Product Introduction

• Keftrio 50 mg Tablet elexacaftor ivacaftor ezacaftor is used for the short-term treatment of moderate to severe pain. It effectively alleviates pain, inflammation, and fever. It should not be used for mild or long-term painful conditions.
• Keftrio 50 mg Tablet should be taken in the dose and duration as advised by your doctor. It should be taken with food to prevent stomach upset. Dissolve it in a glass of water before taking it. Inform your doctor if you have any history of heart disease or stroke.
• Vomiting, stomach pain, nausea, and indigestion are some of the common side effects of this medicine. It may also cause dizziness, drowsiness, or visual disturbances.
• Long-term use may lead to serious complications such as stomach bleeding and kidney problems. Your doctor may regularly monitor your kidney function, liver function, and levels of blood components if you are taking this medicine for long-term treatment.

What Kaftrio is and what it is used for

• Keftrio 50 mg contains three active substances: ivacaftor, Tezacaftor and Elexacaftor. The medicine helps lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.
• Keftrio 50 mg taken with ivacaftor is for patients aged 6 years and over who have CF, with at least one F508del mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Kaftrio 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 CFTR gene.
• Keftrio 50 mg price is normally taken with another medicine, ivacaftor. Ivacaftor causes the protein to work better, while Tezacaftor and Elexacaftor increase the amount of protein at the cell surface.
• Kaftrio (taken with ivacaftor) helps your breathing 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.

What you need to know before you take Kaftrio

Do not take Kaftrio:

If you are allergic to ivacaftor, Tezacaftor, Elexacaftor, or any other ingredients of this medicine (listed in section 6).
Talk to your doctor and do not take the tablets, if this applies to you.

Keftrio, marketed under the brand name Keftrio, is a revolutionary treatment that combines elexacaftor, tezacaftor, and ivacaftor. This combination works effectively to enhance lung function in individuals with cystic fibrosis. Elexacaftor/tezacaftor/ivacaftor targets the underlying cause of the disease by correcting the protein produced by the CFTR gene. The ivacaftor brand name product, part of this trio, is known for its role in improving the flow of chloride ions across cell membranes. With competitive Kaftrio price and kaftrio pret (price in Romanian), it’s becoming more accessible to patients worldwide. For detailed dosage instructions, such as the filmomhulde tabletten 100 mg, consult the prescribing information.

How should I take elexacaftor, ivacaftor, and tezacaftor?

• Keftrio 50 mg price elexacaftor ivacaftor ezacaftor Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
• This medicine is usually taken twice per day, in the morning and in the evening (about 12 hours apart).
• Always take this medicine with food that contains fat, such as butter, peanut butter, eggs, nuts, meat, whole milk, cheese, or yogurt.
• Swallow the tablet whole and do not crush, chew, or break it.
• Mix the granules with one teaspoon (5 mL) of soft food or liquid that is at room temperature such as pureed fruits or vegetables, yogurt, applesauce, water, juice, or milk and take at once within one hour.
• Doses are based on weight in children and teenagers less than 12 years old. Your child’s dose may change if the child gains or loses weight.
• Your dose may change if you also take certain other medications. Do not change your dose or dosing schedule without your doctor’s advice.
• You will need frequent blood tests to check your liver function.
• A child using this medicine may need an eye exam before and after starting this treatment to check for cataracts.
• Store at room temperature away from moisture and heat.

Warnings and precautions

• Ketrio 50 mg price elexacaftor ivacaftor ezacaftor Talk to your doctor if you have liver problems or have had them previously. Your doctor may need to adjust your dose.
• Your doctor will do some blood tests to check your liver before and during treatment with Kaftrio, especially if your blood tests showed high liver enzymes in the past.
• Liver enzymes in the blood can increase in patients receiving Kaftrio 75 Mg
• Tell your doctor right away if you have any symptoms of liver problems. These are listed in section 4.
• Talk to your doctor if you have kidney problems, or you have previously had them.
• Talk to your doctor before starting treatment with Kaftrio if you have received 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 Kaftrio.
• Keftrio 50 mg price Your doctor may do eye examinations before and during treatment with Kaftrio. Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving this treatment.

Children under 6

Do not give this medicine to children under the age of 6 years because it is not known if Kaftrio is safe and effective in this age group.

Other medicines and Kaftrio

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect how Kaftrio works or may make side effects more likely. In particular, tell your doctor if you take any of the medicines listed below. Your doctor may change the dose of one of the medicines if you take any of these.

• 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, rifampicin, rifabutin 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.
• Keftrio 75 Mg Medicines for diabetes. These include glimepiride, glipizide, glyburide, Nateglinide and repaglinide.
• Medicines for lowering blood cholesterol. These include pitavastatin and rosuvastatin.
• Medicines for lowering blood pressure. These include verapamil.
• Kaftrio with food and drink Avoid food or drinks containing grapefruit during treatment as these may increase the side effects of Kaftrio by increasing the amount of Kaftrio in your body.

