Kalydeco

What is Kalydeco?

Kalydeco can be used to treat cystic fibrosis in both children and adults who are at least 4 months old and weigh at least 11 lbs (5 kg). Kalydeco is intended for use only by patients who have a specific gene mutation linked to cystic fibrosis. Before taking Kalydeco, it is possible that you will require a medical exam to confirm that you are carrying this mutation in your gene.

Warnings

Kalydeco should not be taken if you are allergic to Ivacaftor. Before taking Kalydeco, consult your physician to determine whether you suffer from kidney or liver disease. Kalydeco is best taken in conjunction with food products that contain fats, such as peanut butter, butter, cheese pizza, eggs, or dairy products that are whole milk, like whole milk, yogurt, and cheese. Follow your doctor's prescriptions cautiously.

The grapefruits, juice of the grapefruits, and Seville oranges can be in contact with Kalydeco and result in undesirable adverse effects. Discuss using grapefruit and orange products with your physician before doing so. To make sure Kalydeco isn't causing any negative effects on your liver, its function must be checked regularly with blood tests. Visit your doctor regularly. There are other drugs that may interfere with ivacaftor. Discuss with your physician any medication you take. This includes prescriptions, over-the-counter or vitamin products, as well as herbal products. Don't start an entirely new drug without first consulting your physician. Keep a record of all your medications and present it to any health professional who cares for you.

Before you take this drug

It is not recommended to use Kalydeco in the event that you have an allergy to ivacaftor. Certain medicines may cause undesirable or hazardous effects when used together with ivacaftor. Your doctor could alter the treatment plan in the event that you also take:

• Rifabutin or rifampin.
• John's Wort.
• Seizure medication, such as carbamazepine, phenobarbital, and phenytoin.

Inform your doctor if you have ever suffered from:

• Liver disease liver disease.
• kidney disease.

It is unclear if this medicine could cause harm to a baby who is not yet born. Inform your doctor if you are expecting or planning to be pregnant. It might not be safe to breastfeed while taking this medication. Consult with your physician regarding potential risks. Kalydeco is not recommended for a child who is less than 4 months old, as well as for children suffering from liver issues who are between 4 months and less than 6 months old.

How to take Kalydeco?

Kalydeco is usually taken once every 12 hours. Follow the instructions on the prescription label and go through all medication guides or instructions. Take Kalydeco along with foods that contain fats, such as peanut butter, eggs, butter, whole milk, cheese yogurt, and cheese pizza. Follow the instructions of your physician cautiously. To make use of Kalydeco oral granules, mix the granules in one teaspoon of soft or liquid food, such as milk, juice, water pudding, yogurt, or applesauce. Mix only one dose at a time and consume the mixture within one hour after mixing. Give the child a high-fat food right before or shortly after you have given the granule mix.

Make sure you take your doses regularly, at intervals of at least 12 hours between each dose. Ivacaftor dosages are determined by the child's weight and age. Children aged 4 months to 5 years of age should be taking oral granules. Children aged 6 and over are advised to take tablets. You'll need regular blood tests to monitor the liver's function. Children taking this medicine could require regular eye exams. Place it in a cool, dry place free of heat and moisture. Place the tablet in the blister wrapper until you're ready to consume it.

Details on dosage

Usual Adult Dose for Cystic Fibrosis:

One tablet of 150 mg is to be taken orally each day with fat-rich food items.

Usual Pediatric Dose for Cystic Fibrosis:

• Children aged 6 years or older: one 150 mg tablet administered orally every 12 hours along with foods that are high in fat.
• Pediatric patients aged 4 months to under 6 years old:
  • Weighting from 5 to seven kilograms: One 25 mg tablet mixed in 1 teaspoon (5 milliliters) of liquid or soft food and taken by mouth every 12 hours, along with foods that contain fat,
  • 7 to 14 kilograms: one 50 mg packet mixed with 1 teaspoon (5 milliliters) of liquid or soft food and taken by mouth every 12 hours, along with food that is fat-rich.
  • If you weigh 14 kg or more, One 75 mg tablet combined with one teaspoon (5 milliliters) of liquid or soft food and taken orally every 12 hours along with foods that contain fat
• Children younger than 4 months old are not recommended.

It is recommended to take this drug along with food that contains fat. Examples are eggs and peanut butter cheese pizza, as well as dairy products made from whole milk.
The oral granules are suggested for patients younger than 6 years, and tablets are suggested for patients who are 6 years old or older.
If the patient's genetics are not known, a certified CF mutation test must be utilized to identify whether there is a CFTR variant, followed by confirmation using bi-directional sequencing if suggested in the instructions for mutation tests to be used.
Uses: For the treatment of cystic fibrosis patients older than 4 months with a single genetic mutation of the cystic fibrosis transmembrane conductance (CFTR) gene. The gene is responsive to ivacaftor-mediated potentiation, as determined by clinical or in vitro test results.

What happens if I miss a dose?

Utilize the medicine as soon as you can. However, avoid any missed dose if you are more than six hours late to take the dose. Don't take two doses at once.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

What should be avoided?

Avoid driving or engaging in hazardous activities until you are aware of the effects this medication will have on your body. The way you react could be impaired. Grapefruit, along with Seville oranges, can interact with ivacaftor and cause adverse negative side effects. Beware of using citrus marmalades and grapefruit products.

Side effects of Kalydeco

See a doctor immediately. If you are experiencing symptoms of an allergic reaction to Kalydeco, such as hives, breathing problems, and swelling of your lips, face, and tongue,

Contact your doctor immediately for:

• Severe stomach pain.
• Eye problems, vision issues.
• Low blood sugar can cause sweating, headaches, hunger, or irritability. nausea, rapid heart rate, being shaky or anxious.
• Liver issues weight loss nausea, stomach discomfort (upper right side) nausea nausea and dark urine. Jaundice (yellowing of eyes or skin) occurs in children born to mothers who were carrying jaundice-causing bacteria during gestation.

Common Kalydeco side effects can be:

• Dizziness.
• Rash.
• Headache.
• Stomach nausea, pain in the stomach, diarrhea.
• Signs of a cold, like congestion of the nose, nasal congestion, and a sore throat.

This isn't a complete list of all the side effects. Other effects may also be present. Contact your physician to seek medical advice on adverse effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

Discuss with your doctor all other medicines you take, including:

• Antibiotics: Ciprofloxacin, clarithromycin, erythromycin, and telithromycin.
• Antifungal medicine: fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole.

This list isn't complete. Other medications can interact with ivacaftor, such as medications that are prescribed and available over the counter, vitamins, and herbal products. There are many possible interactions between drugs, which are included here.