How to use KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Kaftrio 37.5mg/25mg/50mg film-coated tablets
Kaftrio75mg/50mg/100mg film-coated tablets
ivacaftor/tezacaftor/elexacaftor
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Kaftrio and what is it used for
- What you need to know before you take Kaftrio
- How to take Kaftrio
- Possible side effects
- Storage of Kaftrio
- Contents of the pack and other information
1. What is Kaftrio and what is it used for
Kaftrio contains three active substances:ivacaftor, tezacaftor and elexacaftor. This medicine helps the lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition where the lungs and digestive system can become clogged with thick, sticky mucus.
Kaftrio taken with ivacaftor is for patientsfrom6years of age who have CF withat least one mutationin the CFTR(cystic fibrosis transmembrane conductance regulator) gene that responds to Kaftrio. The medicine is intended as a long-term treatment.
Kaftrio works on a protein called CFTR. The protein is damaged in some people with CF if they have a mutation in the CFTRgene.
Kaftrio is usually taken with another medicine,ivacaftor. Ivacaftor makes the protein work better while tezacaftor and elexacaftor increase the amount of protein on the cell surface.
Kaftrio (taken together with ivacaftor) helps you breathe better by improving your lung function. You may also notice that you do not get ill as often or that it is easier to gain weight.
2. What you need to know before you take Kaftrio
Do not takeKaftrio
Consult your doctorand do not take the tablets if this applies to you.
Warnings and precautions
- Consult your doctorif you have liver problemsor have had them in the past. Your doctor may need to adjust your dose (see section 4).
- Your doctor will do some blood tests to check how your liver is workingbefore and during treatment with Kaftrio, especially if your blood tests have shown raised liver enzymes in the past. Liver enzymes in the blood may increase in patients taking Kaftrio.
Tell your doctor immediatelyif you have any symptoms that may indicate liver problems. These are listed in section 4.
- Depression (including suicidal thoughts, changes in behaviour, anxiety and sleep disturbances) has been reported in patients taking Kaftrio, usually starting in the first three months of treatment. Consult your doctor immediately if you (or someone taking this medicine) experience any of the following symptoms that may be signs of depression: sadness or mood changes, anxiety, feeling of emotional distress or thoughts of self-harm or suicide, and/or difficulty sleeping (see section 4).
Consult your doctor if you notice changes in your child's behaviourin the first 2 months of treatment.
- Consult your doctorif you have kidney problemsor have had them in the past.
- If you have two class I mutations(mutations known not to produce the CFTR protein), you should not take Kaftrio, as it is not expected to respond to this medicine.
- Consult your doctorbefore starting treatment with Kaftrio if you have had an organ transplant.
- Consult your doctorif you are using hormonal contraceptives, for example, women using the contraceptive pill. It may mean that you are more likely to get a skin rash while taking Kaftrio.
- Your doctor may doeye examinationsbefore and during treatment with Kaftrio. In some children and adolescents who have taken this treatment, cataracts (clouding of the lens) have occurred without affecting vision.
Childrenunder 6years
Do not give this medicine to children under 6 years as it is not known if Kaftrio tablets are safe and effective in this age group.
Other medicines andKaftrio
Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines. Some medicines may affect how Kaftrio works or may increase the chance of side effects. In particular, tell your doctor if you are taking any of the medicines listed below. Your doctor may need to change the dose of one of your medicines if you are taking some of these.
- Antifungals(used to treat fungal infections). These include fluconazole, itraconazole, ketoconazole, posaconazole and voriconazole.
- Antibiotics(used to treat bacterial infections). These include clarithromycin, erythromycin, rifampicin, rifabutin and telithromycin.
- Medicines for epilepsy(used to treat seizures or fits). These include carbamazepine, phenobarbital and phenytoin.
- Herbal products. These include St. John's Wort (Hypericum perforatum).
- Immunosuppressants(used after an organ transplant). These include ciclosporin, everolimus, sirolimus and tacrolimus.
- Cardiac glycosides(used to treat certain heart conditions). These include digoxin.
- Anticoagulants(used to prevent blood clots). These include warfarin.
- Medicines for diabetes. These include glimepiride, glipizide, gliburide, nateglinide and repaglinide.
- Medicines to lower cholesterol in the blood. These include pitavastatin and rosuvastatin.
- Medicines to lower blood pressure. These include verapamil.
Taking Kaftrio withfood and drink
Avoid foods or drinks that contain grapefruit during treatment as they may increase the side effects of Kaftrio by increasing the amount of Kaftrio in the body.
