity. The repeated dose and reproduction toxicity studies did not reveal 
any special risk but did not provide adequate documentation of safety margins due to limited exposure 
in the animal species. 
 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Sodium chloride 
Water for injections 
Hydrochloric acid 
Sodium hydroxide 
 
6.2 Incompatibilities  
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years  
 
6.4 Special precautions for storage  
 
Do not freeze. 
 
6.5 Nature and contents of container  
 
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl 
elastomer plunger stopper.  
 
Quixidar 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a magenta 
automatic safety system. Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The subcutaneous injection is administered in the same way as with a classical syringe. 
 
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to 
administration. 
 
Instruction for self-administration is mentioned in the Package Leaflet. 
 
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to 
prevent needle stick injuries following injection. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
This medicinal product is for single use only. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 



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8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/02/207/012-014, 019 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 21 March 2002 
Date of latest renewal: 21 March 2007 
 
 
10. DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMEA) http://www.emea.europa.eu 



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1. NAME OF THE MEDICINAL PRODUCT  
 
Quixidar 10 mg/0.8 ml solution for injection, pre-filled syringe.  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection. 
 
Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially 
sodium free.  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Solution for injection.  
The solution is a clear and colourless to slightly yellow liquid.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), 
except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary 
embolectomy. 
 
4.2 Posology and method of administration 
 
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once 
daily administered by subcutaneous injection. For patients with body weight < 50 kg, the 
recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg. 
 
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established 
(International Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment should be initiated 
as soon as possible and usually within 72 hours. The average duration of administration in clinical 
trials was 7 days and the clinical experience from treatment beyond 10 days is limited.  
 
Special populations 
 
Elderly patients - No dosing adjustment is necessary. In patients ≥75 years, fondaparinux should be 
used with care, as renal function decreases with age (see section 4.4). 
 
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal 
impairment (see section 4.4).  
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). In this subgroup, after an initial 10 mg daily 
dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling 
(see section 4.4). 
 
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 
ml/min) (See section 4.3). 
 



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Hepatic impairment  - No dosing adjustment is necessary. In patients with severe hepatic impairment, 
fondaparinux should be used with care (see section 4.4).  
 
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age 
due to a lack of data on safety and efficacy 
 
Method of administration  
Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. Sites of 
administration should alternate between the left and the right anterolateral and left and right 
posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled 
syringe do not expel the air bubble from the syringe before the injection. The whole length of the 
needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; 
the skin fold should be held throughout the injection. 
 
For additional instructions for use and handling and disposal see section 6.6. 
 
4.3 Contraindications  
 
- hypersensitivity to the active substance or to any of the excipients  
- active clinically significant bleeding  
- acute bacterial endocarditis  
- severe renal impairment defined by creatinine clearance < 30 ml/min. 
 
4.4 Special warnings and precautions for use  
 
Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. 
 
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients 
and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. 
 
Haemorrhage  
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, 
such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active 
ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or 
ophthalmic surgery and in special patient groups as outlined below. 
 
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone 
recent surgery (<3 days) and only once surgical haemostasis has been established. 
 
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with 
fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, 
heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). During treatment of VTE, 
concomitant therapy with vitamin K antagonist should be administered in accordance with the 
information of Section 4.5. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, 
sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-
administration is essential, close monitoring is necessary. 
 
Spinal / Epidural anaesthesia 
In patients receiving fondaparinux for treatment of VTE rather than prophylaxis,  spinal/epidural 
anaesthesia in case of surgical procedures should not be used.  
 
Elderly patients  
The elderly population is at increased risk of bleeding. As renal function generally decreases with age, 
elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 
5.2). Incidences of bleeding events in patients receiving the recommended regimen in the treatment of 
DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. The 
corresponding incidences in patients receiving the recommended regimen of enoxaparin in the 



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treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving 
the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively. 
Fondaparinux should be used with caution in elderly patients (see section 4.2). 
 
Low body weight  
Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with 
caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2). 
 
Renal impairment  
The risk of bleeding increases with increasing renal impairment. Fondaparinux is known to be 
excreted mainly by the kidney. Incidences of bleeding events in patients receiving the recommended 
regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate 
renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), 
and 14.5 % (8/55) respectively. The corresponding incidences in patients receiving the recommended 
regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) 
and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated 
heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), 
respectively.  
 
Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance <30 ml/min) and 
should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 
ml/min). The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) 
(see sections 4.2, 4.3 and 5.2). 
 
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate 
renal impairment (creatinine clearance 30-50 ml/min). Fondaparinux should be used with care in these 
patients. After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, 
based on pharmacokinetic modelling (see section 4.2).  
 
Severe hepatic impairment  
The use of fondaparinux should be considered with caution because of an increased risk of bleeding 
due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2). 
 
Patients with Heparin Induced Thrombocytopenia 
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with 
Heparin Induced Thrombocytopenia (HIT) type II. The efficacy and safety of fondaparinux have not 
been formally studied in patients with HIT type II. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may 
enhance the risk of haemorrhage (see section 4.4). 
 
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with 
the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux 
did not influence the anticoagulation monitoring (INR) activity of warfarin. 
 
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the 
pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did 
not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the 
pharmacokinetics of digoxin at steady state. 
 



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4.6 Pregnancy and lactation  
 
No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to 
effects on pregnancy, embryo/foetal development, parturition and postnatal development because of 
limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary.  
 
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human 
milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the 
child is however unlikely. 
 
4.7 Effects on ability to drive and use machines  
 
No studies on the effect on the ability to drive and to use machines have been performed. 
 
