Elocta

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

  



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1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 250 IU powder and solvent for solution for injection 
 
ELOCTA 500 IU powder and solvent for solution for injection 
 
ELOCTA 750 IU powder and solvent for solution for injection 
 
ELOCTA 1000 IU powder and solvent for solution for injection 
 
ELOCTA 1500 IU powder and solvent for solution for injection 
 
ELOCTA 2000 IU powder and solvent for solution for injection 
 
ELOCTA 3000 IU powder and solvent for solution for injection 
 
ELOCTA 4000 IU powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
ELOCTA 250 IU powder and solvent for solution for injection 
Each vial contains nominally 250 IU efmoroctocog alfa.  
ELOCTA contains approximately 83 IU/mL of recombinant human coagulation factor VIII, efmoroctocog 
alfa after reconstitution. 
 
ELOCTA 500 IU powder and solvent for solution for injection 
Each vial contains nominally 500 IU efmoroctocog alfa. ELOCTA contains approximately 167 IU/mL of 
recombinant efmoroctocog alfa after reconstitution. 
 
ELOCTA 750 IU powder and solvent for solution for injection 
Each vial contains nominally 750 IU efmoroctocog alfa. ELOCTA contains approximately 250 IU/mL of 
recombinant efmoroctocog alfa after reconstitution.  
 
ELOCTA 1000 IU powder and solvent for solution for injection 
Each vial contains nominally 1000 IU efmoroctocog alfa. ELOCTA contains approximately 333 IU/mL of 
recombinant efmoroctocog alfa after reconstitution.  
 
ELOCTA 1500 IU powder and solvent for solution for injection 
Each vial contains nominally 1500 IU efmoroctocog alfa. ELOCTA contains approximately 500 IU/mL of 
recombinant efmoroctocog alfa after reconstitution. 
 
ELOCTA 2000 IU powder and solvent for solution for injection 
Each vial contains nominally 2000 IU efmoroctocog alfa. ELOCTA contains approximately 667 IU/mL of 
recombinant efmoroctocog alfa after reconstitution. 
 
ELOCTA 3000 IU powder and solvent for solution for injection 
Each vial contains nominally 3000 IU efmoroctocog alfa. ELOCTA contains approximately 1000 IU/mL of 
recombinant efmoroctocog alfa after reconstitution. 
 
ELOCTA 4000 IU powder and solvent for solution for injection 
Each vial contains nominally 4000 IU efmoroctocog alfa. ELOCTA contains approximately 1333 IU/mL of 
recombinant efmoroctocog alfa after reconstitution. 
 
The potency (International Units (IU)) is determined using the European Pharmacopoeia chromogenic assay. 
The specific activity of ELOCTA is 4000-10200 IU/mg protein. 
 



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Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 
1,890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell 
line without the addition of any exogenous human- or animal-derived protein in the cell culture process, 
purification or final formulation. 
 
Excipient with known effect 
0.6 mmol (or 14 mg) sodium per vial. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
 
Powder: lyophilised, white to off-white powder or cake. 
Solvent: water for injections, a clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 
 
ELOCTA can be used for all age groups. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of 
haemophilia. 
 
Treatment monitoring 
During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting or 
chromogenic assays) is advised to guide the dose to be administered and the frequency of repeated injections. 
Individual patients may vary in their response to factor VIII, demonstrating different half-lives and 
recoveries. Dose based on bodyweight may require adjustment in underweight and overweight patients. In 
the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means 
of coagulation analysis (plasma factor VIII activity) is indispensable.  
 
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining 
factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly 
affected by both the type of the aPTT reagent and the reference standard used in the assay. Also there can be 
significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the 
chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory 
and/or reagent used in the assay. 
 
Posology 
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the 
location and extent of the bleeding and on the patient's clinical condition.  
 
The number of units of factor VIII administered is expressed in IU, which are related to the current WHO 
standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative 
to normal human plasma) or in IU (relative to an International Standard for factor VIII in plasma). 
 
One IU of recombinant factor VIII Fc activity is equivalent to that quantity of factor VIII in one mL of 
normal human plasma. 



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On-demand treatment 
The calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 IU 
factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL. The required dose is 
determined using the following formula:  
 
Required units = body weight (kg) × desired factor VIII rise (%) (IU/dL) × 0.5 (IU/kg per IU/dL) 
 
The amount to be administered and the frequency of administration should always be oriented to the clinical 
effectiveness in the individual case. 
 
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given 
plasma activity level (in % of normal or IU/dL) in the corresponding period. Table 1 can be used to guide 
dosing in bleeding episodes and surgery: 
 
Table 1: Guide to ELOCTA dosing for treatment of bleeding episodes and surgery 
 

Degree of haemorrhage / 
Type of surgical procedure 

Factor VIII level 
required (%) (IU/dL)  

Frequency of doses (hours)/ Duration of 
therapy (days) 

Haemorrhage   
Early haemarthrosis, muscle 
bleeding or oral bleeding 

20-40 Repeat injection every 12 to 24 hours for at 
least 1 day, until the bleeding episode as 
indicated by pain is resolved or healing is 
achieved. 1 
 

More extensive 
haemarthrosis, muscle 
bleeding or haematoma 

30-60 Repeat injection every 12 to 24 hours for 3-4 
days or more until pain and acute disability 
are resolved. 1 
 

Life threatening 
haemorrhages 

60-100 Repeat injection every 8 to 24 hours until 
threat is resolved. 
 

Surgery   
Minor surgery including 
tooth extraction 

30-60 Repeat injection every 24 hours, for at least 1 
day, until healing is achieved. 
 

Major surgery 80-100 
(pre- and post-
operative) 

Repeat injection every 8 to 24 hours as 
necessary until adequate wound healing, then 
therapy at least for another 7 days to maintain 
a factor VIII activity of 30% to 60% (IU/dL). 
 

