Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
avatrombopag maleate
Swedish Orphan Biovitrum AB (publ)
B02BX
avatrombopag
Antihemorrhagics
Thrombocytopenia
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Revision: 5
Authorised
2019-06-20
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOPTELET 20 MG FILM-COATED TABLETS avatrombopag READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Doptelet is and what it is used for 2. What you need to know before you take Doptelet 3. How to take Doptelet 4. Possible side effects 5. How to store Doptelet 6. Contents of the pack and other information 1. WHAT DOPTELET IS AND WHAT IT IS USED FOR Doptelet contains an active substance called avatrombopag. It belongs to a group of medicines called thrombopoietin receptor agonists. Doptelet is used in adults with chronic liver disease to treat low platelet count (called thrombocytopenia) before having a medical procedure where there is a risk of bleeding. Doptelet is used to treat adults with low platelet counts due to primary chronic immune thrombocytopenia (ITP) when a prior treatment for ITP (such as corticosteroids or immunoglobulins) has not worked well enough. Doptelet works by helping to increase the number of platelets in the blood. Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOPTELET _ _ DO NOT TAKE DOPTELET - if you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Doptelet. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Doptelet if: • you are at risk of blood clots in your veins or arteries, Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Doptelet 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag. Excipient with known effect Each film-coated tablet contains 120.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with “AVA” on one side and “20” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment should be initiated by and remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Doptelet should be taken at the same time of day (e.g., in the morning or evening) with food, including when taking the dose less frequently than once daily. _Chronic liver disease _ Obtain a platelet count prior to the administration of Doptelet therapy and on the day of a procedure to ensure an adequate increase in platelet count, and no unexpectedly high increase in platelet count in the patient populations specified in sections 4.4 and 4.5. The recommended daily dose of avatrombopag is based on the patient’s platelet count (see Table 1). Dosing should begin 10 to 13 days prior to the planned procedure. The patient should undergo their procedure 5 to 8 days after the last dose of avatrombopag. 3 TABLE 1: DAILY DOSE RECOMMENDATION FOR AVATROMBOPAG PLATELET COUNT (×10 9 /L) ONCE-DAILY DOSE DURATION OF DOSING < 40 60 mg (Three 20 mg tablets) 5 days ≥ 40 to < 50 40 mg Soma hati kamili