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Afamac 40 Tablet

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Brand Name: Afamac 40
International Trade Name: Gilotrif & Giotrif
Active Substance: Afatinib Dimaleate
Strength: 40mg
Category: Anti-Cancer
Manufacturer: Admac Life Sciences
Pack: 28 Tablets in a Bottle
Product Form: Tablet

 

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Description of Afamac 40 (Afatinib dimaleate 40mg) tablet

Afamac 40 tablet is a drug that is available in 40mg of Afatinib dimaleate and is classified an an antineoplastic pharmacologic agent used in the management of selected solid neoplasms with the most notable being pulmonary carcinoma. This compound belongs to a pharmacologic group of tyrosine kinase inhibitors (TKI) and it is known to adopt its anticancer efficacies by selectively suppressing the occurrence of aberrant molecular signalling pathways that support unchecked cellular proliferation and metastatic expansion, thus slowing down the events of the disease and reducing the tumour burden in the affected individuals.

Indications of Afamac 40 (Afatinib dimaleate 40mg) tablet

Afamac 40 is mainly used to treat non-small cell lung cancer (NSCLC) and especially in the patients whose tumors have epidermal growth factor receptor (EGFR) mutations that confer sensitivity to EGFR-targeted blocking. Its use is mostly desirable when a specific treatment method has been considered better than traditional cytotoxic chemotherapy or where all other treatment methods have failed.

Mechanism of action of Afamac 40 (Afatinib dimaleate 40mg) tablet 

Afatinib dimaleate is a tyrosine kinase inhibitor, which works by competitively binding to the intra cellular ATP-binding domain of epidermal growth factor receptor (EGFR) on malignant cells. This blockade inhibits downstream intracellular signalling cascades which control cellular proliferation, cell survival and cell differentiation. The growth and proliferation of  malignant cells are thus inhibited and this leads to the improvement of the control of diseases.

How to consume of Afamac 40 (Afatinib dimaleate 40mg) tablet

Administering of Afatinib dimaleate by patients should follow dosage and scheduling prescriptions as defined by an individual treating clinician. The drug is normally administered daily, either with or without food. The tablet is to be swallowed as a whole, with sufficient amount of water and it should not be crushed, chewed or changed as per the directive of a qualified healthcare professional.

Side Effects of Afamac 40 (Afatinib dimaleate 40mg) tablet

  1. Common side effects
  • Feeling tired
  • Headache
  • Problems with diarrhea
  • Mild swelling in hands or feet
  • Appetite gets lower
  • Skin rash
  1. Serious side effects
  • Chest pain, arrhythmia
  • Hepatic malfunction
  • Allergic issues
  • Severe bleeding
  • Eye irritation
  • Breathing difficulty
  1. Rare side effects
  • Low potassium level in blood
  • Muscle spasm
  • Severe stomach pain
  • Stomach ulcer

Safety Advice for Afamac 40 (Afatinib dimaleate 40mg) tablet

Patients on Afatinib dimaleate are supposed to be subjected to regular medical checkups to identify the risk of adverse events such as skin reaction, intense diarrhea, dyspnea, and changes in hepatic lab tests. Clinicians can also prescribe regular haematological testing and renal functional evaluation under the condition of clinical situation of the patient.

Breastfeeding: This medicine should not be administered when one is on lactation because thers is a risk of therapeutic intervention in breast milk and may lead to a teratogenic or neonatal risk. Before the commencement, consultation with a trained medical professional is necessary.

Pregnancy: This medicine should not be used during pregnancy because it may be teratogenic. Potential women need to use effective contraceptive methods and are to receive specialist counselling before beginning therapy.

Alcohol: Must be limited or avoided because it can increase the rate of hepatotoxicity and mucosal gastrointestinal irritation.

Liver: In patients with pre-existent hepatic pathology, Afatinib dimaleate should be used with caution and treatment should be given with carful medical supervision because it has a tendency of increasing hepatic enzymes.

Lungs: Afatinib dimaleate is rarely associated with pulmonary inflammation, that is interstitial lung disease. Patients with a new or aggravated cough, pyrexia, or dyspnea should go to the doctor as soon as possible.

Kidney: Afatinib dimaleate should be used with caution in the presence of renal impairment, and the dose should be changed according to the clinical assessment.

Driving: The drug can cause vertigo, fatigue, or blurring of the vision. In case of such manifestation, patients will be advised not to drive a vehicle or operate a heavy piece of equipment.

Interaction of Afamac 40 (Afatinib dimaleate 40mg) tablet

  • Drug-Drug Interaction :

Aniodarone x Afatinib dimaleate

Use alternative drug because the use of amiodarone will increase the effect of afatinib by P-glycoprotein efflux transporter.

Riociguat x Afatinib dimaleate

Use alternative drug because the use of afatinib will increase the effect of riociguat by decreasing it metabolism.

