Cablivi

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ANNEX I  
 

SUMMARY OF PRODUCT CHARACTERISTICS  
  



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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.  
 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Cablivi 10 mg powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Each vial of powder contains 10 mg of caplacizumab*. 
Each pre-filled syringe of solvent contains 1 mL of water for injections. 
 
* Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant 
DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Powder and solvent for solution for injection. 
 
White lyophilised powder. 
The solvent is a clear, colourless liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
Cablivi is indicated for the treatment of adults and adolescents of 12 years of age and older weighing 
at least 40 kg  experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in 
conjunction with plasma exchange and immunosuppression. 
 
4.2 Posology and method of administration  
 
Treatment with Cablivi should be initiated and supervised by physicians experienced in the 
management of patients with thrombotic microangiopathies.  
 
Posology 
 
First dose 
Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.  
 
Subsequent doses 
Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma 
exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous 
injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment. 
 
If at the end of this period there is evidence of unresolved immunological disease, it is recommended 
to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg 
of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained 
normalisation of ADAMTS13 activity level). 



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In the clinical development program, caplacizumab has been administered daily for up to 65 days. No 
data on re-treatment with caplacizumab are available.  
 
Missed dose 
If a dose of Cablivi is missed, it can be administered within 12 hours. If more than 12 
hours have passed since the dose was to have been given, the missed dose should NOT be 
administered and the next dose should be administered per the usual dosing schedule. 
 
Special populations 
 
Renal impairment 
No dose adjustment is necessary for patients with renal impairment (see section 5.2).  
 
Hepatic impairment 
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). See section 4.4 
for special considerations in patients with severe hepatic impairment. 
 
Elderly 
While experience with the use of caplacizumab in the elderly is limited, there is no evidence to suggest 
that dose adjustment or special precautions are needed for elderly patients (see section 5.2).  
 
Paediatric population 
The safety and efficacy of caplacizumab in the paediatric population have not been established in 
clinical trials. The posology of Cablivi in adolescents of 12 years of age and older weighing at least 40 
kg is the same as in adults (see section 5.2). No recommendations can be made on the posology of 
Cablivi for paediatric patients below 40 kg of body weight.  
 
Method of administration  
The first dose of Cablivi is to be administered as an intravenous injection. Subsequent doses are to be 
administered via subcutaneous injection in the abdomen.  
 
Injections into the area around the navel should be avoided and consecutive injections should not be 
administered in the same abdominal quadrant. 
 
Patients or caregivers may inject the medicinal product after proper training in the subcutaneous 
injection technique.  
 
For instructions on reconstitution of Cablivi 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  
 
Bleeding 
 
Active clinically significant bleeding 
In case of active, clinically significant bleeding, treatment with Cablivi should be interrupted. If 
needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis. 
Cablivi should only be restarted upon the advice of a physician experienced in the management of 
thrombotic microangiopathies.  
 
Increased risk of bleeding 
 
In the setting of concomitant use of oral anticoagulants or high dose heparin 



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Due to a potential increased risk of bleeding, initiation or continuation of treatment with oral 
anticoagulants or high dose heparin requires a benefit/risk assessment and close clinical monitoring. 
 
In the setting of concomitant use of anti-platelet agents and / or low molecular weight heparin 
(LMWH) 
While no increased risk of bleeding was observed in clinical trials, concomitant treatment with anti-
platelet agents and / or LMWH requires a benefit/risk assessment and close clinical monitoring. 
 
In patients with coagulopathies 
Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies 
(e.g. hemophilia, other coagulation factor deficiencies) is to be accompanied by close clinical 
monitoring. 
 
In patients undergoing surgery 
If a patient is to undergo elective surgery or a dental procedure, the patient should be advised to 
inform the physician or dentist that they are using Cablivi, and treatment should be stopped at least 7 
days before the planned intervention. The patient should also notify the physician who supervises the 
treatment with Cablivi about the planned procedure.  
If emergency surgery is needed, the use of von Willebrand Factor concentrate could be considered to 
correct hemostasis. 
 
Severe hepatic impairment 
No formal study with caplacizumab has been conducted in patients with severe acute or chronic 
hepatic impairment and no data regarding the use of caplacizumab in these populations are available. 
Use of Cablivi in this population requires a benefit/risk assessment and close clinical monitoring. 
 
Traceability  
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
No interaction studies evaluating use of caplacizumab with oral anticoagulants (e.g. vitamin K 
antagonists, direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors) or 
high dose heparin have been performed (See section 4.4 In the setting of concomitant use of oral 
anticoagulants or high dose heparin).  
 
