Respiratory and thoracic cancers:

Indications for: GILOTRIF

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.

Adult Dosage:

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.

Children Dosage:

Not established.

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 Classification:

Tyrosine kinase inhibitor.

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.

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.

Generic Drug Availability:


How Supplied: