Afatin Tablet 40 mg

Afatin Tablet 40 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Table Of contents

• Afatin Tablet 40 mg
• Uses
• Dosage
• Side Effect
• Precautions
• Interactions
• Uses during Pregnancy
• Uses during Breastfeeding
• Accute Overdose
• Food Interaction
• Half Life
• Volume of Distribution
• Clearance
• Interaction With other Medicine
• Contradiction
• Storage

Trade Name	Afatin Tablet 40 mg
Generic	Afatinib Dimaleate
Weight	40 mg
Type	Tablet
Therapeutic Class	Tyrosine Kinase Inhibitor
Manufacturer	Beacon Pharmaceuticals PLC
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: Afatinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved ... Read more

Dosage

Afatin Tablet 40 mg dosage

Patient Selection for Non-Resistant EGFR Mutation-Positive Metastatic NSCLC: Select patients for first line treatment of metastatic NSCLC with Afatinib based on the presence of non-resistant EGFR mutations in tumor specimens.Recommended Dose: The recommended dose of Afatinib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.Renal impairment: 30 mg orally, once daily in patients with severe renal impairment.Instruct patients to take Afatinib at least 1 hour before or 2 hours after a meal.

Side Effects

Most common adverse reactions (≥20%) were diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritus.

Precaution

Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold afatinib for severe and prolonged diarrhea not responsive to anti-diarrheal agents.Bullous and exfoliative skin disorders: Severe bullous, blistering, and exfoliating lesions occurred in 0.2% of patients. Discontinue for life-threatening cutaneous reactions. Withhold afatinib for severe and prolonged cutaneous reactions.Interstitial lung disease (ILD): Occurs in 1.6% of patients. Withhold afatinib for acute onset or worsening of pulmonary symptoms. Discontinue afatinib if ILD is diagnosed.Hepatic toxicity: Fatal hepatic impairment occurs in 0.2% of patients. Monitor with periodic liver testing. Withhold or discontinue afatinib for severe or worsening liver tests.Keratitis: Occurs in 0.7% of patients. Withhold afatinib for keratitis evaluation. Withhold or discontinue afatinib for confirmed ulcerative keratitis.Embryo-fetal toxicity: Can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Interaction

Co-administration of P-gp inhibitors can increase afatinib exposure. Reduce Afatinib by 10 mg per day if not tolerated. Co-administration of chronic P-gp inducers orally can decrease afatinib exposure. Increase Afatinib by 10 mg per day as tolerated.

Pregnancy & Breastfeeding use

Based on findings from animal studies and its mechanism of action, Afatinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Afatinib in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.There are no data on the presence of afatinib in human milk or its effects on the breastfed infant or on milk production. Afatinib was present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants from Afatinib, advise a lactating woman not to breastfeed during treatment with Afatinib and for 2 weeks after the final dose.

Storage Condition

Store at 25°C; excursions permitted to 15°-30°C. Dispense medication in the original container to protect from exposure to high humidity and light.

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