Orkambi (Lumacaftor/Ivacaftor) is 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.
Immediately inform your doctor if you suffer any of the following symptoms:
• 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
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The first accepted medication for Orkambi (lumacaftor / ivacaftor) is a rare , life-threatening genetic disorder that is responsible for the root cause of mystic fibrosis. Vertex Pharmaceuticals has found and developed the drug.
The fat-containing food should be included in Orkambi. Just before or after dosage a fat-containing meal or snack should be eaten. When the missing dose has been less than 6 hours, the prescribed dose of Orkambi with food containing fat should be taken. If there have been more than 6 hours, patients should be advised to wait until the next scheduled dosage. To make up for the missing dosage, a double dosage should not be taken.
No dose change is expected in patients who are already on Orkambi when CYP3A inhibitors are initiated. However, during the first week of therapy, as Orkambi is started in patients who take heavy CYP3A inhibitors, the dosage should be decreased daily to one sachet to permit the steady-state lumacaftor induction. The prescribed daily dosage should be continued after this time