Dichlorphenamide x Afatinib dimaleate

The combination should be used with caution as the interaction lowers the levels of serum potassium.

Dexlansoprazole x Afatinib dimaleate

Another acid-suppressing drug is also advised, since dexlansoprazole reduces the impact of Afatinib dimaleate by increasing gastric pH.

Siponimod x Afatinib dimaleate

It is recommended that clinical vigilance be observed because the combination might increase the risk of infection.

  • Drug-Food Interaction:

Food:

Grapefruit must be avoided, if in the process of treatment, it may increase the levels ofsystemic drugs and as a result, induce bradycardia. The patient will need to visit the doctor immediately in case of the emergence of such symptoms like dizziness, feeling light-headed, dyspnea, bleeding, weight loss, chills, or diarrhea.

  • Drug-Disease Interaction:

Dermatologic toxicities:

Prescription of this drug needs caution as reversible cutaneous reactions have been reported. To reduce sun induced dermatitis patients are recommended to cover their skin with sunscreen and hats.

GI disorders:

Prudent use of the drug is observed in people whose history of peptic ulceration because the drug is linked with gastrointestinal perforation.

Pulmonary toxicities:

Patients with the history of interstitial pneumonitis have to be considered carefully because the drug can trigger interstitial lung disease or fibrosis of the lungs.

Contraindication of Afamac 40 (Afatinib dimaleate 40mg) tablet

Application of this formulation predisposes interstitial lung disease, myocardial infarction, cerebrovascular accident, microangiopathic hemolytic anemia, gastrointestinal perforation, and bullous eruptions.

Dosage of Afamac 40 (Afatinib dimaleate 40mg) tablet

Dose depends on the type of cancer. The doctor may make changes depending upon personal tolerance and how the treatment is working.

Storage of Afamac 40 (Afatinib dimaleate 40mg) tablet

Tablets of Afatinib dimaleate need to be kept somewhere with average room temperature conditions, protecting it from too much moisture or heat. You should always have them inside packet they are in and out of reach of children.

Missed Dose of Afamac 40 (Afatinib dimaleate 40mg) tablet

If you miss one tablet, just use planned next dose on the regular schedule. Taking two tablets together to replace a missed one is not required. Do not try to increase your next dose for this.

Other General Information of Afamac 40 (Afatinib dimaleate 40mg) tablet 

The long-term use can cause xerosis, hence use of an appropriate moisturizer. Enough hydration by drinking water and eating a proper diet must be promoted. Patients have to inform their physicians of any abnormal adverse events and they are supposed to do this regularly. To seek further advice depending on the case scenario, one is recommended to consult the prescribing clinician.

FAQs of Afamac 40 (Afatinib dimaleate 40mg) tablet 

1.What is the common cause of Afatinib dimaleate to cause skin rash?

Epidermal growth factor receptors that Afatinib dimaleate targets are also found in epithelial cells of the skin. As a result, acneiform rashes or xerosis can be experienced. Mild eruptions are common and can indicate the effectiveness of the treatment but severe ones require medical treatment.

2. Is it safe to use sunscreen in combination with Afatinib dimaleate?

Yes, broad-spectrum sunscreen hats or protective clothing are highly encouraged because the drug enhances photosensitivity of the skin, and lowers the risk of irritation and hyperpigmentaion

3. Can Afatinib tablet cause severe lung issues?

Yes, the use of this medicine may cause pleural effusion which leads to difficulty in breathing, chest pain, and cough. Kindly inform your doctor if you have developed this symptoms.

4. Does Afatinib dimaleate have any impact on breathing?

In some extreme cases, pulmonary inflammation can present. The clinician must be informed immediately on the occurrence of new onset cough, chest tightness, or dyspnea.

5. What about when one feels extremely tired or lightheaded?

It is advisable that the person should alert his doctor when he experiences such symptoms. The doctor will then alter the dose of the same.

Fact Box of Afamac 40 (Afatinib dimaleate 40mg) tablet:

Field Details
Generic/Molecule Name Afatinib dimaleate
Therapeutic Class Anti-neoplastic agent
Pharmacological Class Tyrosine kinase inhibitor (EGFR inhibitor)
Dosage form Tablet
Habit forming No
Indication Non-Small Cell Lung Cancer (NSCLC)

 

References
  • Chabner BA, Barnes J, Neal J, et al. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines. In: Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 12th ed. New York, New York: McGraw-Hill Medical; 2011. pp. 1734-35.
  • Chu E, Sartorelli AC. Cancer Chemotherapy. In: Katzung BG, Masters SB, Trevor AJ, editors. Basic and Clinical Pharmacology. 11th ed. New Delhi, India: Tata McGraw Hill Education Private Limited; 2009. pp. 954-55.
  • Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. pp. 616-17.
  • Afatinib dimaleate [Prescribing Information]. [Accessed 06 Apr. 2024] (online) Available from: https://www.ciplamed.com/product-index/gefticip-tablets

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