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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.

View Important Safety Information and full Prescribing Information, including Patient Information, for KALYDECO.

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Learn about KALYDECO

A Guide to KALYDECO for Parents of Infants

This brochure provides information on how KALYDECO works, results for studies in children age 4 months to less than 2 years old, and how to give your child KALYDECO oral granules.

Learn how to take KALYDECO

A Guide to KALYDECO (Oral Granules)

Instructions on how to give your child age 4 months to less than 6 years old KALYDECO oral granules.

A Guide to KALYDECO (Tablets)

Instructions for people age 6 years and older on how to take KALYDECO tablets. 

FAQs

Tablets and granules

Additional tablets info

Additional granules info

Tablets and granules

What is KALYDECO? 

Who should not take KALYDECO?

Does KALYDECO cure cystic fibrosis (CF)? 

How does KALYDECO work?

I have 2 copies of the F508del mutation. Why isn't KALYDECO right for me? 

What should I tell my doctor before taking KALYDECO? 

What should I avoid while taking KALYDECO? 

What are the possible side effects of KALYDECO? 

Why do I need my liver enzymes checked every 3 months? 

When should I take KALYDECO? 

Why do I need to take KALYDECO with fat-containing food? 

I have additional questions about KALYDECO. Who should I talk to?

Where can I get my KALYDECO prescription filled?

What 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.

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

711+3A→G* F311del I148T R75Q S589N
2789+5G→A* F311L I175V R117C* S737F
3272-26A→G* F508C I807M R117G S945L*
3849+10kbC→T* F508C;
S1251N†
I1027T R117H* S977F*
A120T F1052V I1139V R117L S1159F
A234D F1074L K1060T R117P S1159P
A349V G178E L206W* R170H S1251N*
A455E* G178R* L320V R347H* S1255P*
A1067T G194R L967S R347L T338I
D110E G314E L997F R352Q* T1053I
D110H G551D* L1480P R553Q V232D
D192G G551S* M152V R668C V562I
D579G* G576A M952I R792G V754M
D924N G970D M952T R933G V1293G
D1152H* G1069R P67L* R1070Q W1282R
D1270N G1244E* Q237E R1070W* Y1014C
E56K G1249R Q237H R1162L Y1032C
E193K G1349D* Q359R R1283M  
E822K H939R Q1291R S549N*  
E831X* H1375P R74W S549R*  
711+3A→G* F311del I148T
2789+5G→A* F311L I175V
3272-26A→G* F508C I807M
3849+10kbC→T* F508C;S1251N† I1027T
A120T F1052V I1139V
A234D F1074L K1060T
A349V G178E L206W*
A455E* G178R* L320V
A1067T G194R L967S
D110E G314E L997F
D110H G551D* L1480P
D192G G551S* M152V
D579G* G576A M952I
D924N G970D M952T
D1152H* G1069R P67L*
D1270N G1244E* Q237E
E56K G1249R Q237H
E193K G1349D* Q359R
E822K H939R Q1291R
E831X* H1375P R74W
R75Q S589N R117C*
S737F R117G S945L*
R117H* S977F* R117L
S1159F R117P S1159P
R170H S1251N* R347H*
S1255P* R347L T338I
R352Q* T1053I R553Q
V232D R668C V562I
R792G V754M R933G
V1293G R1070Q W1282R
R1070W* Y1014C R1162L
Y1032C R1283M  
S549N* S549R*  

*Clinical data exists for these mutations. See Clinical studies.

Complex/compound mutations. Most people with CF have 2 CF mutations, 1 on each copy of the CF gene. However, in rare instances, 1 copy of the CF gene can have more than 1 mutation. This is called a compound, or complex, mutation.

 

Who should not take KALYDECO?

Do not take KALYDECO if you take certain medicines or herbal supplements, such as: the antibiotics rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®); seizure medications such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®) or phenytoin (DILANTIN®, PHENYTEK®); or St. John's wort.

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

Does KALYDECO cure cystic fibrosis (CF)? 

No, KALYDECO is not a cure for CF.

How does KALYDECO work?

KALYDECO affects the CFTR protein "gating" in people with at least one mutation in their CF gene that is responsive to KALYDECO. KALYDECO helps the "gates" of the CFTR proteins stay open longer, allowing more chloride ions to move into and out of the cells. The movement of chloride ions may help keep a balance of salt and water in the lungs. KALYDECO does not increase the amount of CFTR proteins at the cell surface.

What is known about how KALYDECO works was learned from studies conducted in a laboratory. Keep in mind that results from laboratory studies do not always match how these medicines work in a person. If you have any questions about your treatment, please speak with your healthcare provider.

I have 2 copies of the F508del mutation. Why isn't KALYDECO right for me? 

KALYDECO is not indicated for people with 2 copies of the F508del mutation.

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®); or antibiotics such as telithromycin (e.g., KETEK®), clarithromycin (e.g., BIAXIN®), or erythromycin (e.g., ERY-TAB®).

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine or stop taking a medicine.

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, and every year while you are taking KALYDECO
    • For patients who have had high liver enzymes in the past, your 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; or 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), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and 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.

Why do I need my liver enzymes checked every 3 months? 

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, and every year while you are taking KALYDECO
  • For patients who have had high liver enzymes in the past, your 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; or dark, amber-colored urine

When should I take KALYDECO? 

Take KALYDECO orally every 12 hours with fat-containing food unless otherwise directed by your healthcare provider.

Please see full dosing information.

Why do I need to take KALYDECO with fat-containing food? 

KALYDECO should be taken with fat-containing food because fat-containing food helps the body absorb KALYDECO better.

I have additional questions about KALYDECO. Who should I talk to?

If you have questions about KALYDECO, please talk to your doctor. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.

Where can I get my KALYDECO prescription filled?

Prescriptions for KALYDECO can only be filled at authorized specialty pharmacies. If you'd like to see a list of specialty pharmacies and specialty distributors, click here. Based on your health plan, there may be restrictions on which pharmacies you can use.

Additional tablets info

Can I separate the doses on the blister cards? 

How should I store KALYDECO tablets? 

What do KALYDECO tablets look like?

What if I miss a dose of KALYDECO? 

I have additional questions about KALYDECO. Who should I talk to? 

Can I separate the doses on the blister cards? 

You may cut along the dotted line to separate your doses from the blister card.

How should I store KALYDECO tablets? 

KALYDECO should be stored at 68°F to 77°F (20°C to 25°C).

Do not use KALYDECO after the expiration date on the package.

Keep KALYDECO and all medicines out of the reach of children.

What do KALYDECO tablets look like?

For people 6 years and older, KALYDECO tablets are supplied as light blue, film-coated, capsule-shaped tablets containing 150-mg of ivacaftor. Each tablet is printed with the characters "V 150" on one side and plain on the other.

KALYDECO tablets
Not actual size.

 

What if I miss a dose of KALYDECO? 

If you miss a dose of KALYDECO and it is within 6 hours of when you usually take it, take the dose of KALYDECO as prescribed with fat-containing food as soon as possible.

If you miss a dose and it is more than 6 hours after the time you usually take it, skip that dose only and take the next dose with fat-containing food when you usually take it.

Do not take 2 doses at the same time to make up for a missed dose.

I have additional questions about KALYDECO. Who should I talk to? 

If you have questions about KALYDECO, please talk to your healthcare provider. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.

Additional granules info

After the granules are mixed in soft food or liquid, how quickly does my child need to take the medicine? 

How should I store KALYDECO oral granules? 

What do KALYDECO oral granules look like? 

What is the recommended dose of KALYDECO oral granules?

Can I mix KALYDECO oral granules in breast milk or prepared infant formula?

What if my child misses a dose of KALYDECO oral granules? 

Can I mix KALYDECO oral granules in soft food or liquid that contains fat? If so, do I still need to give fat-containing food to my child? 

Do breast milk and prepared infant formula qualify as fat-containing foods that my child can take with KALYDECO?

Does the temperature of the food that I mix with KALYDECO oral granules matter? Can I mix oral granules in breast milk or prepared infant formula that I’ve warmed?

Can my child swallow the granules without mixing them in soft food or liquid? 

Can I give my child KALYDECO oral granules using a bottle?

Do the granules have a taste? 

My child spit up their dose of KALYDECO oral granules. What should I do?

If my child is napping when it is time for KALYDECO oral granules, should I wait until they’re awake to administer them?

Should the granules be removed from the foil packet and stored elsewhere (for example, a pillbox)? 

Are the packets child-proof? 

When should my child transition from taking KALYDECO oral granules (25-mg, 50-mg, or 75-mg) to KALYDECO tablets (150-mg)? 

Will my child require a new prescription when changing strengths or dosage forms? 

I have additional questions about KALYDECO. Who should I talk to? 

After the granules are mixed in soft food or liquid, how quickly does my child need to take the medicine? 

The granules should be taken within 1 hour of mixing with soft food or liquid. Make sure all medicine is taken.

How should I store KALYDECO oral granules? 

KALYDECO should be stored at room temperature between 68°F to 77°F (20°C to 25°C).

Do not use KALYDECO after the expiration date on the package.

Keep KALYDECO and all medicines out of the reach of children.

What do KALYDECO oral granules look like? 

KALYDECO is supplied as oral granules (25-mg, 50-mg, or 75-mg packets) for people age 4 months to less than 6 years.

KALYDECO 25-mg, 50-mg, and 75-mg oral granules packets
Not actual size.

