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SPC: CABLIVI Powder and solvent for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cablivi 10 mg powder and solvent for solution for injection.

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 ...

Pharmaceutical form

Powder and solvent for solution for injection. White lyophilised powder. The solvent is a clear, colourless liquid.

Therapeutic indications

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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 ...

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 ...

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, ...

Effects on ability to drive and use machines

Cablivi has no or negligible influence on the ability to drive and use machines.

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 ...

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 ...

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), ...

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 ...

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 ...

List of excipients

Powder: Sucrose Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80 Solvent: Water for injections

Incompatibilities

In the absence of compatibility studies, Cablivi must not be mixed with other medicinal products.

Shelf life

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 ...

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, ...

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 ...

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 ...

Marketing authorization holder

Ablynx NV, Technologiepark 21, 9052, Zwijnaarde, Belgium

Marketing authorization number(s)

EU/1/18/1305/001 EU/1/18/1305/002 EU/1/18/1305/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 31 August 2018

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