Patient leaflet - Ivacaftor 150 mg film-coated tablets
1. What Ivacaftor Film-coated Tablets are and what they are used for
Ivacaftor Film-coated Tablets contain the active substance ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell. Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF). Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.
Ivacaftor tablets are indicated:
as monotherapy for patients aged 6 years and older
and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Ivacaftor which is contained in Ivacaftor 150 mg Film-coated Tablets is also authorised to treat cystic fibrosis with other medicines which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2. What you need to know before you take Ivacaftor Film-coated Tablets
Do not take Ivacaftor Film-coated Tablets if you:
are allergic to ivacaftor or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivacaftor.
Talk to your doctor if you have liver problems or
have previously had them. Your doctor may need to adjust your dose.
Increased liver enzymes in the blood have been
seen in some people receiving ivacaftor (alone or in combination with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor). Tell your doctor immediately if you have any of these symptoms, which may be a sign of liver problems:
pain or discomfort in the upper right stomach
(abdominal) area
yellowing of the skin or the white part of the
eyes
- loss of appetite
- nausea or vomiting
dark urine.
Your doctor will do some blood tests to check your
liver before and during treatment, particularly during the first year and especially if your blood tests showed high liver enzymes in the past.
Talk to your doctor if you have kidney problems or
have previously had them.
Ivacaftor (alone or in combination with
tezacaftor/ivacaftor or
ivacaftor/tezacaftor/elexacaftor) is not recommended if you have undergone an organ transplant.
Talk to your doctor if you are using hormonal
contraception – for example, women using the contraceptive pill. This may mean you are more likely to get a rash while taking Ivacaftor in combination with ivacaftor/tezacaftor/elexacaftor.
Abnormality of the eye lens (cataract) without any
effect on vision has been noted in some children and adolescents treated with Ivacaftor (alone or in combination with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor). Your doctor may perform some eye examinations prior to and during treatment.
Ivacaftor (alone or in combination with
tezacaftor/ivacaftor or
ivacaftor/tezacaftor/elexacaftor) should only be used if you have one of the mutations in the CFTR gene indicated in section 1 (‘What Ivacaftor Film-coated Tablets are and what they are used for’).
Children and adolescents
Do not give this medicine to children under 1 month of age as it is not known if ivacaftor is safe and effective in these children.
Do not give this medicine in combination with tezacaftor/ivacaftor to children under 6 years of age or in combination with ivacaftor/tezacaftor/elexacaftor to children under 2 years of age as it is not known if they are safe and effective for them.
Other medicines and Ivacaftor Film-coated Tablets
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines can affect how Ivacaftor works or make side effects more likely. In particular, tell your doctor if you are taking any of the medicines listed below. Your doctor may decide to adjust your dose or that you need extra check-ups.
Antifungal medicines (used for the treatment of
fungal infections). These include fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole.
Antibiotic medicines (used for the treatment of
bacterial infections). These include clarithromycin, erythromycin, rifabutin, rifampicin, and telithromycin.
Epilepsy medicines (used for the treatment of
epileptic seizures or fits). These include carbamazepine, phenobarbital, and phenytoin.
Herbal medicines. These include St John’s Wort
(Hypericum perforatum).
Immunosuppressants (used after an organ
transplantation). These include ciclosporin, everolimus, sirolimus and tacrolimus.
Cardiac glycosides (used for the treatment of
some heart conditions). These include digoxin.
Anticoagulant medicines (used to prevent blood
clots). These include warfarin.
Medicines for diabetes. These include glimepiride
and glipizide.
Medicines for lowering blood pressure. These
include verapamil.
Ivacaftor Film-coated Tablets with food and drink
Avoid food or drink containing grapefruit during treatment as they may increase the side effects of Ivacaftor by increasing the amount of ivacaftor in your body.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It may be better to avoid using
Ivacaftor during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
It is unknown whether ivacaftor is excreted in human breast milk. If you plan to breast-feed, ask your doctor for advice before taking Ivacaftor. Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop ivacaftor therapy. Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Driving and using machines
Ivacaftor can make you dizzy. If you feel dizzy, do not drive, cycle or use machines.
Information about some of the ingredients of Ivacaftor Film-coated Tablets
Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to take Ivacaftor Film-coated Tablets
Always take this medicine exactly as your doctor has told you to. Check with your doctor if you are not sure.
Your doctor will determine which medicine and dose is right for you. Ivacaftor dosing recommendations are provided in Table 1.
Table 1: Dosing recommendations
Take the morning and evening doses approximately 12 hours apart with food that contains fat.
You must keep using all other medicines you use, unless your doctor tells you to stop using any.