Pregnancy and breast-feeding

• Ask your doctor for advice before taking 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 child.
• Breast-feeding: It is not known if ivacaftor, tezacaftor or elexacaftor passes into breast milk.
• Your doctor will consider the benefit of breast-feeding for your baby and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.

Driving and using machines

• Keftrio 50 mg elexacaftor ivacaftor ezacaftor can make you dizzy. If you feel dizzy, do not drive, cycle, or use machines unless you are not affected.
• Keftrio 50 mg contains sodium.
• This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

How to take Kaftrio 75 Mg

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Your doctor will determine the correct dose for you.
• Keftrio 75 Mg elexacaftor ivacaftor ezacaftor is usually taken with ivacaftor.
• Recommended dose for patients aged 6 years and over

Age                                                                          Morning dose                                                                                 Evening dose

6 to <12 years weighing <30 kg     2 tablets of ivacaftor 37.5 mg/tezacaftor 25 mg/elexacaftor 50 mg             1 tablet of ivacaftor 75 mg

6 to <12 years weighing >30 kg     2 tablets of ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg              1 tablet of ivacaftor 150 mg

>12 years                                            2 tablets of ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg               1 tablet of ivacaftor 150 mg

Keftrio 75 Mg Take the morning and evening tablets about 12 hours apart.

The Keftrio 75 Mg tablets are for oral use.

Take both Kaftrio and 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.
• Avoid food and drink containing grapefruit while you are taking Kaftrio. See Kaftrio with food and drink in section 2 for more details.

Swallow the tablets whole.

• Do not chew, crush or break the tablets before swallowing.
• You must keep using all your other medicines, unless your doctor tells you to stop.

If you have liver problems,

Keftrio 75 Mg either moderate or severe, your doctor may reduce the dose of your tablets or decide to stop treatment with Kaftrio. See also Warnings and precautions in section 2.

If you take more Kaftrio 75 Mg than you should

Contact your doctor or pharmacist for advice. If possible, take your medicine and this leaflet with you. You may get side effects, including those mentioned in section 4 below.

If you forget to take Kaftrio

So If you forget a dose, work out how long it is since the dose you missed.

If less than 6 hours have passed since you missed a dose, elexacaftor ivacaftor ezacaftor either morning or evening, take the forgotten tablet(s) as soon as possible. Then go back to your usual schedule.
If more than 6 hours have passed:
If you missed a morning dose of Keftrio 50 mg price, 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 missed an evening dose of ivacaftor, do not take the missed dose. Wait for the next day and take the morning dose of Kaftrio tablets as usual.
Do not take a double dose to make up for any missed tablets.

If you stop taking Kaftrio

Your doctor will tell you how long you need to keep taking Kaftrio. Keftrio 50 mg price It is important to take this medicine regularly. Do not make changes unless your doctor tells you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Keftrio 75 Mg Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Possible signs of liver problems

Liver damage and worsening of liver function in people with severe liver disease. Keftrio 75 Mg The worsening of liver function can be serious and may require transplantation.

Increased liver enzymes in the blood are common in patients with CF. Keftrio 75 Mg Elexacaftor Ivacaftor Ezacaftor 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 the 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 side effects (may affect more than 1 in 10 people)

Rash (more common in women than in men)
Tell your doctor straight away if you notice a rash.

Keftrio 75 Mg Other side effects seen with Kaftrio:

Very common (may affect more than 1 in 10 people)

Headache
Dizziness
Upper respiratory tract infection (common cold)
Oropharyngeal pain (sore throat)
Nasal congestion
Stomach or abdominal pain.
Diarrhoea
Increased liver enzymes (signs of stress on the liver)
Changes in the type of bacteria in mucus
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)
Redness or soreness in the throat
Ear problems: ear pain or discomfort, ringing in the ears, inflamed eardrum.
Spinning sensation (inner ear disorder)
Wind (flatulence)
Spots (acne)
Itchy skin
Breast mass
Feeling nauseous
Keftrio 75 Mg Increased creatine phosphokinase (sign of muscle breakdown) seen in blood tests.

Keftrio elexacaftor 50 mg Uncommon (may affect up to 1 in 100 people)

Breast and nipple problems: inflammation, pain
Enlargement of the breast in men
Increases in blood pressure.
Wheezing
Blocked ears (ear congestion)
Additional side effects in adolescents

Keftrio elexacaftor 50 mg Side effects in adolescents are similar to those observed in adults.

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 national reporting system listed in by Keftrio 50 mg price reporting side effects you can help provide more information on the safety of this medicine.