Treating the underlying cause. Another first worth remembering.

Learn about Brody's KALYDECO story

Brody,

Age 3, G551D

We were grateful that we were able to get Brody on KALYDECO as soon as he was eligible.

— Brody's parents, Alissa and Dan

People with CF pictured may or may not be taking 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.

4 months and older
Kalydeco Eligibility

Learn how to enter 2 or more mutations

If you don’t know your or your child's CF gene mutations, it’s important to work with your healthcare provider to identify them. Knowing your mutations can help determine if KALYDECO could be right for you.

You can view the full list of eligible mutations here.

 

Based on the information you entered, you may be eligible for KALYDECO.

Talk with your healthcare provider to see if KALYDECO is right for you.

Here is some information about KALYDECO that may be helpful:

 

Neither CF gene mutation you entered is eligible for KALYDECO.

Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.

You can view the full list of eligible mutations here.

 

We’re sorry, we do not recognize 1 or both of the mutations you entered.

Talk to your healthcare provider to discuss your CF care plan. They can help determine what treatment option is right for you at this time. 

You can view the full list of eligible KALYDECO mutations here.

Brody Started KALYDECO at 6 Months Old

Watch Alissa and Dan share why starting their son, Brody, on KALYDECO at 6 months old was the right decision for them.

 

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Get to Know Vertex GPS™: Guidance & Patient Support

Vertex GPS offers eligible patients ongoing one-on-one support, right from the start of treatment. Patient Support Specialists can help you navigate questions about insurance, reimbursement, and potential co-pay assistance. You can even get tips for your Vertex treatment and resources that may help you stay on track. No matter where you’re headed, Vertex GPS is with you along the way.

Learn more at VertexGPS.com

Important Safety Information

Do not take KALYDECO if you take certain medicines or herbal supplements, such as:

  • the antibiotics rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
  • seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, and EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
  • St. John’s wort

Talk to your doctor before taking KALYDECO if you take any of the medicines or supplements listed above.

What is KALYDECO® (ivacaftor)?

What is KALYDECO®
(ivacaftor)?

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.

It is not known if KALYDECO is safe and effective in children under 4 months of age.

What should I tell my doctor before taking KALYDECO?

Before you take KALYDECO, tell your doctor if you:

  • have liver or kidney problems
  • drink grapefruit juice or eat grapefruit
  • are pregnant or plan to become pregnant. It is not known if KALYDECO will harm your unborn baby. You and your doctor should decide if you will take KALYDECO while you are pregnant
  • are breastfeeding or planning to breastfeed. It is not known if KALYDECO passes into your breast milk. You and your doctor should decide if you will take KALYDECO while you are breastfeeding

KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, as the dose of KALYDECO may need to be adjusted when taken with certain medications.

Especially tell your doctor if you take:

  • antifungal medications such as ketoconazole (e.g., NIZORAL®), itraconazole (e.g., SPORANOX®), posaconazole (e.g., NOXAFIL®), voriconazole (e.g., VFEND®), or fluconazole (e.g., DIFLUCAN®)
  • antibiotics such as telithromycin (e.g., KETEK®), clarithromycin (e.g., BIAXIN®), or erythromycin (e.g., ERY-TAB®)

What should I avoid while taking KALYDECO?

  • KALYDECO can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how KALYDECO affects you
  • You should avoid food containing grapefruit while you are taking KALYDECO

What are the possible side effects of KALYDECO?

KALYDECO can cause serious side effects.

High liver enzymes in the blood have been reported in patients receiving KALYDECO. Your doctor will do blood tests to check your liver:

  • before you start KALYDECO
  • every 3 months during your first year of taking KALYDECO
  • every year while you are taking KALYDECO

For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • pain or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • loss of appetite
  • nausea or vomiting
  • dark, amber-colored urine

Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations prior to and during treatment with KALYDECO to look for cataracts.

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

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KALYDECO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

For further information, please see full Prescribing Information, including Patient Information.

People with CF pictured may or may not be taking KALYDECO.