Erloren 100

• Non-Small Cell Lung Cancer (NSCLC): First-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 substitution mutations.
• Pancreatic Cancer: First-line treatment of locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.

Adult Dose:

• NSCLC: 150 mg PO once daily (empty stomach); continue until disease progression or unacceptable toxicity.
• Pancreatic Cancer (with gemcitabine): 100 mg PO once daily (empty stomach); continue until disease progression or unacceptable toxicity.
• With strong CYP3A4 inhibitors: Reduce by 50 mg decrements.
• With CYP3A4 inducers: Increase by 50 mg increments at 2-week intervals (max 450 mg).
• Smoking patients: Increase by 50 mg increments at 2-week intervals (max 300 mg); reduce dose upon smoking cessation.

Hepatic Impairment: Mild-moderate: No dosage adjustment needed; Severe: Limited data.

Renal Impairment: Safe; no dose adjustment recommended (severe kidney disease: not advised).

Common Side Effects (≥20%):

• Rash
• Diarrhea
• Anorexia/Decreased appetite
• Fatigue
• Dyspnea
• Cough
• Nausea
• Vomiting
• Abdominal pain
• Weight loss
• Stomatitis

Serious Side Effects: Interstitial Lung Disease (ILD), Renal Failure, Hepatotoxicity, Gastrointestinal Perforation, Bullous and Exfoliative Skin Disorders, MI/Ischemia, Cerebrovascular Accident.

Precautions:

• It is not known whether Erlotinib alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
• Take on an empty stomach (1 hour before or 2 hours after meal).
• Diarrhea may occur; drink plenty of fluids and inform doctor if blood in stools.
• Use reliable contraceptive method during treatment and for one month after stopping.
• Makes skin sensitive to sunlight; apply sunscreen or wear protective clothing.
• Avoid smoking while taking this medicine.
• Do not take with medications lowering stomach acid (antacids, H2 blockers, PPIs).
• Inform doctor if mouth ulceration, vision changes, worsening cough, or breathing difficulties occur.
• Regular blood tests to monitor liver function required.