Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
ELEXACAFTOR; IVACAFTOR; IVACAFTOR; TEZACAFTOR
VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL
R07AX32
FILM COATED TABLETS
IVACAFTOR 75 MG; TEZACAFTOR 50 MG; ELEXACAFTOR 100 MG; IVACAFTOR 150 MG
PER OS
Required
VERTEX PHARMACEUTICALS (IRELAND) LIMITED, IRELAND
IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR
Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data.
2021-04-04
TRIK-PIL-0923-V1 Page 1 of 6 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only TRIKAFTA 100MG/50MG/75MG & 150MG FILM-COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITIES Orange film-coated tablets Each film coated tablet contains elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg. Light blue film-coated tablets Each film coated tablet contains ivacaftor 150 mg. Inactive ingredients and allergens - see section 6 “ ADDITIONAL INFORMATION ” . See also “IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS” in section 2. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, consult your doctor 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 to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one _F508del_ mutation in the CFTR gene or another mutation that is responsive to treatment with Trikafta. THERAPEUTIC GROUP: Elexacaftor – CFTR Corrector Tezacaftor – CFTR Corrector Ivacaftor – Potentiator of the CFTR protein Tezacaftor and elexacaftor increase the amount of CFTR protein at the cell surface and ivacaftor causes the protein to work better. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredients (elexacaftor, tezacaftor, or ivacaftor) or to any of the other ingredients in this medicine (see section 6 “ADDITIONAL INFORMATION” ). SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE TAKING TRIKAFTA, TELL YOUR DOCTOR ABOUT ALL OF YOUR MEDICAL CONDITIONS, INCLUDING IF YOU: • have kidney problems • have or have had liver problems • are pregnant or plan to become pregnant TRIK-P Soma hati kamili
TRIK-SPC-0923-V1 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trikafta 100mg/50mg/75mg & 150mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ELEXACAFTOR/TEZACAFTOR/IVACAFTOR TABLET: Each film-coated tablet contains 100 mg elexacaftor, 50 mg tezacaftor and 75 mg ivacaftor IVACAFTOR TABLET: Each film-coated tablet contains 150 mg ivacaftor. EXCIPIENTS WITH KNOWN EFFECT: Each Ivacaftor tablet contains 167.2 mg of lactose. For the full list of excipients, _see Description (12)_. 3 PHARMACEUTICAL FORM FILM-COATED TABLETS ELEXACAFTOR/TEZACAFTOR/IVACAFTOR TABLET: Orange film- coated tablet, debossed with “T100” on one face and plain on the other face. IVACAFTOR TABLET: Light blue film- coated tablet, printed in black ink with “V 150” on one face. 4 THERAPEUTIC INDICATION Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one _F508del_ mutation in the _CFTR_ gene or a mutation in the _CFTR_ gene that is responsive based on _in vitro_ data [_see Clinical Pharmacology (13.1)_]. 5 DOSAGE AND ADMINISTRATION 5.1 GENERAL DOSING INFORMATION Swallow the tablets whole. Trikafta should be taken with fat-containing food. Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs, peanut butter, cheeses, nuts, whole milk, or meats _[see Clinical Pharmacology (13.3)]_. 5.2 RECOMMENDED DOSAGE IN ADULTS AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER The recommended dosage is two tablets (each containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg) taken in the morning and one ivacaftor tablet (containing ivacaftor 150 mg) taken in the evening, administered orally, approximately 12 hours apart. Information for Missed Doses: If 6 hours or less have passed since the missed morning or evening dose, the patient should take the missed dose as soon as possible and continue on the original schedule. If more than 6 hours have passed since: • the missed MORNING dose, the patie Soma hati kamili