4.8 Undesirable effects   
 
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo-
Embolism and treated with fondaparinux for an average of 7 days. The most common adverse 
reactions were bleeding complications (see section 4.4). 
 
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are 
presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; 
uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ 
class by decreasing order of seriousness. 



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System organ class 
MedDRA 
 

Undesirable effects in patients treated for VTE1 
 

Blood and lymphatic 
system disorders 

 

Common: bleeding (gastrointestinal, haematuria, 
haematoma, epistaxis, haemoptysis, utero-vaginal 
haemorrhage, haemarthrosis, ocular, purpura, 
bruise) 

Uncommon: anaemia, thrombocytopaenia 

Rare: other bleeding (hepatic, retroperitoneal, 
intracranial/intracerebral), thrombocythaemia 

Immune system 
disorders 

Rare: allergic reaction 
 

Metabolism and 
nutrition disorders 

Rare: non-protein-nitrogen (Npn) 2 increased 

Nervous system 
disorders 

Uncommon: headache 

Rare: dizziness 

Gastrointestinal 
disorders 

Uncommon: nausea, vomiting 

Hepatobiliary disorders  Uncommon: abnormal liver function 

Skin and subcutaneous 
tissue disorders 

Rare: rash erythematous 

General disorders and 
administration site 
conditions 

Uncommon: pain, oedema, 

Rare: reaction at injection site 
 

 
 (1) Isolated AEs have not been considered except if they were medically relevant. 
 (2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. 
 
4.9 Overdose  
 
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. 
There is no known antidote to fondaparinux. 
 
Overdose associated with bleeding complications should lead to treatment discontinuation and search 
for the primary cause. Initiation of appropriate therapy such as surgical haemostasis, blood 
replacements, fresh plasma transfusion, plasmapheresis should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties  
 
Pharmacotherapeutic group: antithrombotic agents. 
ATC code: B01AX05 
 



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Pharmacodynamic effects 
  
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic 
activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition 
of Factor Xa. By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the 
innate neutralization of Factor Xa by antithrombin. Neutralisation of Factor Xa interrupts the blood 
coagulation cascade and inhibits both thrombin formation and thrombus development. Fondaparinux 
does not inactivate thrombin (activated Factor II) and has no effects on platelets.  
 
At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine 
coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) 
or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or 
fibrinolytic activity. At higher doses, moderate changes in aPTT can occur. At the 10 mg dose used in 
interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of 
warfarin. 
 
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia. 
 
Clinical studies 
 
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to 
demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and 
pulmonary embolism (PE). Over 4874 patients were studied in controlled Phase II and III clinical 
studies. 
 
Treatment of Deep Venous Thrombosis 
In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute 
symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 
kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC 
twice daily. A total of 2192 patients were treated; for both groups, patients were treated for at least 5 
days and up to 26 days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy 
usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 
days, with regular dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the 
composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. 
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 
4.1%, respectively). 
 
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, 
compared to 1.2% with enoxaparin. 
 
Treatment of Pulmonary Embolism 
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE. The 
diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan). 
Patients who required thrombolysis or embolectomy or vena cava filter were excluded. Randomised 
patients could have been pre-treated with UFH during the screening phase but patients treated for 
more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were 
excluded. Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 
mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5000 IU) 
followed by a continuous IV infusion adjusted to maintain 1.5–2.5 times aPTT control value.. A total 
of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 
days (mean 7 days). Both treatment groups received Vitamin K antagonist therapy usually initiated 
within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular 
dose adjustments to achieve an INR of 2-3. The primary efficacy endpoint was the composite of 
confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97. Treatment with 
fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 
5.0%, respectively). 
 



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Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, 
compared to 1.1% with unfractionated heparin. 
 
5.2 Pharmacokinetic properties  
 
The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations 
quantified via anti factor Xa activity. Only fondaparinux can be used to calibrate the anti-Xa assay (the 
international standards of heparin or LMWH are not appropriate for this use). As a result, the 
concentration of fondaparinux is expressed as milligrams (mg). 
 
Absorption  
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 
100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 
peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing. Plasma 
concentrations of half the mean Cmax values are reached 25 minutes post-dosing. 
 
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by 
subcutaneous route. Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 
days with a 1.3-fold increase in Cmax and AUC. 
 
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients 
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 
(31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). In hip fracture patients, associated with their 
increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), 
Cmin (mg/l) - 0.19 (58%). 
 
In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body 
weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted 
doses provide similar exposure across all body weight categories. The mean (CV%) steady state 
pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the 
fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) – 2.4 (8%) and 
Cmin (mg/l) -0.52 (45 %). The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for 
Cmax (mg/l), and 0.24 and 0.95 for Cmin (mg/l). 
 
Distribution  
The distribution volume of fondaparinux is limited (7-11 litres). In vitro, fondaparinux is highly and 
specifically bound to antithrombin protein with a dose-dependant plasma concentration binding 
(98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l). Fondaparinux does not bind 
significantly to other plasma proteins, including platelet factor 4 (PF4). 
 
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no 
interaction with other medicinal products by protein binding displacement are expected. 
 
Metabolism  
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no 
evidence for the formation of active metabolites. 
 
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, 
CYP2E1 or CYP3A4) in vitro. Thus, fondaparinux is not expected to interact with other medicinal 
products in vivo by inhibition of CYP-mediated metabolism.  
 
Excretion/Elimination  
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy 
elderly subjects. Fondaparinux is excreted to 64 – 77 % by the kidney as unchanged compound. 
 