1 In some patients and circumstances the dosing interval can be prolonged up to 36 hours. See section 5.2 for 
pharmacokinetic data. 
 
Prophylaxis  
For long term prophylaxis, the recommended dose is 50 IU of factor VIII per kg body weight at intervals of  
3 to 5 days. The dose may be adjusted based on patient response in the range of 25 to 65 IU/kg (see section 
5.1 and 5.2).  
In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. 
 
Elderly 
There is limited experience in patients ≥65 years. 
 
Paediatric population 
For children below the age of 12, more frequent or higher doses may be required (see section 5.1). For 
adolescents of 12 years of age and above, the dose recommendations are the same as for adults.  



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Method of administration  
ELOCTA is for intravenous use. 
 
ELOCTA should be injected intravenously over several minutes. The rate of administration should be 
determined by the patient’s comfort level and should not exceed 10 mL/min.  
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Hypersensitivity 
Allergic type hypersensitivity reactions are possible with ELOCTA. If symptoms of hypersensitivity occur, 
patients should be advised to discontinue use of the medicinal product immediately and contact their 
physician. Patients should be informed of the signs of hypersensitivity reactions including hives, generalised 
urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.  
 
In case of shock, standard medical treatment for shock should be implemented. 
 
Inhibitors 
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the 
management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed 
against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma 
using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well 
as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues 
throughout life although the risk is uncommon. 
 
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing 
less of a risk of insufficient clinical response than high titre inhibitors. 
 
In general, all patients treated with coagulation factor VIII products should be carefully monitored for the 
development of inhibitors by appropriate clinical observations and laboratory tests. If the expected 
factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, 
testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, 
factor VIII therapy may not be effective and other therapeutic options should be considered. Management of 
such patients should be directed by physicians with experience in the care of haemophilia and factor VIII 
inhibitors. 
 
Cardiovascular events 
In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the 
cardiovascular risk. 
 
Catheter-related complications 
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local 
infections, bacteraemia and catheter site thrombosis should be considered. 
 
Traceability  
In order to improve traceability of biological medicinal products, the name and the batch number of the 
administered product should be clearly recorded. 
 
Paediatric population  
The listed warnings and precautions apply both to adults, children and adolescents. 
 



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Excipient related considerations 
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 
‘sodium-free’. 
However, depending on the body weight and posology, the patient could receive more than one vial (see 
section 2 for information on content per vial). This should be taken into consideration by patients on a 
controlled sodium diet. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported. 
No interaction studies have been performed. 
 
4.6 Fertility, pregnancy and lactation 
 
Animal reproduction studies have not been conducted with factor VIII. A placental transfer study in mice 
was conducted with ELOCTA (see section 5.3). Based on the rare occurrence of haemophilia A in women, 
experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, 
factor VIII should be used during pregnancy and breast-feeding only if clearly indicated. 
 
4.7 Effects on ability to drive and use machines 
 
ELOCTA has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion 
site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, 
tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some 
cases progress to severe anaphylaxis (including shock). 
 
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with 
factor VIII, including with ELOCTA. If such inhibitors occur, the condition will manifest itself as an 
insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be 
contacted. 
 
Tabulated list of adverse reactions 
The frequencies in Table 2 below were observed in a total of 276 patients with severe haemophilia A in 
phase III clinical studies and an extension study with a duration of up to four years. Adverse reactions were 
monitored for a total of 893.72 subject-years. The total number of exposure days was 80,848 with a median 
of 294 (range 1-735) exposure days per subject. 
 
The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred 
Term Level). 
 
Frequencies have been evaluated according to the following convention: 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), not 
known (cannot be estimated from the available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 



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Table 2: Adverse reactions reported for ELOCTA in clinical trials 
MedDRA System Organ Class Adverse reactions Frequency category 
Blood and lymphatic system disorders FVIII inhibition Uncommon (PTPs)1 

Very common (PUPs)1 
Nervous system disorders Headache 

Dizziness 
Dysgeusia 

Uncommon 
 

Cardiac disorders Bradycardia Uncommon 
Vascular disorders Hypertension  

Hot flush 
Angiopathy2 

Uncommon 
 

Respiratory, thoracic, and mediastinal disorders Cough Uncommon 
Gastrointestinal disorders Abdominal pain, lower Uncommon 
Skin and subcutaneous tissue disorders Rash Uncommon 
Musculoskeletal and connective tissue disorders Arthralgia 

Myalgia 
Back pain 
Joint swelling 

Uncommon 
 

General disorders and administration site conditions Malaise 
Chest pain 
Feeling cold 
Feeling hot 

Uncommon 
 

Injury, poisoning, and procedural complications Procedural hypotension Uncommon 
 1 Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. 

PTPs= previously treated patients, PUPs= previously untreated patients. 
2 Investigator term: vascular pain after injection of ELOCTA 
 
Paediatric population 
No age-specific differences in adverse reactions were observed between paediatric and adult subjects. 
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. 
 
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 
 
No symptoms of overdose have been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02 
 
Mechanism of action 
The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand 
factor) with different physiological functions. When infused into a haemophiliac patient, factor VIII binds to 
von Willebrand factor in the patient’s circulation. Activated factor VIII acts as a cofactor for activated 
factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts 
prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. 
 
Haemophilia A is an X-linked hereditary disorder of blood coagulation due to decreased levels of functional 
factor VIII:C and results in bleeding into joints, muscles or internal organs, either spontaneously or as a 

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


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result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, 
thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. 
 
Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and 
between different clinical studies. 
 
