This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Afatinib Dimaleate is an anticancer medicine containing afatinib dimaleate as an active ingredient. It was approved by the US Food and Drug Administration (FDA) on July 12, 2013, to treat patients with non-small cell lung cancer (NSCLC) whose tumors have certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) genes and patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy. Cancer is a disorder in which cells multiply in an abnormal and uncontrolled manner.

Mechanism of Action of undefined

The mechanism of action of afatinib dimaleate is primarily related to its ability to inhibit the activity of certain proteins in cancer cells, specifically the epidermal growth factor receptor (EGFR) family of proteins. These proteins play a key role in promoting the growth and spread of cancer cells, and inhibiting their activity can help slow or stop the progression of cancer.

Uses of undefined

Afatinib dimaleate is used to treat certain types of cancer, including non-small cell lung cancer with specific EGFR mutations.

undefined Drug administaration and Dosage available

Afatinib Dimaleate is an oral medication that is usually taken once a day, at approximately the same time each day, with or without food. It should be taken as prescribed by a doctor or other healthcare provider. These capsules should be swallowed whole with a glass of water. They should not be crushed, chewed, or opened, as this can affect the way the medication is absorbed and decrease its effectiveness. You should not take a double dose to make up the second dose.

Warnings, Precautions and Side Effects of undefined


Afatinib dimaleate can cause interstitial lung disease (ILD), a serious and potentially life-threatening condition that can cause inflammation and scarring of the lungs. This medication can cause severe diarrhea and dehydration, which can be life-threatening in some cases. Sometimes this medication results in eye problems, such as corneal erosion or ulceration, which can lead to vision loss or blindness. In rare cases, it can cause kidney problems (acute kidney injury, renal failure) and cardiac problems (irregular heartbeat).


Patients with pre-existing cardiac conditions and renal problems should monitor kidney and heart function regularly before and while taking afatinib dimaleate. Any signs or symptoms of dehydration, such as dry mouth or decreased urination, should report to a healthcare provider immediately. Patients should immediately report any new or worsening eye symptoms, such as eye pain or redness, to a healthcare provider. You should tell your doctor about skin symptoms, such as rashes or blisters. Patients should report any signs or symptoms of infection to a healthcare provider. You should avoid any traumatic or penetrative procedure in the body, like tooth extraction or surgery while taking this medication because it can result in excessive bleeding.

Side Effects

Afatinib dimaleate can cause various side effects, ranging from mild to severe. Some common side effects include diarrhea, skin rash, nail changes, mouth sores, and fatigue. These side effects can often be managed with medication or other treatments. However, it can also cause more serious side effects, such as severe diarrhea, dehydration, and kidney problems.

Word Of Advice

Follow all instructions and dosing recommendations provided by your healthcare provider. Only take the medication as prescribed. Report any new or worsening symptoms to your healthcare provider immediately, especially if they relate to your lungs, eyes, skin, liver, kidneys, heart, or bleeding. Stay well-hydrated and report any signs or symptoms of dehydration to your healthcare provider immediately, especially if you experience severe diarrhea. Women should avoid pregnancy or breastfeeding. Reproductive-age women should use effective birth control during the treatment and for at least two weeks after their last dose. Patients should report any signs or symptoms of dehydration, such as dry mouth or decreased urination, to a healthcare provider immediately.

Frequently Asked Question


The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.


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  2. Boehringer Ingelheim International GmbH, Electronic medicines compendium (emc), [ Revised on Sept 2020] [ Accessed on 21st April 2023],
  3. Helga Wecker, Cornelius F Waller; Afatinib; Recent Results in Cancer Research 2018;