Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
zanubrutinib
BeiGene Ireland Ltd
L01EL03
zanubrutinib
Antineoplastic agents
Waldenstrom Macroglobulinemia
Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
Revision: 7
Authorised
2021-11-22
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRUKINSA 80 MG HARD CAPSULES zanubrutinib 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 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, 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 BRUKINSA is and what it is used for 2. What you need to know before you take BRUKINSA 3. How to take BRUKINSA 4. Possible side effects 5. How to store BRUKINSA 6. Contents of the pack and other information 1. WHAT BRUKINSA IS AND WHAT IT IS USED FOR BRUKINSA is an anticancer medicine that contains the active substance zanubrutinib. It belongs to a class of medicines called protein kinase inhibitors. This medicine works by blocking Bruton's tyrosine kinase, a protein in the body that helps cancer cells grow and survive. By blocking this protein, BRUKINSA reduces the number of cancer cells and slows down the worsening of the cancer. BRUKINSA is used to treat Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma), a cancer affecting a type of white blood cells called B lymphocytes or B cells that make too much of a protein called IgM. This medicine is used when the disease has come back, or treatment has not worked or in patients who cannot have chemotherapy together with an antibody. BRUKINSA is also used to treat marginal zone lymphoma. This is a type of cancer that also affects Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. NAM E OF THE MEDICINAL PRODUCT BRUKINSA 80 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 80 mg of zanubrutinib. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard capsule. White to off-white opaque hard capsule of 22 mm in length, marked with “ZANU 80” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily (four 80 mg capsules) or divided into two doses of 160 mg twice daily (two 80 mg capsules). Treatment with BRUKINSA should be continued until disease progression or unacceptable toxicity. 3 _BRUKINSA in combination with obinutuzumab _ Zanubrutinib must be administered orally before obinutuzumab infusion. The recommended Lire le document complet