ELOCTA (efmoroctocog alfa) is a fully recombinant fusion protein with extended half-life. ELOCTA is 
comprised of recombinant B-domain deleted human coagulation factor VIII covalently linked to the 
Fc domain of human immunoglobulin G1. The Fc region of human immunoglobulin G1 binds to the neonatal 
Fc receptor. This receptor is expressed throughout life and is part of a naturally occurring pathway that 
protects immunoglobulins from lysosomal degradation by cycling these proteins back into circulation, 
resulting in their long plasma half-life. Efmoroctocog alfa binds to neonatal Fc receptor thereby utilising this 
same naturally occurring pathway to delay lysosomal degradation and allow for longer plasma half-life than 
endogenous factor VIII. 
 
Clinical efficacy and safety 
The safety, efficacy, and pharmacokinetics of ELOCTA were evaluated in 2 multinational, open-label, 
pivotal studies; a phase 3 study, referred to as Study I and a phase 3 paediatric study, referred to as Study II 
(see Paediatric population). 
 
Study I enrolled 165 previously treated male patients (12 to 65 years of age) with severe haemophilia A. 
Subjects on prophylaxis regimens prior to entering the study were assigned to the individualised prophylaxis 
arm. Subjects on on-demand therapy prior to entry either entered the individualised prophylaxis arm or were 
randomised to the weekly prophylaxis or on-demand arms. 
 
Prophylaxis regimens: 
Individualised prophylaxis: 25 to 65 IU/kg every 3 to 5 days. 
Weekly prophylaxis: 65 IU/kg 
 
Out of 153 subjects who completed Study I, 150 were enrolled onto Study III (extension study). Median total 
time on Study I+III was 4.2 years and median no of exposure days was 309. 
 
Individualised prophylaxis: Median annual factor consumption was 4212 IU/kg (min. 2877, max. 7943) in 
Study I and 4223 IU/kg (min. 2668, max 8317) in Study III. Respective median Annualized Bleed Rate 
(ABR) was 1.60 (min. 0, max. 18.2) and 0.74 (min. 0, max. 15.6). 
 
Weekly prophylaxis: Median annual factor consumption was 3805 IU/kg (min. 3353, max. 6196) in Study I 
and 3510 IU/kg (min. 2758, max. 3984) in Study III. Respective median ABR was 3.59 (min. 0, max. 58.0) 
and 2.24 (min. 0, max. 17.2). 
 
On-demand treatment: Median annual factor consumption was 1039 IU/kg (min. 280, max. 3571) for 
23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min. 286, max. 913) for 
6 patients remaining on on-demand treatment for at least one year in Study III. 
 
Subjects that switched from on-demand treatment to weekly prophylaxis during Study III had a median ABR 
of 1.67. 
 
Treatment of bleeding: 2490 bleeding events were treated during Study I and III with a median dose of 
43.8 IU/kg (min. 13.0, max. 172.8) to control each bleed. 79.2 % of first injections were rated as excellent or 
good by the patients. 
 
Perioperative management (surgical prophylaxis): A total of 48 major surgical procedures were performed 
and assessed in 34 subjects in Study I and Study III. The haemostatic response was rated by the physicians as 
excellent in 41 and as good in 3 of 44 major surgeries. Median dose to maintain haemostasis during surgery 
was 60.6 IU/kg (min. 38, max. 158).  
 



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Paediatric population 
Study II enrolled a total of 71 previously treated male paediatric patients <12 years of age with severe 
haemophilia A. Of the 71 enrolled subjects, 69 received at least 1 dose of ELOCTA and were evaluable for 
efficacy (35 were <6 years of age and 34 were 6 to <12 years of age). The starting prophylactic regimen 
consisted of 25 IU/kg on the first day followed by 50 IU/kg on the fourth day. Dosing of up to 80 IU/kg and 
a dosing interval as short as 2 days was allowed and used in a limited number of patients. Out of 67 subjects 
having completed Study II, 61 enrolled onto Study III (extension study). Median total time on study II+III 
was 3.4 years and median no of exposure days was 332. 
 
Prophylaxis, age <6 years: Median dose interval was 3.50 days in Study II and Study III. Median annual 
factor consumption was 5146 IU/kg (min. 3695, max 8474) in Study II and 5418 IU/kg (min. 3435, max. 
9564) in Study III. Respective median Annualized Bleed Rate (ABR) was 0.00 (min. 0, max. 10.5) and 1.18 
(min. 0, max. 9.2). 
 
Prophylaxis, age 6 up to 12 years: Median dose interval was 3.49 days in Study II and 3.50 days in Study III. 
Median annual factor consumption was 4700 IU/kg (min. 3819, max. 8230 IU/kg) in Study II and 
4990 IU/kg (min. 3856, max. 9527) in Study III. Respective median ABR was 2.01 (min. 0, max. 27.2) and 
1.59 (min. 0, max. 8.0). 
 
12 adolescent subjects age 12 up to 18 years were included in the adult study population on prophylactic 
treatment. Median annual factor consumption was 5572 IU/kg (min. 3849, max. 7035) in Study I and 
4456 IU/kg (min. 3563, max. 8011) in Study III. Respective median ABR was 1.92 (min. 0, max. 7.1) and 
1.25 (min. 0, max. 9.5). 
 
Treatment of bleeding: 447 bleeding events were treated during Study II and III with a median dose of 
63 IU/kg (min. 28, max. 186) to control each bleed. 90.2 % of first injections were rated as excellent or good 
by the patients and their caregivers. 
 
Immunogenicity 
The immunogenicity of ELOCTA was evaluated in the clinical trial programme in 276 previously treated 
patients with severe haemophilia A (207 adolescents and adult and 69 paediatric patients). None of these 
patients developed inhibitors. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with ELOCTA 
in one or more subsets of the paediatric population in the treatment of hereditary Factor VIII deficiency (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
All pharmacokinetic studies with ELOCTA were conducted in previously treated patients with severe 
haemophilia A. Data presented in this section were obtained by chromogenic and one-stage clotting assays. 
The pharmacokinetic parameters from the chromogenic assay data were similar to those derived for the 
one-stage assay. 
 