4.6 Fertility, pregnancy and lactation  
 
Pregnancy 
There are no data on the use of caplacizumab in pregnant women. Studies in guinea pigs showed no 
effect of caplacizumab on the dams or foetuses (see section 5.3).  
As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy. 
 
Breastfeeding 
There are no data on the use of caplacizumab in breastfeeding women. It is unknown whether 
caplacizumab is excreted in human milk. A risk to the child cannot be excluded.  
A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, 
taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. 
 
Fertility 
The effects of caplacizumab on fertility in humans are unknown. In animal toxicology studies, no 
impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).  
 
4.7 Effects on ability to drive and use machines  
 
Cablivi has no or negligible influence on the ability to drive and use machines.  



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4.8 Undesirable effects  
 
Summary of the safety profile 
 
The most frequent adverse reactions in clinical trials were epistaxis, headache and gingival bleeding. 
The most common serious adverse reaction was epistaxis.  
 
Tabulated list of adverse reactions 
Adverse reactions are listed below by MedDRA system organ class and by frequency. Frequencies are 
defined as follows: 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).   
 
System organ class Very common Common 

Nervous system disorders Headache Cerebral infarction 

Eye disorders  Eye Haemorrhage* 

Vascular disorders  Haematoma* 

Respiratory, thoracic and 
mediastinal disorders 

Epistaxis* Dyspnoea, Haemoptysis* 
 

Gastrointestinal disorders Gingival bleeding*  Haematemesis*, haematochezia*, 
melaena*, upper gastrointestinal 
haemorrhage*, haemorrhoidal 
haemorrhage*, rectal haemorrhage *, 
abdominal wall haematoma* 

Skin and subcutaneous tissue 
disorders 

Urticaria  

Musculoskeletal and 
connective tissue disorders 

 Myalgia 

Renal And Urinary Disorders  Haematuria* 

Reproductive system and 
breast disorders 

 Menorrhagia*, vaginal haemorrhage* 

General disorders and 
administration site conditions 

Pyrexia, Fatigue  Injection site haemorrhage*, injection site 
pruritus, injection site erythema, injection 
site reaction 

Injury, Poisoning And 
Procedural Complications 

 Subarachnoid haemorrhage* 

*Bleeding events: see below  
 
Description of selected adverse reactions 
 
Bleeding  
In clinical studies, bleeding events occurred in different body systems, independent of treatment 
duration. Although in some cases these events were serious and required medical attention, most were 
self-limited and all resolved. In case of active clinically significant bleeding, consider actions outlined 
in sections 4.4 and 4.9.  
 
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 



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professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose  
 
In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an 
increased risk of bleeding. Close monitoring for signs and symptoms of bleeding is recommended. 
(see section 4.4).  
 
 
5. PHARMACOLOGICAL PROPERTIES  
 
5.1  Pharmacodynamic properties  
 
Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AX07. 
 
Mechanism of action 
Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building 
blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von 
Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets. As such, 
caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is 
characteristic of aTTP. It also affects the disposition of von Willebrand factor, leading to transient 
reductions of total von Willebrand factor antigen levels and to concomitant reduction of factor VIII:C 
levels during treatment. 
 
Pharmacodynamic effects 
 
Target inhibition 
The pharmacologic effect of caplacizumab on target inhibition was assessed using two biomarkers for 
von Willebrand factor activity; ristocetin-induced platelet aggregation (RIPA) and ristocetin cofactor 
(RICO). Full inhibition of von Willebrand factor-mediated platelet aggregation by caplacizumab is 
indicated by RIPA and RICO levels dropping below 10% and 20%, respectively. All clinical studies 
with caplacizumab demonstrated rapid decreases in RIPA and/or RICO levels after the start of the 
treatment, with recovery to baseline levels within 7 days of discontinuation. The 10 mg subcutaneous 
dose in patients with aTTP elicited full inhibition of von Willebrand factor-mediated platelet 
aggregation, as evidenced by RICO levels of < 20% throughout the treatment period. 
 
Target disposition 
The pharmacologic effect of caplacizumab on target disposition was measured using von Willebrand 
factor antigen and factor VIII clotting activity (factor VIII:C) as biomarkers. Upon repeated 
administration of caplacizumab, a decrease of 30-50% in von Willebrand factor antigen levels was 
observed in clinical studies, reaching a maximum within 1-2 days of treatment. Because von 
Willebrand factor acts as a carrier for factor VIII, reduced von Willebrand factor antigen levels 
resulted in a similar reduction in factor VIII:C levels. The reduced von Willebrand factor antigen and 
FVIII:C levels were transient and returned to baseline upon cessation of treatment. 
 
