Brand Name
Gilotrif
Generic Name
Afatinib
View Brand Information FDA approval date: July 12, 2013
Classification: Kinase Inhibitor
Form: Tablet
What is Gilotrif (Afatinib)?
GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test.
Approved To Treat
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Brand Information
Gilotrif (afatinib)
1DOSAGE 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.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Diarrhea
- Bullous and Exfoliative Skin Disorders
- Interstitial Lung Disease
- Hepatic Toxicity
- Gastrointestinal Perforation
- Keratitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the Warnings and Precautions section reflect exposure to GILOTRIF for clinically significant adverse reactions in 4257 patients enrolled in LUX-Lung 3 (n=229) and LUX-Lung 8 (n=392), and 3636 patients with cancer enrolled in 42 studies of GILOTRIF administered alone or in combination with other anti-neoplastic drugs at GILOTRIF doses ranging from 10-70 mg daily or at doses 10-160 mg in other regimens. The mean exposure was 5.5 months. The population included patients with various cancers, the most common of which were NSCLC, breast, colorectal, brain, and head and neck.
The data described below reflect exposure to GILOTRIF as a single agent in LUX-Lung 3, a randomized, active-controlled trial conducted in patients with EGFR mutation-positive, metastatic NSCLC, and in LUX-Lung 8, a randomized, active-controlled trial in patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of GILOTRIF. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Pancreatitis
- Toxic epidermal necrolysis/Stevens Johnson syndrome
4OVERDOSAGE
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.
5DESCRIPTION
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,
Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of C
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).
6HOW SUPPLIED/STORAGE AND HANDLING
GILOTRIF tablets are available as follows:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
NDC 0597-0141-30
GILOTRIF
20 mg*
Attention: Dispense and Store
Recommended Dosage: See Prescribing
30 tablets
Boehringer
Rx only
9PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Carton
NDC 0597-0137-30
GILOTRIF
30 mg*
Attention: Dispense and Store
Recommended Dosage: See Prescribing
30 tablets
Boehringer
Rx only
10PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Carton
NDC 0597-0138-30
GILOTRIF
40 mg*
Attention: Dispense and Store
Recommended Dosage:
30 tablets
Boehringer
Rx only
