Kengrexal

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Kengrexal 50 mg powder for concentrate for solution for injection/infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL 
of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms 
cangrelor. 
 
Excipient with known effect 
Each vial contains 52.2 mg sorbitol. 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for concentrate for solution for injection/infusion. 
White to off-white lyophilised powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of 
thrombotic cardiovascular events in adult patients with coronary artery disease undergoing 
percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the 
PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 
 
4.2 Posology and method of administration 
 
Kengrexal should be administered by a physician experienced in either acute coronary care or in 
coronary intervention procedures and is intended for specialised use in an acute and hospital setting. 
 
Posology 
 
The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous 
bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion 
should be initiated prior to the procedure and continued for at least two hours or for the duration of the 
procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a 
total duration of four hours, see section 5.1. 
 
Patients should be transitioned to oral P2Y12 therapy for chronic treatment. For transition, a loading 
dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately 
following discontinuation of cangrelor infusion. Alternatively, a loading dose of ticagrelor or prasugrel, 
but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see 
section 4.5. 
 
Use with other anticoagulant agents 
In patients undergoing PCI, standard procedural adjunctive therapy should be implemented (see 
section 5.1). 
 
Elderly  
No dose adjustment is needed in elderly (≥75 years) patients. 
 



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Renal impairment 
No dose adjustment is needed in patients with mild, moderate or severe renal insufficiency (see 
sections 4.4 and 5.2). 
 
Hepatic impairment 
No dose adjustment is needed (see section 5.2). 
 
Paediatric population 
The safety and efficacy of cangrelor in children aged less than 18 years has not been established. No 
data are available. 
 
Method of administration 
 
Kengrexal is intended for intravenous use, only after reconstitution and dilution. 
 
Kengrexal should be administered via an intravenous line. The bolus volume should be administered 
rapidly (<1 minute), from the diluted bag via manual intravenous push or pump. Ensure the bolus is 
completely administered before the start of PCI. Start the infusion immediately after administration of 
the bolus. 
 
For instructions on reconstitution and dilution of the medicinal product before administration see 
section 6.6. 
 
4.3 Contraindications 
 
• Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or 

irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe 
hypertension. 

• Any history of stroke or transient ischaemic attack (TIA). 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Risk of bleeding 
 
Treatment with Kengrexal may increase the risk of bleeding. 
 
In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open 
Occluded Arteries), moderate and mild bleeding events were more common in patients treated with 
cangrelor than in patients treated with clopidogrel, see section 4.8. 
 
Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, 
haemorrhage can occur at any site. Any unexplained fall in blood pressure or haematocrit should lead 
to the serious consideration of a haemorrhagic event and the cessation of cangrelor administration. 
Cangrelor should be used with caution in patients with disease states associated with an increased 
bleeding risk. Cangrelor should be used with caution in patients taking medicines that may increase 
the risk of bleeding. 
 
Cangrelor has a half-life of three to six minutes. Platelet function is restored within 60 minutes of 
stopping infusion. 
 
Intracranial haemorrhage 
 
Treatment with Kengrexal may increase the risk of intracranial haemorrhage. In pivotal studies 
conducted in patients undergoing PCI, there were more intracranial bleeds at 30 days with cangrelor 
(0.07%) than with clopidogrel (0.02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel 



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were fatal. Cangrelor is contraindicated in patients with any history of stroke/TIA, (see sections 4.3 
and 4.8). 
 
Cardiac tamponade 
 
Treatment with Kengrexal may increase the risk of cardiac tamponade. In pivotal studies conducted in 
patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than 
with clopidogrel (0.02%), (see section 4.8). 
 
Effects on renal function 
 
In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal 
failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of 
cangrelor in clinical trials (see section 4.8). In patients with severe renal impairment (creatinine 
clearance 15-30 mL/min) a higher rate of worsening in renal function (3.2%) was reported in the 
cangrelor group compared to clopidogrel (1.4%). In addition, a higher rate of GUSTO moderate 
bleeding was reported in the cangrelor group (6.7%) compared to clopidogrel (1.4%). Cangrelor 
should be used with caution in these patients. 
 
Hypersensitivity 
 
Hypersensitivity reactions may occur after treatment with Kengrexal. A higher rate of serious cases of 
hypersensitivity were recorded with cangrelor (0.05%) than with control (0.007%). These included 
cases of anaphylactic reactions/shock and angioedema (see section 4.8). 
 
