Erlotinib Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Non-Small Cell Lung Cancer

150 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-There is no evidence that treatment beyond disease progression is beneficial.

Uses:
-First-line 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.
-Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
-Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Usual Adult Dose for Pancreatic Cancer

100 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Use: First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Renal Dose Adjustments

Severe renal dysfunction: Use is not recommended

Liver Dose Adjustments

Severe liver dysfunction: Use is not recommended

Treatment should be interrupted or discontinued, if:
-Total serum bilirubin doubles and/or serum transaminases triple in patients with baseline hepatic impairment
-Total serum bilirubin is greater than 3 times the upper limit of normal (3 x ULN) and/or serum transaminases are greater than 5 x ULN in patients with normal pre-treatment values.

Dose Adjustments

Discontinuation of Therapy:
-Interstitial Lung Disease
-Severe hepatic toxicity that does not improve significantly or resolve within three weeks
-Gastrointestinal perforation
-Severe bullous, blistering, or exfoliating skin conditions
-Corneal perforation or severe ulceration

Interruption of Therapy:
-During diagnostic evaluation for Interstitial Lung Disease
-For severe (grade 3 to 4) renal toxicity and consider discontinuation of therapy
-In patients without preexisting-existing hepatic impairment for total bilirubin levels greater than 3 x ULN or transaminases greater than 5 x ULN, and consider discontinuation of therapy
-In patients with preexisting-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline and consider discontinuation of therapy
-For persistent severe diarrhea not responsive to medical management
-For severe rash not responsive to medical management.
-For keratitis of grade 3-4 or for grade 2 lasting more than 2 weeks
-For acute/worsening ocular disorders such as eye pain and consider discontinuation of therapy

Reduce Dose by 50 mg Decrements:
-If severe reactions occur with concomitant use of strong CYP450 3A4 inhibitors or when using concomitantly with an inhibitor of CYP450 3A4 and CYP450 1A2. Avoid concomitant use if possible.
-When restarting therapy following interruption of treatment for a dose-limiting toxicity that has resolved to baseline or grade less than or equal to 1.

Increase Dose by 50 mg Increments:
-Concomitant use with CYP450 3A4 inducers. Increase dose by 50 mg increments every two weeks to a maximum dose of 450 mg. Avoid concomitant use if possible.
-Concurrent cigarette smoking. Increase the dose by 50 mg every two weeks to a maximum dose of 300 mg. Upon cessation of smoking, immediately reduce dose to the recommended dose (150 mg or 100 mg daily).

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take this drug at least one hour before or two hours after food.
-Avoid taking this drug with antacids, histamine-2 antagonists, and proton pump inhibitors.

Monitoring:
-Dermatologic: Bullous and exfoliative skin conditions
-Gastrointestinal: Diarrhea, gastrointestinal perforation
-Hepatic: Liver function tests (for hepatotoxicity, hepatitis, and hepatic failure)
-Metabolic: Dehydration, serum electrolytes (e.g., potassium)
-Ophthalmologic: Acute or worsening ocular disorders (e.g., corneal perforation or ulceration)
-Renal: Renal function
-Respiratory: Interstitial lung disease

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