LUMACAFTOR/IVACAFTOR - ORAL

LUMACAFTOR/IVACAFTOR - ORAL

PHONETIC PRONUNCIATION: (LOO-ma-KAF-tor/EYE-va-KAF-tor)

COMMON BRAND NAME(S): Orkambi

GENERIC NAME(S): lumacaftor/ivacaftor

Uses

USES: This medication is a combination of 2 medications: lumacaftor and ivacaftor. It is used to treat cystic fibrosis in certain people (those with 2 copies of an abnormal "CFTR" gene). It may help to improve breathing, reduce the risk of lung infections, and improve weight gain.


How to use LUMACAFTOR/IVACAFTOR - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking lumacaftor/ivacaftor and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually twice daily (12 hours apart). For the best effect, take it with food that contains fat (such as eggs, avocados, cheese, nuts, butter, peanut butter). The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: Nausea, gas, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: vision changes. This medication may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. Some people who already have severe lung disease may develop breathing problems after starting this medication. Get medical help right away if you have: chest pain, shortness of breath. Lumacaftor/ivacaftor can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to lumacaftor or ivacaftor; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of lumacaftor/ivacaftor from your body, which may affect how this medication works. Examples include rifamycins (such as rifampin, rifabutin), drugs for seizures (such as carbamazepine, phenytoin), St. John's wort, among others. This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include azole antifungals (such as itraconazole, voriconazole), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), macrolide antibiotics (such as erythromycin, clarithromycin), certain drugs that weaken the immune system (such as cyclosporine, everolimus, tacrolimus), certain sedatives (such as midazolam, triazolam), warfarin, among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for LUMACAFTOR/IVACAFTOR - ORAL

Lumacaftor/Ivacaftor is used to treat cystic fibrosis in patients aged 6 years and older who have a specific genetic mutation.

Lumacaftor/Ivacaftor is a combination medication that helps improve lung function in cystic fibrosis patients by increasing the amount of functional protein at the surface of the cells in the lungs.

Common side effects of Lumacaftor/Ivacaftor may include respiratory symptoms (such as shortness of breath and chest discomfort), increased respiratory infections, sinus congestion, nausea, diarrhea, fatigue, and abnormal liver function tests.

Lumacaftor/Ivacaftor may start showing improvements in lung function within a few weeks of starting treatment. However, the full effects may take several months to be noticeable.

Lumacaftor/Ivacaftor is approved for use in patients aged 6 years and older who have the specific genetic mutation that the medication targets. It is not recommended for use in younger children.

Lumacaftor/Ivacaftor is not a cure for cystic fibrosis. It is a medication that helps improve lung function and reduce symptoms in patients with this condition.

Lumacaftor/Ivacaftor should be taken exactly as prescribed by a healthcare professional. It is usually taken twice daily with fat-containing food, as this improves the absorption of the medication.

Lumacaftor/Ivacaftor can be used in combination with other medications prescribed for cystic fibrosis. However, it is important to consult with a healthcare professional and disclose all other medications being taken to avoid potential interactions.

If a dose of Lumacaftor/Ivacaftor is missed, it should be taken as soon as remembered. However, if it is close to the time of the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.