Clinical efficacy and safety 
 
The efficacy and safety of caplacizumab in adults experiencing an episode of aTTP were established 
in 2 randomised, controlled studies: Phase III study ALX0681-C301 “HERCULES” and Phase II 
study ALX-0681-2.1/10 “TITAN”.  
 
Efficacy 
 
Study ALX0681-C301  
In this double-blind, placebo-controlled study, patients with an episode of aTTP were randomised 1:1 
to receive either caplacizumab or placebo in addition to daily plasma exchange and 

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


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immunosuppression. Patients received a single intravenous bolus injection of 10 mg caplacizumab or 
placebo prior to the first plasma exchange on study. This was followed by daily subcutaneous 
injections of 10 mg caplacizumab or placebo after completion of each plasma exchange for the 
duration of the daily plasma exchange period and for 30 days thereafter. If at the end of this treatment 
period there was evidence of persistent underlying disease activity (indicative of an imminent risk for 
recurrence), treatment could be extended weekly for a maximum of 4 weeks, together with 
optimisation of immunosuppression. If a recurrence occurred while on study drug treatment, patients 
were switched to open-label caplacizumab. They were again treated for the duration of daily plasma 
exchange and for 30 days thereafter. If at the end of this treatment period there were was evidence of 
ongoing underlying disease, open-label treatment with caplacizumab could be extended weekly for a 
maximum of 4 weeks, together with optimisation of immunosuppression. Patients were followed for 1 
month after discontinuation of treatment. In case of recurrence during the follow up period (i.e. after 
all study drug treatment had been stopped), there was no re-initiation of study drug and the recurrence 
was to be treated according to the standard of care. 
  
In this study, 145 patients experiencing an episode of aTTP were randomised (72 to caplacizumab and 
to 73 placebo). Patient age ranged from 18 to 79 years, with a mean of 46 years. Half of the patients 
were experiencing their first episode of aTTP. Baseline disease characteristics were typical of aTTP.  
 
The median treatment duration with caplacizumab in the double blind period was 35 days. 
 
Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count 
response (p<0.01). Patients treated with caplacizumab were 1.55 times more likely to achieve platelet 
count response at any given time point, compared to patients treated with placebo.  
 
Treatment with caplacizumab resulted in a 74% reduction in the composite endpoint of the percentage 
of patients with aTTP-related death (0/72; placebo 3/73), exacerbation of aTTP (3/72; placebo 28/73), 
or at least one major thromboembolic event during study drug treatment (6/72; placebo 6/73) 
(p<0.0001). There were no deaths in the caplacizumab group and 3 deaths in the placebo group during 
the study drug treatment period. 
 
The proportion of patients with a recurrence of aTTP (exacerbation or relapse) in the overall study 
period (including the 28 day follow-up after discontinuation of study drug treatment) was 67% lower 
in the caplacizumab group (9/72; relapse : 6/72) compared to the placebo group (28/73; relapse 0/73) 
(p<0.001). 
 
No patients treated with caplacizumab (0/72) were refractory to treatment (defined as absence of 
platelet count doubling after 4 days of standard treatment and elevated LDH) compared to three 
patients treated with placebo (3/73).  
 
Treatment with caplacizumab reduced the mean number of days of plasma exchange, the volume of 
plasma used, the mean length of Intensive Care Unit stay and the mean length of hospitalization 
during the study drug treatment period. 
 

  Placebo Caplacizumab 
Number of days of Plasma Exchange (days) N 

Mean (SE) 
73 
9.4 (0.81)     

71 
5.8 (0.51) 

Total volume of plasma used (liter) N 
Mean (SE) 

73 
35.93 (4.17)         

71 
21.33 (1.62)                                                

Length of hospitalization (days) N 
Mean (SE) 

73 
14.4 (1.22)                 

71 
9.9 (0.70) 

Number of days in ICU N 
Mean (SE) 

27 
9.7 (2.12)                                      

28 
3.4 (0.40) 

N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit 
 



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Immunogenicity 
In clinical studies, up to 9% of patients developed treatment-emergent anti-drug antibodies (ADA). No 
impact on clinical efficacy was observed and no serious adverse events were found to be associated 
with these ADA responses. 
 
Paediatric population 
See section 4.2 for information on paediatric use and section 5.2 for results of modeling and 
simulation studies for paediatric patients. There are no clinical data for paediatric patients. 
 
5.2 Pharmacokinetic properties  
 
The pharmacokinetics of caplacizumab have been investigated in healthy subjects after single 
intravenous infusions and after single and repeated subcutaneous injections. Pharmacokinetics in 
patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.  
 
Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by target-
mediated disposition. In healthy volunteers receiving 10 mg caplacizumab subcutaneoulsy once daily, 
the maximum concentration was observed at 6-7 hours post-dose and steady-state was reached 
following the first administration, with minimal accumulation.  
 
