The side effects from this study were similar to those observed in ORKAMBI studies in older people. See additional safety information here.
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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.