Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Caplacizumab
Ablynx NV
B01A
caplacizumab
Antithrombotic agents
Purpura, Thrombotic Thrombocytopenic
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
Revision: 8
Authorised
2018-08-30
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER CABLIVI 10 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION caplacizumab 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 or experience unusual symptoms such as headache, shortness of breath, tiredness, or fainting which may indicate serious internal bleeding. Your doctor may ask you to stop the treatment. The doctor will say when you can start your treatm Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 immunosuppression 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). 3 In the clinical development program, caplacizumab has been administered daily for up to 71 days consecutively. Data on re-treatment with caplacizumab are available (see section 5.1). _Missed dose _ Aqra d-dokument sħiħ