Patient information: uses, side effects, how to take - Afatinib

What are afatinib tablets?

Afatinib tablets are a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s). Your healthcare provider will perform a test to make sure that afatinib tablets are right for you.
has spread to other parts of the body (metastatic), and
has not been previously treated for metastatic lung cancer

It is not known if afatinib tablets are safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.

is used to treat people with squamous cell lung cancer that:
has spread to other parts of the body, and
has been previously treated with chemotherapy that contains platinum.

It is not known if afatinib tablets are safe and effective in children.

Before you take afatinib tablet, 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 possible side effects of afatinib tablets?”
have a history of severe dry eye or any other eye problems. Tell your healthcare provider if you wear contact lenses.
have heart problems
are pregnant or plan to become pregnant. Afatinib tablets can harm your unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with afatinib tablets and for at least 2 weeks after your last dose of afatinib tablets. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with afatinib tablets.
are breastfeeding or plan to breastfeed. It is not known if afatinib passes into your breast milk. Do not breastfeed during treatment with afatinib tablets and for 2 weeks after your last dose of afatinib tablets. Talk to your healthcare provider about the best way to feed your baby if you take afatinib tablets.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Afatinib tablets may affect the way other medicines work, and other medicines may affect the way afatinib tablets work. Taking certain medicines with afatinib tablets may increase your risk of developing a tear (perforation) in your stomach or intestine. See “What are the possible side effects of afatinib tablets?”

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take afatinib tablets?

Take afatinib tablets exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how many afatinib tablets to take and when to take them. Do not change your dose or stop afatinib tablets unless your healthcare provider tells you to.
Take afatinib tablets on an empty stomach at least 1 hour before a meal or 2 hours after a meal.
If you miss a dose of afatinib tablets, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time. Do not take 2 doses of afatinib tablets at the same time.
If you take too much afatinib, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking afatinib tablets?

Limit your time in the sun. Afatinib tablets can make your skin sensitive to sunlight. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight during treatment with afatinib tablets.

What are the possible side effects of afatinib tablets?

Afatinib tablets may cause serious side effects, including:

diarrhea.Diarrhea is common with afatinib tablets 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 tablets, 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 tablets 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 tablets 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 tablets 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 afatinib tablets.

tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with afatinib tablets 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 tablets 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 tablets.

eye problems.Tell your healthcare provider right away if you have symptoms of eye problems which may include:
eye pain, swelling, redness, or tearing o sensitivity to light
blurred vision o 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 o swelling of your ankles, feet, or legs
cough o feeling that your heart is pounding or racing (palpitations)
tiredness o sudden weight gain

Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with afatinib tablets if you have certain side effects.

The most common side effects of afatinib tablets include:

diarrhea • dry skin • nausea
rash • decreased appetite • vomiting
acne • itching
mouth sores
nail inflammation

Afatinib tablets 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 afatinib tablets. 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-FDA-1088.

How should I store afatinib tablets?

Store afatinib tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep afatinib tablets in the original container and keep the container tightly closed.
Keep afatinib tablets away from moisture and light.
Safely throw away (discard) any afatinib tablets that are out of date or no longer needed.

Keep afatinib tablets and all medicines out of the reach of children.

General information about afatinib tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use afatinib tablets for a condition for which it was not prescribed. Do not give afatinib tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about afatinib tablets that is written for health professionals.

For more information, call Hetero Labs Limited at 1-866-495-1995.

What are the ingredients in afatinib tablets?

Active ingredient:afatinib dimaleate

Inactive ingredients: Tablet Core:colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Tablet Coating:hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854.

By: HETERO ^TM

Hetero Labs Limited, Unit V, Polepally, Jadcherla,

Mahabubnagar - 509 301, India.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 06/2026

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