Orkambi (Lumacaftor / Ivacaftor)

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Lumacaftor / Ivacaftor Information

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.

They need to know if you have any of these conditions: -kidney disease -liver disease -an unusual reaction to lumacaftor, ivacaftor, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

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.

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.

Do not take this medicine with any of the following medications: -artemether; lumefantrine -boceprevir -cobicistat; elvitegravir; emtricitabine; tenofovir -cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide -dasabuvir; ombitasvir; paritaprevir; ritonavir -emtricitabine; rilpivirine; tenofovir -lurasidone -nifedipine -ombitasvir; paritaprevir; ritonavir -praziquantel -ranolazine -rilpivirineThis 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 -digoxin -female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections -grapefruit juice -ibuprofen -montelukast -rifabutin -rifampin -St. John's Wort -steroid medicines like prednisone or methylprednisolone -warfarin

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.

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.

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 -confusion -dark urine -general ill feeling or flu-like symptoms -light-colored stools -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.): -diarrhea -headache -irregular, missed, or abnormal menstrual periods -nausea -signs and symptoms of infection like fever or chills; cough; sore throat -tiredness

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.

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.

Lumacaftor, Ivacaftor Oral tablet