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Hear from the KALYDECO community

Brody

Age 21 months, G551D

Brody got an early start with KALYDECO

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

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

For Kristen and Makson, sticking to a routine works

My son Makson is 7 years old. He loves baseball, karate, fishing, and just being outside.

For Kristen and Makson, sticking to a routine works

My son Makson is 7 years old. He loves baseball, karate, fishing, and just being outside. He also has CF with an R117H mutation and takes KALYDECO.

Makson started KALYDECO when he was 6 years old. I had heard about KALYDECO from other parents of kids with CF, so I decided to talk to Makson's doctor about it. After going through the benefits and risks, we agreed to start.

Since then, KALYDECO has become part of our everyday routine. Maintaining a routine for my children is very important to me, whether it’s homework, eating, or getting outside—so we were able to fit it in pretty smoothly with the rest of Makson’s treatments. He usually takes KALYDECO tablets with peanut butter, his favorite fat-containing food. He’d eat peanut butter with every meal if he could. And now that he’s been taking it for a while, he’ll even remind me, “Mom, it’s time to take my KALYDECO!”

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

Stacy is passionate about her music and her health

Music has always been a passion of mine, and I enjoy sharing music with others; it comes naturally to me.

Stacy is passionate about her music and her health

Music has always been a passion of mine, and I enjoy sharing music with others; it comes naturally to me. I’ve known I wanted to be a music teacher since I was 9 years old.

I was diagnosed with cystic fibrosis when I was 6 years old; a genetic test showed I had the G551D mutation. I had to make adjustments to my diet and some of my activities, but I’ve tried to never let CF hold me back.

Managing CF can be complex, so it’s really important to have a close relationship with your doctor. During one of my regular appointments with my CF healthcare team, I heard about KALYDECO. I was very interested and started asking my doctor a lot of questions.

My doctor felt it would be a good choice for me, because I have the G551D mutation. Before taking KALYDECO, my doctor and I discussed the possible side effects of KALYDECO, including that KALYDECO can cause serious side effects.

It’s always been important to me to find ways to follow my passion for playing music, while making my health a priority. And that includes taking KALYDECO, along with my other prescribed CF treatments.

Stacy was sponsored by Vertex Pharmaceuticals Incorporated to share her story.

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

Carter stays diligent about taking his KALYDECO

I first heard about KALYDECO from my dad. During one of my appointments, he asked my doctor if I have the G551D mutation.

Carter stays diligent about taking his KALYDECO

I first heard about KALYDECO from my dad. During one of my appointments, he asked my doctor if I have the G551D mutation. My doctor checked and, sure enough, I did. I immediately got excited because of everything my doctor and my dad told me about KALYDECO. My doctor told me about potential side effects and, in the end, my dad and I felt comfortable moving forward with KALYDECO.

When I began taking KALYDECO, my mom helped me get organized and made sure I took it as my doctor had instructed. These days, I stay diligent about my routine and make sure I carve out time for my treatments.

Life with CF can sometimes be challenging, but I stay positive thanks to my relationships and knowing that my friends and family are always there for me.

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

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Videos

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

Downloadable Resources

Learn about KALYDECO

A Guide to KALYDECO for Caregivers of Infants

This brochure provides information on how KALYDECO works, results for studies in children age 1 month to less than 2 years old, and how to give your loved one KALYDECO oral granules.

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Descargar Recurso en Español

Learn how to take KALYDECO

A Guide to KALYDECO (Oral Granules)

Instructions on how to give your loved one age 1 month to less than 6 years old KALYDECO oral granules.

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A Guide to KALYDECO (Tablets)

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

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FAQs

Tablets and granules

What is KALYDECO?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) 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 1 month 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.

Does KALYDECO cure cystic fibrosis (CF)?

No, KALYDECO is not a cure for CF.

How does KALYDECO work?

KALYDECO affects the CFTR protein "gating". 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 taking KALYDECO, tell your doctor about all of your medical conditions, including if you:

have liver or kidney problems
are allergic to KALYDECO or any ingredients in KALYDECO. See the Patient Information for a list of ingredients
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

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

the antibiotics rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®)
seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®)
St. John’s wort
antifungal medicines such as ketoconazole, itraconazole (SPORANOX^®), posaconazole (NOXAFIL^®), voriconazole (VFEND^®), or fluconazole (DIFLUCAN^®)
antibiotics such as telithromycin, clarithromycin (BIAXIN^®), or erythromycin (ERY-TAB^®)

What should I avoid while taking KALYDECO?

KALYDECO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve.

Avoid food or drink containing grapefruit while you are taking KALYDECO.

What are the possible side effects of KALYDECO?

KALYDECO can cause serious side effects, including:

High liver enzymes in the blood, which have happened in people 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 people 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
dark, amber-colored urine

Serious allergic reactions have happened to people who are treated with KALYDECO. Call your healthcare provider or go to the emergency room right away if you have symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

rash or hives
tightness of the chest or throat or difficulty breathing
light-headedness or dizziness

Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations before 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.

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

High liver enzymes in the blood have happened in people receiving KALYDECO.

High liver enzymes in the blood, which have happened in people 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 people 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
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?

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.

Image of KALYDECO® (ivacaftor) packaging with 150 mg 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 loved one 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.

How are KALYDECO oral granules packaged?

