People with CF pictured may
or may not be taking ORKAMBI.
How to take ORKAMBI®
Take ORKAMBI every 12 hours as directed
Your healthcare provider will tell you exactly how much ORKAMBI you or your child should take and when it should be taken.
A fat-containing meal or snack helps the body better absorb the medicine. ORKAMBI should always be taken before or after a meal or snack that contains fat. Get recipes for fat-containing meals and snacks.
Avoid foods and drinks that contain grapefruit during your child's first week taking ORKAMBI because they can increase the amount of ORKAMBI in their body.
How to Take ORKAMBI
Oral Granules (Children
Age 1 Through 5 Years)
How to Take ORKAMBI
Tablets (People Age 6
Years and Older)
FAQs
Select a button below for information and tips on giving your child ORKAMBI granules.
What to take when
Designed with a young child in mind
ORKAMBI comes in single-use, oral granule packets for children age 1 through 5 years with cystic fibrosis (CF). The oral granules are similar in size to flour particles and should be mixed with 1 teaspoon (5 mL) of soft food or liquid.
Dosage strengths for ORKAMBI oral granules
ORKAMBI oral granules are prescribed based on weight and come in 3 different strengths.
| AGE 1 THROUGH 2 YEARS OLD |
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| WEIGHT-BASED DOSE |
| 15 lbs to less than 20 lbs (7 kg to less than 9 kg) lumacaftor 75 mg/ivacaftor 94 mg |
| 20 lbs to less than 31 lbs (9 kg to less than 14 kg) lumacaftor 100 mg/ivacaftor 125 mg |
| 31 lbs or more (14 kg or more) lumacaftor 150 mg/ivacaftor 188 mg |
| Recommended Dose |
| 1 packet every 12 hours (2 packets per day) |
| AGE | WEIGHT-BASED DOSE | RECOMMENDED DOSE |
|---|---|---|
|
1 through 2 years old
|
15 lbs to less than 20 lbs (7 kg to less than 9 kg) lumacaftor 75 mg/ivacaftor 94 mg |
1 packet every 12 hours (2 packets per day) |
| 20 lbs to less than 31 lbs (9 kg to less than 14 kg) lumacaftor 100 mg/ivacaftor 125 mg |
||
| 31 lbs or more (14 kg or more) lumacaftor 150 mg/ivacaftor 188 mg |
||
|
2 through 5 years old
|
Less than 31 lbs (less than 14 kg) lumacaftor 100 mg/ivacaftor 125 mg |
|
| 31 lbs or more (14 kg or more) lumacaftor 150 mg/ivacaftor 188 mg |
| AGE 2 THROUGH 5 YEARS OLD |
|---|
| WEIGHT-BASED DOSE |
| Less than 31 lbs (less than 14 kg) lumacaftor 100 mg/ivacaftor 125 mg |
| 31 lbs or more (14 kg or more) lumacaftor 150 mg/ivacaftor 188 mg |
| Recommended Dose |
| 1 packet every 12 hours (2 packets per day) |
Your child should take ORKAMBI, plus all of your child's other CF therapies, exactly as your child's healthcare provider says they should be taken.
How ORKAMBI oral granules are packaged
Every carton of ORKAMBI has 56 ORKAMBI oral granule packets, organized in 4 weekly wallets. Each wallet has 2 packets for each of the 7 days in a week.
For children age 1 through 2 years
weighing 15 lbs to less than 20 lbs
(7 kg to less than 9 kg)
For children age 1 through 2 years weighing
20 lbs to less than 31 lbs (9 kg to less than 14 kg)
and children age 2 through 5 years
weighing less than 31 lbs (less than 14 kg)
For children age 1 through 2 years
weighing 31 lbs or more (14 kg or more)
and children age 2 through 5 years
weighing 31 lbs or more (14 kg or more)
What if your child misses a dose of ORKAMBI?
- If your child misses a dose of ORKAMBI and it is within 6 hours of when they usually take it, have your child take the dose of ORKAMBI 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 they usually take it, have your child skip that dose only and take the next dose with fat-containing food when they usually take it. Do not take 2 doses at the same time to make up for a missed dose
- Tell your child’s healthcare provider if your child stops taking ORKAMBI for more than 1 week. The healthcare provider may need to change your child’s ORKAMBI dose or other medicines your child takes
How to give your child ORKAMBI oral granules
 STEP 1: Preparation
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| STEP 1: Preparation | ||
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 STEP 2: Administration
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| STEP 2: Administration |
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 STEP 3: Fat-containing food before or after dose
Always take ORKAMBI with fat-containing food
Here are suggestions for fat-containing foods to give your child:
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| STEP 3: Fat-containing food before or after dose | ||
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Always take ORKAMBI with fat-containing food
Here are suggestions for fat-containing foods to give your child:
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Tips for helping your child take ORKAMBI oral granules
Your child may find that ORKAMBI oral granules have a bitter taste. Every dose matters, so it's important to make sure your child completely finishes the ORKAMBI mixture at each dose. Here are a few tips that may help.
Mix the granules with 1 teaspoon
(5 mL) of soft food or liquid that is sweet or rich, like pudding, chocolate sauce, caramel sauce, or melted ice cream.