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Special populations  
 
Paediatric patients - Fondaparinux has not been investigated in this population.  
 
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for 
fondaparinux may be reduced in elderly. In patients >75 years undergoing orthopaedic surgery and 
receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower 
than in patients <65 years. A similar pattern is observed in DVT and PE treatment patients. 
 
Renal impairment - Compared with patients with normal renal function (creatinine clearance 
> 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma 
clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 
80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine 
clearance 30 to 50 ml/min). In severe renal impairment (creatinine clearance <30 ml/min), plasma 
clearance is approximately 5 times lower than in normal renal function. Associated terminal half-life 
values were 29 h in moderate and 72 h in patients with severe renal impairment. A similar pattern is 
observed in DVT and PE treatment patients. 
 
Body weight -  Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). 
 
Gender - No gender differences were observed after adjustment for body weight.  
 
Race - Pharmacokinetic differences due to race have not been studied prospectively. However, studies 
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile 
compared to Caucasian healthy subjects. Similarly, no plasma clearance differences were observed 
between black and Caucasian patients undergoing orthopaedic surgery. 
 
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.  
 
5.3 Preclinical safety data  
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology and genotoxicity. The repeated dose and reproduction toxicity studies did not reveal 
any special risk but did not provide adequate documentation of safety margins due to limited exposure 
in the animal species. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Sodium chloride 
Water for injections 
Hydrochloric acid 
Sodium hydroxide 
 
6.2 Incompatibilities  
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years  
 



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6.4 Special precautions for storage  
 
Do not freeze. 
 
6.5 Nature and contents of container  
 
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl 
elastomer plunger stopper.  
 
Quixidar 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a violet 
automatic safety system. Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The subcutaneous injection is administered in the same way as with a classical syringe. 
 
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to 
administration. 
 
Instruction for self-administration is mentioned in the Package Leaflet. 
 
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to 
prevent needle stick injuries following injection. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
This medicinal product is for single use only. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/02/207/015-017, 020 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 21 March 2002 
Date of latest renewal: 21 March 2007 
 
 
10. DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMEA) http://www.emea.europa.eu 
 



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ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDER 
RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 



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A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
 RELEASE  
 
Name and address of the manufacturer responsible for batch release 
 
Glaxo Wellcome Production 
1, rue de l’Abbaye 
F-76960 Notre Dame de Bondeville 
France 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

IMPOSED ON THE MARKETING AUTHORISTION HOLDER 
 
Medicinal product subject to medical prescription. 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
Pharmacovigilance system 
The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version 
presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning 
before and whilst the product is on the market. 
 
Risk Management Plan 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in 
the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented 
in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP 
agreed by the CHMP. 
 
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the 
updated RMP should be submitted at the same time as the next Periodic Safety Update Report 
(PSUR). 
 
In addition, an updated RMP should be submitted: 

• When new information is received that may impact on the current Safety Specification, 
Pharmacovigilance Plan or risk minimisation activities  

• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 
reached 

• At the request of the EMEA. 
 
 
 
 
 
 



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER BOX  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 1.5 mg/0.3 ml solution for injection 
Fondaparinux sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe (0.3 ml) contains 1.5 mg fondaparinux sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection, 2 pre-filled syringes with an automatic safety system 
Solution for injection, 7 pre-filled syringes with an automatic safety system 
Solution for injection, 10 pre-filled syringes with an automatic safety system 
Solution for injection, 20 pre-filled syringes with an automatic safety system 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/207/005- 2 pre-filled syringes 
EU/1/02/207/006 - 7 pre-filled syringes 
EU/1/02/207/007 - 10 pre-filled syringes 
EU/1/02/207/008 - 20 pre-filled syringes 
 
 
13.  BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quixidar 1.5 mg/0.3 ml injection 
fondaparinux Na 
 
SC 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER BOX 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 2.5 mg/0.5 ml solution for injection 
Fondaparinux sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection, 2 pre-filled syringes with an automatic safety system 
Solution for injection, 7 pre-filled syringes with an automatic safety system 
Solution for injection, 10 pre-filled syringes with an automatic safety system 
Solution for injection, 20 pre-filled syringes with an automatic safety system 
 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous or intravenous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/207/001 - 2 pre-filled syringes 
EU/1/02/207/002 - 7 pre-filled syringes 
EU/1/02/207/003 - 10 pre-filled syringes 
EU/1/02/207/004 - 20 pre-filled syringes 
 
 
13.  BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quixidar 2.5 mg/0.5 ml injection 
fondaparinux Na 
 
SC/IV 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER BOX  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 5 mg/0.4 ml solution for injection 
Fondaparinux sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection, 2 pre-filled syringes with an automatic safety system 
Solution for injection, 7 pre-filled syringes with an automatic safety system 
Solution for injection, 10 pre-filled syringes with an automatic safety system 
Solution for injection, 20 pre-filled syringes with an automatic safety system 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
Body weight below 50 kg 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/207/009- 2 pre-filled syringes 
EU/1/02/207//010 - 7 pre-filled syringes 
EU/1/02/207/011 - 10 pre-filled syringes 
EU/1/02/207/018 - 20 pre-filled syringe 
 
13.  BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quixidar 5 mg/0.4 ml injection 
fondaparinux Na 
 
SC 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER BOX  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 7.5 mg/0.6 ml solution for injection 
Fondaparinux sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection, 2 pre-filled syringes with an automatic safety system 
Solution for injection, 7 pre-filled syringes with an automatic safety system 
Solution for injection, 10 pre-filled syringes with an automatic safety system 
Solution for injection, 20 pre-filled syringes with an automatic safety system 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
Body weight 50-100 kg 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/207/012- 2 pre-filled syringes 
EU/1/02/207/013 - 7 pre-filled syringes 
EU/1/02/207/014 - 10 pre-filled syringes 
EU/1/02/207/019 - 20 pre-filled syringe 
 
