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Lumacaftor/ivacaftor (Oral route)

Pronunciation:

loo-ma-KAF-tor, eye-va-KAF-tor

Brand Names:

  • Orkambi

Dosage Forms:

  • Tablet

Uses of This Medicine:

Lumacaftor and ivacaftor combination is used to treat cystic fibrosis (CF) in patients 12 years of age and older. It is only used for patients who have two copies of F508del mutation in their CF transmembrane conductance regulator (CFTR) gene. Your doctor will use a test to check for the mutation before you receive the medicine.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of lumacaftor and ivacaftor combination in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults

Appropriate studies on the relationship of age to the effects of lumacaftor and ivacaftor combination have not been performed in the geriatric population.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Aprepitant
  • Atazanavir
  • Boceprevir
  • Budesonide
  • Buspirone
  • Carbamazepine
  • Clarithromycin
  • Conivaptan
  • Cyclosporine
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Desogestrel
  • Dienogest
  • Dihydroergotamine
  • Diltiazem
  • Dronedarone
  • Drospirenone
  • Eletriptan
  • Eliglustat
  • Eplerenone
  • Ergotamine
  • Erythromycin
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Everolimus
  • Felodipine
  • Fentanyl
  • Fluconazole
  • Fluticasone
  • Fosaprepitant
  • Fosphenytoin
  • Gestodene
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Levonorgestrel
  • Lopinavir
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Mestranol
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nefazodone
  • Nelfinavir
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Osimertinib
  • Phenytoin
  • Pimozide
  • Posaconazole
  • Quetiapine
  • Quinidine
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Sildenafil
  • Simvastatin
  • Sirolimus
  • St John's Wort
  • Tacrolimus
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Tolvaptan
  • Topotecan
  • Triazolam
  • Vardenafil
  • Verapamil
  • Voriconazole

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cataracts or
  • Organ transplant, history of Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease, moderate or severe Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with fat-containing foods such as avocado, butter, cheese pizza, eggs, nuts, peanut butter, or whole milk dairy products (eg, whole milk, cheese, yogurt).

Tell your doctor if you stop taking this medicine for more than 1 week. Your doctor may need to change your dose of Orkambi® or other medicines you take.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For cystic fibrosis:
      • Adults and children 12 years of age and older 2 tablets every 12 hours, taken with fat-containing food. Each tablet contains 200 milligrams (mg) of lumacaftor and 125 mg of ivacaftor.
      • Children younger than 12 years of age Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as you can. If your next regular dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

Birth control pills and other forms of hormone-based contraceptives (such as patches, rings, implants, and injections) may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control (including condoms, diaphragms, or contraceptive foams or jellies) while using Orkambi®.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Difficult or labored breathing
tightness in the chest
Incidence not known
Blurred vision
dark urine
dizziness
headache
loss of appetite
nausea and vomiting
nervousness
pain or discomfort in upper right stomach area
pounding in the ears
slow or fast heartbeat
unusual tiredness
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Absent, missed, or irregular menstrual periods
bloated
body aches or pain
chills
cough
cramps
diarrhea
ear congestion
excess air or gas in the stomach or intestines
fever
full feeling
heavy bleeding
high blood pressure
longer or heavier menstrual periods
loss of voice
muscle aches
passing gas
rash
sneezing
sore throat
stopping of menstrual bleeding
stuffy or runny nose
unusual weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/15/2016
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