Страна: Израел
Език: английски
Източник: Ministry of Health
FOSTAMATINIB AS DISODIUM HEXAHYDRATE
MEDISON PHARMA LTD
B02BX09
FILM COATED TABLETS
FOSTAMATINIB AS DISODIUM HEXAHYDRATE 150 MG
PER OS
Required
RIGEL PHARMACEUTICALS, INC., USA
FOSTAMATINIB
TAVALISSE is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
2021-08-04
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a physician’s prescription only TAVALISSE 100 MG TAVALISSE 150 MG FILM-COATED TABLETS THE ACTIVE INGREDIENT AND ITS QUANTITY: Each film-coated tablet of Tavalisse 100 mg and 150 mg contains: 100 mg and 150 mg of FOSTAMATINIB )AS DISODIUM HEXAHYDRATE( RESPECTIVELY For a list of inactive and allergenic ingredients in the preparation, see section 6 ”FURTHER INFORMATION“. See also ”IMPORTANT INFORMATION ABOUT SOME OF THE MEDICINE’S INGREDIENTS“ in section 2. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult the physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Tavalisse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. THERAPEUTIC GROUP - The medicine belongs to the group of spleen tyrosine kinase (Syk) inhibitors 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to the active ingredient (FOSTAMATINIB) or to any of the additional ingredients that the medicine contains (see section 6 ”FURTHER INFORMATION“(. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Before treatment with Tavalisse, tell the physician if: • You suffer from: o High blood pressure o Liver problems • You are pregnant or are planning to get pregnant. Tavalisse may cause harm to the fetus. o The physician will check if you are pregnant before starting treatment o If you are of childbearing age, you must use effective means of contraception during treatment with Tavalisse until at least a month after taking the last dose. • You are breastfeeding or are planning to breastfeed. Do not breastfeed durin Прочетете целия документ
PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT TAVALISSE 100 mg TAVALISSE 150 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAVALISSE 100 mg film-coated tablets Each film-coated tablet contains 126.2 mg of fostamatinib disodium hexahydrate equivalent to 100 mg fostamatinib _Excipient(s) with known effect _ Each 100 mg tablet contains 23 mg sodium (from excipients and fostamatinib disodium hexahydrate). TAVALISSE 150 mg film-coated tablets Each film-coated tablet contains 189.3 mg of fostamatinib disodium hexahydrate equivalent to 150 mg fostamatinib. _Excipient(s) with known effect _ Each 150 mg tablet contains 34 mg sodium (from excipients and fostamatinib disodium hexahydrate). For the full list of excipients, see section 11 3. THERAPEUTIC INDICATIONS TAVALISSE is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. 4 DOSAGE AND ADMINISTRATION 4.1 RECOMMENDED DOSAGE Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. After a month, if platelet count has not increased to at least 50 × 10 9 /L, increase TAVALISSE dose to 150 mg twice daily. Use the lowest dose of TAVALISSE to achieve and maintain a platelet count at least 50 × 10 9 /L as necessary to reduce the risk of bleeding. TAVALISSE may be taken with or without food. In the case of a missed dose of TAVALISSE, instruct patients to take their next dose at its regularly scheduled time. 4.2 MONITORING After obtaining baseline assessments: Monitor CBCs, including platelet counts, monthly until a stable platelet count (at least 50 × 10 9 /L) is achieved. Thereafter, continue to monitor CBCs, including neutrophils, regularly. Monitor liver function tests (LFTs) (e.g., ALT, AST, and bilirubin) monthly. Monitor blood pressure every 2 weeks until establishment of a stable dose, then monthly thereafter. 4.3 DOSE MODIFICATION FOR ADVERSE REACTIONS TAVALISSE dose modification is recommended based on individual safety and tolerability. Management of some adv Прочетете целия документ