13.  BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quixidar 7.5 mg/0.6 ml injection 
fondaparinux Na 
 
SC 
 
2. METHOD OF ADMINISTRATION 
 
 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER BOX  

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quixidar 10 mg/0.8 ml solution for injection 
Fondaparinux sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection, 2 pre-filled syringes with an automatic safety system 
Solution for injection, 7 pre-filled syringes with an automatic safety system 
Solution for injection, 10 pre-filled syringes with an automatic safety system 
Solution for injection, 20 pre-filled syringes with an automatic safety system 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
Body weight above 100 kg 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford 
Middlesex 
UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/207/015 - 2 pre-filled syringes 
EU/1/02/207/016 - 7 pre-filled syringes 
EU/1/02/207/017 - 10 pre-filled syringes 
EU/1/02/207/020 - 20 pre-filled syringe 
 
13.  BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quixidar 10 mg/0.8 ml injection 
fondaparinux Na 
 
SC 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
 
 
 



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B. PACKAGE LEAFLET 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Quixidar 1.5 mg/0.3 ml solution for injection 
fondaparinux sodium 

 
 
Read all of this leaflet carefully before you start using this medicine. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm 

them, even if their symptoms seem to be the same as yours. 
• If any of the side effects get serious or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Quixidar is and what it is used for 
2. Before you use Quixidar 
3. How to use Quixidar 
4. Possible side effects  
5. How to store Quixidar 
6. Further information 
 
 
1. WHAT QUIXIDAR IS AND WHAT IT IS USED FOR 
 
Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an 
antithrombotic agent).  
 
Quixidar contains a synthetic substance called fondaparinux sodium.  This stops a clotting factor Xa 
(“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from 
forming in the blood vessels.  
 
Quixidar is used to:  
• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic 

surgery (such as hip or knee surgery) or abdominal surgery 
• prevent the formation of blood clots during and shortly after a period of restricted mobility due 

to acute illness. 
 
 
2. BEFORE YOU USE QUIXIDAR 
 
Do not use Quixidar:  
• if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of 

Quixidar 
• if you are bleeding excessively  
• if you have a bacterial heart infection 
• if you have very severe kidney disease. 
→  Tell your doctor if you think any of these applies to you.  If they do, you must not use Quixidar. 
 
Take special care with Quixidar: 
Your doctor needs to know before you take Quixidar: 
• if you have a risk of uncontrolled bleeding (haemorrhage) including: 

· stomach ulcer 
· bleeding disorders 
· recent bleeding into the brain (intracranial bleeding) 
· recent surgery on the brain, spine or eye  



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• if you have severe liver disease  
• if you have kidney disease  
• if you are 75 years old or older  
• if you weigh less than 50 kg. 
→  Tell your doctor if any of these applies to you. 
 
Children 
Quixidar has not been tested in children and adolescents under the age of 17 years. 
 
Using other medicines 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.  
This includes medicines you bought without a prescription.  Some other medicines may affect the way 
that Quixidar works or be affected by Quixidar. 
 
Pregnancy and breast feeding 
Quixidar should not be prescribed to pregnant women unless clearly necessary.  Breast-feeding is not 
recommended during treatment with Quixidar.  If you are pregnant, think you might be, or if you are 
breast feeding: 
→  tell your doctor or pharmacist. 
 
Important information about some of the ingredients of Quixidar 
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially 
sodium-free. 
 
3. HOW TO USE QUIXIDAR 
 
Always use Quixidar exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure.   
 
The usual dose is 2.5 mg once a day, injected at about the same time each day. 
 
If you have kidney disease, the dose may be reduced to 1.5 mg once a day. 
 
How is Quixidar given 
• Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower 

abdominal area. The syringes are pre-filled with the exact dose you need.  There are different 
syringes for the 2.5 mg and 1.5 mg doses.  For step-by-step instructions please see over the 
page 

• Do not inject Quixidar into muscle. 
 
How long should Quixidar be taken for 
You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar 
prevents development of a serious condition. 
 
If you inject too much Quixidar 
Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of 
bleeding.  
 
If you forget to take Quixidar 
• Take the dose as soon as you remember.  Do not inject a double dose to make up for a 

forgotten dose.  
• If you are not sure what to do, ask your doctor or pharmacist. 
 
Don’t stop using Quixidar without advice  
If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a 
vein of your leg or lung. Contact your doctor or pharmacist before stopping. 



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If you have any further questions about how to use this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Quixidar can cause side effects, although not everybody gets them.  
 
Common side effects 
These may affect more than 1 in 100 people treated with Quixidar. 
• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) 
• anaemia (a reduction in the number of red blood cells). 
 
Uncommon side effects  
These may affect up to 1 in 100 people treated with Quixidar. 
• bruising or swelling (oedema) 
• feeling sick or being sick (nausea or vomiting) 
• chest pain 
• breathlessness 
• rash or itchy skin 
• oozing from operation wound site 
• fever 
• reduction or increase in the number of platelets (blood cells necessary for blood clotting) 
• increase in some chemicals (enzymes) produced by the liver. 
 
