TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL

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TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL

PHONETIC PRONUNCIATION: (TEZ-a-KAF-tor/EYE-va-KAF-tor and EYE-va-KAF-tor)

COMMON BRAND NAME(S): Symdeko

GENERIC NAME(S): tezacaftor/ivacaftor

Uses

USES: This product contains 2 different tablets. One tablet contains 2 medications ("multi-drug"): tezacaftor and ivacaftor. The other tablet contains only ivacaftor. This product is used to treat cystic fibrosis in certain people (those with an abnormal "CFTR" gene). It may help to improve breathing, reduce the risk of lung infections, and improve weight gain.


How to use TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take the multi-drug tablet by mouth in the morning and take ivacaftor tablet by mouth in the evening as directed by your doctor, usually 12 hours apart. Take both tablets with food that has fat (such as eggs, avocados, cheese, nuts, butter, peanut butter). The dosage is based on your 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). Avoid eating/drinking grapefruit products or Seville oranges (often found in marmalade) while using this product unless your doctor or pharmacist says you may do so safely. These can increase the chance of side effects with this product. Ask your doctor or pharmacist for more details. Use this product 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, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this product because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: vision changes. This product may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. 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 product, tell your doctor or pharmacist if you are allergic to tezacaftor 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 product, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease. This product 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 product should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this product 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 tezacaftor/ivacaftor from your body, which may affect how this product works. Examples include mifepristone, rifamycins (such as rifampin, rifabutin), drugs for seizures (such as carbamazepine, phenytoin), St. John's wort, among others.

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.

Images

SYMDEKO 100/150 MG-150 MG TABS
SYMDEKO 100/150 MG-150 MG TABS
color
multi-color (2)
shape
oblong
imprint
V100 or V150

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Faq for TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL

Tezacaftor/Ivacaftor is a combination medication that is used to treat cystic fibrosis in patients who have specific gene mutations. Tezacaftor helps to improve the function of the protein CFTR, while Ivacaftor helps to increase the activity of the protein.

Tezacaftor/Ivacaftor works by targeting the underlying cause of cystic fibrosis. Tezacaftor helps to increase the amount of CFTR protein at the surface of cells, while Ivacaftor helps to improve the function of the CFTR protein.

The common side effects of Tezacaftor/Ivacaftor include headache, respiratory tract infection, common cold symptoms, gastrointestinal symptoms such as nausea, diarrhea, or abdominal pain, and rash. It is important to consult with a healthcare professional for a complete list of potential side effects.

Tezacaftor/Ivacaftor is usually taken orally twice a day, with approximately 12 hours between doses. The medication should be taken with fat-containing food to ensure proper absorption.

Tezacaftor/Ivacaftor may interact with certain medications, so it is important to inform your healthcare provider about all the medications you are taking. This includes prescription drugs, over-the-counter medications, and any supplements.

The time it takes for Tezacaftor/Ivacaftor to start working may vary for each individual. Some patients may start experiencing improvements in lung function and symptoms within a few weeks, while others may take longer. It is important to continue taking the medication as prescribed by your healthcare provider.

The coverage of Tezacaftor/Ivacaftor by insurance can vary depending on the specific policy. It is recommended to contact your insurance provider to determine the coverage details and any potential requirements or restrictions.

Tezacaftor/Ivacaftor is approved for use in children aged 6 years and older who have specific gene mutations that are responsive to the medication. The dosing and administration may vary for children, and it is important to consult a healthcare professional for proper guidance.

If you miss a dose of Tezacaftor/Ivacaftor, it is recommended to take the missed dose as soon as possible. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.

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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.