Absorption 
After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed 
(estimated F> 0.901) in the systemic circulation. 
 
Distribution 
After absorption, caplacizumab binds to the target and distributes to well perfused organs. In patients 
with aTTP the central volume of distribution was estimated at 6.33 L. 
 
Biotransformation/Elimination 
The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor. 
Higher levels of von Willebrand factor antigen, such as in patients with aTTP, increase the fraction of 
drug-target complex retained in the circulation. The t1/2 of caplacizumab is, therefore, concentration- 
and target level-dependent. Target-bound caplacizumab is assumed to be catabolised within the liver, 
whereas unbound caplacizumab is assumed to be renally cleared. 
 
Characteristics in specific groups 
The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis 
on pooled pharmacokinetic data. Body weight was allometrically included in the model. Differences in 
the different subpopulations were investigated. In studied populations; gender, age, blood group and 
race did not affect the pharmacokinetics of caplacizumab.  
 
Renal or hepatic impairment 
No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of caplacizumab 
has been conducted. In the population PK/PD model, renal function (CRCL) had a statistically 
significant effect resulting in limited increase in predicted exposure (AUCss) in severe renal 
impairment. In the clinical studies of patients with TTP, those with renal impairment did not show 
additional risk of adverse events.   
 
Paediatric population  
Based on data pooled from clinical studies in adults, a pharmacokinetic-pharmacodynamic (PK/PD) 
population model was developed, describing the interaction between caplacizumab and von 
Willebrand factor antigen (vWF:Ag), in different adult populations following intravenous and 
subcutaneous administration of caplacizumab at various dose levels. For children aged 2 to below 18 
years of age, simulations were performed based on this PK/PD model predicting that exposure and 
suppression of vWF:Ag are expected to be similar to those in adults when 10 mg/day is used in 
children with a bodyweight of ≥40 kg, and when 5 mg/day is used in children with a bodyweight of 
<40 kg.  



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5.3 Preclinical safety data  
 
Consistent with its mode of action, toxicology studies of caplacizumab have shown an increased 
bleeding tendency in guinea pigs (haemorrhagic subcutaneous tissue at the injection sites) and 
cynomolgus monkeys (haemorrhagic subcutaneous tissue at the injection sites, nose bleed, 
exaggerated menstrual bleeding, haematoma at sites of animal handling or experimental procedures, 
prolonged bleeding at injection sites). Furthermore, pharmacology-related decreases of von 
Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to 
a lesser extent for factor VIII:C, in guinea pigs. 
 
An embryo-foetal development study was conducted in guinea pigs, with no reported signs of toxicity. 
A follow-up toxicokinetic study in pregnant guinea pigs assessed exposure of caplacizumab in the 
dams and foetuses. The results indicated exposure to caplacizumab in dams and, to a much lesser 
extent, foetuses, with no reported effects on foetal development. Foetal exposure to caplacizumab in 
primates and humans remains uncertain, as proteins lacking an Fc portion are not thought to freely 
pass the placental barrier. 
 
No studies have been performed to evaluate the mutagenic potential of caplacizumab, as such tests are 
not relevant for biologicals. Based on a carcinogenicity risk assessment, dedicated studies were not 
deemed necessary.  
 
Dedicated animal studies assessing the effects of caplacizumab on male and female fertility have not 
been performed. In repeat-dose toxicity tests in cynomolgus monkeys, no impact of caplacizumab on 
fertility parameters in male (testicular size, sperm function, histopathological analysis of testis and 
epididymis) and female (histopathological analysis of reproductive organs, periodic vaginal cytology) 
animals was observed.  
 
 
6. PHARMACEUTICAL PARTICULARS  
 
6.1 List of excipients  
 
Powder 
Sucrose 
Citric acid anhydrous 
Trisodium citrate dihydrate 
Polysorbate 80 
 
Solvent 
Water for injections 
 
6.2 Incompatibilities  
 
In the absence of compatibility studies, Cablivi must not be mixed with other medicinal products. 
 
6.3 Shelf life  
 
Unopened vial 
4 years. 
 
Reconstituted solution 
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. 
From a microbiological point of view, unless the method of reconstitution precludes the risk of 
microbial contamination, the product should be used immediately.  
If not used immediately, in-use storage times and conditions are the responsibility of user. 



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6.4 Special precautions for storage  
 
Store in a refrigerator (2 °C - 8 °C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not 
beyond the expiry date. Do not return Cablivi to refrigerated storage after storage at room temperature. 
 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
6.5 Nature and contents of container  
 
Powder 
Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), 
containing 10 mg of caplacizumab. 
 
Solvent 
Pre-filled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of water 
for injections. 
 