Rare side effects 
These may affect up to 1 in every 1000 people treated with Quixidar. 
• allergic reaction 
• internal bleeding in the brain or abdomen 
• anxiety or confusion 
• headache 
• fainting or dizziness, low blood pressure 
• drowsiness or tiredness 
• flushing 
• coughing 
• leg pain or stomach pain 
• diarrhoea or constipation 
• indigestion 
• wound infection 
• increase in bilirubin (a substance produced by the liver) in the blood 
• reduction in potassium in your blood. 
 
If you get side effects 
→ Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 
 
 
5. HOW TO STORE QUIXIDAR 
 
• Keep out of the reach and sight of children 
• Do not freeze 
• Quixidar does not need to be kept in the fridge.  
 
Do not use Quixidar: 
• after the expiry date stated on the label and carton 



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• if you notice any particles in the solution, or if the solution is discoloured  
• if you notice that the syringe is damaged  
• if you have opened a syringe and you do not use it straightaway. 
 
Disposal of syringes 
Medicines and syringes should not be disposed of via wastewater or household waste. Ask your 
pharmacist how to dispose of medicines no longer required. These measures will help to protect the 
environment. 
 
 
6. FURTHER INFORMATION 
 
What Quixidar contains 
• The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection  
 
• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or 

sodium hydroxide to adjust the pH. 
 
Quixidar does not contain any animal products. 
 
What Quixidar looks like and contents of the pack 
Quixidar is a clear and colourless solution for injection. It is supplied in a pre-filled, single-use syringe 
fitted with an automatic safety system to help prevent needle stick injuries after use. It is available in 
packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed). 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorization Holder: 
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom  
 
Manufacturer: 
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. 
 
This leaflet was last approved in 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu 
 



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For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder. 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 (0)2 656 21 11 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)2 656 21 11 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 

Polska 
GSK Commercial Sp. z o.o.  
Tel.: + 48 (0)22 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 
 

Portugal 
GlaxoSmithKline – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France 
Laboratoire GlaxoSmithKline 
Tél.: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: + 354 530 3700 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 



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Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0) 8 638 93 00  
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

 

 



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Parts of the safety syringe 
 
 
1 Rigid needle guard 
 
2 Cap 
 
3 Plunger  
 
4 Finger-grip 
 
5  Security sleeve 

 

 

 
Syringe BEFORE USE Syringe AFTER USE 

 
 

 
STEP BY STEP GUIDE TO USING QUIXIDAR 
 
Instructions for use 

 
1. Wash your hands thoroughly with soap and water and dry them with a towel. 
 
2. Remove the syringe from the carton and check that: 

• the expiry date has not passed 
• the solution is clear and colourless and doesn’t contain particles 
• the syringe has not been opened or damaged 

 
3. Sit or lie down in a comfortable position.  
Choose a place in the lower abdominal (tummy) area, at least 
5 cm below your belly button (picture A).  
Alternate the left and right side of the lower abdominal area 
at each injection. This will help to reduce the discomfort at the 
injection site.   
If injecting in the lower abdominal area is not possible, ask 
your nurse or doctor for advice. 

 

 
 

Picture A 

4. Clean the injection area with an alcohol wipe. 
 
 
 
5. Hold the body of the syringe firmly in one hand. 
Remove the cap that protects the plunger by pulling it off 
(picture B).  
Discard the plunger cap. 
 
 

 
 Picture B 



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6. Remove the needle guard, by first twisting it and then 
pulling it in a straight line away from the body of the syringe 
(picture C).  
Discard the needle guard. 
 
Important note 
• Do not touch the needle or allow it to touch any surface 

before the injection.  
• It is normal to see a small air bubble in this syringe. Do 

not try to remove this air bubble before making the 
injection - you may lose some of the medicine if you do. 

 

 

 
Picture C 
 

 
 
7. Gently pinch the skin that has been cleaned to make a 
fold. Hold the fold between the thumb and the forefinger 
during the entire injection (picture D). 
 

 
 Picture D 
 
 
8. Hold the syringe firmly by the finger grip. 
Insert the full length of the needle at right angles into the skin 
fold (picture E). 
  
 Picture E 
 
 
9. Inject ALL of the contents of the syringe by pressing 
down on the plunger as far as it goes. This will activate the 
automatic needle protection system (picture F). 
 
 

 
 Picture F 
 
 
10. Release the plunger and the needle will automatically 
withdraw from the skin and go back into the security sleeve 
where it will be locked permanently (picture G). 
 
 

 
 Picture G 
 
Do not dispose of the used syringe in the household waste. Dispose of it as your doctor or 
pharmacist has instructed. 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Quixidar 2.5 mg/0.5 ml solution for injection 

fondaparinux sodium 
 
 
Read all of this leaflet carefully before you start using this medicine. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm 

them, even if their symptoms seem to be the same as yours. 
• If any of the side effects get serious or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Quixidar is and what it is used for 
2. Before you use Quixidar 
3. How to use Quixidar 
4. Possible side effects  
5. How to store Quixidar 
6. Further information 
 
 
1. WHAT QUIXIDAR IS AND WHAT IT IS USED FOR 
 
Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an 
antithrombotic agent).  
 
Quixidar contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa 
(“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from 
forming in the blood vessels.  
 
Quixidar is used to:  
• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic 

surgery (such as hip or knee surgery) or abdominal surgery 
• prevent the formation of blood clots during and shortly after a period of restricted mobility due 

to acute illness 
• treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in 

the heart). 
 
 
2. BEFORE YOU USE QUIXIDAR 
 
Do not use Quixidar:  
• if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of 

Quixidar  
• if you are bleeding excessively  
• if you have a bacterial heart infection 
• if you have very severe kidney disease. 
→  Tell your doctor if you think any of these applies to you.  If they do, you must not use Quixidar. 
 