Risk of dyspnoea 
 
Treatment with Kengrexal may increase the risk of dyspnoea. In pivotal studies conducted in patients 
undergoing PCI dyspnoea (including exertional dyspnoea) occurred more commonly in patients 
treated with cangrelor (1.3%) than clopidogrel (0.4%). Most dyspnoea events were mild or moderate 
in severity and the median duration of dyspnoea was two hours in patients receiving cangrelor (see 
section 4.8). 
 
Fructose intolerance 
 
This medicinal product contains 52.2 mg sorbitol in each vial.  Patients with hereditary fructose 
intolerance (HFI) must not be given this medicine unless strictly necessary. 
 
Sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
Oral P2Y12 agents (clopidogrel, prasugrel, ticagrelor) 
 
When clopidogrel is administered during infusion of cangrelor, the expected inhibitory effect of 
clopidogrel on platelets is not achieved. Administration of 600 mg clopidogrel immediately after the 
cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect. No 
clinically relevant interruption of P2Y12 inhibition was observed in phase III studies when 600 mg 
clopidogrel was administered immediately after discontinuation of the cangrelor infusion. 
 
A pharmacodynamic interaction study has been conducted with cangrelor and prasugrel, which 
demonstrated that cangrelor and prasugrel can be administered concomitantly. Patients can be 



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transitioned from cangrelor to prasugrel when prasugrel is administered immediately following 
discontinuation of the cangrelor infusion or up to one hour before, optimally at 30 minutes before the 
end of the cangrelor infusion to limit recovery of platelet reactivity. 
 
A pharmacodynamic interaction study has also been conducted with cangrelor and ticagrelor. No 
interaction on cangrelor was observed. Patients can be transitioned from cangrelor to ticagrelor 
without interruption of antiplatelet effect. 
 
Pharmacodynamic effects 
 
Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry 
(light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12 test, VASP-P 
and flow cytometry. 
 
Following the administration of a 30 micrograms/kg bolus followed by a 4 micrograms/kg/min 
infusion (the PCI dose), platelet inhibition is observed within two minutes. The 
pharmacokinetic/pharmacodynamic (PK/PD) effect of cangrelor is maintained consistently for the 
duration of the infusion. 
 
Irrespective of dose, following cessation of the infusion, cangrelor blood levels decrease rapidly and 
platelet function returns to normal within one hour. 
 
Acetylsalicylic acid, heparin, nitrogycerin 
 
No pharmacokinetic or pharmacodynamic interaction with cangrelor was observed in an interaction 
study with aspirin, heparin, or nitroglycerin. 
 
Bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors 
 
In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, 
fondaparinux, and GP IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban) with no apparent effect 
upon the pharmacokinetics or pharmacodynamics of cangrelor. 
 
Cytochrome P450 (CYP) 
 
Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by 
therapeutic concentrations of cangrelor or its major metabolites. 
 
Breast cancer resistance protein (BCRP) 
 
In vitro inhibition of BCRP by the metabolite ARC-69712XX at clinically relevant concentrations has 
been observed. Possible implications for the in vivo situation have not been investigated, but caution is 
advised when cangrelor is to be combined with a BCRP substrate. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of Kengrexal in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). 
 
Kengrexal is not recommended during pregnancy. 
 
Breast-feeding 
 
It is unknown whether Kengrexal is excreted in human milk. A risk to the newborns/infants cannot be 
excluded. 



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Fertility 
 
No effect on female fertility parameters were observed in animal studies of Kengrexal. A reversible 
effect on fertility was observed in male rats treated with Kengrexal (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Kengrexal has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reactions with cangrelor include mild and moderate bleeding and dyspnoea. 
Serious adverse reactions associated with cangrelor in patients with coronary artery disease include 
severe/life threatening bleeding and hypersensitivity. 
 
Tabulated list of adverse reactions 
 
Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data 
from all CHAMPION studies. Adverse reactions are classified according to frequency and system 
organ class. Frequency categories are defined according to the following conventions: 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). 
 
