Afanat 40mg Afatinib Tablet NATCO

[Drug Name]

Generic Name: Afatinib Dimaleate Tablets

Brand Name: Afatinib Dimaleate Tablets (Gilotrif)

[Active Ingredient] Afatinib.

[Description] Light blue, round, biconvex, film-coated tablets with beveled edges.

[Indications/Therapeutic Uses] Indicated for the first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR gene mutations, and for patients with advanced HER2-positive breast cancer. Afatinib is an oral medication and an irreversible inhibitor of epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinases. It is a second-generation EGFR-targeted therapy.

[Specification] 40 mg × 28 tablets

[Dosage and Administration] (1) The recommended dose of Gilotrif is 40 mg once daily, taken until disease progression or until the patient is no longer able to tolerate the treatment. (2) For oral administration. Take on an empty stomach; Gilotrif should be taken at least 1 hour before a meal or 2 hours after a meal.

[Adverse Reactions] The most common toxic side effects include diarrhea, rash associated with afatinib treatment, nausea, hypertension, and anorexia; as well as asymptomatic QT interval prolongation and proteinuria. With increasing doses, adverse events such as hypophosphatemia, folliculitis, elevated transaminases, non-specific intestinal obstruction, thrombocytopenia, congestive heart failure, deep vein thrombosis, and pulmonary embolism may occur. The most common dose-limiting toxicities (DLTs) are diarrhea, hypertension, and rash.

[Contraindications] Not yet established.

[Precautions] (1) Diarrhea: Diarrhea may lead to dehydration and renal failure. Afatinib-induced diarrhea may be severe and unresponsive to standard anti-diarrheal medications; if prolonged diarrhea occurs, Gilotrif administration should be immediately discontinued. (2) Bullous and Exfoliative Skin Disorders: The prescribing information for Afatinib Tablets notes that severe bullous, blistering, and exfoliative skin lesions occurred in 0.15% of patients. The drug should be discontinued in the event of life-threatening skin reactions. For severe and prolonged skin reactions, Gilotrif administration should be discontinued. (3) Interstitial Lung Disease (ILD): Occurred in 1.5% of patients. Discontinue Gilotrif administration in cases of acute onset or worsening of pulmonary symptoms. If ILD is diagnosed, Gilotrif should be permanently discontinued. (4) Hepatotoxicity: Fatal hepatic injury occurred in 0.18% of patients. Monitor with periodic liver function tests. Discontinue or permanently discontinue Gilotrif in cases of severe or worsening liver function abnormalities. (5) Keratitis: Occurred in 0.8% of patients. (6) Embryo-fetal Toxicity: May cause fetal harm. Advise women of the potential hazard to the fetus and the need for effective contraception.

[Pediatric Use] Not established.

[Geriatric Use] Not established.

[Use in Pregnant and Lactating Women] Not established.

[Drug Interactions] Not established.

[Overdosage] Not established.

[Pharmacology and Toxicology] Afatinib (Gilotrif) is an irreversible inhibitor of the ErbB family, capable of suppressing signal transduction and blocking key pathways associated with cancer cell growth and division. Since signal transduction via the ErbB family mechanism can be triggered by various homodimers and heterodimers, the simultaneous inhibition of multiple ErbB family members (e.g., EGFR, HER2, ErbB3, and ErbB4) can more effectively interrupt downstream signal transduction. In cancer cells, the function of the ErbB family is frequently dysregulated. When factors controlling cell growth mechanisms are overexpressed or function abnormally, it may trigger various solid tumors. Receptor overexpression stimulates intracellular signal transduction beyond normal levels, leading to uncontrolled tumor cell growth, migration, and metastasis, as well as the inhibition of apoptosis. The various mechanisms that trigger these cellular signaling abnormalities include: receptor mutations (e.g., EGFR mutations in lung tumors), receptor overexpression (e.g., HER2 overexpression in breast tumors), or ligand overexpression.

[Pharmacokinetics] Not established.

[Packaging] 40 mg × 28 tablets/box. [Shelf Life] 36 Months

Product Specifications

Product Name: Afatinib Dimaleate Tablets (Jitairui) 40mg × 28 Tablets — Afanat 40mg Afatinib Tablet (NATCO)

Common Name: Afatinib Dimaleate Tablets

Composition: Afatinib

Dosage Form: Tablets

Specification: 40mg × 28 Tablets

Manufacturer: NATCO Pharma (India)

Indications:

1. Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene-sensitizing mutations, in patients who have not previously received treatment with an EGFR tyrosine kinase inhibitor (TKI).

2. Locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology, in which the disease has progressed during or after platinum-based chemotherapy.

Dosage and Administration: This product should be used under the guidance of an experienced physician. Prior to initiating treatment, the EGFR mutation status should be determined using a fully validated testing method.

Recommended Dosage

The recommended dosage for this product is 40 mg, taken once daily. Currently, there is insufficient evidence to support that patients derive greater benefit from a 50 mg dose.

This product should not be taken with food. It should be taken at least 3 hours after a meal or at least 1 hour before a meal.