Pharmacokinetic properties were evaluated in 28 subjects (≥15 years) receiving ELOCTA (rFVIIIFc). 
Following a washout period of at least 96 hours (4 days), the subjects received a single dose of 50 IU/kg of 
ELOCTA. Pharmacokinetic samples were collected pre-dose and then subsequently at 7 time points up to 
120 hours (5 days) post-dose. Pharmacokinetic parameters after 50 IU/kg dose of ELOCTA are presented in 
Tables 3 and 4. 
 



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Table 3: Pharmacokinetic parameters of ELOCTA using the one-stage clotting assay 

Pharmacokinetic parameters1  
ELOCTA  
(95% CI) 

N=28 

Incremental Recovery (IU/dL per IU/kg) 2.24 (2.11-2.38) 
AUC/Dose 

(IU*h/dL per IU/kg) 
51.2 

(45.0-58.4) 

Cmax (IU/dL) 108 (101-115) 

CL (mL/h/kg) 1.95 (1.71-2.22) 

t½ (h) 
19.0 

(17.0-21.1) 

MRT (h) 25.2 (22.7-27.9) 

Vss (mL/kg) 
49.1 

(46.6-51.7) 
1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI)  
Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time 
curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean 
residence time. 
 
Table 4: Pharmacokinetic parameters of ELOCTA using the chromogenic assay 

Pharmacokinetic parameters1 
  

ELOCTA  
(95% CI) 

N=27 

Incremental Recovery (IU/dL per IU/kg) 2.49 (2.28-2.73) 
AUC/Dose 

(IU*h/dL per IU/kg) 
47.5 

(41.6-54.2) 

Cmax (IU/dL) 131 (104-165) 

CL (mL/h/kg) 2.11 (1.85-2.41) 

t½ (h) 
20.9 

(18.2-23.9) 

MRT (h) 25.0 (22.4-27.8) 

Vss (mL/kg) 
52.6 

(47.4-58.3) 
1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI)  
Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time 
curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean 
residence time. 
 
The PK data demonstrate that ELOCTA has a prolonged circulating half-life.  
 
Paediatric population 
Pharmacokinetic parameters of ELOCTA were determined for adolescents in study I (pharmacokinetic 
sampling was conducted pre-dose followed by assessment at multiple time points up to 120 hours (5 days) 
post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by 
assessment at multiple time points up to 72 hours (3 days) post-dose). Tables 5 and 6 present the 
pharmacokinetic parameters calculated from the paediatric data of subjects less than 18 years of age. 
 



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Table 5: Pharmacokinetic parameters of ELOCTA for paediatrics using the one-stage clotting assay 

Pharmacokinetic 
parameters1 

Study II  Study I* 

<6 years 6 to <12 years 12 to <18 years 

N = 23 N = 31 N = 11 

Incremental Recovery 
(IU/dL per IU/kg) 

1.90 
(1.79-2.02) 

2.30 
(2.04-2.59) 

1.81 
(1.56-2.09) 

AUC/Dose 
(IU*h/dL per IU/kg) 

28.9 
(25.6-32.7) 

38.4 
(33.2-44.4) 

38.2 
(34.0-42.9) 

t½ (h) 12.3 
(11.0-13.7) 

13.5 
(11.4-15.8) 

16.0 
(13.9-18.5) 

MRT (h) 16.8 
(15.1-18.6) 

19.0 
(16.2-22.3) 

22.7 
(19.7-26.1) 

CL (mL/h/kg) 3.46 
(3.06-3.91) 

2.61 
(2.26-3.01) 

2.62 
(2.33-2.95) 

Vss (mL/kg) 57.9 
(54.1-62.0) 

49.5 
(44.1-55.6) 

59.4 
(52.7-67.0) 

1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI)  
Abbreviations: CI = confidence interval; AUC = area under the FVIII activity time curve; t½ = terminal 
half-life;  
CL = clearance; MRT = mean residence time; Vss = volume of distribution at steady-state 
*Pharmacokinetic parameters in 12 to <18 years included subjects from all the arms in Study I with 
different sampling schemes  

 
Table 6: Pharmacokinetic parameters of ELOCTA for paediatrics using the chromogenic assay 

Pharmacokinetic 
parameters1 

Study II  Study I* 

<6 years 6 to <12 years 12 to <18 years 

N = 24 N = 27 N = 11 

Incremental Recovery 
(IU/dL per IU/kg) 

1.88 
(1.73-2.05) 

2.08 
(1.91-2.25) 

1.91 
(1.61-2.27) 

AUC/Dose 
(IU*h/dL per IU/kg) 

25.9 
(23.4-28.7) 

32.8 
(28.2-38.2) 

40.8 
(29.3-56.7) 

t½ (h) 14.3 
(12.6-16.2) 

15.9 
(13.8-18.2) 

17.5 
(12.7-24.0) 

MRT (h) 17.2 
(15.4-19.3) 

20.7 
(18.0-23.8) 

23.5 
(17.0-32.4) 

CL (mL/h/kg) 3.86 
(3.48-4.28) 

3.05 
(2.62-3.55) 

2.45 
(1.76-3.41) 

Vss (mL/kg) 66.5 
(59.8-73.9) 

63.1 
(56.3-70.9) 

57.6 
(50.2-65.9) 

1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI)  
Abbreviations: CI = confidence interval; AUC = area under the FVIII activity time curve; t½ = terminal 
half-life;  
CL = clearance; MRT = mean residence time; Vss = volume of distribution at steady-state 
* Pharmacokinetic parameters in 12 to <18 years included subjects from all the arms in Study I with 
different sampling schemes  

