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Tarceva

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Tarceva

INDICATIONS

Non-Small Cell Lung Cancer (NSCLC)

TARCEVA is indicated for:

Limitations of use

TARCEVA is not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies].

Safety and efficacy of TARCEVA have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution [see Clinical Studies].

Pancreatic Cancer

TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with TARCEVA based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [See Clinical Studies]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics

Recommended Dose – NSCLC

The recommended daily dose of TARCEVA for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.

Recommended Dose – Pancreatic Cancer

The recommended daily dose of TARCEVA for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take TARCEVA on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs [see Clinical Studies].

Dose Modifications

Discontinue TARCEVA for:
  • Interstitial Lung Disease (ILD) [see WARNINGS AND PRECAUTIONS].
  • Severe hepatic toxicity that does not improve significantly or resolve within three weeks [see WARNINGS AND PRECAUTIONS].
  • Gastrointestinal perforation [see WARNINGS AND PRECAUTIONS].
  • Severe bullous, blistering or exfoliating skin conditions [see WARNINGS AND PRECAUTIONS].
  • Corneal perforation or severe ulceration [see WARNINGS AND PRECAUTIONS].
Withhold TARCEVA:
  • During diagnostic evaluation for possible ILD.
  • For severe (CTCAE grade 3 to 4) renal toxicity, and consider discontinuation of TARCEVA [see WARNINGS AND PRECAUTIONS].
  • In patients without pre-existing hepatic impairment for total bilirubin levels greater than 3 times the upper limit of normal or transaminases greater than 5 times the upper limit of normal, and consider discontinuation of TARCEVA [see WARNINGS AND PRECAUTIONS].
  • In patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline and consider discontinuation of TARCEVA [see WARNINGS AND PRECAUTIONS].
  • For persistent severe diarrhea not responsive to medical management (e.g., loperamide).
  • For severe rash not responsive to medical management.
  • For keratitis of (NCI-CTC version 4.0) grade 3-4 or for grade 2 lasting more than 2 weeks [see WARNINGS AND PRECAUTIONS].
  • For acute/worsening ocular disorders such as eye pain, and consider discontinuation of TARCEVA [see WARNINGS AND PRECAUTIONS].
Reduce TARCEVA by 50 mg decrements:
  • If severe reactions occur with concomitant use of strong CYP3A4 inhibitors [such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., ciprofloxacin). Avoid concomitant use if possible [see DRUG INTERACTIONS].
  • When restarting therapy following withholding treatment for a dose-limiting toxicity that has resolved to baseline or grade ≤ 1.
Increase TARCEVA by 50 mg increments as tolerated for:
  • Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort. Increase doses by 50 mg increments at 2 week intervals to a maximum of 450 mg. Avoid concomitant use, if possible [see DRUG INTERACTIONS].
  • Concurrent cigarette smoking. Increase by 50 mg increments at 2 week intervals to a maximum of 300 mg. Immediately reduce the dose of TARCEVA to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Drugs Affecting Gastric pH
  • Avoid concomitant use of TARCEVA with proton pump inhibitors if possible. Separation of doses may not eliminate the interaction since proton pump inhibitors affect the pH of the upper GI tract for an extended period.
  • If treatment with an H2-receptor antagonist such as ranitidine is required, TARCEVA must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist.
  • Although the effect of antacids on erlotinib pharmacokinetics has not been evaluated, the antacid dose and the TARCEVA dose should be separated by several hours, if an antacid is necessary.

HOW SUPPLIED

Dosage Forms And Strengths

25 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in orange with a “T” and “25” on one side and plain on the other side.

100 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on the other side.

150 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in maroon with “T” and “150” on one side and plain on the other side.

Storage And Handling

25 mg Tablets

Round, biconvex face and straight sides, white film-coated, printed in orange with a “T” and “25” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-062-01

100 mg Tablets

Round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-063-01

150 mg Tablets

Round, biconvex face and straight sides, white film-coated, printed in maroon with “T” and “150” on one side and plain on the other side; supplied in: Bottles of 30: NDC 50242-064-01

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). See USP Controlled Room Temperature.

Manufactured for: OSI Pharmaceuticals, LLC, Northbrook, IL 60062 an affiliate of Astellas Pharma US, Inc., Product of Japan or Italy – See bottle label for origin. Manufactured by: Kremers Urban Pharmaceuticals, Inc., Seymour, IN 47274, Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Rev Apr 2014

Last reviewed on RxList: 4/28/2014
This monograph has been modified to include the generic and brand name in many instances.

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