TRIKAFTA®
KALYDECO®
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Prescription Medicine
TRIKAFTA is for the treatment of cystic fibrosis in patients aged 6 years and older with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. TRIKAFTA has risks and benefits. Do not use TRIKAFTA if you are allergic to any component of this medicine or under 6 years of age. Tell your doctor if you have kidney disease or previous kidney problems; liver disease or liver problems in the past; are pregnant or are breastfeeding; are taking any other medicines or herbal formulations as these medicines may interfere with how TRIKAFTA works or TRIKAFTA may interfere with how well these other medications work. Possible side effects: All medicines can have side effects. This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Some common side effects include headache, common cold symptoms or diarrhoea. If you experience significant pain or discomfort in the upper right stomach (abdominal) area or yellowing of your skin or the white parts of your eyes, these may be serious side effects associated with liver problems and you need to seek medical attention. Tell your doctor or pharmacist as soon as possible if you notice anything else that may be making you feel unwell, even if it is not on the list. Dosage:Your doctor will tell you how much TRIKAFTA you need to take each day. TRIKAFTA should be taken with fat-containing foods. Grapefruit should be avoided. TRIKAFTA film-coated tablets are available in two strengths (elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 150 mg) and (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg and ivacaftor 75 mg).
For additional information, check with your doctor or the Consumer Medicine Information at medsafe.govt.nz. TRIKAFTA® is listed in the Pharmaceutical Schedule. Your doctor can advise on the eligibility criteria.
TRIKAFTA® is manufactured for Vertex Pharmaceuticals Incorporated.
TRIKAFTA®, VERTEX® and the VERTEX triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated.
KALYDECO (ivacaftor), Prescription Medicine
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 4 months and older who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. Do not use KALYDECO if you are allergic to any component of this medicine or under the recommended age. Tell your doctor if you have kidney disease or previous kidney problems; liver disease or liver problems in the past; are pregnant or are breastfeeding; are taking any other medicines or herbal formulations as these medicines may interfere with how KALYDECO works or KALYDECO may interfere with how well these other medications work. KALYDECO may cause dizziness in some people. Do not drive or use machines unless you are sure that you are not affected. If your child is taking KALYDECO, it is advised that they do not ride their bike or do anything else that needs their full attention unless you are sure that your child is not affected. Possible side effects: All medicines can have side effects. This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Some side effects include the common cold, sore throat and nasal congestion, headache, abdominal pain, diarrhoea and rash. If you experience significant pain or discomfort in the upper right stomach (abdominal) area or yellowing of your skin or the white parts of your eyes, these may be indicative of serious side effects, and you need to seek medical attention. Tell your doctor or pharmacist as soon as possible if you notice anything else that may be making you feel unwell, even if it is not on the list. Dosage: Your doctor will tell you how much KALYDECO you need to take each day. Tablets and granules should be taken with fat-containing foods. Grapefruit should be avoided. KALYDECO is available in 150 mg film-coated tablets or 25 mg, 50 mg and 75 mg granules.
For additional information check with your doctor or the Consumer Medicine Information on www.medsafe.govt.nz KALYDECO is listed in the Pharmaceutical Schedule. Your doctor can advise on the eligibility criteria.
Funding Information: TRIKAFTA® is listed in Section B (as PCT only - subject to Special Authority) and Part II of Section H of the Pharmaceutical Schedule for eligible patients with cystic fibrosis aged 6 years and above. Refer to the Schedule for the Special Authority criteria at https://pharmac.govt.nz/pharmaceutical-schedule/. |
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Prescription Medicine. Before prescribing TRIKAFTA® please refer to the Data Sheet for information on dosage, contraindictions, precautions, interactions and adverse events. The Data Sheet is on the Medsafe website at www.medsafe.govt.nz.
APPROVED TRIKAFTA® DATA SHEET IS AVAILABLE HERE.
Funding Information: KALYDECO® is listed in Section B (as PCT only - Specialist subject to Special Authority) and Section H of the Pharmaceutical Schedule for patients with cystic fibrosis and a G551D or other gating (class III) mutation in the CFTR gene on at least one allele. Refer to the Schedule for full eligibility criteria. KALYDECO® is not funded for patients with an R117H mutation. |
KALYDECO® (ivacaftor), Prescription Medicine. Before prescribing KALYDECO® please refer to the Data Sheet for information on dosage, contraindictions, precautions, interactions and adverse events. The Data Sheet is on the Medsafe website at www.medsafe.govt.nz.
APPROVED KALYDECO® DATA SHEET IS AVAILABLE HERE.
Reporting suspected adverse effects
Reporting of suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at
https://nzphvc.otago.ac.nz/reporting/.