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Take special care with Quixidar: 
Your doctor needs to know before you take Quixidar: 
• if you have a risk of uncontrolled bleeding (haemorrhage) including: 

· stomach ulcer 
· bleeding disorders 
· recent bleeding in the brain (intracranial bleeding) 
· recent surgery on the brain, spine or eye 

• if you have severe liver disease  
• if you have kidney disease  
• if you are 75 years old or older  
• if you weigh less than 50 kg. 
→  Tell your doctor if any of these applies to you. 
 
Children 
Quixidar has not been tested in children and adolescents under the age of 17 years. 
 
Using other medicines 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.   
This includes medicines you bought without a prescription. Some other medicines may affect the way 
that Quixidar works or be affected by Quixidar. 
 
Pregnancy and breast feeding 
Quixidar should not be prescribed to pregnant women unless clearly necessary.  Breast-feeding is not 
recommended during treatment with Quixidar.  If you are pregnant, think you might be, or if you are 
breast-feeding: 
→  tell your doctor or pharmacist. 
 
Important information about some of the ingredients of Quixidar 
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially 
sodium-free. 
 
3. HOW TO USE QUIXIDAR 
 
Always use Quixidar exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure.   
 
The usual dose is 2.5 mg once a day, injected at about the same time each day. 
 
If you have kidney disease, the dose may be reduced to 1.5 mg once a day. 
 
How Quixidar is given 
• Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower 

abdominal area. The syringes are pre-filled with the exact dose you need.  There are different 
syringes for the 2.5 mg and 1.5 mg doses.  For step-by-step instructions please see over the 
page. To treat some types of heart attack, a health professional may give the first dose into a 
vein (intravenously). 

• Do not inject Quixidar into muscle. 
 
How long Quixidar should be taken for 
You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar 
prevents development of a serious condition. 
 
If you inject too much Quixidar 
Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of 
bleeding.  
 



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If you forget to take Quixidar 
• Take the dose as soon as you remember.  Do not inject a double dose to make up for a 

forgotten dose.  
• If you are not sure what to do, ask your doctor or pharmacist. 
 
Don’t stop using Quixidar without advice  
If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a 
vein of your leg or lung. Contact your doctor or pharmacist before stopping. 
 
If you have any further questions about how to use this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Quixidar can cause side effects, although not everybody gets them.  
 
Common side effects 
These may affect more than 1 in 100 people treated with Quixidar. 
• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) 
• anaemia (a reduction in the number of red blood cells) 
 
Uncommon side effects  
These may affect up to 1 in 100 people treated with Quixidar. 
• bruising or swelling (oedema) 
• feeling sick or being sick (nausea or vomiting) 
• chest pain 
• breathlessness 
• rash or itchy skin 
• oozing from operation wound site 
• fever 
• reduction or increase in the number of platelets (blood cells necessary for blood clotting) 
• increase in some chemicals (enzymes) produced by the liver. 
 
Rare side effects  
These may affect up to 1 in 1000 people treated with Quixidar. 
• allergic reaction 
• internal bleeding in the brain or abdomen 
• anxiety or confusion 
• headache 
• fainting or dizziness, low blood pressure 
• drowsiness or tiredness 
• flushing 
• coughing 
• leg pain or stomach pain 
• diarrhoea or constipation 
• indigestion 
• wound infection 
• increase in bilirubin (a substance produced by the liver) in the blood 
• reduction in potassium in your blood 
 
If you get side effects 
→  Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 
 
 



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5. HOW TO STORE QUIXIDAR 
 
• Keep out of the reach and sight of children 
• Do not freeze 
• Quixidar does not need to be kept in a fridge.  
 
Do not use Quixidar: 
• after the expiry date stated on the label and carton 
• if you notice any particles in the solution, or if the solution is discoloured  
• if you notice that the syringe is damaged  
• if you have opened a syringe and you do not use it straightaway. 
 
Disposal of syringes: 
Medicines and syringes should not be disposed of via wastewater or household waste. Ask your 
pharmacist how to dispose of medicines no longer required. These measures will help to protect the 
environment. 
 
 
6. FURTHER INFORMATION 
 
What Quixidar contains 
• The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection  

 
• The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or 

sodium hydroxide to adjust the pH. 
 
Quixidar does not contain any animal products. 
 
What Quixidar looks like and contents of the pack 
Quixidar is a clear and colourless solution for injection. It is supplied in a pre-filled, single-use syringe 
fitted with an automatic safety system to help prevent needle stick injuries after use. It is available in 
packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed). 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorization Holder: 
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom  
 
Manufacturer: 
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. 
 
This leaflet was last approved in 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu  
 



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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 (0)2 656 21 11 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)2 656 21 11 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 

Polska 
GSK Commercial Sp. z o.o.  
Tel.: + 48 (0)22 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 
 

Portugal 
GlaxoSmithKline – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France 
Laboratoire GlaxoSmithKline 
Tél.: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: + 354 530 3700 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 



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Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0) 8 638 93 00  
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

 

 



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Parts of the safety syringe 
 
 
1 Rigid needle guard 
 
2 Cap 
 
3 Plunger  
 
4 Finger-grip 
 
5  Security sleeve 

 

 

 
Syringe BEFORE USE Syringe AFTER USE 

 
 

 
STEP BY STEP GUIDE TO USING QUIXIDAR 
 
Instructions for use 

 
1. Wash your hands thoroughly with soap and water and dry them with a towel. 
 
2. Remove the syringe from the carton and check that: 

• the expiry date has not passed 
• the solution is clear and colourless and doesn’t contain particles 
• the syringe has not been opened or damaged 

 
3. Sit or lie down in a comfortable position.  
Choose a place in the lower abdominal (tummy) area, at least 
5 cm below your belly button (picture A).  
Alternate the left and right side of the lower abdominal area 
at each injection. This will help to reduce the discomfort at the 
injection site.   
If injecting in the lower abdominal area is not possible, ask 
your nurse or doctor for advice. 