 



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In comparison with adolescents and adults, children less than 12 years of age may have a higher clearance 
and a shorter half-life which is consistent with observations of other coagulation factors. These differences 
should be taken into account when dosing. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on acute and repeated dose toxicity studies 
(which included assessments of local toxicity and safety pharmacology). Studies to investigate genotoxicity, 
carcinogenicity, toxicity to reproduction or embryo-foetal development have not been conducted. In a 
placental transfer study, ELOCTA has been shown to cross the placenta in small amounts in mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder 
Sucrose 
Sodium chloride 
Histidine 
Calcium chloride dihydrate 
Polysorbate 20 
Sodium hydroxide (for pH adjustment) 
Hydrochloric acid (for pH adjustment) 
 
Solvent 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
Only the provided infusion set should be used because treatment failure can occur as a consequence of 
coagulation factor VIII adsorption to the internal surfaces of some injection equipment. 
 
6.3 Shelf life 
 
Unopened vial 
4 years 
 
During the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not 
exceeding 6 months. The date that the product is removed from refrigeration should be recorded on the 
carton. After storage at room temperature, the product may not be returned to the refrigerator. Do not use 
beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, 
whichever is earlier. 
 
After reconstitution 
After reconstitution, chemical and physical stability has been demonstrated for 6 hours when stored at room 
temperature (up to 30°C). Protect product from direct sunlight. After reconstitution, if the product is not used 
within 6 hours, it must be discarded. From a microbiological point of view, the product should be used 
immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are 
the responsibility of the user. 
 



13 

6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from 
light. 
 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Each pack contains: 
- powder in a type 1 glass vial with a chlorobutyl rubber stopper 
- 3 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper 
- a plunger rod 
- a sterile vial adapter for reconstitution 
- a sterile infusion set 
- two alcohol swabs 
- two plasters 
- one gauze pad. 
 
Pack size of 1. 
 
6.6 Special precautions for disposal and other handling 
 
The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent (water 
for injections) from the pre-filled syringe using the sterile vial adapter for reconstitution. 
The vial should be gently swirled until all of the powder is dissolved.  
 
Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to 
administration. The solution should be clear to slightly opalescent and colourless. Do not use solutions that 
are cloudy or have deposits. 
 
Additional information on reconstitution and administration: 
 
ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the 
solvent supplied in the pre-filled syringe. ELOCTA pack contains: 
 
 
 
 
 
 
 
 
 
 
 
 
 
ELOCTA should not be mixed with other solutions for injection or infusion. 
 
Wash your hands before opening the pack 
 
Preparation: 
 

1. Check the name and strength of the package, to make sure it contains the correct medicine. 
Check the expiry date on the ELOCTA carton. Do not use if the medicine has expired. 

 

A) 1 Powder vial 
B) 3 mL solvent in pre-filled syringe 
C) 1 Plunger rod  
D) 1 Vial adapter 
E) 1 Infusion set 
F) 2 Alcohol swabs 
G) 2 Plasters  
H) 1 Gauze pad 
 



14 

2. If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe 
 with solvent (B) to reach room temperature before use. Do not use external heat. 
 
3. Place the vial on a clean flat surface. Remove the plastic flip-top 
 cap from the ELOCTA vial. 
 
 
 
 
 

 

4. Wipe the top of the vial with one of the alcohol swabs (F) 
 provided in the pack, and allow to air dry. Do not touch the top of 
 the vial or allow it to touch anything else once wiped. 
 
 
 
 

 

5. Peel back the protective paper lid from the clear plastic vial adapter (D). Do not remove the 
 adapter from its protective cap. Do not touch the inside of the vial adapter package. 
 
6. Hold the vial adapter in its protective cap and place it squarely 
 over the top of the vial. Press down firmly until the adapter snaps 
 into place on top of the vial, with the adapter spike penetrating the 
 vial stopper. 

 
 

 
7. Attach the plunger rod (C) to the solvent syringe by inserting the 
 tip of the plunger rod into the opening in the syringe plunger. Turn 
 the plunger rod firmly clockwise until it is securely seated in the 
 syringe plunger. 

 

8. Break off the white, tamper-resistant, plastic cap from the solvent 
 syringe by bending at the perforation cap until it snaps off. Set the 
 cap aside by placing it with the top down on a flat surface. Do not 
 touch the inside of the cap or the syringe tip. 
 

 

9. Lift the protective cap away from the adapter and discard.  

10.  Connect the solvent syringe to the vial adapter by inserting the tip 
 of the syringe into the adapter opening. Firmly push and turn the 
 syringe clockwise until it is securely connected. 

 



15 

11. Slowly depress the plunger rod to inject all the solvent into the  
 ELOCTA vial. 

 

12. With the syringe still connected to the adapter and the plunger rod 
 pressed down, gently swirl the vial until the powder is dissolved.  
 Do not shake. 

 

13. The final solution must be inspected visually before administration. The solution should appear 
 clear to slightly opalescent and colourless. Do not use the solution if cloudy or contains visible 
 particles. 
 
14. Ensuring that the syringe plunger rod is still fully pressed down, 
 invert the vial. Slowly pull on the plunger rod to draw back all the 
 solution through the vial adapter into the syringe. 
 

 

15. Detach the syringe from the vial adapter by gently pulling and 
 turning the vial counterclockwise. 
 

 

Note: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately 
as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the 
vial adapter in place. A single large luer lock syringe may be used to draw back the prepared contents 
of each of the individual vials. 
 
16. Discard the vial and the adapter. 
 
Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the 
syringe tip. Do not touch the syringe tip or the inside of the cap. 
 
After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration. 
After this time, the prepared ELOCTA should be discarded. Protect from direct sunlight. 
 

