Gilotrif
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 (14)].
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations [see Clinical Studies (14)].
History
There is currently no drug history available for this drug.
Other Information
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, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-, (2Z)-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 C32H33ClFN5O11, 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. Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).
Sources
Gilotrif Manufacturers
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Boehringer Ingelheim Pharmaceuticals, Inc.
![Gilotrif (Afatinib) Tablet, Film Coated [Boehringer Ingelheim Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gilotrif | Lupin Pharmaceuticals, Inc.
2.1 Adult Patients The recommended oral dose of lamivudine tablets in HIV-1-infected adults is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen[see WARNINGS AND PRECAUTIONS (5.2)]. Lamivudine tablets may be taken with or without food. 2.2 Pediatric PatientsLamivudine is available as a scored tablet for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1: Dosing Recommendations for Lamivudine Tablets Scored (150 mg) in Pediatric Patients Weight (kg)
Twice-daily Dosing Regimen Using Scored 150-mg Tablet
AM Dose
PM Dose
Total Daily Dose
14 to <20
½ tablet (75 mg)
½ tablet (75 mg)
150 mg
>20 to <25
½ tablet (75 mg)
1 tablet (150 mg)
225 mg
>25
1 tablet (150 mg)
1 tablet (150 mg)
300 mg
Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company's EPIVIR® (lamivudine) tablets and oral solution. However, due to ViiV Healthcare Company's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Patients with Renal ImpairmentDosing of lamivudine tablets are adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see CLINICAL PHARMACOLOGY (12.3)].
Table 2: Adjustment of Dosage of Lamivudine in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance Creatinine Clearance (mL/min)
Recommended Dosage of Lamivudine
≥50
150 mg twice daily or 300 mg once daily
30 to 49
150 mg once daily
15 to 29
150 mg first dose, then 100 mg once daily
5 to 14
150 mg first dose, then 50 mg once daily
<5
50 mg first dose, then 25 mg once daily
No additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
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