 

 
 

Picture A 

4. Clean the injection area with an alcohol wipe. 
 
 
 
5. Hold the body of the syringe firmly in one hand. 
Remove the cap that protects the plunger by pulling it off 
(picture B).  
Discard the plunger cap. 
 
 

 
 Picture B 



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6. Remove the needle guard, by first twisting it and then 
pulling it in a straight line away from the body of the syringe 
(picture C).  
Discard the needle guard. 
 
Important note 
• Do not touch the needle or allow it to touch any surface 

before the injection.  
• It is normal to see a small air bubble in this syringe. Do 

not try to remove this air bubble before making the 
injection - you may lose some of the medicine if you do. 

 

 

 
Picture C 
 

 
 
7. Gently pinch the skin that has been cleaned to make a 
fold. Hold the fold between the thumb and the forefinger 
during the entire injection (picture D). 
 

 
 Picture D 
 
 
8. Hold the syringe firmly by the finger grip. 
Insert the full length of the needle at right angles into the skin 
fold (picture E). 
  
 Picture E 
 
 
9. Inject ALL of the contents of the syringe by pressing 
down on the plunger as far as it goes. This will activate the 
automatic needle protection system (picture F). 
 
 

 
 Picture F 
 
 
10. Release the plunger and the needle will automatically 
withdraw from the skin and go back into the security sleeve 
where it will be locked permanently (picture G). 
 
 

 
 Picture G 
 
Do not dispose of the used syringe in the household waste. Dispose of it as your doctor or 
pharmacist has instructed. 
 



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PACKAGE LEAFLET 
 

Quixidar 5 mg/0.4 ml solution for injection. 
Quixidar 7.5 mg/0.6 ml solution for injection 
Quixidar 10 mg/0.8 ml solution for injection 

Fondaparinux sodium 
 
Read all of this leaflet carefully before you start using this medicine. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm 

them, even if their symptoms seem to be the same as yours. 
• If any of the side effects get serious or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Quixidar is and what it is used for 
2. Before you use Quixidar 
3. How to use Quixidar 
4. Possible side effects  
5. How to store Quixidar 
6. Further information 
 
 
1. WHAT QUIXIDAR IS AND WHAT IT IS USED FOR 
 
Quixidar is a medicine that treats or helps to prevent blood clots from forming in the blood 
vessels (an antithrombotic agent). 
 
Quixidar contains a synthetic substance called fondaparinux sodium.  This stops a clotting factor Xa 
(“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from 
forming in the blood vessels.  
 
Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein 
thrombosis) and/or lungs (pulmonary embolism). 
 
 
2. BEFORE YOU USE QUIXIDAR 
 
Do not use Quixidar:  
• if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of 

Quixidar  
• if you are bleeding excessively 
• if you have a bacterial heart infection 
• if you have severe kidney disease. 
→  Tell your doctor if you think any of these applies to you.  If they do, you must not use Quixidar. 
 
Take special care with Quixidar: 
Your doctor needs to know before you take Quixidar: 
• if you have a risk uncontrolled bleeding (haemorrhage) including: 

· stomach ulcer 
· bleeding disorders 
· recent bleeding into the brain (intracranial bleeding) 
· recent surgery on the brain, spine or eye  

• if you have severe liver disease  
• if you have kidney disease  



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• if you are 75 years old or older. 
→  Tell your doctor if any of these applies to you. 
 
Children 
Quixidar has not been tested in children and adolescents under the age of 17 years. 
 
Using other medicines 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.  
This includes medicines you bought without a prescription.  Some other medicines may affect the way 
that Quixidar works or be affected by Quixidar. 
 
Pregnancy and breast feeding 
Quixidar should not be prescribed to pregnant women unless clearly necessary.  Breast-feeding is not 
recommended during treatment with Quixidar.  If you are pregnant, think you might be, or if you are 
breast feeding: 
→  tell your doctor or pharmacist. 
 
Important information about some of the ingredients of Quixidar 
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially 
sodium-free. 
 
3. HOW TO USE QUIXIDAR 
 
Always use Quixidar exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. 
 
Your weight Usual dose 
Below 50 kg 5 mg once a day 
Between 50 kg and 100 kg 7.5 mg once a day 
Over 100 kg 10 mg once a day.  This dose may be reduced to 

7.5 mg once a day if you have moderate kidney 
disease. 

 
You should inject at about the same time each day. 
 
How Quixidar is given 
• Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower 

abdominal area. They syringes are pre-filled with the exact dose you need.  There are different 
syringes for the 5 mg, 7.5 mg and 10 mg doses.  For step-by-step instructions please see over 
the page. 

• Do not inject Quixidar into muscle. 
  
How long should Quixidar be taken for 
You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar 
prevents development of a serious condition. 
 
If you inject too much Quixidar 
Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of 
bleeding.  
 
If you forget to take Quixidar 
• Take the dose as soon as you remember.  Do not inject a double dose to make up for a 

forgotten dose.  
• If you are not sure what to do, ask your doctor or pharmacist. 
 



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Don’t stop using Quixidar without advice  
If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and 
you may also be at risk of developing a new blood clot in a vein of your leg or in the lung. Contact 
your doctor or pharmacist before stopping. 
 