Table 1: Adverse reactions for cangrelor in CHAMPION pooled studies within 48 hours 

System organ 
class  

Common  Uncommon  Rare  Very rare  

Infections and 
infestations 

   Haematoma 
infection 

Neoplasms 
benign, malignant 
and unspecified 
(includes cysts 
and polyps) 

   Skin neoplasm 
bleeding 

Blood and 
lymphatic system 
disorders 

  Anaemia, 
thrombo-
cytopenia 

 

Immune system 
disorders 

  Anaphylactic 
reaction 
(anaphylactic 
shock), 
hypersensitivity 

 

Nervous system 
disorders 

  Haemorrhage 
intracranial d * 

 

Eye disorders   Eye haemorrhage  

Ear and labyrinth 
disorders 

   Ear haemorrhage 

Cardiac disorders  Cardiac 
tamponade 
(pericardial 
haemorrhage) 

  



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System organ 
class  

Common  Uncommon  Rare  Very rare  

Vascular 
disorders 

Haematoma 
<5 cm, 
haemorrhage 

Haemodynamic 
instability 

Wound 
haemorrhage, 
vascular 
pseudoaneurysm 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

Dyspnoea 
(dyspnoea 
exertional) 

Epistaxis, 
haemoptysis 

Pulmonary 
haemorrhage 

 

Gastrointestinal 
disorders 

 Retroperitoneal 
haemorrhage,* 
peritoneal 
haematoma, 
gastrointestinal 
haemorrhage a 

  

Skin and 
subcutaneous 
tissue disorders 

Ecchymosis 
(petechiae, 
purpura) 

Rash, pruritus, 
urticaria f 

Angioedema  

Renal and urinary 
disorders 

 Haemorrhage 
urinary tract, e 
acute renal failure 
(renal failure) 

  

Reproductive 
system and breast 
disorders 

  Pelvic 
haemorrhage 

Menorrhagia, 
penile 
haemorrhage 

General disorders 
and 
administration 
site conditions 

Vessel puncture 
site discharge 

Vessel puncture 
site haematoma b  

  

Investigations Haematocrit 
decreased, 
haemoglobin 
decreased** 

Blood creatinine 
increased 

Platelet count 
decreased, red 
blood cell count 
decreased, 
international 
normalised ratio 
increased c 

 

Injury, poisoning 
and procedural 
complications 

Haematoma 
>5 cm 

 Contusion Periorbital 
haematoma, 
subcutaneous 
haematoma 

 
Multiple related adverse reaction terms have been grouped together in the table and include medical 
terms as described below: 
a. Upper gastrointestinal haemorrhage, mouth haemorrhage, gingival bleeding, oesophageal 

haemorrhage, duodenal ulcer haemorrhage, haematemesis, lower gastrointestinal haemorrhage, 
rectal haemorrhage, haemorrhoidal haemorrhage, haematochezia. 

b. Application site bleeding, catheter site haemorrhage or haematoma, infusion site haemorrhage 
or haematoma. 

c. Coagulation time abnormal, prothrombin time prolonged. 
d. Cerebral haemorrhage, cerebrovascular accident. 
e. Haematuria, blood urine present, urethral haemorrhage. 
f. Erythema, rash erythematous, rash pruritic. 
*  Including events with fatal outcome. 
** Transfusion was uncommon 101/12,565 (0.8%). 
 



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Description of selected adverse reactions 
 
The GUSTO bleeding scale was measured in the CHAMPION (PHOENIX, PLATFORM, and PCI) 
clinical trials. An analysis of non-coronary artery bypass grafting (CABG)-related bleeding is 
presented in Table 2. 
 
When administered in the PCI setting, cangrelor was associated with a greater incidence of GUSTO 
mild bleeding compared with clopidogrel. Further analysis of GUSTO mild bleeding revealed that a 
large proportion of mild bleeding events were ecchymosis, oozing and <5 cm haematoma. Transfusion 
and GUSTO severe/life-threatening bleeding rates were similar. In the pooled safety population from 
the CHAMPION trials, the incidence of fatal bleeding within 30 days of dosing was low and similar in 
patients who received cangrelor compared to clopidogrel (8 [0.1%] vs. 9 [0.1%]). 
 
No baseline demographic factor altered the relative risk of bleeding with cangrelor. 
 
Table 2: Non-CABG-related bleeding 
GUSTO bleeding, n (%)   

CHAMPION pooled  Cangrelor (N=12,565) 
Clopidogrel 
(N=12,542) 

Any GUSTO bleeding 2,196 (17.5) 1,696 (13.5) 
Severe/life-threatening 28 (0.2) 23 (0.2) 
Moderate 76 (0.6) 56 (0.4) 
Mild a 2,109 (16.8) 1,627 (13.0) 
Mild w/o ecchymosis, oozing and haematoma <5 cm  707 (5.6) 515 (4.1) 
Patients with any transfusion 90 (0.7) 70 (0.6) 

CHAMPION PHOENIX Cangrelor (N=5,529) 
Clopidogrel 
(N=5,527) 