Pack size 
 
• Single pack containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 

hypodermic needle (30 gauge) and 2 alcohol swabs. 
• Multipack containing 7 single packs.  
• Multidose pack containing 7 vials with powder, 7 pre-filled syringes with solvent, 7 vial adapters, 

7 hypodermic needles (30 gauge) and 14 alcohol swabs. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling  
 
For both intravenous and subcutaneuous administration,reconstitute the powder contained in the vial 
using the vial adapter and all solvent in the pre-filled syringe. The solvent should be added slowly and 
mixed gently to avoid foaming of the solution. Allow the vial with connected syringe to stand on a 
surface for 5 minutes at room temperature. 
 
The reconstituted solution is clear, colourless, or slightly yellowish. It must be visually inspected for 
particulate matter. Do not use solution exhibiting particulates.  
 
Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately 
administer the entire volume of the syringe (see section 6.3).  
 
Cablivi is for single use only. Any unused medicinal product or waste material should be disposed of 
in accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER  
 
Ablynx NV 
Technologiepark 21  
9052 Zwijnaarde 
Belgium 
 
 



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8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1305/001 
EU/1/18/1305/002 
EU/1/18/1305/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 31 August 2018 
 
 
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/


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ANNEX II 

A. MANUFACTURER 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 
 



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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer of the biological active substance 
Richter-Helm BioLogics GmbH & Co. KG 
Dengelsberg 
24796 Bovenau 
Germany 
 
Name and address of the manufacturer responsible for batch release 
Ablynx NV 
Technologiepark 21 
9052 Zwijnaarde 
Belgium 
 
 
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. 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 
months following authorisation. 
 
 
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.  
 

• Additional risk minimisation measures 
 

Prior to launch of Cablivi in each Member State the Marketing Authorisation Holder (MAH) must 
agree about the content and format of the patient alert card, including communication media, 
distribution modalities, and any other aspects, with the National Competent Authority.  
The MAH shall ensure that in each Member State where Cablivi is marketed, all patients/carers 
who are expected to use Cablivi are provided with the following patient alert card which shall 



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contain the following key message: 
• to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. 

accident) to inform physicians about the medical blockage of the von Willebrand Factor. 
  



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ANNEX III  
 

LABELLING AND PACKAGE LEAFLET  
  



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A. LABELLING  
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cablivi 10 mg powder and solvent for solution for injection 
caplacizumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE  
 
Each  vial of powder contains 10 mg caplacizumab. 
Each  pre-filled syringe of solvent contains 1 mL of water for injections. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 
1 vial with powder 
1 syringe with solvent 
1 sterile vial adapter 
1 sterile needle 
2 alcohol swabs 
 
 
Content : 
7 vials with powder 
7 syringes with solvent 
7 sterile vial adapters 
7 sterile needles 
14  alcohol swabs 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use 
Intravenous and subcutaneous use 
For single use only 
 
 
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 
 



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8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect 
from light. 
 
Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months. 
 
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 
 
Ablynx NV 
Technologiepark 21  
9052 Zwijnaarde, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/18/1305/001 
EU/1/18/1305/003 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cablivi 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



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PC: 
SN: 
NN: 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
Multipack (contains Blue Box) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cablivi 10 mg powder and solvent for solution for injection 
caplacizumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each vial of powder contains 10 mg caplacizumab. 
Each pre-filled syringe of solvent contains 1 mL of water for injections. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Multipack: 7 packs of 1 single dose kit.  
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
For single use only 
Read the package leaflet before use 
Intravenous and subcutaneous 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 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect 
from light. 
 
Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months. 



21 

 
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 
 
Ablynx NV 
Technologiepark 21  
9052 Zwijnaarde 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/18/1305/002 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cablivi 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON 
Multipack (without Blue Box) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cablivi 10 mg powder and solvent for solution for injection 
caplacizumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE  
 
Each vial of powder contains 10 mg caplacizumab. 
Each pre-filled syringe of solvent contains 1 mL of water for injections. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Content: 
1 vial with powder 
1 syringe with solvent 
1 sterile vial adapter 
1 sterile needle 
2 alcohol swabs 
 
Component of a multipack, cannot be sold separately.  
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use 
Intravenous and subcutaneous use 
For single use only 
 
 
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 
 
 



23 

8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect 
from light. 
 
Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months. 
 
