Erlotinib hyrochloride 150 mg tablets

Erlotinib tablets are a kinase inhibitor indicated for:

• The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.
• First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Limitations of Use:

• Safety and efficacy of erlotinib have not been established in patients with NSCLC whose tumors have other EGFR mutations.
• Erlotinib is not recommended for use in combination with platinum-based chemotherapy.

• NSCLC: 150 mg orally, on an empty stomach, once daily.
• Pancreatic cancer: 100 mg orally, on an empty stomach, once daily.

Tablets: 25 mg, 100 mg, and 150 mg

None.

• Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold erlotinib for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue erlotinib if ILD is diagnosed.
• Renal failure: Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold erlotinib for severe renal toxicity.
• Hepatotoxicity: Occurs with or without hepatic impairment, including hepatic failure and hepatorenal syndrome: Monitor periodic liver testing. Withhold or discontinue erlotinib for severe or worsening liver tests.
• Gastrointestinal perforations: Discontinue erlotinib.
• Bullous and exfoliative skin disorders: Discontinue erlotinib.
• Cerebrovascular accident (CVA): The risk of CVA is increased in patients with pancreatic cancer.
• Microangiopathic hemolytic anemia (MAHA): The risk of MAHA is increased in patients with pancreatic cancer.
• Ocular disorders: Discontinue erlotinib for corneal perforation, ulceration or persistent severe keratitis.
• Hemorrhage in patients taking warfarin: Regularly monitor INR in patients taking warfarin or other coumarin-derivative anticoagulants.
• Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.