 
 



16 

Administration (Intravenous injection): 
 
ELOCTA should be administered using the infusion set (E) provided in this pack. 
 

1. Open the infusion set package and remove the cap at the end of 
 the tubing. Attach the syringe with the prepared ELOCTA 
 solution to the end of the infusion set tubing by turning 
 clockwise. 

 

2. If needed apply a tourniquet and prepare the injection site by wiping the skin well with the 
 other alcohol swab provided in the pack. 

 

3. Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid 
 has reached the infusion set needle. Do not push the solution through the needle. Remove the 
 clear plastic protective cover from the needle. 

4. Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the 
 tourniquet. If preferred, you may use one of the plasters (G) provided in the pack to hold the 
 plastic wings of the needle in place at the injection site. The prepared product should be 
 injected intravenously over several minutes. Your doctor may change your recommended 
 injection rate to make it more comfortable for you. 

5. After completing the injection and removing the needle, you 
 should fold over the needle protector and snap it over the needle. 

 

6. Please safely dispose of the used needle, any unused solution, the syringe and the empty vial 
 in an appropriate medical waste container as these materials may hurt others if not disposed of 
 properly. Do not reuse equipment. 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 



17 

8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/001 
EU/1/15/1046/002 
EU/1/15/1046/003 
EU/1/15/1046/004 
EU/1/15/1046/005 
EU/1/15/1046/006 
EU/1/15/1046/007 
EU/1/15/1046/008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 November 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/


18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER 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 



19 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance 
 
Biogen Inc 
250 Binney Street 
Cambridge, MA 
02142 
USA 
 
Biogen Inc.  
5000 Davis Drive 
Research Triangle Park, NC 27709 
USA 
 
Name and address of the manufacturer responsible for batch release 
 
Swedish Orphan Biovitrum AB (publ) 
Strandbergsgatan 49  
SE-112 76 Stockholm 
Sweden 
 
 
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. 

 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



22 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 250 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 250 IU efmoroctocog alfa (approx. 83 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


23 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 250  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



24 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
  



25 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 250 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
250 IU 
 
 
6. OTHER 
  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 500 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 500 IU efmoroctocog alfa (approx. 167 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


27 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 500  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



28 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



29 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 500 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
500 IU 
 
 
6. OTHER 
  



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 750 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 750 IU efmoroctocog alfa (approx. 250 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


31 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 750  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



32 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



33 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 750 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
750 IU 
 
 
6. OTHER 
  



34 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 1000 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 1000 IU efmoroctocog alfa (approx. 333 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


35 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 1000  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



36 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



37 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 1000 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1000 IU 
 
 
6. OTHER 
  



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 1500 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 1500 IU efmoroctocog alfa (approx. 500 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


39 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 1500  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



40 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



41 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 1500 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1500 IU 
 
 
6. OTHER 
  



42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 2000 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 2000 IU efmoroctocog alfa (approx. 667 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


43 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 2000  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



44 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



45 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 2000 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2000 IU 
 
 
6. OTHER 
  



46 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 3000 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 3000 IU efmoroctocog alfa (approx. 1000 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


47 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 3000  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



48 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



49 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 3000 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3000 IU 
 
 
6. OTHER 
  



50 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ELOCTA 4000 IU powder and solvent for solution for injection 
 
efmoroctocog alfa  
(recombinant coagulation factor VIII, Fc fusion protein) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 powder vial contains 4000 IU efmoroctocog alfa (approx. 1333 IU/mL after reconstitution) 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, 
hydrochloric acid. 
 
Solvent: water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 
alcohol swabs, 2 plasters, 1 gauze. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use, after reconstitution.  
Read the package leaflet before use. 
 
An instructional video on how to prepare and administer ELOCTA is available by scanning the QR code 
with a smartphone or via the website.  
 
QR code to be included+ http://www.elocta-instructions.com 
 
 
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 
 
 

http://www.eloct-instructions.com/


51 

8. EXPIRY DATE 
 
EXP 
 
Use within 6 hours after reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
Can be stored at room temperature (up to 30°C) for a single period up to 6 months. Must not be returned to 
refrigerator after storage at room temperature. Date removed from refrigerator: 
 
 
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 
 
Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1046/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ELOCTA 4000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



52 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



53 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ELOCTA 4000 IU powder for injection 
 
efmoroctocog alfa 
recombinant coagulation factor VIII 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
4000 IU 
 
 
6. OTHER 
  



54 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for ELOCTA 
water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
 
  



55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



56 

Package leaflet: information for the user 
 

ELOCTA 250 IU powder and solvent for solution for injection 
ELOCTA 500 IU powder and solvent for solution for injection 
ELOCTA 750 IU powder and solvent for solution for injection 

ELOCTA 1000 IU powder and solvent for solution for injection 
ELOCTA 1500 IU powder and solvent for solution for injection 
ELOCTA 2000 IU powder and solvent for solution for injection 
ELOCTA 3000 IU powder and solvent for solution for injection 
ELOCTA 4000 IU powder and solvent for solution for injection 

 
efmoroctocog alfa (recombinant coagulation factor VIII)  

 
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, pharmacist or nurse.  
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What ELOCTA is and what it is used for  
2. What you need to know before you use ELOCTA 
3. How to use ELOCTA  
4. Possible side effects  
5. How to store ELOCTA 
6. Contents of the pack and other information 
7. Instructions for preparation and administration 
 
 
1. What ELOCTA is and what it is used for 
 
ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion 
protein. Factor VIII is a protein produced naturally in the body and is necessary for the blood to form clots 
and stop bleeding.  
 
ELOCTA is a medicine used for the treatment and prevention of bleeding in all age groups of patients with 
haemophilia A (inherited bleeding disorder caused by factor VIII deficiency). 
 