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 
 
Ablynx NV 
Technologiepark 21  
9052 Zwijnaarde 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBERS 
 
EU/1/18/1305/002 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cablivi 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



24 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



25 

PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  
 
Cablivi 10 mg powder for injection 
caplacizumab 
IV and SC 
 
 
2. METHOD OF ADMINISTRATION  
 
 
3. EXPIRY DATE  
 
EXP 
 
 
4. BATCH NUMBER  
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT   
 
 
 
6. OTHER  
 
  



26 

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



27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET  
 



28 

  
Package leaflet: Information for the user 

 
Cablivi 10 mg powder and solvent for solution for injection 

caplacizumab 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
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 or pharmacist. 
• 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
1. What Cablivi is and what it is used for  
2. What you need to know before you use Cablivi  
3. How to use Cablivi  
4. Possible side effects  
5. How to store Cablivi  
6. Contents of the pack and other information 
 
 
1. What Cablivi is and what it is used for  
 
Cablivi contains the active substance caplacizumab. It is used to treat an episode of acquired 
thrombotic thrombocytopenic purpura in adults and adolescents of 12 years of age and older 
weighing at least 40 kg. This is a rare blood clotting disorder in which clots form in small blood 
vessels. These clots can block blood vessels and damage the brain, heart, kidneys, or other organs. 
Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping 
together. By doing so, Cablivi reduces the risk of experiencing another episode of aTTP soon after the 
first.  
 
 
2. What you need to know before you use Cablivi  
 
Do not use Cablivi 
• if you are allergic to caplacizumab or any of the other ingredients in this medicine (listed in 

section 6) 
 
Warnings and precautions  
 
Tell your doctor if you:  
• bleed excessively during treatment. Your doctor may ask you to stop the treatment. The doctor 

will say when you can start your treatment again. 
• are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood 

clots). Your doctor will decide how you should be treated.  
• are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent 

blood clots). Your doctor will decide how you should be treated.  
• have a bleeding disorder such as haemophilia. Your doctor will decide how you should be treated. 
• have severely reduced liver function. Your doctor will decide how you should be treated. 



29 

• are going to have an operation or dental treatment. Your doctor will decide if it can be postponed 
or if you should stop Cablivi before your surgery or dental treatment.  

 
Children and adolescents 
Cablivi is not recommended for children under 12 years and below 40 kg body weight.  
 
Other medicines and Cablivi 
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. 
 
Also tell your doctor if you are using an anticoagulant medicine such as vitamin K antagonists, 
rivaroxaban, or apixaban which treat blood clots or anti-platelet agents, such as aspirin, or low 
molecular weight heparin which prevent blood clots. 
 
Pregnancy and breast-feeding 
Tell your doctor if you are pregnant or plan to get pregnant. Use of Cablivi is not recommended during 
pregnancy. 
 
Tell your doctor if you are breastfeeding. Your doctor will advise you whether to discontinue 
breastfeeding or not use Cablivi, considering the benefit of breastfeeding to the baby and the benefit of 
Cablivi to you. 
 
Driving and using machines 
Cablivi is not expected to influence the ability to drive or use machines. 
 
Cablivi contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’. 
 
 
3. How to use Cablivi  
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Treatment with Cablivi is started by a doctor experienced in blood disorders.  
 
The recommended treatment is 

• first dose 
- 1 vial injected into a vein by a healthcare professional  
- the medicine will be given before starting plasma exchange 

 
• subsequent doses: 

-  1 vial once daily as a subcutaneous injection (under the skin of the belly)  
-  the subcutaneous injection will be given after each daily plasma exchange   
-  after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 

30 days with injection of 1 vial once daily.  
-  your doctor may ask you to continue daily treatment until the underlying signs of your disease 

are resolved 
 
Your doctor may decide that you or your caregiver may inject Cablivi. In this case, your doctor or 
healthcare provider will train you or your caregiver on how to use Cablivi. 
 
Instructions for use  
The first injection of Cablivi into your vein must be given by a healthcare professional. Instructions 
for healthcare professionals on how to inject Cablivi into your vein are  at the end of the leaflet. 
 



30 

For each injection, use a fresh kit package to prepare the injection solution. Do not try to inject Cablivi 
until you have been taught how to do so by a healthcare professional. Never use the kit for another 
injection. 
 
Step 1 - Cleaning  
• Wash your hands thoroughly with soap and water. 
• Prepare a clean flat surface for placing the kit package. 
• Make sure you have a disposal container at hand. 
 
Step 2 - Before use  
• Make sure the kit package is complete. 
• Check the expiry date. Do not use if the expiry date has passed.  
• Do not use the kit if the packaging or the items in it are damaged in any way. 
• Place all components of the kit on the clean flat surface.  
• If the kit was not stored at room temperature, allow the vial and the syringe to reach room 

temperature (15°C – 25°C) by letting them stand at room temperature for a few minutes. Do not 
warm them up in any other way. 
  

