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Taking
ORKAMBI

Every Dose Matters

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.

How to Take ORKAMBI

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.

Recommended dose of ORKAMBI

Recommended dose of ORKAMBI

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.”

— Heather, mother of 2 boys with CF

If You Miss a Dose of ORKAMBI

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.

Always Take ORKAMBI® (lumacaftor/ivacaftor) With Foods that Contain Fat

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.


How ORKAMBI Is Packaged

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.

How ORKAMBI® (lumacaftor/ivacaftor) Is Packaged

Packaging of ORKAMBI tablets for adults and children

Tips for Remembering to Take ORKAMBI® (lumacaftor/ivacaftor)

Download an app

to help manage your or your child’s treatment routine.

“I know she’s going to be a teenager, she’s going to rebel, but I want to create habits and form positive choices for her so she’ll choose to make them herself.”

Emily, mother of 7-year-old daughter with CF

Important Safety Information for ORKAMBI® (lumacaftor/ivacaftor)

Do not take ORKAMBI® (lumacaftor/ivacaftor) if you take certain medicines or herbal supplements, such as:

  • antibiotics: rifampin (Rifamate®, Rifater®) or rifabutin (Mycobutin®)
  • seizure medicines: phenobarbital, carbamazepine (Tegretol®, Carbatrol®, and Equetro®), or phenytoin (Dilantin®, Phenytek®)
  • sedatives and anti-anxiety medicines: triazolam (Halcion®) or midazolam (Dormicum®, Hypnovel®, and Versed®)
  • immunosuppressant medicines: cyclosporin, everolimus (Zortress®), sirolimus (Rapamune®), or tacrolimus (Astagraf XL®, Envarsus XR®, Prograf®, Protopic®)
  • St. John’s wort (Hypericum perforatum)

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

Before you take ORKAMBI, tell your doctor about all of your medical conditions, including if you:

  • have or have had liver problems
  • have had an organ transplant
  • have kidney problems
  • are using birth control (hormonal contraceptives, including oral, injectable, transdermal, or implantable forms). Hormonal contraceptives should not be used as a method of birth control when taking ORKAMBI. Talk to your doctor about the best birth control method you should use while taking ORKAMBI
  • are pregnant or plan to become pregnant. It is not known if ORKAMBI will harm your unborn baby. You and your doctor should decide if you will take ORKAMBI while you are pregnant
  • are breastfeeding or planning to breastfeed. It is not known if ORKAMBI passes into your breast milk. You and your doctor should decide if you will take ORKAMBI while you are breastfeeding

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:

  • antifungal medicines including ketoconazole (such as Nizoral®), itraconazole (such as Sporanox®), posaconazole (such as Noxafil®), or voriconazole (such as Vfend®)
  • antibiotics including telithromycin (such as Ketek®), clarithromycin (such as Biaxin®), or erythromycin (such as Ery-Tab®)

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.

What are the possible side effects of ORKAMBI?

ORKAMBI can cause serious side effects, including:

  • Worsening of liver function in people with severe liver disease. The worsening of liver function can be serious or cause death. Talk to your doctor if you have been told you have liver disease as your doctor may need to adjust the dose of ORKAMBI.
  • High liver enzymes in the blood, which can be a sign of liver injury in people receiving ORKAMBI. Your doctor will do blood tests to check your liver:
    • before you start ORKAMBI
    • every 3 months during your first year of taking ORKAMBI
    • every year while you are taking ORKAMBI

    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
    • confusion
  • Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI, especially in patients who have poor lung function. If you have poor lung function, your doctor may monitor you more closely when you start ORKAMBI.
  • An increase in blood pressure in some people receiving ORKAMBI. Your doctor should monitor your blood pressure during treatment with ORKAMBI.
  • Abnormality of the eye lens (cataract) in some children and adolescents receiving ORKAMBI. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with ORKAMBI to look for cataracts.
The most common side effects of ORKAMBI include:
  • breathing problems, such as shortness of breath and/or chest tightness
  • nausea
  • diarrhea
  • gas
  • rash
  • fatigue
  • flu or flu-like symptoms
  • increase in a certain blood enzyme called creatine phosphokinase
  • common cold, including sore throat, stuffy or runny nose
  • irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding

Side effects seen in children are similar to those seen in adults and adolescents. Additional common side effects seen in children include:

  • cough with sputum
  • stuffy nose
  • headache
  • stomach pain
  • increase in sputum

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.

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

What is ORKAMBI?

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.