ELOCTA is prepared by recombinant technology without addition of any human- or animal-derived 
components in the manufacturing process.  
 
How ELOCTA works 
In patients with haemophilia A, factor VIII is missing or not working properly. ELOCTA is used to replace 
the missing or deficient factor VIII. ELOCTA increases factor VIII level in the blood and temporarily 
corrects the bleeding tendency. 
 
 



57 

2. What you need to know before you use ELOCTA 
 
Do not use ELOCTA: 
• if you are allergic to efmoroctocog alfa or any other ingredients of this medicine (listed in section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using ELOCTA. 
 
• There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic 

reaction) to ELOCTA. Signs of allergic reactions may include generalised itching, hives, tightness of 
the chest, difficulty breathing and low blood pressure. If any of these symptoms occur, stop the 
injection immediately and contact your doctor. 

 
• The formation of inhibitors (antibodies) is a known complication that can occur during treatment with 

all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working 
properly and you or your child will be monitored carefully for the development of these inhibitors. If 
your or your child’s bleeding is not being controlled with ELOCTA, tell your doctor immediately. 

 
Cardiovascular events 
If you have heart disease or are at risk for heart disease, take special care when using factor VIII medicines 
and talk to your doctor. 
Catheter-related complications 
If you require a central venous access device (CVAD), risk of CVAD-related complications including local 
infections, presence of bacteria in the blood and catheter site thrombosis should be considered. 
 
Documentation 
It is strongly recommended that every time ELOCTA is given, the name and batch number of the product are 
recorded. 
 
Other medicines and ELOCTA 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines  
No effects on ability to drive or use of machines have been observed. 
 
ELOCTA contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. 
However, depending on your body weight and dose, you could receive more than one vial. This should be 
taken into consideration if you are on a controlled sodium diet. 
 
 
3. How to use ELOCTA 
 
Treatment with ELOCTA will be started by a doctor who is experienced in the care of patients with 
haemophilia. Always use this medicine exactly as your doctor has told you (see section 7). Check with your 
doctor, pharmacist or nurse if you are not sure. 
 
ELOCTA is given as an injection into a vein. Your doctor will calculate the dose of ELOCTA (in 
International Units or “IU”) depending on your individual needs for factor VIII replacement therapy and on 
whether it is used for prevention or treatment of bleeding. Talk to your doctor if you think that your bleeding 
is not being controlled with the dose you receive. 
 



58 

How often you need an injection will depend on how well ELOCTA is working for you. Your doctor will 
perform appropriate laboratory tests to make sure that you have adequate factor VIII levels in your blood.  
 
Treatment of bleeding  
The dose of ELOCTA is calculated depending on your body weight and the factor VIII levels to be achieved. 
The target factor VIII levels will depend on the severity and location of the bleeding. 
 
Prevention of bleeding 
The usual dose of ELOCTA is 50 IU per kg of body weight, given every 3 to 5 days. The dose may be 
adjusted by your doctor in the range of 25 to 65 IU per kg of body weight. In some cases, especially in 
younger patients, shorter dosing intervals or higher doses may be necessary. 
 
Use in children and adolescents 
ELOCTA can be used in children and adolescents of all ages. In children below the age of 12, higher doses 
or more frequent injections may be needed. 
 
If you use more ELOCTA than you should 
Tell your doctor as soon as possible. You should always use ELOCTA exactly as your doctor has told you, 
check with your doctor, pharmacist or nurse if you are not sure. 
 
If you forget to use ELOCTA 
Do not take a double dose to make up for a forgotten dose. Take your dose as soon as you remember and 
then resume your normal dosing schedule. If you are not sure what to do, ask your doctor or pharmacist. 
 
If you stop using ELOCTA 
Do not stop using ELOCTA without consulting your doctor. If you stop using ELOCTA you may no longer 
be protected against bleeding or a current bleed may not stop. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects  
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately. 
You must contact your doctor immediately if you experience any of the following symptoms of allergic 
reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, 
burning and stinging at the injection site, chills, flushing, headache, low blood pressure, general feeling of 
being unwell, nausea, restlessness and fast heartbeat, feeling dizzy or loss of consciousness. 
 
For children previously untreated with factor VIII medicines, inhibitor antibodies (see section 2) may form 
very commonly (more than 1 in 10 patients); however, patients who have received previous treatment with 
factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this 
happens the medicines may stop working properly and you may experience persistent bleeding. If this 
happens, you should contact your doctor immediately. 
 
The following side effects may occur with this medicine. 
 
Uncommon side effects (may affect up to 1 in 100 people) 
Headache, dizziness, taste alteration, slow heartbeat, high blood pressure, hot flushes, vascular pain after 
injection, cough, lower abdominal pain, rash, joint swelling, muscle pain, back pain, joint pain, general 
discomfort, chest pain, feeling cold, feeling hot and low blood pressure. 
 



59 

Reporting of side effects  
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. 
 
 
5. How to store ELOCTA 
 
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 carton and the vial label after “EXP”. 
The expiry date refers to the last day of that month. Do not use this medicine if it has been stored at room 
temperature for longer than 6 months. 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
Alternatively, ELOCTA may be stored at room temperature (up to 30°C) for a single period not exceeding 
6 months. Record on the carton the date that ELOCTA is removed from the refrigerator and set at room 
temperature. After storage at room temperature, the product must not be put back in the refrigerator. 
 
Once you have prepared ELOCTA it should be used right away. If you cannot use the prepared ELOCTA 
solution immediately, it should be used within 6 hours. Do not refrigerate the prepared solution. Protect the 
prepared solution from direct sunlight. 
 
The prepared solution will be clear to slightly opalescent and colourless. Do not use this medicine if you 
notice that it is cloudy or contains visible particles. 
 