Pregnancy and breast-feeding
- Consult your doctorbefore using this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
- Pregnancy: it may be better to avoid using this medicine during pregnancy. Your doctor will help you decide what is best for you and your baby.
- Breast-feeding: ivacaftor, tezacaftor and elexacaftor are excreted in breast milk. Your doctor will consider the benefit of breast-feeding for your child and the benefit of treatment for you to help you decide whether to stop breast-feeding or stop the treatment.
Driving and using machines
Kaftrio may cause dizziness. If you feel dizzy, do not drive, ride a bicycle or use machines unless you are sure that you are not affected.
Kaftrio contains sodium
This medicinecontainsless than 23 mg of sodium (1 mmol) per dose; this is, essentially “sodium-free”.
3. How to take Kaftrio
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
Your doctor will decide the correct dose for you.
Kaftrio is usually taken with ivacaftor.
Recommended dose for patients 6years of age and older
Age | Weight | Morning dose | Evening dose |
6 years to <12 years | <30 kg | Two 37.5 mg ivacaftor/25 mg tezacaftor/50 mg elexacaftor tablets | One 75 mg ivacaftor tablet |
6 years to <12 years | ≥30 kg | Two 75 mg ivacaftor/50 mg tezacaftor/100 mg elexacaftor tablets | One 150 mg ivacaftor tablet |
12 years or older | - | Two 75 mg ivacaftor/50 mg tezacaftor/100 mg elexacaftor tablets | One 150 mg ivacaftor tablet |
Take the morning and evening tablets with an interval of about 12 hours.
The tablets are taken by mouth.
Take the Kaftrio and ivacaftor tablets withfat-containing foods. Fat-containing meals or snacks are those prepared with butter or oils or those that contain eggs. Examples of other fat-containing foods are:
- Cheese, whole milk, whole milk dairy products, yoghurt, chocolate
- Meat, oily fish
- Avocado, hummus (chickpea paste), soy products (tofu)
- Nuts, bars or nutritional drinks that contain fat
Avoid foods and drinks that contain grapefruit while taking Kaftrio. See Taking Kaftrio with food and drinkin section 2 for more information.
Swallow the tablets whole.Do not chew, crush or break the tablets before swallowing.
You should continue to take all your other medicines as well unless your doctor tells you to stop.
If you have liver problems,your doctor may reduce your dose of Kaftrio tablets or decide to stop your treatment with Kaftrio. See Warnings and precautionsin section 2.
If you take moreKaftriothan you should
Consult your doctor or pharmacist.If possible, take the medicine and this leaflet with you. You may experience side effects, including those mentioned in section 4 below.
If you forget to takeKaftrio
If you miss a dose, calculate how much time has passed since the time you should have taken the dose.
- Ifless than 6hourshave passed since the time you should have taken the dose, whether it is the morning or evening dose, take the missed tablet(s) as soon as possible. Then continue with your normal schedule.
- Ifmore than 6hourshave passed:
- If you misseda morningdose of Kaftrio, take it as soon as you remember. Do not take the evening dose of ivacaftor. Take the next morning dose at the usual time.
- If you missedan eveningdose of ivacaftor, do not take the missed dose. Wait until the next day and take the morning dose of Kaftrio at the usual time.
Do nottake a double dose to make up for a forgotten dose.
If you stop takingKaftrio
Your doctor will tell you how long you need to take Kaftrio. It is important that you take this medicine regularly. Do not make any changes unless your doctor tells 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
Signs of liver problems
Liver damage and worsening of liver functionin people with or without liver disease. Worsening of liver function may be severe and may require a transplant (see section 2).
Increased liver enzymes in the blood are common in patients with Kaftrio. The following may be signs of liver problems:
- Pain or discomfort in the upper right side of the stomach (abdominal area).
- Yellowing of the skin or the white part of the eyes.
- Lack of appetite.
- Feeling sick or being sick.
- Dark urine.
Depression.Signs include feeling sad or having mood changes, anxiety, feeling emotionally upset.
Tell your doctor immediatelyif you get any of these symptoms.
Very common side effects(may affect more than 1 in 10 people)
- Skin rash (more common in children and women than in men).
Tell your doctor immediatelyif you get a rash.
Other side effects:
Very common(may affect more than 1 in 10 people)
- Headache.
- Dizziness.
- Upper respiratory tract infection (common cold).
- Sore throat.
- Nasal congestion.
- Stomach or abdominal pain.
- Diarrhoea.
- Increased liver enzymes (signs of liver stress).
- Changes in the type of bacteria in the mucus.
- Increased creatine phosphokinase (sign of muscle breakdown), seen in blood tests.
