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Afatinib (Gilotrif)

Trade Name : Gilotrif

Boehringer Ingelheim Pharmaceuticals, Inc.

TABLET, FILM COATED

Strength 30 mg/1

AFATINIB Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Afatinib (Gilotrif) which is also known as Gilotrif and Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. It is available in strength of 30 mg/1 per ml. Read more

Afatinib (Gilotrif) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • 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 ()n : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations ()
  • Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ()
  • No data
  • Recommended dosage
  • Renal impairment
  • Instruct patients to take GILOTRIF at least 1 hour before or 2 hours after a meal ()
  • GILOTRIF is available as:
  • Tablets: 40 mg, 30 mg, and 20 mg ()
  • None.
  • None. ()
  • No data
  • Diarrhea
  • Bullous and exfoliative skin disorders
  • Interstitial lung disease (ILD)
  • Hepatic toxicity
  • Gastrointestinal perforation
  • Keratitis
  • Embryo-fetal toxicity
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (u226520%) were diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritus ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or .
  • Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
  • Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib Reduce GILOTRIF daily dose as recommended n
  • Concomitant taking of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort) with GILOTRIF can decrease exposure to afatinib Increase GILOTRIF daily dose as recommended n
  • P-glycoprotein (P-gp) Inhibitors
  • P-gp Inducers
  • Lactation
  • 8.2
  • Overdose was reported in 2 healthy adolescents each of whom ingested 360 mg of GILOTRIF (as part of a mixed-drug ingestion) resulting in nausea, vomiting, asthenia, dizziness, headache, abdominal pain, and elevated amylase [<1.5 times upper limit of normal (ULN)]. Both subjects recovered.
  • GILOTRIF tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, -[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2)-, (2)-2-butenedioate (1:2). Its structural formula is:
  • Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of CHClFNO, and a molecular weight of 718.1 g/mol.
  • GILOTRIF tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of GILOTRIF are the following: Tablet Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate and Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).
  • No data
  • Carcinogenicity studies have not been conducted with afatinib.
  • A marginal response to afatinib was observed in a single tester strain of a bacterial (Ames) mutagenicity assay. No mutagenic or genotoxic potential was identified in an chromosomal aberration test at non-cytotoxic concentrations as well as in the bone marrow micronucleus assay, the Comet assay, and an 4-week oral mutation study in the Muta Mouse.
  • In a dedicated fertility study, male and female rats received afatinib daily by oral administration at doses of 4, 6, or 8 mg/kg. In males at doses of 6 mg/kg (approximately equal to the exposure by AUC in patients at the recommended human dose of 40 mg daily) or greater, there was an increase in the incidence of low or no sperm count, though overall fertility was not affected; decreases in sperm count were supported by findings of increased apoptosis in the testes and atrophy in the seminal vesicles and the prostate in general toxicology studies. In females at the high dose of 8 mg/kg (approximately 0.63 times the exposure by AUC in patients at the recommended human dose of 40 mg daily), there was a mild decrease in the number of corpora lutea along with a mild increase in post-implantation loss due to early resorptions. In a 4-week general toxicology study, female rats had decreases in ovarian weights at all dose levels; organ weight had not fully recovered by the end of a 2-week recovery period.
  • No data
  • GILOTRIF tablets are available as follows:
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) [see USP Controlled Room Temperature]. Dispense medication in the original container to protect from exposure to high humidity and light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Distributed by:Boehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, CT 06877 USA
  • Licensed from:Boehringer Ingelheim International GmbH
  • GILOTRIF is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.
  • The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.
  • Copyright u00a9 2019 Boehringer Ingelheim International GmbHALL RIGHTS RESERVED
  • IT5562SJ162019
  • No data
  • Gilotrif 20 mg TabletsNDC: 0597-0141-30
  • Gilotrif 30 mg TabletsNDC: 0597-0137-30
  • Gilotrif 40 mg TabletsNDC: 0597-0138-30

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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