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Afatinib Dimaleate

This page provides concise information about the drug afatinib dimaleate, including its indications, dosage and administration, mechanism of action, related brands with strengths, warnings, and common side effects.

Background and Date of Approval

Afatinib Dimaleate is an anticancer medication comprising afatinib dimaleate as its active ingredient. It received approval from the US Food and Drug Administration (FDA) on July 12, 2013, for the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors exhibit specific (non-resistant) abnormal epidermal growth factor receptor (EGFR) genes. It is also indicated for patients with metastatic squamous NSCLC experiencing progression after platinum-based chemotherapy. Cancer is a condition characterized by abnormal and uncontrolled cell multiplication.

Mechanism of Action of Afatinib Dimaleate

The primary mechanism of action of afatinib dimaleate is associated with its capacity to inhibit the activity of specific proteins within cancer cells, particularly those in the epidermal growth factor receptor (EGFR) family. These proteins play a pivotal role in fostering the growth and dissemination of cancer cells, and suppressing their activity can contribute to slowing or halting the advancement of cancer.

Uses of Afatinib Dimaleate

Afatinib dimaleate is prescribed for the treatment of specific types of cancer, including non-small cell lung cancer with distinct EGFR mutations.

Afatinib Dimaleate Drug administaration and Dosage available

Afatinib Dimaleate is an oral medication typically administered once daily, around the same time each day, with or without food. It must be taken as directed by a doctor or another healthcare professional. The capsules should be swallowed whole with a glass of water, and it is important not to crush, chew, or open them, as doing so may impact the medication’s absorption and reduce its efficacy. It is advised not to take a double dose to compensate for a missed one.

Warnings, Precautions and Side Effects of Afatinib Dimaleate

Warnings

Afatinib dimaleate has the potential to induce interstitial lung disease (ILD), a grave and potentially life-threatening condition characterized by inflammation and scarring of the lungs. This medication may also trigger severe diarrhea and dehydration, posing life-threatening risks in certain cases. Additionally, it has been associated with eye issues, such as corneal erosion or ulceration, which may result in vision loss or blindness. In rare instances, afatinib dimaleate can contribute to kidney problems (acute kidney injury, renal failure) and cardiac issues (irregular heartbeat).

Precautions

Patients with pre-existing cardiac conditions and renal issues should regularly monitor their kidney and heart function before and during the administration of afatinib dimaleate. Immediate reporting to a healthcare provider is crucial for any signs or symptoms of dehydration, such as a dry mouth or reduced urination. Any new or worsening eye symptoms, such as eye pain or redness, should be promptly reported to a healthcare provider. Inform your doctor about any skin symptoms, such as rashes or blisters. Report any signs or symptoms of infection to a healthcare provider. It is advisable to avoid traumatic or penetrative procedures in the body, such as tooth extraction or surgery, while taking this medication to prevent excessive bleeding.

Side Effects

Afatinib dimaleate may elicit a spectrum of side effects, varying from mild to severe. Common side effects encompass diarrhea, skin rash, nail changes, mouth sores, and fatigue. Many of these side effects can be effectively addressed with medication or other therapeutic measures. Nevertheless, more serious side effects, including severe diarrhea, dehydration, and kidney problems, can also occur.

Word Of Advice

Adhere strictly to all instructions and dosing recommendations provided by your healthcare provider. Take the medication only as prescribed. Promptly report any new or worsening symptoms to your healthcare provider, especially those pertaining to your lungs, eyes, skin, liver, kidneys, heart, or bleeding. Ensure adequate hydration and immediately inform your healthcare provider of any signs or symptoms of dehydration, particularly if you are experiencing severe diarrhea. Women should refrain from pregnancy or breastfeeding. Reproductive-age women should utilize effective birth control throughout the treatment and for at least two weeks after their final dose. Report any signs or symptoms of dehydration, such as dry mouth or reduced urination, to a healthcare provider immediately.

Frequently Asked Question

Patients should not donate blood while taking afatinib dimaleate, as the medication can harm the recipient. It is important to inform your healthcare provider if you plan to donate blood, as they may advise you to wait until after you have finished treatment.
The ability to work or go to school while taking afatinib dimaleate will depend on your condition and response to treatment. Some patients may experience fatigue or other side effects that can impact their ability to perform daily activities.
There is limited information on the effects of afatinib dimaleate on fertility. However, it is important to inform your healthcare provider if you are trying to conceive, as some cancer treatments can affect fertility.
If you have a history of heart problems, discussing the potential risks and benefits of using afatinib dimaleate with your healthcare provider before starting treatment is important. This medication can cause cardiac problems, and your healthcare provider may need to monitor you closely during treatment.
Afatinib dimaleate is sometimes used in combination with other cancer treatments, such as chemotherapy or immunotherapy. However, the safety and effectiveness of these combinations will depend on your individual condition and treatment plan.

References

  1. Boehringer Ingelheim Pharmaceuticals, Inc, US Food and Drug Administration, [ Revised on Jan 2018] [ Accessed on 21st April 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf
  2. Boehringer Ingelheim International GmbH, Electronic medicines compendium (emc), [ Revised on Sept 2020] [ Accessed on 21st April 2023], https://www.medicines.org.uk/emc/files/pil.5147.pdf
  3. Helga Wecker, Cornelius F Waller; Afatinib; Recent Results in Cancer Research 2018; https://pubmed.ncbi.nlm.nih.gov/30069769/

Disclaimer

The drug information on this page is different from 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.