Common(may affect up to 1 in 10 people)
- Flu.
- Abnormal breathing (shortness of breath or difficulty breathing).
- Low blood sugar (hypoglycaemia).
- Runny nose.
- Sinus problems (sinus congestion).
- Sore or painful throat.
- Ear problems: ear pain or discomfort, ringing in the ears, inflamed eardrum.
- Feeling of spinning (inner ear disorder).
- Wind (flatulence).
- Spots (acne).
- Itchy skin.
- Breast lump.
- Feeling sick.
Uncommon(may affect up to 1 in 100 people)
- Breast or nipple problems: inflammation, pain.
- Increased breast size in men.
- Increased blood pressure.
- Wheezing.
- Ear blockage (ear congestion).
Frequency not known(cannot be estimated from the available data)
- Allergic reactions (hypersensitivity)
- Liver damage (liver injury).
- Increased bilirubin (liver blood test).
- Changes in behaviour
Additional side effects in adolescents
Side effects seen in adolescents are similar to those seen in adults.
Additional side effects in children
Most cases of changes in behaviour have been reported in young children aged 2 to 5 years.
Reporting of side effects
If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Kaftrio
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 on the blister after EXP. The expiry date is the last day of the month shown.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Package Contents and Additional Information
Composition ofKaftrio
- The active ingredients are ivacaftor, tezacaftor, and elexacaftor.
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets
Each film-coated tablet contains 37.5 mg of ivacaftor, 25 mg of tezacaftor, and 50 mg of elexacaftor.
Kaftrio 75 mg/50 mg/100 mg film-coated tablets
Each film-coated tablet contains 75 mg of ivacaftor, 50 mg of tezacaftor, and 100 mg of elexacaftor.
- The other ingredients are:
- Tablet core: hypromellose (E464), hypromellose acetate succinate, sodium lauryl sulfate (E487), sodium croscarmellose (E468), microcrystalline cellulose (E460(i)), and magnesium stearate (E470b).
- Tablet coating: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).
See the end of section 2 for important information about the contents of Kaftrio.
Appearance and Package Contents
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets are capsule-shaped, light orange tablets with the imprint “T50” on one side and smooth on the other.
Kaftrio 75 mg/50 mg/100 mg film-coated tablets are capsule-shaped, orange tablets with the imprint “T100” on one side and smooth on the other.
Kaftrio is available in pack sizes of 56 tablets (4 blister packs of 14 tablets each).
Marketing Authorization Holder
Vertex Pharmaceuticals (Ireland) Limited
Unit 49, Block 5, Northwood Court, Northwood Crescent,
Dublin 9, D09 T665,
Ireland
Tel.: +353 (0)1 761 7299
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland
Almac Pharma Services Limited
Seagoe Industrial Estate
Craigavon
Northern Ireland
BT63 5UA
United Kingdom
You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:
| Spain Vertex Pharmaceuticals Spain, S.L. Tel: + 34 91 7892800 |
Greece Vertex Φαρμακευτικ? Μονοπρ?σωπη Αν?νυμη Εταιρ?α Tel: +30 (211) 2120535 | Italy Vertex Pharmaceuticals (Italy) S.r.l. Tel: +39 0697794000 |
Date of the last revision of this leaflet:
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.
-
- Country of registration
- Dosage formTABLET, 37.5 mg/25 mg/50 mg
- ATC codeR07AX32
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETSDosage form: ORAL SOLUTION/SUSPENSION, 60 mg/40 mg/80 mgActive substance: ivacaftor, tezacaftor and elexacaftorManufacturer: Vertex Pharmaceuticals (Ireland) LimitedPrescription requiredDosage form: TABLET, 75 mg/50 mg/100 mgActive substance: ivacaftor, tezacaftor and elexacaftorManufacturer: Vertex Pharmaceuticals (Ireland) LimitedPrescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 75 mg/50 mg/100 mgActive substance: ivacaftor, tezacaftor and elexacaftorManufacturer: Vertex Pharmaceuticals (Ireland) LimitedPrescription required
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Frequently Asked Questions
KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS is ivacaftor, tezacaftor and elexacaftor. This information helps identify medicines with the same composition but different brand names.
KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS is manufactured by Vertex Pharmaceuticals (Ireland) Limited. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy KAFTRIO 37.5 mg/25 mg/50 mg FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (ivacaftor, tezacaftor and elexacaftor) include KAFTRIO 60 mg/40 mg/80 mg granules in sachet, KAFTRIO 75 mg/50 mg/100 mg FILM-COATED TABLETS, KAFTRIO 75 mg/50 mg/100 mg granules in sachet. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
