AFATINIB DIMALEATE
Background and Date of Approval
Afatinib Dimaleate is an anticancer medicine approved by the US Food and Drug Administration (FDA) on July 12, 2013, to treat patients with non-small cell lung cancer (NSCLC) whose tumours harbour specific non-resistant epidermal growth factor receptor (EGFR) gene mutations and patients with metastatic squamous NSCLC whose disease has progressed following platinum-based chemotherapy.
Uses
Afatinib dimaleate is used to treat certain types of cancer, including non-small cell lung cancer with specific EGFR mutations.
How is it administered?
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.
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.
Warnings
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.
Precautions
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.
Word of Advice
Take afatinib dimaleate exactly as prescribed by your healthcare provider. Do not exceed or reduce the prescribed dose. Report any new or worsening symptoms to your healthcare provider immediately, particularly those affecting your lungs, eyes, skin, liver, kidneys, heart, or bleeding. Women must avoid pregnancy and breastfeeding during treatment. Patients of reproductive age should use effective contraception during treatment and for at least two weeks after the final dose. Inform your healthcare provider immediately of any signs or symptoms of dehydration, including dry mouth or reduced urination. Maintain adequate fluid intake while taking afatinib dimaleate to prevent dehydration, particularly if diarrhoea occurs as a side effect. Avoid grapefruit and grapefruit juice during treatment with afatinib dimaleate, as they may interact with the medication and increase the risk of adverse effects.
References
Boehringer Ingelheim Pharmaceuticals, Inc, US Food and Drug Administration, [ Revised on Jan 2018] [ Accessed on 16-02-2024 ], https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf Boehringer Ingelheim International GmbH, Electronic medicines compendium (emc), [ Revised on 21-06-2023 ] [ Accessed on 16-02-2024], https://www.medicines.org.uk/emc/files/pil.5147.pdf Boehringer Ingelheim pvt ltd, Therapeutic goods administration, [Revised on April 2014], [Accessed n 16-02-2024], https://www.tga.gov.au/sites/default/files/auspar-afatinib-dimaleate-140414.pdf Helga Wecker, Cornelius F Waller; Afatinib; Recent Results in Cancer Research 2018; https://pubmed.ncbi.nlm.nih.gov/30069769/
Frequently Asked Questions
Can I donate blood while taking afatinib dimaleate?
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.
Can I continue to work or go to school while taking Afatinib dimaleate?
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.
Does afatinib dimaleate have any effect on fertility?
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.
Can I take afatinib dimaleate if I have a history of heart problems?
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.
Can afatinib dimaleate be used in combination with other cancer treatments?
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.