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Gilotrif

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Gilotrif

Indications
Dosage
How Supplied

INDICATIONS

GILOTRIF is indicated for the 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 as detected by an FDA-approved test [see Clinical Studies].

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [see INDICATIONS AND USAGE and 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

The recommended dose of GILOTRIF is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take GILOTRIF at least 1 hour before or 2 hours after a meal.

Do not take a missed dose within 12 hours of the next dose.

Dose Modification

Withhold GILOTRIF for any drug-related adverse reactions of:

  • NCI CTCAE* Grade 3 or higher
  • Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking anti-diarrheal medication [see WARNINGS AND PRECAUTIONS]
  • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable [see WARNINGS AND PRECAUTIONS]
  • Renal dysfunction of Grade 2 or higher

Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute GILOTRIF at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.

Permanently discontinue GILOTRIF for:

  • Life-threatening bullous, blistering, or exfoliative skin lesions [see WARNINGS AND PRECAUTIONS]
  • Confirmed interstitial lung disease (ILD) [see WARNINGS AND PRECAUTIONS]
  • Severe drug-induced hepatic impairment [see WARNINGS AND PRECAUTIONS]
  • Persistent ulcerative keratitis [see WARNINGS AND PRECAUTIONS]
  • Symptomatic left ventricular dysfunction
  • Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

P-gp Inhibitors

For patients who require therapy with a P-glycoprotein (P-gp) inhibitor, reduce GILOTRIF daily dose by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

P-gp Inducers

For patients who require chronic therapy with a P-gp inducer, increase GILOTRIF daily dose by 10 mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

GILOTRIF is available as:

40 mg tablets: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.

30 mg tablets: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.

20 mg tablets: white to slightly yellowish, film-coated, round, biconvex, bevel-edged tablets debossed with “T20” on one side and the Boehringer Ingelheim company symbol on the other side.

Storage And Handling

GILOTRIF tablets are available as follows:

40 mg: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0138-30

30 mg: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0137-30

20 mg: white to slightly yellowish, film-coated, round, biconvex, bevel-edged tablets debossed with “T20” on one side and the Boehringer Ingelheim company symbol on the other side.

Unit of use bottles of 30 NDC: 0597-0141-30

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense medication in the original container to protect from exposure to high humidity and light.

*National Cancer Institute Common Terminology Criteria for Adverse Events, v 3.0

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: November 2013

Last reviewed on RxList: 12/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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