KALYDECO is supplied as oral granules (5.8-mg, 13.4-mg, 25-mg, 50-mg, or 75-mg packets) for people age 1 month to less than 6 years.

Image showing how KALYDECO® (ivacaftor) oral granules are packaged

What is the recommended dose of KALYDECO oral granules?

The recommended dose of KALYDECO oral granules for children age 1 month to less than 6 years old is based on weight.

The recommended dose of KALYDECO oral granules for children age 1 month to less than 2 months old who weigh 3 kg (~7 lb) or more is one 5.8-mg packet mixed with 1 teaspoon (5 mL) of soft food or liquid every 12 hours for a total daily dose of 11.6 mg.

The recommended dose of KALYDECO oral granules for children age 2 months to less than 4 months old who weigh 3 kg (~7 lb) or more is one 13.4-mg packet mixed with 1 teaspoon (5 mL) of soft food or liquid every 12 hours for a total daily dose of 26.8 mg.

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

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

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

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

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

Your healthcare provider may give you different instructions on how much KALYDECO to give your loved one and when you should give 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 your loved one within 1 hour. Remember you should always give your loved one KALYDECO with a fat-containing food.

What if my loved one misses a dose of KALYDECO oral granules?

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

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

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 loved one?

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 loved one. But your loved one should still eat fat-containing food just before or after taking the mixture.

Do breast milk and prepared infant formula qualify as fat-containing foods that my loved one 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.

Can my loved one 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 given within 1 hour of being mixed. Make sure all medicine is taken.

Do the granules have a taste?

The granule formulation is sweetened but unflavored.

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

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

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

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

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 loved one transition from taking KALYDECO oral granules (5.8-mg, 13.4-mg, 25-mg, 50-mg, or 75-mg) to KALYDECO tablets (150-mg)?

KALYDECO granules (5.8-mg, 13.4-mg, 25-mg, 50-mg, or 75-mg) are for use in children who are 1 month 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 loved one's healthcare provider should discuss when to transition your loved one to KALYDECO tablets.

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

Yes, your loved one will need a new prescription when they change 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.

IMPORTANT SAFETY INFORMATION

Before taking KALYDECO, tell your doctor about all of your medical conditions, including if you:

have liver or kidney problems
are allergic to KALYDECO or any ingredients in KALYDECO. See the Patient Information for a list of ingredients
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

What is KALYDECO^® (ivacaftor)?

What is KALYDECO^®
(ivacaftor)?

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 1 month of age.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

the antibiotics rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®)
seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®)
St. John’s wort
antifungal medicines such as ketoconazole, itraconazole (SPORANOX^®), posaconazole (NOXAFIL^®), voriconazole (VFEND^®), or fluconazole (DIFLUCAN^®)
antibiotics such as telithromycin, clarithromycin (BIAXIN^®), or erythromycin (ERY-TAB^®)

What should I avoid while taking KALYDECO?

KALYDECO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve
Avoid food or drink containing grapefruit while you are taking KALYDECO

What are the possible side effects of KALYDECO?

KALYDECO can cause serious side effects, including:

High liver enzymes in the blood, which have happened in people 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 people 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
dark, amber-colored urine

Serious allergic reactions have happened to people who are treated with KALYDECO. Call your healthcare provider or go to the emergency room right away if you have symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

rash or hives
tightness of the chest or throat or difficulty breathing
light-headedness or dizziness

Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations before 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.

Use of KALYDECO in children aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated.

Call your doctor for medical advice about side effects. You may 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.

Resources

Hear from the KALYDECO community

For Kristen and Makson, sticking to a routine works

Stacy is passionate about her music and her health

Carter stays diligent about taking his KALYDECO

All content

Why Brody's Parents Chose KALYDECO

Mark strives to stay strong and active

Kaitlin finds strength in her support system

Vertex GPS™: Guidance & Patient Support is there for Lily

Amanda teaches Cooper the importance of taking his medicines

For Kristen and Makson, sticking to a routine works

Stacy is passionate about her music and her health

Carter stays diligent about taking his KALYDECO

Watch Next

How to Take KALYDECO® Oral Granules

How Does KALYDECO® Work?

Downloadable Resources

Learn about KALYDECO

Learn how to take KALYDECO

IMPORTANT SAFETY INFORMATION

Before taking KALYDECO, tell your doctor about all of your medical conditions, including if you:

What is KALYDECO® (ivacaftor)?

What is KALYDECO® (ivacaftor)?

What should I avoid while taking KALYDECO?

What are the possible side effects of KALYDECO?

IMPORTANT SAFETY INFORMATION

Before taking KALYDECO, tell your doctor about all of your medical conditions, including if you:

What is KALYDECO® (ivacaftor)?

What is KALYDECO® (ivacaftor)?

What is KALYDECO® (ivacaftor)?

Before taking KALYDECO, tell your doctor about all of your medical conditions, including if you:

What should I tell my doctor before taking KALYDECO?

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

What should I avoid while taking KALYDECO?

What are the possible side effects of KALYDECO?

How to Take KALYDECO^® Oral Granules

How Does KALYDECO^® Work?

What is KALYDECO^® (ivacaftor)?

What is KALYDECO^®
(ivacaftor)?

What is KALYDECO^® (ivacaftor)?

What is KALYDECO^®
(ivacaftor)?

What is KALYDECO^® (ivacaftor)?