Any GUSTO bleeding 178 (3.2) 107 (1.9) 
Severe/life-threatening 9 (0.2) 6 (0.1) 
Moderate 22 (0.4) 13 (0.2) 
Mild b 150 (2.7) 88 (1.6) 
Mild w/o ecchymosis, oozing and haematoma <5 cm 98 (1.8) 51 (0.9) 
Patients with any transfusion 25 (0.5) 16 (0.3) 
CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary 
Arteries; w/o: without 
a In the CHAMPION pooled analysis, GUSTO Mild was defined as other bleed not requiring blood 
transfusion or causing haemodynamic compromise. 
b In CHAMPION PHOENIX, GUSTO Mild was defined as other bleeding requiring intervention but 
not requiring blood transfusion or causing haemodynamic compromise. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
In clinical studies, healthy volunteers received up to two times the proposed daily dose. In clinical 
trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally 
administered and bleeding was the most frequently observed adverse event. 
 
Bleeding is the most likely pharmacological effect of overdose. If bleeding occurs appropriate 
supportive measures should be taken, which may include stopping the medicinal product so platelet 
function can return. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to 
six minutes. Platelet function is restored within 60 minutes of stopping the infusion. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC25. 
 
Mechanism of action 
 
Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine 
diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo. Cangrelor binds 
selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation. 
 
Pharmacodynamic effects 
 
Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry 
(light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12test, VASP-P 
and flow cytometry. Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration. 
 
Following the administration of a 30 microgram/kg bolus followed by a 4 microgram/kg/min infusion, 
platelet inhibition is observed within two minutes. The pharmacokinetic/pharmacodynamic (PK/PD) 
effect of cangrelor is maintained consistently for the duration of the infusion. 
 
Irrespective of dose, following cessation of the infusion, blood levels decrease rapidly and platelet 
function returns to normal within one hour. 
 
Clinical efficacy and safety 
 
The primary clinical evidence for the efficacy of cangrelor is derived from CHAMPION PHOENIX, a 
randomised, double-blind study comparing cangrelor (n=5,472) to clopidogrel (n=5,470), both given 
in combination with aspirin and other standard therapy, including unfractionated heparin (78%), 
bivalirudin (23%), LMWH (14%) or fondaparinux (2.7%). The median duration of cangrelor infusion 
was 129 minutes. GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of 
patients. Patients with coronary atherosclerosis were included who required PCI for stable angina 
(58%), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) (26%), or ST-elevation 
myocardial infraction (STEMI) (16%). 
 
Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical 
support for safety. 
 
In CHAMPION PHOENIX, cangrelor significantly reduced (relative risk reduction 22%; absolute risk 
reduction 1.2%) the primary composite endpoint of all-cause mortality, MI, IDR, and ST compared to 
clopidogrel at 48 hours (Table 3). 
 



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Table 3: Thrombotic events at 48 hours in CHAMPION PHOENIX (mITT population) 
  Cangrelor vs. Clopidogrel 

n (%) 
Cangrelor 
N=5,470 

Clopidogrel 
N=5,469 OR (95% CI) p-value 

Primary Endpoint 
Death/MI/IDR/ST a 

 
257 (4.7) 

 
322 (5.9) 

 
0.78 (0.66,0.93) 

 
0.005 

Key Secondary Endpoint     
Stent thrombosis 46 (0.8) 74 (1.4) 0.62 (0.43, 0.90) 0.010 
Death 18 (0.3) 18 (0.3) 1.00 (0.52, 1.92) >0.999 

MI 207 (3.8) 255 (4.7) 0.80 (0.67, 0.97) 0.022 

IDR 28 (0.5) 38 (0.7) 0.74 (0.45, 1.20) 0.217 
a Primary endpoint from logistic regression adjusted for loading dose and patient status. p-values for 
secondary endpoints based on Chi-squared test. 
OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = 
myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis. 
 
Significant reductions in death/MI/IDR/ST and ST observed in the cangrelor group at 48 hours were 
maintained at 30 days (Table 4). 
 