Discard any unused solution appropriately. Do not throw away any medicines via wastewater or household 
waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help 
protect the environment. 
 
 
6. Contents of the pack and other information 
 
What ELOCTA contains 
 
• The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein). 

Each vial of ELOCTA contains nominally 250, 500, 750, 1000, 1500, 2000, 3000 or 4000 IU 
efmoroctocog alfa. 

• The other ingredients are sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 
20, sodium hydroxide, hydrochloric acid and water for injections. If you are on a controlled sodium 
diet, see section 2. 

 
What ELOCTA looks like and contents of the pack 
 
ELOCTA is provided as a powder and solvent for solution for injection. The powder is a white to off-white 
powder or cake. The solvent provided for preparation of the solution to inject, is a clear, colourless solution. 
After preparation, the solution to inject is clear to slightly opalescent and colourless. 
 
Each pack of ELOCTA contains 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial 
adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad. 
 

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


60 

Marketing Authorisation Holder and Manufacturer 
Swedish Orphan Biovitrum AB (publ)  
SE-112 76 Stockholm, 
Sweden 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 
Turn the leaflet over for instructions for preparation and administration 



61 

Instructions for preparation and administration 
 
ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the 
solvent supplied in the pre-filled syringe. ELOCTA pack contains: 
 
 
 
 
 
 
 
 
 
 
 
 
 
ELOCTA should not be mixed with other solutions for injection or infusion. 
 
Wash your hands before opening the pack 
 
Preparation: 
 

1. Check the name and strength of the package, to make sure it contains the correct medicine. 
Check the expiry date on the ELOCTA carton. Do not use if the medicine has expired. 

 
2. If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe 
 with solvent (B) to reach room temperature before use. Do not use external heat. 
 
3. Place the vial on a clean flat surface. Remove the plastic flip-top 
 cap from the ELOCTA vial. 
 
 
 
 
 

 

4. Wipe the top of the vial with one of the alcohol swabs (F) 
 provided in the pack, and allow to air dry. Do not touch the top of 
 the vial or allow it to touch anything else once wiped. 
 
 
 
 

 

5. Peel back the protective paper lid from the clear plastic vial adapter (D). Do not remove the 
 adapter from its protective cap. Do not touch the inside of the vial adapter package. 
 
6. Hold the vial adapter in its protective cap and place it squarely 
 over the top of the vial. Press down firmly until the adapter snaps 
 into place on top of the vial, with the adapter spike penetrating the 
 vial stopper. 

 
 

 

A) 1 Powder vial 
B) 3 mL solvent in pre-filled syringe 
C) 1 Plunger rod  
D) 1 Vial adapter 
E) 1 Infusion set 
F) 2 Alcohol swabs 
G) 2 Plasters  
H) 1 Gauze pad 
 



62 

7. Attach the plunger rod (C) to the solvent syringe by inserting the 
 tip of the plunger rod into the opening in the syringe plunger. Turn 
 the plunger rod firmly clockwise until it is securely seated in the 
 syringe plunger. 

 

8. Break off the white, tamper-resistant, plastic cap from the solvent 
 syringe by bending at the perforation cap until it snaps off. Set the 
 cap aside by placing it with the top down on a flat surface. Do not 
 touch the inside of the cap or the syringe tip. 
 

 

9. Lift the protective cap away from the adapter and discard.  

10.  Connect the solvent syringe to the vial adapter by inserting the tip 
 of the syringe into the adapter opening. Firmly push and turn the 
 syringe clockwise until it is securely connected. 

 

11. Slowly depress the plunger rod to inject all the solvent into the  
 ELOCTA vial. 

 

12. With the syringe still connected to the adapter and the plunger rod 
 pressed down, gently swirl the vial until the powder is dissolved.  
 Do not shake. 

 

13. The final solution must be inspected visually before administration. The solution should appear 
 clear to slightly opalescent and colourless. Do not use the solution if cloudy or contains visible 
 particles. 
 
14. Ensuring that the syringe plunger rod is still fully pressed down, 
 invert the vial. Slowly pull on the plunger rod to draw back all the 
 solution through the vial adapter into the syringe. 
 

 

15. Detach the syringe from the vial adapter by gently pulling and 
 turning the vial counterclockwise. 
 

 



63 

Note: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately 
as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the 
vial adapter in place. A single large luer lock syringe may be used to draw back the prepared contents 
of each of the individual vials. 
 
16. Discard the vial and the adapter. 
 
Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the 
syringe tip. Do not touch the syringe tip or the inside of the cap. 
 
After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration. 
After this time, the prepared ELOCTA should be discarded. Protect from direct sunlight. 
 

 
 
Administration (Intravenous injection): 
 
ELOCTA should be administered using the infusion set (E) provided in this pack. 
 

1. Open the infusion set package and remove the cap at the end of the 
tubing. Attach the syringe with the prepared ELOCTA solution to 
the end of the infusion set tubing by turning clockwise. 

 

2. If needed apply a tourniquet and prepare the injection site by wiping the skin well with the other 
alcohol swab provided in the pack. 

 

3. Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid 
 has reached the infusion set needle. Do not push the solution through the needle. Remove the 
 clear plastic protective cover from the needle. 

4. Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the 
 tourniquet. If preferred, you may use one of the plasters (G) provided in the pack to hold the 
 plastic wings of the needle in place at the injection site. The prepared product should be 
 injected intravenously over several minutes. Your doctor may change your recommended 
 injection rate to make it more comfortable for you. 

5. After completing the injection and removing the needle, you 
 should fold over the needle protector and snap it over the needle. 

 



64 

6. Please safely dispose of the used needle, any unused solution, the syringe and the empty vial 
 in an appropriate medical waste container as these materials may hurt others if not disposed of 
 properly. Do not reuse equipment. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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