If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not clear the medicine as fast as in people who have normal liver function.
This medicine is for oral use.
Swallow the tablet whole. Do not break, chew or dissolve the tablets. Take Ivacaftor tablets with food that contains fat.
Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs. Other fat-containing foods are:
- cheese, whole milk, whole-milk dairy products, yogurt, chocolate
- meats, oily fish
- avocados, hummus, soy-based products (tofu)
nuts, fat-containing nutritional bars or drinks.
Morning Evening
Ivacaftor as monotherapy
6 years and
older, ≥ 25 kg
One Ivacaftor
150 mg Tablet
One Ivacaftor
150 mg Tablet
361-33-32124062 361-33-32124062
361-33-32124062 If you take more Ivacaftor Film-coated Tablets than you should
You may experience side effects, including those mentioned in section 4 below. If so, contact your doctor or pharmacist to ask for advice. If possible, have your medicine and this leaflet with you.
If you forget to take Ivacaftor Film-coated Tablets
Take the missed dose if less than 6 hours have passed since the time you missed the dose. Otherwise, wait until your next scheduled dose as you normally would. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ivacaftor Film-coated Tablets
Take Ivacaftor for as long as your doctor recommends. Do not stop unless your doctor advises you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stomach (abdominal) ache and increased liver enzymes in the blood.
Possible signs of liver problems
Increased liver enzymes in the blood are common in patients with CF and have also been reported in patients taking Ivacaftor alone or in combination with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor.
In patients taking Ivacaftor in combination with ivacaftor/tezacaftor/elexacaftor, liver damage and worsening of liver function in people with severe liver disease has been reported. The worsening of liver function can be serious and may require transplantation.
These may be signs of liver problems:
pain or discomfort in the upper right area of the
stomach (abdominal) area
- yellowing of the skin or white part of the eyes
- loss of appetite
- nausea or vomiting
- dark urine.
Tell your doctor straight away if you have any of these symptoms.
Very common: may affect more than 1 in 10 people
upper respiratory tract infection (the common cold),
including sore throat and nasal congestion
- headache
- dizziness
- diarrhoea
- stomach or abdominal pain
- changes in the type of bacteria in mucus
increased liver enzymes (signs of stress on the
liver)
- rash.
Common: may affect up to 1 in 10 people
- runny nose
- ear pain, ear discomfort
- ringing in the ears
- redness inside the ear
- inner ear disorder (feeling dizzy or spinning)
- sinus problems (sinus congestion)
- redness in the throat
- breast mass
- feeling sick (nausea)
- flu
- low blood sugar (hypoglycaemia)
abnormal breathing (shortness of breath or
difficulty breathing)
- wind (flatulence)
- spots (acne)
- itchy skin
increased creatine phosphokinase (sign of muscle
breakdown) seen in blood tests.
Uncommon: may affect up to 1 in 100 people
- ear congestion
- breast inflammation
- enlargement of the breast in males
- nipple changes or pain
- wheezing
- increased blood pressure.
Additional side effects in children and adolescents
Side effects seen in children and adolescents are similar to those observed in adults. However, increased liver enzymes in the blood are more frequently seen in young children.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ivacaftor Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ivacaftor Film-coated Tablets contains
The active substance is ivacaftor.
Each film-coated tablet contains 150 mg of ivacaftor.
The other ingredients are:
- Tablet core: cellulose microcrystalline, lactose monohydrate, povidone, poloxamer, croscarmellose sodium, sodium laurilsulfate (E487), silica colloidal anhydrous and magnesium stearate.
- Tablet film-coating: polyvinyl alcohol part hydrolyzed (E1203), calcium carbonate (E170), polyethylene glycol (E1521), talc (E553b) and indigo carmine aluminum lake (E132).
What Ivacaftor Film-coated Tablets look like and contents of the pack
Ivacaftor Film-coated Tablets are blue, oval shaped, 16.7 mm × 8.5 mm, and debossed with “TV” on one side and debossed with “L15” on the other.
Ivacaftor Film-coated Tablets are available in PVC/Aclar/PVC-Al blister and PVC/Aclar/PVC-Al perforated unit dose blister packs containing 28 and 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer: Actavis International Ltd, 4, Sqaq tal-Gidi off Valletta Road, Luqa LQA 6000, Malta
This leaflet was last revised in July 2026.
PL 00289/2675
Other sources of information
To request a copy of this leaflet in braille, large print or audio please contact:
Email: medinfo@tevauk.com, Telephone: +44 (0)207 540 7117 Please provide the following information:
Product name: Ivacaftor 150 mg Film-coated Tablets Reference: PL 00289/2675