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 test.

Limitation of Use: The safety and efficacy of Afatinib have not been established in patients whose tumors have resistant EGFR mutations.

Previously Treated, Metastatic Squamous NSCLC: Afatinib is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

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.

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

Pregnancy & Lactation

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.

Precautions & Warnings

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.