Lumacaftor/Ivacaftor, Oral

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KEY POINTS

• This medicine is taken by mouth to treat cystic fibrosis caused by a specific gene problem. Take it exactly as directed.
• Keep all appointments for checkups to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: cystic fibrosis treatment

Generic and brand names: lumacaftor/ivacaftor, oral; Orkambi

What is this medicine used for?

This medicine is taken by mouth to treat cystic fibrosis caused by a specific gene problem.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An organ transplant
• Liver or kidney disease

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, are breast-feeding, or plan to breast-feed. It is not known if this medicine can harm an unborn baby. It is not known if this medicine passes into your breast milk. Do not breast-feed while taking this medicine without your healthcare provider's approval.

Hormonal birth control may not be effective while you are taking this medicine. Talk to your healthcare provider about effective birth control methods.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 12.

Take this medicine with food that contains fat, such as eggs, butter, cheese, avocados, nuts, or peanut butter. Do not take this medicine with grapefruit juice or Seville oranges.

While you are taking this medicine, do not start or stop any medicine or supplement unless you check with your healthcare provider or pharmacist.

What if I miss a dose?

If you miss a dose and it is within 6 hours of when you usually take it, take your dose (with food that contains fat) as soon as possible. If you miss a dose and it is more than 6 hours after the time you usually take it, skip that dose and take the next dose when you usually take it. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

If you stop taking this medicine for more than 1 week, tell your healthcare provider. Your healthcare provider may need to change your dose of this medicine or other medicines you take.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You need to have blood tests and blood pressure checks regularly to see how this medicine affects you. Keep all appointments.

This medicine may increase the risk of cataracts. You should have regular eye exams before and during treatment with this medicine.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Shortness of breath; severe diarrhea, stomach pain, nausea, or vomiting; unusual loss of appetite; yellowing of the skin or eyes; dark urine; light-colored bowel movements; confusion; chest pain; vision changes.

Other: Rash, mild stomach pain or nausea, diarrhea, headache, dizziness, stuffy or runny nose, sore throat, changes in menstrual periods (women), joint or muscle pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), and oxazepam
• Antibiotics such as clarithromycin (Biaxin), rifampin (Rifadin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), and sertraline (Zoloft)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), luliconazole (Luzu), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), cariprazine (Vraylar), clozapine (Clozaril, FazaClo), haloperidol (Haldol), lurasidone (Latuda), paliperidone (Invega), pimozide (Orap), and quetiapine (Seroquel)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), perampanel (Fycompa), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Apremilast (Otezla)
• Aprepitant (Emend)
• Bosentan (Tracleer)
• Brexpiprazole (Rexulti)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), cabozantinib (Cometriq), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), doxorubicin (Doxil), enzalutamide (Xtandi), erlotinib (Tarceva), ibrutinib (Imbruvica), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), olaparib (Lynparza), osimertinib (Tagrisso), palbociclib (Ibrance), panobinostat (Farydak), pazopanib (Votrient), ponatinib (Iclusig), regorafenib (Stivarga), romidepsin (Istodax), sonidegib (Odomzo), sorafenib (Nexavar), sunitinib (Sutent), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Colchicine (Colcrys)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), nateglinide (Starlix), repaglinide (Prandin), rosiglitazone/glimepiride (Avandaryl), and tolbutamide
• Eliglustat (Cerdelga)
• Everolimus (Afinitor, Zortress)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), ivabradine (Corlanor), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, and mefloquine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (AcipHex), and ranitidine (Zantac)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), macitentan (Opsumit), sildenafil (Revatio), and tadalafil (Adcirca)
• Mifepristone (Korlym, Mifeprex)
• Naloxegol (Movantik)
• Natural remedies such as bitter orange and St. John’s wort
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone, methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Praziquantel (Biltricide)
• Roflumilast (Daliresp)
• Silodosin (Rapaflo)
• Sleeping pills such as flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), and zaleplon (Sonata)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tasimelteon (Hetlioz)
• Theophylline
• Tofacitinib (Xeljanz)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.