Table 4: Thrombotic events at 30 days in CHAMPION PHOENIX (mITT population) 
  Cangrelor vs. Clopidogrel 

n (%) 
Cangrelor 
N=5,462 

Clopidogrel 
N=5,457 OR (95% CI) p-value a 

Primary Endpoint 
Death/MI/IDR/ST 326 (6.0) 380 (7.0) 0.85 (0.73, 0.99) 0.035 

Key Secondary Endpoint     

Stent thrombosis 71 (1.3) 104 (1.9) 0.68 (0.50, 0.92) 0.012 

Death 60 (1.1) 55 (1.0) 1.09 (0.76, 1.58) 0.643 

MI 225 (4.1) 272 (5.0) 0.82 (0.68, 0.98) 0.030 

IDR 56 (1.0) 66 (1.2) 0.85 (0.59, 1.21) 0.360 
a p-values based on Chi-squared test. 
OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = 
myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis. 
 
Paediatric Population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Kengrexal in one or more subsets of the paediatric population in the prevention of non-site specific 
embolism and thrombosis, for the treatment of thrombosis in paediatric patients undergoing diagnostic 
and / or therapeutic percutaneous vascular procedures. See section 4.2 for information on paediatric 
use. 
 



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5.2 Pharmacokinetic properties 
 
Absorption 
 
The bioavailability of cangrelor is complete and immediate. Cangrelor is rapidly distributed reaching 
Cmax within two minutes after administration of an intravenous bolus followed by infusion. The mean 
steady state concentration of cangrelor during a constant intravenous infusion of 4 micrograms/kg/min 
is 488 ng/mL. 
 
Distribution 
 
Cangrelor has a volume of distribution of 3.9 L. Cangrelor is 97-98% plasma-protein bound. 
 
Biotransformation 
 
Cangrelor is deactivated rapidly in the plasma by dephosphorylation to form its primary metabolite, a 
nucleoside. The metabolism of cangrelor is independent of organ function and does not interfere with 
other drugs metabolised by hepatic enzymes. 
 
Elimination 
 
The half-life of Kengrexal is three to six minutes, independent of dose. Following the intravenous 
administration of a 2 micrograms/kg/min infusion of [3H] cangrelor to healthy male volunteers, 93% 
of total radioactivity was recovered. Of the recovered material, 58% was found in urine and the 
remaining 35% was found in faeces, presumably following biliary excretion. Initial excretion was 
rapid, such that approximately 50% of the administered radioactivity was recovered in the first 
24 hours, and 75% was recovered by 48 hours. Mean clearance was approximately 43.2 L/kg. 
 
Linearity/non-linearity 
 
The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients 
and healthy volunteers. 
 
Pharmacokinetic/pharmacodynamic relationship(s) 
 
Special populations 
The pharmacokinetics of cangrelor are not affected by gender, age, or renal or hepatic status. No dose 
adjustment is needed for these populations. 
 
Paediatric population 
Cangrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1). 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special safety risk for humans based on studies of safety pharmacology, 
mutagenicity and clastogenic potential. 
 
Carcinogenicity studies have not been performed. 
 
The primary adverse effects of cangrelor in rats and dogs occurred in the upper urinary tract and 
consisted of injury to renal tubules, renal pelvis, and ureter. Anatomical changes correlated with 
increased plasma creatinine and urea, and increased albumin and blood cells in urine. Injury to the 
urinary tract was reversible following cessation of dosing in an investigative study in rats. 
 



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Reproductive toxicity 
 
Cangrelor produced dose-related foetal growth retardation characterised by increased incidences of 
incomplete ossification and unossified hind limb metatarsals in rats. In rabbits, cangrelor was 
associated with increased incidences of abortion and intrauterine losses, as well as foetal growth 
retardation at higher doses which may have been secondary to maternal toxicity. Cangrelor did not 
produce malformations in either the rat or rabbit reproductive studies. 
 
Impairment of fertility 
 
Effects on fertility, ability to produce a pregnancy with female partner(s), sperm morphology and 
sperm motility were observed in the male rat fertility study when cangrelor was administered at human 
equivalent doses equal to 1.8 fold the recommended PCI dose. These effects were not apparent at 
lower doses and were reversible following cessation of dosing. In this study, semen analysis was 
conducted after 8 weeks of continuous treatment. 
 
Female fertility was not affected at any dose. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Mannitol 
Sorbitol 
Sodium hydroxide (for pH-adjustment) 
 
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. 
 
The powder should be reconstituted immediately prior to dilution and use. Do not refrigerate. 
From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk 
of microbiological contamination, the product should be used immediately. If not used immediately, 
in-use storage times and conditions prior to use are the responsibility of the user. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. For storage conditions after 
reconstitution and dilution of the medicinal product see section 6.3. 
 
6.5 Nature and contents of container  
 
Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed 
with crimped aluminium seal. 
 
Kengrexal is available in packs of 10 vials. 
 



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6.6 Special precautions for disposal and other handling 
 
Instructions for preparation 
 
Aseptic procedures should be used for the preparation of Kengrexal. 
 
The vial should be reconsituted immediately prior to dilution and use. Reconstitute each 50 mg/vial by 
adding 5 mL of sterile water for injection. Swirl gently until all material is dissolved. Avoid vigorous 
mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the 
reconstituted material is a clear, colourless to pale yellow solution. 
 
Do not use without dilution. Before administration, 5 mL reconstituted solution has to be withdrawn 
from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for 
injection or glucose (5%) solution for injection. Mix the bag thoroughly. 
 
The medicinal product should be inspected visually for particulate matter after reconstitution. 
 
Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus 
followed by an intravenous infusion. The bolus and infusion should be administered from the infusion 
solution. 
 
This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least 
two hours of dosing as required. Patients 100 kg and over will require a minimum of two bags. 
 
Disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Chiesi Farmaceutici S.p.A. 
Via Palermo, 26/A 
43122 Parma 
Italy 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/994/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 March 2015 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



15 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Hälsa Pharma GmbH 
Hafenweg 18-20 
48155 Münster 
GERMANY 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 
 



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kengrexal 50 mg powder for concentrate for solution for injection/infusion 
cangrelor 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. 
After reconstitution 1 mL contains 10 mg cangrelor. 
After dilution 1 mL contains 200 micrograms cangrelor. 
 
 
3. LIST OF EXCIPIENTS 
 
Mannitol 
Sorbitol 
Sodium hydroxide 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for concentrate for solution for injection/infusion 
10 vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use after reconstitution and dilution. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
The powder should be reconstituted immediately prior to dilution and use. Do not refrigerate. If not 
used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 



19 

 
 
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 
 
Chiesi Farmaceutici S.p.A. 
Via Palermo, 26/A 
43122 Parma 
Italy 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/994/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



20 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kengrexal 50 mg powder for concentrate 
cangrelor 
Intravenous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
50 mg 
 
 
6. OTHER 
 
 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



22 

Package leaflet: Information for the patient 
 

Kengrexal 50 mg powder for concentrate for solution for injection/infusion 
cangrelor 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor. 
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Kengrexal is and what it is used for 
2. What you need to know before you use Kengrexal 
3. How to use Kengrexal 
4. Possible side effects 
5. How to store Kengrexal 
6. Contents of the pack and other information 
 
 
1. What Kengrexal is and what it is used for 
 
Kengrexal is an anti-platelet medicine that contains the active substance cangrelor. 
 
Platelets are very small cells in the blood that can clump together and help the blood to clot. 
Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can 
be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack 
(myocardial infarction). 
 
Kengrexal diminishes the clumping of platelets and so reduces the chance of a blood clot forming. 
 
You have been prescribed Kengrexal because you have blocked blood vessels in your heart (coronary 
artery disease) and you need a procedure (called a percutaneous coronary intervention – PCI) to 
remove the blockage. During this procedure you may have a stent inserted in your blood vessel to help 
to keep it open. Using Kengrexal reduces the risk that this procedure will cause a clot to form and 
block the blood vessels again. 
 
Kengrexal is only for use in adults. 
 
 
2. What you need to know before you use Kengrexal 
 
Do not use Kengrexal 
- If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in 

section 6). 
- If you have a medical condition that is currently causing bleeding such as bleeding from the 

stomach or intestines or you have a condition which makes you more prone to uncontrolled 
bleeding (impaired haemostasis or irreversible coagulation disorders). 

- If you have recently undergone major surgery or suffered from any form of serious physical 
trauma such as a bone fracture or road traffic accident. 

- If you have uncontrolled very high blood pressure. 
- If you have ever had a stroke, or a ‘mini-stroke’ (also known as a transient ischaemic attack, 

TIA) caused by the temporary interruption of the blood supply to the brain. 
 



23 

Warnings and precautions 
Talk to your doctor before using Kengrexal if: 
• You are, or you think you may be at increased risk of bleeding. For example, if you have a 

medical condition that affects blood clotting or because of another medical condition that may 
increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a 
stroke or a transient ischaemic attack  or recent bleeding from your stomach or gut. 

• You suffer from impaired kidney function or require dialysis. 
• You have ever suffered from an allergic reaction to Kengrexal or any of its constituents. 
• You suffer from breathing difficulties such as asthma. 
• You have been told by your doctor that you have an intolerance to some sugars. 
 
