• Respiratory and thoracic cancers

Gilotrif Generic Name & Formulations

General Description

Afatinib 20mg, 30mg, 40mg; tabs.

Pharmacological Class

Tyrosine kinase inhibitor.

How Supplied


Generic Availability


Gilotrif Indications


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. Limitations of use: safety and efficacy have not been established in patients whose tumors have resistant EGFR mutations. Treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

Gilotrif Dosage and Administration


Take on an empty stomach at least 1 hr before or 2 hrs after a meal. 40mg once daily until disease progression or not tolerated. Severe renal impairment (eGFR 15–29mL/min/1.73m2): 30mg once daily. Concomitant P-gp inhibitors: reduce afatinib daily dose by 10mg if not tolerated; resume previous dose after discontinuing the inhibitor. Concomitant P-gp inducers: increase afatinib daily dose by 10mg as tolerated; resume previous dose 2–3 days after discontinuing the inducer. Dose modifications: see full labeling.


Not established.

Gilotrif Contraindications

Not Applicable

Gilotrif Boxed Warnings

Not Applicable

Gilotrif Warnings/Precautions


Permanently discontinue for life-threatening bullous, blistering, or exfoliative skin lesions, confirmed interstitial lung disease (ILD), severe drug-induced hepatic impairment, GI perforation, persistent ulcerative keratitis, symptomatic left ventricular dysfunction, or severe/intolerable adverse reactions (at dose 20mg/day). Withhold for any Grade ≥3 reactions, prolonged Grade 2 diarrhea lasting for ≥2 consecutive days while taking antidiarrheal, prolonged Grade 2 cutaneous reactions (lasting >7 days) or intolerable, during evaluation of suspected ILD or keratitis, or worsening liver function. Increased risk of GI perforation with increasing age, underlying history of GI ulcer, diverticular disease, or bowel metastases. History of keratitis, ulcerative keratitis, or severe dry eye. Obtain LFTs periodically during treatment. Hepatic impairment: monitor and adjust dose. Renal impairment (eGFR 15–29mL/min/1.73m2): see Adults; (eGFR <15mL/min/1.73m2) or on dialysis: not studied. Embryo-fetal toxicity. Pregnancy: avoid. Advise females of reproductive potential to use effective contraception during and for at least 2 weeks after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Gilotrif Pharmacokinetics

See Literature

Gilotrif Interactions


See Adults. Potentiated by P-gp inhibitors (eg, ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, amiodarone). Antagonized by P-gp inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John’s wort). Increased risk of GI perforation with concomitant corticosteroids, NSAIDs, anti-angiogenic agents.

Gilotrif Adverse Reactions

Adverse Reactions

Diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritus; bullous/exfoliative skin disorders, ILD, hepatotoxicity, GI perforation (may be fatal), keratitis.

Gilotrif Clinical Trials

See Literature

Gilotrif Note

Not Applicable

Gilotrif Patient Counseling

See Literature