If you have any further questions about how to use this product, ask your doctor or pharmacist. 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Quixidar can cause side effects, although not everybody gets them.  
 
Common side effects 
These may affect more than 1 in 100 people treated with Quixidar. 
• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)  
 
Uncommon side effects  
These may affect up to 1 in 100 people treated with Quixidar. 
• swelling (oedema)  
• headache 
• pain 
• feeling sick or being sick (nausea or  vomiting) 
• low number of red blood cells (anaemia) 
• low number of platelets (blood cells necessary for blood clotting) 
• increase in some chemical (enzymes) produced by the liver 
 
Rare side effects 
These may affect up to 1 in every 1000 people treated with Quixidar. 
• allergic reaction 
• internal bleeding in the brain, liver or abdomen 
• rash 
• dizziness 
• pain and swelling at injection site 
• high number of platelets (blood cells necessary for blood clotting) 
• increase in the amount of non-protein nitrogen in the blood 

 
If you get side effects 
→  Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 
 
 
5. HOW TO STORE QUIXIDAR 
• Keep out of the reach and sight of children 
• Do not freeze 
• Quixidar does not have to be kept in the fridge.  
 
Do not use Quixidar: 
• after the expiry date stated on the label and carton 
• if you notice any particles in the solution, or if the solution is discoloured  
• if you notice that the syringe is damaged  
• if you have opened a syringe and you do not use it straightaway. 
 
Disposal of syringes: 
Medicines and syringes should not be disposed of via wastewater or household waste. Ask your 
pharmacist how to dispose of medicines no longer required. These measures will help to protect the 
environment. 
 



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6. FURTHER INFORMATION 
 
What Quixidar contains 
The active substance is: 
• 5 mg fondaparinux sodium in 0.4 ml solution for injection  
• 7.5 mg fondaparinux sodium in 0.6 ml solution for injection 
• 10 mg fondaparinux sodium in 0.8 ml solution for injection 
 
The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium 
hydroxide to adjust the pH. 
 
Quixidar does not contain any animal products. 
 
What Quixidar looks like and contents of the pack 
Quixidar is a clear and colourless to slightly yellow solution for injection. It is supplied in a pre-filled 
syringe fitted with an automatic safety system to help prevent needle stick injuries after use. 
It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed). 
 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorization Holder: 
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom  
 
Manufacturer: 
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. 
 
This leaflet was last approved in 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web 
site: http://www.emea.europa.eu  



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For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder. 
 
België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 (0)2 656 21 11 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)2 656 21 11 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 

Polska 
GSK Commercial Sp. z o.o.  
Tel.: + 48 (0)22 576 9000 
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 
 

Portugal 
GlaxoSmithKline – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France 
Laboratoire GlaxoSmithKline 
Tél.: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: + 354 530 3700 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 



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Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 89 95 01 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0) 8 638 93 00  
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 7312687 
lv-epasts@gsk.com 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

 

 
 



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Parts of the safety syringe 
 
 
1 Rigid needle guard 
 
2 Cap 
 
3 Plunger  
 
4 Finger-grip 
 
5  Security sleeve 

 

 

 
Syringe BEFORE USE Syringe AFTER USE 

 
 

 
STEP BY STEP GUIDE TO USING QUIXIDAR 

 
1. Wash your hands thoroughly with soap and water and dry them with a towel. 
 
2. Remove the syringe from the carton and check that: 

• the expiry date has not passed 
• the solution is clear and colourless to slightly yellow and doesn’t contain particles 
• the syringe has not been opened or damaged 

 
3. Sit or lie down in a comfortable position.  
Choose a place in the lower abdominal (tummy) area, at least 
5 cm below your belly button (picture A).  
Alternate the left and right side of the lower abdominal area 
at each injection. This will help to reduce the discomfort at the 
injection site.   
If injecting in the lower abdominal area is not possible, ask 
your nurse or doctor for advice. 

 

 
 

Picture A 

4. Clean the injection area with an alcohol wipe. 
 
 
 
5. Hold the body of the syringe firmly in one hand. 
Remove the cap that protects the plunger by pulling it off 
(picture B).  
Discard the plunger cap. 
 
 

 
 Picture B 
6. Remove the needle guard, by first twisting it and then 
pulling it in a straight line away from the body of the syringe 
(picture C).  

 



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Discard the needle guard. 
 
Important note 
• Do not touch the needle or allow it to touch any surface 

before the injection.  
• It is normal to see a small air bubble in this syringe. Do 

not try to remove this air bubble before making the 
injection - you may lose some of the medicine if you do. 

  Picture C 
 

 
 
7. Gently pinch the skin that has been cleaned to make a 
fold. Hold the fold between the thumb and the forefinger 
during the entire injection (picture D). 
 

 
 Picture D 
 
 
8. Hold the syringe firmly by the finger grip. 
Insert the full length of the needle at right angles into the skin 
fold (picture E). 
  
 Picture E 
 
 
9. Inject ALL of the contents of the syringe by pressing 
down on the plunger as far as it goes. This will activate the 
automatic needle protection system (picture F). 
 
 

 
 Picture F 
 
 
10. Release the plunger and the needle will automatically 
withdraw from the skin and go back into the security sleeve 
where it will be locked permanently (picture G). 
 
 

 
 Picture G 
 
Do not dispose of the used syringe in the household waste. Dispose of it as your doctor or 
pharmacist has instructed. 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCHRELEASE
	CONDITIONS OF THE MARKETING AUTHORISATION
	LABELLING
	PACKAGE LEAFLET