What kind of drug is Kalydeco?
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What kind of drug is Kalydeco?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Talk to your doctor to learn if you have an indicated CF gene mutation.
Is Kalydeco the same as ivacaftor?
What Is Kalydeco? Kalydeco (ivacaftor) film-coated tablets are a CFTR potentiator indicated for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
Is Kalydeco a pill?
KALYDECO is supplied as tablets (150 mg) for people 6 years and older.
Is Kalydeco a cure for CF?
Kalydeco® (ivacaftor) is approved to treat cystic fibrosis (CF) in people with one of 97 different kinds of CFTR mutations. It can be used by people with CF who are 4 months and older.
Who can take Kalydeco?
Check Your Eligibility. KALYDECO is for people with cystic fibrosis (CF) age 4 months and older with at least one mutation in their CF gene that is responsive to KALYDECO. Enter your mutations to see if at least one of them is eligible.
How much does Kalydeco cost?
The cost for Kalydeco oral tablet 150 mg is around $26,405 for a supply of 56 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
Is Kalydeco a biologic?
Cystic Fibrosis Biologic Response Modifers Prior Authorization Criteria: Cystic Fibrosis Biologic Response Modifiers include Kalydeco (ivacaftor), Symdeko (tezacaftor/ivacaftor), Orkambi (lumacaftor/ivacaftor), and Trikafta (elexacaftor, tezacaftor, ivacaftor).
When was Kalydeco invented?
Kalydeco was initially approved in 2012 for treatment of people ages 6 and older with the gating mutation G551D, who make up 4 percent of the 30,000 people with CF in the U.S. Last year, approval was expanded to babies ages 6 months and older with one of 38 mutations. It was developed by Vertex Pharmaceuticals Inc.
How much does kalydeco cost?
What are the side effects of Kalydeco?
The most common side effects of KALYDECO include:
- headache.
- upper respiratory tract infection (common cold), including: sore throat. nasal or sinus congestion. runny nose.
- stomach (abdominal) pain.
- diarrhea.
- rash.
- nausea.
- dizziness.
How effective is Kalydeco?
But Kalydeco only helps 6% of the 30,000 Americans who live with cystic fibrosis, which is caused by many different genetic mutations. Trikafta, a combination of three medicines, including Kalydeco, can help 90% of cystic fibrosis patients.
Can Kalydeco be crushed?
Usual dose: KALYDECO Tablets (for patients aged 6 years and older and weighing 25 kg or more): One tablet every 12 hours by mouth with fat containing food (see below). Do not crush or chew the tablet. Swallow the tablet whole.
Who created Kalydeco?
The drug was developed by Vertex Pharmaceuticals Inc. with scientific, clinical and significant funding support — $75 million — from the CF Foundation. Kalydeco (kuh-LYE-deh-koh) is a groundbreaking new drug in pill form that is the first to address the underlying cause of cystic fibrosis (CF). The FDA.
What is the cost of Kalydeco?
When did the FDA approve kalydeco?
How long can CF patients live?
People with CF typically live into their 30s or 40s. The authors of a 2018 study estimated that more than 50% of babies born with CF that year would live to at least the age of 41 years. Some people with CF live into their 70s.
When was Kalydeco approved by FDA?
01/31/2012
Approval Date: 01/31/2012.
