Fat-containing meals and snacks
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Every dose matters, so it’s important that you or your child take ORKAMBI exactly as prescribed.
See the sections below to learn how to take ORKAMBI, including helpful information about how it is packaged and what to do if you or your child misses a dose. You can also learn about the importance of taking ORKAMBI with fat-containing foods and get tips for helping you or your child to remember to take it.
ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del-CFTR mutation.
The recommended dose of ORKAMBI is 2 tablets every 12 hours with food that contains fat. Your or your child’s dose may be different. Your healthcare provider will tell you exactly how much ORKAMBI you or your child should take and when it should be taken.
Taking ORKAMBI® (lumacaftor/ivacaftor) every 12 hours helps keep enough medicine in the body.
Remember, taking ORKAMBI every 12 hours is not the same as taking it twice a day.
You or your child should take ORKAMBI, plus all other prescribed CF therapies, exactly as directed by your or your child’s healthcare provider.
“Liam and Nolan both play a role in managing their treatments and spend a lot of time together because of that. Doing treatments together has made them very close.”
Within 6 hours of when it’s usually taken
If you miss a dose of ORKAMBI and it is within 6 hours of when it is usually taken, you should take the dose of ORKAMBI as prescribed with fat-containing food as soon as possible.
More than 6 hours after the time it is usually taken
If you miss a dose of ORKAMBI and it is more than 6 hours after the time when it is usually taken, skip that dose only and take the next dose at the usual time. Do not take 2 doses at the same time to make up for a missed dose.
More than 1 week of not taking ORKAMBI
Tell your doctor if you stop taking ORKAMBI for more than 1 week. Your doctor may need to change the dose of ORKAMBI or other medicines being taken.
ORKAMBI should always be taken with a fat-containing meal or snack because the fat helps the body absorb the medicine better. ORKAMBI can be taken right before, during, or right after a meal or snack.
There are many healthy fat-containing foods—like eggs, avocados, nuts, butter, peanut butter, cheese pizza, and whole-milk dairy products (such as whole milk, cheese, and yogurt)—that you or your child can take with ORKAMBI.
To get a better understanding of the different types of fats, speak with the CF healthcare team in charge of your or your child’s CF care. They can help you choose healthy fat-containing meals and snacks.
Each box of ORKAMBI has 4 weekly cartons. Inside each weekly carton 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).
To help you keep track, you can cut along the blister strip’s dotted line to separate your or your child’s morning dose from the evening dose. Morning and evening doses contain the same amount of medicine.
to help manage your or your child’s treatment routine.
Talk to your doctor before taking ORKAMBI if you take any of the medicines or supplements listed above.
ORKAMBI may affect the way other medicines work, and other medicines may affect how ORKAMBI works.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because the dose of ORKAMBI may need to be adjusted when taken with certain medicines.
Especially tell your doctor if you take:
Tell your doctor if you stop ORKAMBI for more than 1 week. Your doctor may need to change your dose of ORKAMBI or other medicines you take.
ORKAMBI can cause serious side effects, including:
every year while you are taking ORKAMBI
Side effects seen in children are similar to those seen in adults and adolescents. Additional common side effects seen in children include:
These are not all the possible side effects of ORKAMBI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene.
ORKAMBI should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene.
It is not known if ORKAMBI is safe and effective in children under 6 years of age.