البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ERDAFITINIB
J-C HEALTH CARE LTD
L01EX16
FILM COATED TABLETS
ERDAFITINIB 3 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
ERDAFITINIB
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has:- Susceptible FGFR3 or FGFR2 genetiic alterations, and- Progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
2020-11-10
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only BALVERSA ® 3 MG FILM COATED TABLETS BALVERSA ® 4 MG FILM COATED TABLETS BALVERSA ® 5 MG FILM COATED TABLETS ACTIVE INGREDIENT AND ITS QUANTITY Each tablet of Balversa 3 mg contains: Erdafitinib 3 mg Each tablet of Balversa 4 mg contains: Erdafitinib 4 mg Each tablet of Balversa 5 mg contains: Erdafitinib 5 mg Inactive and allergenic ingredients in the preparation – see section 6 “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Balversa is used to treat adults with locally advanced or metastatic bladder cancer )urothelial carcinoma( and is characterized by: • Abnormal changes in the FGFR2 or FGFR3 genes • Disease that has progressed during or following at least one line of therapy that includes platinum-containing chemotherapeutic drugs, including within 12 months of pre-operative adjunctive therapy )neoadjuvant( that includes platinum- containing chemotherapeutic drugs, or after surgery )adjuvant( that includes platinum- containing chemotherapeutic drugs. THERAPEUTIC GROUP Kinase inhibitors 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive )allergic( to the active ingredient )erdafitinib( or to any of the additional ingredients contained in the medicine. For a list of additional ingredients, see section 6 “Further Information”. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH BALVERSA, TELL THE DOCTOR ABOUT YOUR MEDICAL CONDITION, ESPECIALLY IF: • You have eye problems or vision problems • You are pregnant or plan to b اقرأ الوثيقة كاملة
PAGE 1 OF 21 Balversa_Film_Coated_Tablets_PI_Sep_2022_sub_USPI_Sep2022 1 NAME OF THE MEDICINAL PRODUCT Balversa 3mg film coated tablets Balversa 4mg film coated tablets Balversa 5mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains either 3, 4 or 5mg of erdafitinib 3 PHARMACEUTICAL FORM Film coated tablet. 3mg: Yellow, round biconvex, film-coated, debossed with “3” on one side and “EF” on the other side. 4mg: Orange, round biconvex, film-coated, debossed with “4” on one side and “EF” on the other side. 5mg: Brown, round biconvex, film-coated, debossed with “5” on one side and “EF” on the other side. 4 INDICATIONS AND USAGE BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum- containing chemotherapy. 5 DOSAGE AND ADMINISTRATION 5.1 Select patients for treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA based on the presence of susceptible FGFR genetic alterations in tumor specimens _[see Clinical Studies (14.1)]_ . 5.2 RECOMMENDED DOSAGE AND SCHEDULE The recommended starting dose of BALVERSA is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO 4 ) levels and tolerability at 14 to 21 days _[see Dosage and Administration _ _(_ 5 _.3)]._ PAGE 2 OF 21 Balversa_Film_Coated_Tablets_PI_Sep_2022_sub_USPI_Sep2022 Swallow tablets whole with or without food. If vomiting occurs any time after taking BALVERSA, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs. If a dose of BALVERSA is missed, it can be taken as soon as possible on the same day. Resume the regular daily اقرأ الوثيقة كاملة