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Taking
ORKAMBI

ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have 2 copies of the F508del-CFTR mutation.

Take ORKAMBI®  (lumacaftor/ivacaftor) Every 12 Hours as Directed

Remember, every 12 hours is not the same as “twice a day.” Your healthcare provider will tell you exactly how much ORKAMBI you or your child should take and when it should be taken.

Take ORKAMBI With Foods That Contain Fat

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.

How to Take ORKAMBI Oral Granules (Children Age 2 Through 5 Years)

Designed With a Young Child in Mind

ORKAMBI comes in single-use, oral granule packets for children age 2 through 5 years with 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 2 different strengths.

    WEIGHT-BASED DOSE EACH DOSE TOTAL DAILY DOSE
    Less than ~31 lbs(less than 14 kg)
    lumacaftor 100 mg/ivacaftor 125 mg
    1 packet
    every 12 hours
    2 packets
    per day
    Greater than or equal to ~31 lbs (more than 14 kg)
    lumacaftor 150 mg/ivacaftor 188 mg
    1 packet
    every 12 hours
    2 packets
    per day

    Remember, having your child take ORKAMBI every 12 hours is not the same as having him or her take it twice a 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.

    Not actual size
  • How to Give Your Child ORKAMBI Oral Granules

    STEP 1: Preparation

    • Hold the packet with the cut line on top, shake it gently to settle the ORKAMBI granules, and either tear or cut the packet open along the cut line
    • Carefully pour all of the ORKAMBI granules in the packet into 1 teaspoon (5 mL) of soft food such as flavored pudding or yogurt, or liquid such as juice, in a small container. Food or liquid should be at or below room temperature. Then mix the granules with the food or liquid

    STEP 2: Administration

    • Have your child take ORKAMBI within 1 hour of mixing
    • Make sure your child completely finishes the full ORKAMBI mixture at each dose

    STEP 3: Fat-containing food before or after dose

    • Make sure to always give your child food that contains fat just before or after the dose of ORKAMBI oral granules
    • Some fat-containing foods include eggs, avocados, nuts, butter, and whole milk dairy products. Get fat-containing recipes
  • What to Do if Your Child Misses a Dose of ORKAMBI

    If a dose of ORKAMBI is missed within 6 hours of when it’s usually taken, your child should take the dose as prescribed with fat-containing food as soon as possible.

    If a dose of ORKAMBI is missed more than 6 hours after the time 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.

    If your child goes more than 1 week without taking ORKAMBI, tell your child’s healthcare provider. He or she may need to change the ORKAMBI dose, or other medicines being taken.

  • 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.

    1. Give your child ORKAMBI oral granules with 5 mL of soft food or liquid that is sweet or rich like pudding, yogurt, chocolate sauce, or caramel sauce. Melted ice cream is also a nice treat to mix with granules.
    2. Maple syrup or honey may help with the aftertaste of ORKAMBI—you can give some to your child after he or she completely finishes the dose of ORKAMBI. It’s worth a sweet shot!
    3. Numb the taste buds before taking ORKAMBI by having your child eat an ice pop or another cold treat before his or her dose.
    4. Put some control in your child’s hands by letting him or her decide what fat-containing food to eat before or after the dose. A slice of whole-milk cheese pizza or another favorite fat-containing food after ORKAMBI could be a tasty reward.
    5. Does your child have a favorite doll or toy? Holding a special toy while taking ORKAMBI may make your child feel more comfortable.
    6. Try creating a rewards system for finishing ORKAMBI, such as collecting stickers. You know best how to keep your child motivated!

How to Take ORKAMBI Tablets (People Age 6 Years and Older)

  • 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


    Make sure to take ORKAMBI before or after a meal or snack that contains fat.
  • 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.

    Not actual size

    For children age 6 through 11 years

    For people age 12 years and older
  • What to Do if You or Your Child Misses a Dose of ORKAMBI

    If a dose of ORKAMBI is missed 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 a dose of ORKAMBI is missed more than 6 hours after the time 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.

    If you go or your child goes more than 1 week without taking ORKAMBI, tell your or your child’s healthcare provider. He or she may need to change the ORKAMBI dose, or other medicines being taken.



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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: cyclosporine, 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 chest tightness
  • nausea
  • diarrhea
  • fatigue
  • increase in a certain blood enzyme called creatine phosphokinase
  • rash
  • gas
  • common cold, including sore throat, stuffy or runny nose
  • flu or flu-like symptoms
  • 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 are encouraged to 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 2 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 2 years of age.

Click here for ORKAMBI® (lumacaftor/ivacaftor) Important Safety Information and full Prescribing Information, including Patient Information.