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 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. 

Mechanism of Action of undefined

It functions by inhibiting the ErbB family of proteins, which includes EGFR (also known as the epidermal growth factor receptor, or ErbB1, ErbB2, ErbB3, and ErbB4) and HER2. Changes in the genes that create these proteins can have an impact on how cancer cells multiply and disseminate. Through the inhibition of these proteins and its activities, this medication can prevent the growth and proliferation of cancer cells and can help to 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, before food. If you have already eaten, wait at least 3 hours before taking this medicine.

It should be taken as prescribed by a doctor. These tablets should be swallowed whole with a glass of water. They should not be crushed, chewed, or opened, as this can affect how the medication is absorbed and decrease its effectiveness. Take the missed dose as soon as you recall if your next planned dose is more than eight hours away. You should not take a double dose to make up for the second dose.

Warnings, Precautions and Side Effects of undefined


It is not recommended to use this medication if you are allergic to the active compound afatinib dimaleate or its components. It is not recommended for female patients weighing below 50 kilograms.  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. It is not recommended for children and adolescents under the age of 18. 


 It is not recommended to use during pregnancy and breastfeeding, it is advised to consult your physician regarding further queries.  Tell your doctor if you have a history of eye problems or wearing contact lenses. Limit your time in the sun as this medicine may make your skin sensitive to the sun. 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. 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, interstitial lung disease and Hemorrhage or bleeding problems.

Word Of Advice

Follow all instructions and dosing recommendations provided by your healthcare provider. Do not take more or less of the medication than 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. Women should avoid pregnancy or breastfeeding. Men and women of reproductive-age should use effective birth control during the treatment and for at least two weeks after your last dose. Patients should report any signs or symptoms of dehydration, such as dry mouth or decreased urination, to a healthcare provider immediately. It is advised to drink plenty of fluids while taking afatinib dimaleate to stay hydrated, especially if you experience diarrhea as a side effect. When taking afatinib dimaleate, stay away from grapefruit and grapefruit juice as they may interact with the medication and raise the risk of side effects.

Frequently Asked Question


  1. Boehringer Ingelheim Pharmaceuticals, Inc, US Food and Drug Administration, [ Revised on Jan 2018] [ Accessed on 16-02-2024 ],
  2. Boehringer Ingelheim International GmbH, Electronic medicines compendium (emc), [ Revised on 21-06-2023 ] [ Accessed on 16-02-2024], 
  3. Boehringer Ingelheim pvt ltd, Therapeutic goods administration, [Revised on April 2014], [Accessed n 16-02-2024],
  4. Helga Wecker, Cornelius F Waller; Afatinib; Recent Results in Cancer Research 2018;


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.