Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
LONAFARNIB
NEOPHARM LTD, ISRAEL
A16AX20
HARD GELATIN CAPSULES
LONAFARNIB 50 MG
PER OS
Required
EIGER BIOPHARMACEUTICALS, INC., USA
LONAFARNIB
ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of0.39 m2 and above:To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)• For the treatment of processing-deficient Progeroid Laminopathies with either:o Heterozygous LMNA mutation with progerin-like protein accumulationo Homozygous or compound heterozygous ZMPSTE24 mutationsLimitations of UseZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.
2022-05-23
Zokinvy cap. PIL vr. 1A PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only ZOKINVY 50 MG hard gelatin capsules ZOKINVY 75 MG hard gelatin capsules THE ACTIVE INGREDIENT AND ITS QUANTITY IN A DOSAGE UNIT: Each ZOKINVY capsule contains lonafarnib 50 mg or 75 mg. For a list of inactive ingredients and allergens in the preparation: see section 6 “Additional information” in this leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? ZOKINVY is intended for the treatment of adults and children 12 months of age and older, who have a certain body surface area: • To lower the mortality risk in patients with Hutchinson-Gilford progeria syndrome (HGPS). • For treatment of patients with certain types of processing-deficient progeroid laminopathies. ZOKINVY is not intended for patients with non-Hutchinson-Gilford progeria syndromes or for treatment of progeroid laminopathies that are not of the processing-deficient types, since ZOKINVY would not be expected to be effective in these patients THERAPEUTIC CLASS: ZOKINVY belongs to a group of preparations that are basic substances for body metabolism. ZOKINVY contains the active ingredient lonafarnib, which inhibits the enzyme farnesyltransferase, thus preventing the accumulation of progerin or progerin-like proteins in the inner membrane of the cell nucleus. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients the medicine contains (see section 6). • You are taking: ‐ Medicines that are strong or moderate CYP3A inhibitors or inducers ‐ Mid Přečtěte si celý dokument
1 FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT Zokinvy 50 mg Zokinvy 75 mg QUALITATIVE AND QUANTITATIVE COMPOSITION ZOKINVY (lonafarnib) capsules for oral administration contain 50 mg or 75 mg of lonafarnib as the active ingredient. The inactive ingredients listed in section 11. PHARMACEUTICAL FORM Hard gelatin capsules for oral use 1 INDICATIONS AND USAGE ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: • To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) • For the treatment of processing-deficient Progeroid Laminopathies with either: o Heterozygous _LMNA _mutation with progerin-like protein accumulation o Homozygous or compound heterozygous _ZMPSTE24 _mutations Limitations of Use ZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE • The starting dosage of ZOKINVY for patients with a BSA of 0.39 m 2 and above is 115 mg/m 2 twice daily with morning and evening meals (see Table 1) to reduce the risk of gastrointestinal adverse reactions _[see Adverse Reactions (6.1)]_. An appropriate dosage strength of ZOKINVY is not available for patients with a BSA of less than 0.39 m 2 _[see _ _Indications and Usage (1)]_. • After 4 months of treatment, increase the dosage to 150 mg/m 2 twice daily with morning and evening meals (see Table 2). • Round all total daily dosages to the nearest 25 mg increment (see Table 1 and Table 2). 2 • If a dose is missed, take the dose as soon as possible with food, up to 8 hours prior to the next scheduled dose. If less than 8 hours remains before the next scheduled dose, skip the missed dose, and resume taking ZOKINVY at the next scheduled dose. Table 1 provides the BSA-based dosage recommendations for the starting dosage of 115 mg/m 2 twice daily. TABLE 1: RECOMMENDED D Přečtěte si celý dokument