Step 3 - Disinfect the rubber stopper  
• Remove the plastic flip-off cap from the vial. Do not use the vial if the green plastic cap is 

missing. 
• Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for 

a few seconds. 
• After cleaning, do not touch the rubber stopper or allow it to touch any surface.  

 
Step 4 - Attaching the adapter  
• Take the packed vial adapter and remove the paper cover. Leave the adapter in its opened 

plastic packaging. Do not touch the adapter itself.  

 
• Place the adapter over the vial, while keeping the adapter in its plastic packaging. 
• Press down firmly until the adapter snaps into place, with the adapter spike going through the 

vial stopper. Leave the adapter attached to the vial, still in its outer packaging. 
 



31 

 
Step 5 - Prepare the syringe  
• Holding the syringe in your hand, break off the white cap with your other hand.  
• Do not use the syringe if this white cap is missing, loose or damaged. 

 
• Do not touch the syringe tip or allow it to come into contact with any surfaces. 
• Place the syringe on the clean flat surface.  
 
Step 6 - Connect syringe with adapter and vial  
• Take the vial with the attached adapter. 
• Remove the plastic packaging from the adapter by holding the vial with one hand, pressing the 

sides of the adapter packaging with your other hand, and then lifting the packaging upwards. 
Take care that the adapter does not come away from the vial. 

 
 
 
 
 
 
 
 
 
 

• Hold the adapter with the attached vial with one hand. Place the tip of the syringe on the 
connector part of the vial adapter.  

• Gently lock the syringe onto the vial by turning it clockwise until resistance is felt. 

 



32 

Step 7 - Prepare the solution  
• Keep the vial standing vertically on the surface with the syringe pointing downwards. 
• Slowly push the syringe’s plunger down until the syringe is empty. Do not remove the syringe 

from the vial. 
• With the syringe still connected to the vial adapter, gently swirl the vial with connected syringe 

until the powder is dissolved. Avoid foaming. Do not shake the vial. 

 
• Allow the vial with connected syringe to stand on the surface for 5 minutes at room temperature 

to allow the solution to completely dissolve. The plunger may rise up by itself again - this is 
normal.  

• Go to step 8 immediately after these 5 minutes. 
 
Step 8 - Draw up solution  
• Check the solution for particles. All powder must be dissolved and the solution must be clear. 
• Slowly press the syringe’s plunger fully down.  
• Turn the whole - vial, adapter and syringe - upside down. 
• While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe. Do 

not shake it. 

 
Step 9 - Prepare the syringe for administration  

 
• Turn the whole - vial, adapter and syringe - right-side up (with the syringe at the top). 

Disconnect the filled syringe from the adapter by holding the adapter in one hand and gently 
turning the syringe counter-clockwise. 

• Put the vial and the attached adapter into the supplied disposal container. 
• Do not touch the syringe tip or allow it to touch the surface. Place the syringe on the clean flat 

surface. 



33 

• Go to step 10 to inject caplacizumab under the skin of the belly. Instructions for healthcare 
professionals on how to inject Cablivi into your vein are at the end of the leaflet. 

 
Step 10 - Attach the needle  
• Unpack the needle by tearing the paper cover off the needle packaging and removing the needle 

with protective cap.  

 
• Without removing the needle cap, attach the needle to the syringe by turning clockwise until 

resistance is felt.  
• Pull back the needle safety shield. 
• Check the content of the syringe. Do not use the medicine if you see any cloudiness, clumps 

or anything else that looks abnormal. Contact your doctor or nurse if this happens. 
 
Step 11 - Prepare injection site for injection under the skin  

 
• Select a suitable place (‘injection site’) on your belly for injection under your skin.Avoid the 

area around the belly button. Select a different injection site from the one you used on the 
previous day to help the skin to recover after the injection.' 

• Use the second alcohol pad to clean the injection site you have chosen. 
 

Step 12 - Administration  
• Carefully remove the needle protection cap from the needle and throw it away. Make sure the 

needle does not touch anything before the injection. 
• Hold the syringe at eye level with the needle pointing upwards. 
• Remove any air bubbles by tapping the side of the syringe with your finger to make the bubbles 

rise towards the tip. Then, slowly push the plunger until a small amount of liquid comes out of 
the needle. 



34 

• Gently pinch the cleaned skin between your thumb and forefinger to make a fold.  

 
• Hold this skin fold during the entire injection. 
• Insert the full length of the needle into the skin fold at an angle as shown in the illustration. 
• Press the plunger down as far as it goes. 

 
• Pull out the needle at the same angle you inserted it. Do not rub the injection site. 
 
Step 13 - After administration  
• Immediately after the injection, move the needle safety shield over the needle, until it clicks into 

place. 

 
• Put the syringe with the needle in a disposal container. 
 