Children and adolescents 
Kengrexal is not recommended for children and adolescents under 18 years. 
 
Other medicines and Kengrexal 
You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of 
anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal. 
 
Tell your doctor if you are taking other medicines that may increase the risk of side effects such as 
bleeding including blood thinners (anticoagulants e.g. warfarin). 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 
Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before taking this medicine. Kengrexal is not recommended for use during pregnancy. 
 
Driving and using machines 
The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use 
machines. 
 
Kengrexal contains sodium and sorbitol 
Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic 
disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which 
may cause serious side effects. 
You must tell your doctor before receiving this medicine if you have HFI. 
 
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Kengrexal 
 
Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with 
heart disease. The doctor will decide how much Kengrexal you receive, and will prepare the medicine. 
 
Kengrexal is for injection, followed by infusion (drip), into a vein. The dose given depends on your 
weight.  
 
The recommended dose is: 
• 30 micrograms per kilogram body weight by injection, followed immediately by  
• 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours. The 

doctor will decide if you will need to be treated for longer periods. 
 
If you use more Kengrexal than you should 
This medicine will be given to you by a healthcare professional. Your doctor will decide how to treat 
you, including stopping the medicine and monitoring for signs of side effects. 



24 

 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
If side effects occur, they may need medical attention. 
 
Tell your doctor immediately if you notice any of the following: 
• Bleeding from anywhere in the body. Bleeding is a common side effect of treatment with 

Kengrexal (may affect up to 1 in 10 people). Bleeding can be serious, and fatal outcomes have 
been reported. 

• Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, 
difficulty breathing). Allergic reaction is a rare side effect of treatment with Kengrexal (may 
affect up to 1 in 1,000 people) but may be potentially serious. 

 
Common side effects: may affect up to 1 in 10 people 
• Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the 

site of an injection under the skin causing swelling),  
• dyspnoea (shortness of breath),  
• bleeding leading to decreases in blood volume or red blood cell numbers, 
• fluid discharge from injection or catheter sites.  
 
Uncommon side effects: may affect up to 1 in 100 people 
• Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose, 

gastrointestinal tract, in the abdomen, or in the urine or from injection or catheter sites,  
• increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney 

function, 
• variations in blood pressure, 
• rash, pruritus, urticaria, 
• vessel puncture site haematoma. 
 
Rare side effects: may affect up to 1 in 1,000 people 
• Bleeding leading to low platelet count or anaemia,  
• bleeding in the eye, brain (including stroke), pelvis and lung,  
• bleeding from the site of wounds,  
• balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the 

vessel walls, 
• severe allergic reactions,  
• reduced clotting of the blood,  
• bruising, 
• swollen face. 
 
Very rare side effects: may affect up to 1 in 10,000 people 
• Bleeding under the skin or around the eye,  
• infection of bleeding sites,  
• heavy menstrual bleeding,  
• bleeding from the penis, ear or pre-existing skin tumours. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. 
You can also report side effects directly via the national reporting system listed in Appendix V. By 
reporting side effects you can help provide more information on the safety of this medicine. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


25 

 
 
5. How to store Kengrexal 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Reconstituted solution: the powder should be reconstituted immediately prior to dilution and use. Do 
not refrigerate. 
 
Diluted solution: From a microbiological point of view, unless the method of reconstitution/dilution 
precludes the risk of microbiological contamination, the product should be used immediately. If not 
used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
 
 
6. Contents of the pack and other information 
 
What Kengrexal contains 
The active substance is cangrelor. Each vial contains 50 mg cangrelor. After reconstitution 1 mL of 
concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms 
cangrelor. 
The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment. 
 
What Kengrexal looks like and contents of the pack 
Powder for concentrate for solution for injection/infusion in a glass vial. 
Kengrexal is a white to off-white freeze-dried powder. 
Kengrexal is available in packs of 10 vials. 
 