 

What is the recommended dose of KALYDECO oral granules?

The recommended dose of KALYDECO oral granules for children age 4 months to less than 6 months old who weigh more than 11 pounds (5 kg) is one 25-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 50 mg.

The recommended dose of KALYDECO oral granules for children age 6 months to less than 6 years old is based on weight.

Children who weigh 11 pounds to less than 15 pounds (5 kg to less than 7 kg) should take one 25-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 50 mg.

Children who weigh 15 pounds to less than 31 pounds (7 kg to less than 14 kg) should take one 50-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 100 mg.

Children who weigh 31 pounds (14 kg) or more should take one 75-mg packet mixed with one teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 150 mg.

Give your child fat-containing food just before or just after the dose of KALYDECO granules. This helps the body absorb KALYDECO better.

Your child's dose may be different. Your doctor should tell you how much KALYDECO your child should take and when to take it.

Can I mix KALYDECO oral granules in breast milk or prepared infant formula?

Yes, KALYDECO oral granules can be mixed with 1 teaspoon (5 mL) of breast milk or prepared infant formula at or below room temperature. Be sure that the entire mixture is taken by the child within 1 hour. Remember your child should always take KALYDECO with a fat-containing food.

What if my child misses a dose of KALYDECO oral granules? 

If your child misses a dose of KALYDECO and it is within 6 hours of when your child usually takes it, give the dose of KALYDECO as prescribed with fat-containing food as soon as possible.

If your child misses a dose and it is more than 6 hours after the time your child usually takes it, skip that dose only and give the next dose with fat-containing food when your child usually takes it.

Do not give 2 doses at the same time to make up for a missed dose.

Can I mix KALYDECO oral granules in soft food or liquid that contains fat? If so, do I still need to give fat-containing food to my child? 

Yes, you can mix KALYDECO granules with fat-containing food, for example, 1 teaspoon (5 mL) of whole-milk yogurt or milk, to give to your child. But your child should still eat fat-containing food just before or after taking the spoonful of the mixture.

Do breast milk and prepared infant formula qualify as fat-containing foods that my child can take with KALYDECO?

Yes, breast milk and prepared infant formula qualify as fat-containing food.

Does the temperature of the food that I mix with KALYDECO oral granules matter? Can I mix oral granules in breast milk or prepared infant formula that I’ve warmed?

The granules should be mixed with soft food or liquid at room temperature or below. The granules should not be mixed in items that are frozen or hot.

Can my child swallow the granules without mixing them in soft food or liquid? 

The entire contents of each packet should be mixed with 1 teaspoon (5 mL) of age-appropriate soft food or liquid. The mixture should be taken within 1 hour of being mixed. Make sure all medicine is taken.

Can I give my child KALYDECO oral granules using a bottle?

In the clinical study, instruction was provided to give the dose of KALYDECO oral granules mixed into 1 teaspoon of an age-appropriate soft food or liquid, either orally with a syringe or with a spoon, every 12 hours along with a fat-containing food. 

Direction was given to ensure the full contents of the syringe were administered.

KALYDECO granules should not be given with a bottle.

Do the granules have a taste? 

The granule formulation is sweetened but unflavored.

My child spit up their dose of KALYDECO oral granules. What should I do?

You should contact your child’s healthcare provider to discuss this. Your pharmacist may also be a good resource.

If my child is napping when it is time for KALYDECO oral granules, should I wait until they’re awake to administer them?

You should give your child KALYDECO oral granules every 12 hours or as prescribed by your child’s healthcare provider.

If your child misses a dose of KALYDECO and it is within 6 hours of when that dose is usually taken, give your child that dose of KALYDECO as prescribed with fat-containing food as soon as possible.

If more than 6 hours have passed, skip that dose only and give your child the next dose when you usually take it.

Do not give your child 2 doses at the same time to make up for a missed dose.

Should the granules be removed from the foil packet and stored elsewhere (for example, a pillbox)? 

No, granules should be kept in the foil packet until they are ready to be used.

Are the packets child-proof? 

The packets are child-resistant.

When should my child transition from taking KALYDECO oral granules (25-mg, 50-mg, or 75-mg) to KALYDECO tablets (150-mg)? 

KALYDECO granules (25-mg, 50-mg, or 75-mg) are for use in children who are 4 months to less than 6 years of age, while KALYDECO tablets (150-mg) are for use in children age 6 years and older. You and your child's healthcare provider should discuss when to transition your child to KALYDECO tablets.

Will my child require a new prescription when changing strengths or dosage forms? 

Yes, you will need a new prescription when your child changes to a new strength or dosage form.

I have additional questions about KALYDECO. Who should I talk to? 

If you have questions about KALYDECO, please talk to your doctor. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.