Give your child something sweet, like maple syrup or honey, after they completely finish the dose. It may help with the aftertaste.
Numb the taste buds before taking ORKAMBI by having your child eat an ice pop or another cold treat before each dose.
Put some control in your child’s hands by letting them choose a favorite fat-containing food to eat before or after taking ORKAMBI.
Does your child have a favorite doll or toy? Holding a special toy while taking ORKAMBI may make your child feel more comfortable.
Try creating a rewards system for finishing ORKAMBI, such as collecting stickers. You know best how to keep your child motivated!
Dosage strengths for ORKAMBI tablets
| AGE | EACH TABLET | EACH DOSE | TOTAL DAILY DOSE |
|---|---|---|---|
| Children age 6 through 11 years |
Lumacaftor 100 mg/ ivacaftor 125 mg |
2 tablets every 12 hours |
4 tablets per day |
| People age 12 years and older |
Lumacaftor 200 mg/ ivacaftor 125 mg |
2 tablets every 12 hours |
4 tablets per day |
| AGE |
| Children age 6 through 11 years |
| EACH TABLET |
| Lumacaftor 100 mg/ ivacaftor 125 mg |
| EACH DOSE |
| 2 tablets every 12 hours |
| TOTAL DAILY DOSE |
| 4 tablets per day |
| AGE |
| People age 12 years and older |
| EACH TABLET |
| Lumacaftor 200 mg/ ivacaftor 125 mg |
| EACH DOSE |
| 2 tablets every 12 hours |
| TOTAL DAILY DOSE |
| 4 tablets per day |
How ORKAMBI tablets are packaged
Each carton of ORKAMBI has 4 weekly wallets. Inside each weekly wallet are 7 daily blister strips. Every blister strip contains 4 tablets: 2 for the morning, and 12 hours later, 2 for the evening. When taking ORKAMBI, remove 2 tablets from the blister strip (do not push tablet through backing).
You can cut along the blister strip’s dotted line to separate your or your child’s morning and evening doses, which contain the same amount of medicine.
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What if you or your child misses a dose of ORKAMBI?
- If you or your child misses a dose of ORKAMBI and it is within 6 hours of when it's usually taken, you or your child should take the dose as prescribed with fat-containing food as soon as possible
- If you or your child misses a dose and it is more than 6 hours after the time it's usually taken, you or your child should skip that dose only and take the next dose with fat-containing food at the usual time. Do not take 2 doses at the same time to make up for a missed dose
- Tell your healthcare provider if you or your child stops taking ORKAMBI for more than 1 week. Your healthcare provider may need to change the ORKAMBI dose or other medicines
If I mix the ORKAMBI oral granules with a fat-containing food, do I still need to give my child fat-containing food afterwards?
Yes, your child should still eat fat-containing food just before or just after taking the entire mixture.
Does the temperature of the food that I mix with ORKAMBI oral granules matter? Can the granules be mixed in foods that are hot or cold?
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.
My child vomited after taking the dose of ORKAMBI 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 ORKAMBI oral granules, should I wait until they’re awake to administer them?
You should give your child ORKAMBI oral granules every 12 hours or as prescribed by your child’s healthcare provider.
What can I do if my child doesn't like the taste of ORKAMBI granules?
It's important to make sure your child completely finishes the ORKAMBI mixture at each dose. If they don’t like the taste, there are a few tips that may help.
Start by mixing the granules into a food that is sweet or rich, like pudding, chocolate sauce, caramel sauce, or melted ice cream. You can also try giving your child something sweet, like maple syrup or honey, after the dose. Giving your child an ice pop or cold treat before they take ORKAMBI may help by numbing their taste buds.
For a different approach, put some control in your child’s hands by letting them choose a favorite fat-containing food to eat before or after taking ORKAMBI. Letting your child hold a special toy while taking ORKAMBI may make them feel more comfortable. You could also try creating a rewards system for finishing ORKAMBI, such as collecting stickers or something else that motivates your child.
How are ORKAMBI oral granules packaged?
Every carton has 56 ORKAMBI oral granule packets, organized in 4 weekly wallets. Each wallet has 2 packets for each of the 7 days in a week.
Are the oral granules packets child proof?
The packets are child-resistant.
How should ORKAMBI oral granules and tablets be stored?
ORKAMBI should be stored at 68°F to 77°F (20°C to 25°C). Do not use ORKAMBI after the expiration date on the package. Keep ORKAMBI and all medicines out of the reach of children.
How are ORKAMBI tablets packaged?
Each carton of ORKAMBI has 4 weekly wallets. Inside each weekly wallet are 7 daily blister strips. Every blister strip contains 4 tablets: 2 for the morning, and 12 hours later, 2 for the evening.
Can I separate the doses on the blister cards?
You may cut along the dotted line to separate your doses from the blister card.
My child is over 6 years old and has trouble swallowing pills. Can my child take oral granules?
ORKAMBI oral granules are for patients age 1 through 5 years old. ORKAMBI tablets are for people age 6 years and older.
What should my child avoid while taking ORKAMBI?
Avoid foods and drinks that contain grapefruit during your child's first week taking ORKAMBI because they can increase the amount of ORKAMBI in their body.