Marketing Authorisation Holder 
Chiesi Farmaceutici S.p.A. 
Via Palermo, 26/A 
43122 Parma 
Italy 
 
Manufacturer 
Hälsa Pharma GmbH 
Hafenweg 18-20 
48155 Münster 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferrer Internacional, S.A.. 
Tél/Tel: +32 15 28 74 15 
 

Lietuva 
Chiesi Pharmaceuticals GmbH  
Tel: +43 1 4073919 
 

България 
Chiesi Bulgaria EOOD  
Teл.: + 359 29201205 
 

Luxembourg/Luxemburg 
Ferrer Internacional, S.A. 
Tél/Tel: +32 15 28 74 15 
 



26 

Česká republika 
Chiesi CZ s.r.o. 
Tel: +420 261221745 
 

Magyarország 
Chiesi Hungary Kft. 
Tel.: +36-1-429 1060 
 

Danmark 
Chiesi Pharma AB 
Tlf: +46 8 753 35 20 
 

Malta 
Chiesi Farmaceutici S.p.A. 
Tel: + 39 0521 2791 
 

Deutschland 
Ferrer Deutschland GmbH 
Tel: +49 (0) 2407 502311-0 
 

Nederland 
Ferrer Internacional, S.A. 
Tél/Tel: +32 15 28 74 15 
 

Eesti 
Chiesi Pharmaceuticals GmbH 
Tel: +43 1 4073919 
 

Norge 
Chiesi Pharma AB 
Tlf: +46 8 753 35 20 
 

Ελλάδα 
Chiesi Hellas AEBE 
Τηλ: + 30 210 6179763 
 

Österreich 
Chiesi Pharmaceuticals GmbH  
Tel: + 43 1 4073919 
 

España 
Ferrer Farma, S.A. 
Tel: +34 93 600 3700 
 

Polska 
Chiesi Poland Sp. z.o.o. 
Tel.: + 48 22 620 1421 
 

France 
Bioprojet Pharma  
+33 (0)1 47 03 66 33 
 

Portugal 
Ferrer Portugal, S.A 
Tel: +351 214449600 
 

Hrvatska 
Chiesi Pharmaceuticals GmbH 
Tel: + 43 1 4073919 
 

România 
Chiesi Romania S.R.L. 
Tel: + 40 212023642 
 

Ireland 
Chiesi Farmaceutici S.p.A. 
Tel: + 39 0521 2791 
 

Slovenija 
Chiesi Slovenija d.o.o. 
Tel: + 386-1-43 00 901 
 

Ísland 
Chiesi Pharma AB 
Tlf: +46 8 753 35 20 
 

Slovenská republika 
Chiesi Slovakia s.r.o. 
Tel: + 421 259300060 
 

Italia 
Chiesi Farmaceutici S.p.A. 
Tel: + 39 0521 2791 
 

Suomi/Finland 
Chiesi Pharma AB 
Tlf: +46 8 753 35 20 
 

Κύπρος 
Chiesi Farmaceutici S.p.A. 
Τηλ: + 39 0521 2791 
 

Sverige 
Chiesi Pharma AB 
Tlf: +46 8 753 35 20 
 

Latvija 
Chiesi Pharmaceuticals GmbH  
Tel: +  43 1 4073919 
 

United Kingdom 
Chiesi Ltd  
Tel: + 44 (0)161 4885555 
 

 
This leaflet was last revised in {MM/YYYY}. 
 



27 

Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
------------------------------------------------------------------------------------------------------------ 
 
The following information is intended for healthcare professionals only: 
 
Kengrexal should be administered by a physician experienced in either acute coronary care or in 
coronary intervention procedures and is intended for specialised use in an acute and hospital setting. 
 
Posology 
 
The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous 
bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion 
should be initiated prior to the procedure and continued for at least two hours or for the duration of the 
procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a 
total duration of four hours, see section 5.1. 
 
Patients should be transitioned to oral P2Y12 therapy for chronic treatment. For transition, a loading 
dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel) should be administered immediately 
following discontinuation of cangrelor infusion. Alternatively, a loading dose of ticagrelor or prasugrel, 
but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see 
section 4.5. 
 
Instructions for preparation 
 
Aseptic procedures should be used for the preparation of Kengrexal. 
 
The vial should be reconsituted immediately prior to dilution and use. Reconstitute each 50 mg/vial by 
adding 5 mL of sterile water for injection. Swirl gently until all material is dissolved. Avoid vigorous 
mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the 
reconstituted material is a clear, colourless to pale yellow solution. 
 
Do not use without dilution. Before administration, 5 mL reconstituted solution has to be withdrawn 
from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for 
injection or glucose (5%) solution for injection. Mix the bag thoroughly. 
 
The medicinal product should be inspected visually for particulate matter after reconstitution. 
 
Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus 
followed by an intravenous infusion. The bolus and infusion should be administered from the infusion 
solution. 
 
This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least 
two hours of dosing as required. Patients 100 kg and over will require a minimum of two bags. 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET