June 28, 2016
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Gilotrif

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Gilotrif

Indications
Dosage
How Supplied

INDICATIONS

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer

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

The safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies].

Previously Treated, Metastatic Squamous NSCLC

GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection For EGFR Mutation-Positive Metastatic NSCLC

Select patients for 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.

Severe Renal Impairment

The recommended dose of GILOTRIF in patients with severe renal impairment (estimated glomerular filtration rate [eGFR*] 15 to 29 mL/min /1.73 m²) is 30 mg orally, once daily [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

*Use the Modification of Diet in Renal Disease [MDRD] formula to estimate eGFR.

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 Modifications For Adverse Reactions

Withhold GILOTRIF for any 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 impairment of Grade 2 or higher [see WARNINGS AND PRECAUTIONS]

*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v 3.0

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:

Dose Modifications For Drug Interactions

P-gp Inhibitors

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

P-gp Inducers

Increase GILOTRIF daily dose by 10 mg as tolerated for patients who require chronic therapy with a P-gp inducer. 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.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: April 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/9/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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