Tarceva Dosage & Drug Information

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Core Prescribing Info

Contents

Erlotinib HCl

Indications/Uses

1st-line treatment of patients w/ locally advanced or metastatic NSCLC w/ EGFR activating mutations. Switch maintenance treatment in patients w/ locally advanced or metastatic NSCLC w/ EGFR activating mutations & stable disease after 1st-line chemotherapy. Patients w/ locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine for 1st-line treatment of locally advanced, unresectable or metastatic pancreatic cancer.

Dosage/Direction for Use

NSCLC Recommended daily dose: 150 mg at least 1 hr before or 2 hr after ingestion of food. Perform EGFR mutation testing prior to treatment initiation in patients w/ advanced or metastatic NSCLC. Pancreatic cancer Recommended daily dose: 100 mg at least 1 hr before or 2 hr after ingestion of food in combination w/ gemcitabine. Smokers Max tolerated dose: 300 mg.

Administration

Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.

Contraindications

Hypersensitivity.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Tarceva FC tab 100 mg

Packing/Price

1's

Form

Tarceva FC tab 150 mg

Packing/Price

1's

Tarceva

erlotinib

Manufacturer:

Delpharm Milano S.r.l.