GILOTRIF- afatinib tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

AFATINIB (UNII: 41UD74L59M) (AFATINIB - UNII:41UD74L59M)

Disponibbli minn:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

afatinib

Kompożizzjoni:

afatinib 20 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [see Dosage and Administration (2.1), Clinical Pharmacology (12.1), Clinical Studies (14.1)]. Limitations of Use : The safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations [see Clinical Studies (14.1)]. GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy. None. Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , GILOTRIF can cause fetal harm when administered to a pregnant woman. There are no available data on the use of GILOTRIF in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the rec

Sommarju tal-prodott:

GILOTRIF tablets are available as follows: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense medication in the original container to protect from exposure to high humidity and light.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

GILOTRIF- AFATINIB TABLET, FILM COATED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GILOTRIF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GILOTRIF.
GILOTRIF (AFATINIB TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
GILOTRIF is a kinase inhibitor indicated for:
First-line treatment of patients with metastatic non-small cell lung
cancer (NSCLC) whose tumors have
non-resistant epidermal growth factor receptor (EGFR) mutations as
detected by an FDA-approved test
(1.1)
Limitations of Use: Safety and efficacy of GILOTRIF were not
established in patients whose tumors have
resistant EGFR mutations (1.1)
Treatment of patients with metastatic, squamous NSCLC progressing
after platinum-based
chemotherapy (1.2)
DOSAGE AND ADMINISTRATION
Recommended dosage: 40 mg orally once daily (2.2)
Renal impairment: 30 mg orally once daily in patients with severe
renal impairment (2.4, 8.6, 12.3)
Instruct patients to take GILOTRIF at least 1 hour before or 2 hours
after a meal (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg, 30 mg, and 20 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Diarrhea: Diarrhea may result in dehydration and renal failure.
Withhold GILOTRIF for severe and
prolonged diarrhea not responsive to anti-diarrheal agents. (2.3, 5.1)
Bullous and exfoliative skin disorders: Severe bullous, blistering,
and exfoliating lesions occurred in 0.2%
of patients. Discontinue for life-threatening cutaneous reactions.
Withhold GILOTRIF for severe and
prolonged cutaneous reactions. (2.3, 5.2)
Interstitial lung disease (ILD): Occurs in 1.6% of patients. Withhold
GILOTRIF for acute onset or
worsening of pulmonary symptoms. Discontinue GILOTRIF if ILD is
diagnosed. (2.3, 5.3)
Hepatic toxicity: Fatal hepatic impairment occurs in 0.2% of patients.
Monitor with periodic liver testing.
Withhold or discontinue GILOTRIF for severe or worsening liver tests.
(2.3, 5.4)
Gastrointest