If you use more Cablivi than you should 
An overdose is unlikely since one vial contains only a single dose. Tell your doctor if you think you 
have had an overdose.  
 
If you forget to use Cablivi 
If you miss a dose you should still take it if it is within 12 hours of the scheduled time. If more than 12 
hours have passed since the dose should have been given, do not take the missed dose, but inject the 
next dose at the usual time. 
 



35 

If you stop using Cablivi 
To get the most benefit from your treatment, it is important to use Cablivi as prescribed and for as long 
as your doctor tells you to use it. Please talk to your doctor before you stop the treatment because 
stopping it too early can cause your condition to come back. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects  
  
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Contact your doctor immediately if any of the following serious side effects occur.  
Long or excessive bleeding.  
Your doctor may decide to keep you under closer observation or change your treatment.  
 
Side effects in a clinical study were reported with the following frequencies: 
 
Very common, may affect more than 1 in 10 people 
• bleeding gums 
• fever 
• tiredness 
• headache 
• nosebleeds 
• hives 
 
Common, may affect up to 1 in 10 people 
• bleeding from eye 
• vomiting blood  
• blood in the stools 
• black, tarry stools 
• bleeding from the stomach  
• bleeding hemorrhoids 
• rectal bleeding 
• injection site reactions: rash, itching and bleeding  
• bleeding in brain as evidenced by severe headache of rapid onset, vomiting, decreased level of 

consciousness, fever, sometimes seizures and neck stiffness or neck pain 
• muscle pain 
• stroke 
• blood in urine 
• excessive bleeding during periods 
• vaginal bleeding  
• coughing blood 
•     shortness of breath  
• bruise 
 
Reporting of side effects 
If you experience any side effects, talk to your doctor or pharmacist. 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. 
 
 

https://en.wikipedia.org/wiki/Thunderclap_headache
https://en.wikipedia.org/wiki/Vomiting
https://en.wikipedia.org/wiki/Decreased_level_of_consciousness
https://en.wikipedia.org/wiki/Decreased_level_of_consciousness
https://en.wikipedia.org/wiki/Fever
https://en.wikipedia.org/wiki/Seizure
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


36 

5. How to store Cablivi  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2 °C - 8 °C). Do not freeze. 
Store in the original package in order to protect from light. 
 
Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not 
beyond the expiry date. Do not return Cablivi to refrigerated storage after storage at room temperature. 
Never expose to temperatures above 30 °C. 
 
Do not use Cablivi if you notice any particulate matter or discolouration prior to administration. 
 
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 Cablivi contains 
 
• powder vial 

- The active substance is caplacizumab. 
Each vial contains 10 mg caplacizumab. 

- The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate and 
polysorbate 80. 

• pre-filled syringe 
The pre-filled syringe contains 1 mL water for injections. 

 
What Cablivi looks like and contents of the pack 
 
Cablivi is provided as: 
• a white powder for solution for injection in a glass vial, and 
• water for injections in a pre-filled syringe to dissolve the powder 
After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish. 
 
Cablivi is available in  

• single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 
1 vial adapter, 1 needle and 2 alcohol swabs 

• multipacks each containing 7 single packs 
• multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with 

solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.  
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Ablynx NV 
Technologiepark 21  
9052 Zwijnaarde  
Belgium 
 
  



37 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 

Lietuva 
UAB «SANOFI-AVENTIS LIETUVA»  
Tel: +370 5 2755224 
 

България 
Sanofi Bulgaria EOOD 
Тел.: +359 (0)2 970 53 00 

Luxembourg/Luxemburg 
Sanofi Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
Tel.: +36 1 505 0050 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 

Malta 
Sanofi S.p.A. 
Tel: +39 02 39394275 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 04 36 996 
Tel. aus dem Ausland: +49 69 305 70 13 
 

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 20 245 4000 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Norge 
sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

España 
sanofi-aventis, S.A. 
Tel: +34 93 485 94 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

Portugal 
Sanofi - Produtos Farmacêuticos, Lda. 
Tel: +351 21 35 89 400 

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 
 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 

Ireland 
sanofi-aventis Ireland Ltd.  T/A SANOFI 
Tel: +353 (0) 1 403 56 00 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 

Italia 
Sanofi S.p.A. 
Tel: 800536389 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: +358 (0) 201 200 300 
 



38 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Latvija  
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
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: 
 
The intravenous bolus injection of Cablivi given at the start of the treatment must be administered by a 
health care professional. Preparing a dose of Cablivi for intravenous injection should be done in the 
same way as for a subcutaneous injection (see Instructions for Use, step 1 to 9, in section 3). 
 
Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks 
of IV lines or using a suitable needle. The line can be flushed with 0.9% sodium chloride. 
 

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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