ORKAMBI is for people with cystic fibrosis (CF) age 6 years and older with 2 copies of the F508del-CFTR mutation. It should not be used in people with other CFTR gene mutations and it is not known if ORKAMBI is safe and effective in younger children.
Continue reading below for information about the serious and most common side effects that were seen in clinical studies and additional safety information for consideration before starting treatment with ORKAMBI.
ORKAMBI Can Cause Serious Side Effects
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
You or your child may be able to get these tests done during regular CF Center visits. Talk to your (or your child’s) healthcare provider about how best to schedule these tests.
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 the skin or the white part of your eyes
- Loss of appetite
- Nausea or vomiting
- Dark, amber-colored urine
Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI® (lumacaftor/ivacaftor), 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 healthcare provider 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
- increase in a certain blood enzyme called creatine phosphokinase
- 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
- 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.
Considerations Before Starting ORKAMBI® (lumacaftor/ivacaftor)
Before you start ORKAMBI, there are some important things you should discuss with your doctor. This includes your medical history and the medicines you take.
Do not take ORKAMBI 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®, and 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:
Taking ORKAMBI® (lumacaftor/ivacaftor) With Other Medicines
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 medications including:||Antibiotics including:|
|Ketoconazole (such as Nizoral®)||Telithromycin (such as Ketek®)|
|Itraconazole (such as Sporanox®)||Clarithromycin (such as Biaxin®)|
|Posaconazole (such as Noxafil®)||Erythromycin (such as Ery-Tab®)|
|Voriconazole (such as Vfend®)|
|Antifungal medications including:|
|Ketoconazole (such as Nizoral®)|
|Itraconazole (such as Sporanox®)|
|Posaconazole (such as Noxafil®)|
|Voriconazole (such as Vfend®)|
|Telithromycin (such as Ketek®)|
|Clarithromycin (such as Biaxin®)|
|Erythromycin (such as Ery-Tab®)|
Remember, it is important to know all the medicines you take. Keep a list to show your doctor and pharmacist whenever you get a new medicine.