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Medicines/Generics/Afatinib

Afatinib

Generic medicine reference

Not yet clinically reviewed

This entry was migrated from the earlier Pharmapedia app bundle and has not been reviewed by a named clinician on this site. It is provided for educational reference only — verify dosage and safety information against current, authoritative sources and a qualified healthcare professional before any clinical use.

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Overview
Afatinib ( Gilotrif ) is a cancer drug used to treat non-small cell lung cancer (NSCLC) that is EGFR (epidermal growth factor receptor)-positive, which means that it is caused by an abnormal EGFR gene or genes. The EGFR protein is found on the surface of cells and helps them to grow, but when the gene for EGFR is defective or abnormal cells can grow out of control causing cancer. Afatinib belongs to a class of drugs called kinase inhibitors. It is an EGFR tyrosine kinase inhibitor that works by irreversibly blocking EGFR. Afatinib helps to stop or slow the spread of cancer and may help people with EGFR-positive NSCLC live longer. It was approved by the US Food and Drug Administration in 2013.
Indications
Afatinib ( Gilotrif ) is a cancer drug used to treat non-small cell lung cancer (NSCLC) that is EGFR (epidermal growth factor receptor)-positive, which means that it is caused by an abnormal EGFR gene or genes. The EGFR protein is found on the surface of cells and helps them to grow, but when the gene for EGFR is defective or abnormal cells can grow out of control causing cancer. Afatinib belongs to a class of drugs called kinase inhibitors. It is an EGFR tyrosine kinase inhibitor that works by irreversibly blocking EGFR. Afatinib helps to stop or slow the spread of cancer and may help people with EGFR-positive NSCLC live longer. It was approved by the US Food and Drug Administration in 2013.
Contraindications
Before you take afatinib, tell your healthcare provider about all of your medical conditions, including if you: have kidney or liver problems have lung or breathing problems other than lung cancer have a history of an ulcer, a tear (perforation) in your stomach or intestine, or diverticular disease (inflammation) in parts of your large intestine. See “What are the side effects of afatinib?” below have a history of severe dry eye or any other eye problems. Tell your healthcare provider if you wear contact lenses. have heart problems
Side Effects
Serious side effects of afatinib include: Diarrhea. Diarrhea is common with this medication and may sometimes be severe. Severe diarrhea can cause loss of too much body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with afatinib, your healthcare provider should prescribe medicines to treat diarrhea. Take this medicine exactly as your healthcare provider tells you to. Tell your healthcare provider if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe. Skin reactions. Afatinib can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your healthcare provider tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth. Lung or breathing problems. Afatinib may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever. Liver problems. Afatinib can cause liver problems that can sometimes lead to death. Tell your healthcare provider right away if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired Your healthcare provider will do blood tests to check your liver function during your treatment with this medication. Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with this medication and can sometimes lead to death. Your risk of developing a tear in your stomach or intestine may be increased if you: take certain medicines with afatinib including: corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDS), and certain other medicines. have a history of stomach or intestinal ulcers, or if you have had diverticular disease (inflammation in parts of the large intestine). Get medical help right away if you develop severe stomach-area (abdomen) pain during treatment with afatinib. Eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include: eye pain, swelling, redness, or tearing blurred vision sensitivity to light other changes in your vision Heart problems. Tell your healthcare provider right away if you have symptoms of a heart problem which may include: new or worsening shortness of breath while at rest or with activity cough tiredness swelling of your ankles, feet, or legs feeling that your heart is pounding or racing (palpitations) sudden weight gain Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with this medication if you have certain side effects. The most common side effects of afatinib include: diarrhea rash acne mouth sores nail inflammation dry skin decreased appetite nausea vomiting itching Afatinib may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of this medication. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
Warnings
diarrhea,bullous and exfoliative skin disorders, interstitial lung disease, hepatic toxicity, keratitis, embryofetal toxicity. caution should be taken in all these conditions.
High Risk Groups
Drug should not be given to Paediatrics, Pregnant Mothers, and Neonates.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.
Adult Dosage
Scraped Dose — Take afatinib exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how many tablets to take and when to take them. Do not change your dose or stop taking this medication unless your healthcare provider tells you to. Take afatinib on an empty stomach at least 1 hour before a meal or 2 hours after a meal.
Child Dosage
No child dosage information is recorded for this medicine yet.
Neonatal Dosage
No neonatal dosage information is recorded for this medicine yet.
Drug Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Afatinib may affect the way other medicines work, and other medicines may affect the way afatinib works. Taking certain medicines with this medication may increase your risk of developing a tear (perforation) in your stomach or intestine. See “What are the side effects of afatinib?” above. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
Storage
Tablet Store Between 15°C-30°C. Protect from Sunlight and Moisture.

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