Lumacaftor, Ivacaftor Oral tablet
What is this medicine?
LUMACAFTOR; IVACAFTOR (LOO ma KAF tor; EYE va KAF tor) is used to treat cystic fibrosis (CF) in patients who have certain mutations in their CF gene.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual reaction to lumacaftor, ivacaftor, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with fat-containing foods such as eggs, peanut butter, or cheese pizza. Follow the directions on the prescription label. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more than directed. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 6 hours, then do not take
the missed dose. Take the next dose at your regular time. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
cobicistat; elvitegravir; emtricitabine; tenofovir
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide
dasabuvir; ombitasvir; paritaprevir; ritonavir
emtricitabine; rilpivirine; tenofovir
ombitasvir; paritaprevir; ritonavir
This medicine may also interact with the following medications:
certain antibiotics like clarithromycin, erythromycin, telithromycin
certain medicines for depression, anxiety, or sleep
certain medicines for diabetes, like glipizide or repaglinide
certain medicines for immunosuppression like cyclosporine, everolimus, sirolimus, or tacrolimus
certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
St. John's Wort
steroid medicines like prednisone or methylprednisolone
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.
Your vision and blood may be tested before and during use of this medicine.
Tell your doctor or health care professional right away if you have any change in your eyesight.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.
You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To avoid dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older person. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in vision
chest pain or chest tightness
general ill feeling or flu-like symptoms
loss of appetite
right upper belly pain
unusually weak or tired
worsening breathing problems
yellowing of the eyes or skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
irregular, missed, or abnormal menstrual periods
signs and symptoms of infection like fever or chills; cough; sore throat
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 to 25 degrees C (68 to 77 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert