"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Kalydeco Patient Information Including Side Effects
Brand Names: Kalydeco
Generic Name: ivacaftor (Pronunciation: EYE va KAF tor)
- What is ivacaftor (Kalydeco)?
- What are the possible side effects of ivacaftor (Kalydeco)?
- What is the most important information I should know about ivacaftor (Kalydeco)?
- What should I discuss with my healthcare provider before taking ivacaftor (Kalydeco)?
- How should I take ivacaftor (Kalydeco)?
- What happens if I miss a dose (Kalydeco)?
- What happens if I overdose (Kalydeco)?
- What should I avoid while taking ivacaftor (Kalydeco)?
- What other drugs will affect ivacaftor (Kalydeco)?
- Where can I get more information?
What is ivacaftor (Kalydeco)?
Ivacaftor is used to treat cystic fibrosis in adults and children who are at least 6 years old.
Ivacaftor is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take ivacaftor, you may need a medical test to make sure you have this gene mutation.
Ivacaftor may also be used for purposes not listed in this medication guide.
What are the possible side effects of ivacaftor (Kalydeco)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe stomach pain;
- chest pain, wheezing, feeling short of breath;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).
Less serious side effects may include:
- nausea, diarrhea, stomach pain;
- acne or mild rash;
- joint or muscle pain; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Kalydeco (ivacaftor) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about ivacaftor (Kalydeco)?
You should not use ivacaftor if you are allergic to it.
Before you take ivacaftor, tell your doctor if you have liver or kidney disease.
Ivacaftor should be taken with a food that contains fat, such as butter, peanut butter, eggs, cheese pizza. Follow your doctor's instructions very carefully.
Grapefruit, grapefruit juice, and Seville oranges may interact with ivacaftor and lead to unwanted effects. Discuss the use of grapefruit and orange products with your doctor.
To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.
There are many other drugs that can interact with ivacaftor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Additional Kalydeco Information
- Kalydeco Drug Interactions Center: ivacaftor oral
- Kalydeco Side Effects Center
- Kalydeco FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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