• First-line treatment of metastatic non-small cell lung cancer (NSCLC) where the tumor has non-resistant epidermal growth factor receptor (EGFR) mutations.
• Treatment of metastatic squamous NSCLC progressing after platinum chemotherapy.

Contraindicated in:

• Tumors with resistant EGFR mutations
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Concurrent use of corticosteroids, NSAIDs, or antiangiogenic drugs, history of GI ulceration, history of diverticular disease, or history of bowel metastases (↑ risk of GI perforation)
• Severe renal impairment (↓ dose)
• Severe hepatic impairment (dose adjustment may be necessary)
• Asian ethnicity (may be ↑ susceptible to interstitial lung disease)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: ↑ risk of GI perforation in older adults.

Derm: cutaneous reactions (including bullous/blistering/exfoliating reactions, acneiform eruptions and palmar-plantar erythrodysesthesia), dry skin, paronychia, pruritus, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

EENT: conjunctivitis, epistaxis, keratitis, rhinorrhea.

F and E: hypokalemia.

GI: ↓ appetite, ↓ weight, diarrhea, nausea, stomatitis, vomiting, GI PERFORATION, HEPATOTOXICITY, PANCREATITIS.

Resp: INTERSTITIAL LUNG DISEASE (ILD).

Misc: fever.

Drug-Drug:

• P-glycoprotein (P-gp) inhibitors, including amiodarone, cyclosporine, erythromycin, itraconazole, ketoconazole, quinidineritonavir, tacrolimus, or verapamil, may ↑ levels and risk of toxicity; dosage adjustment may be necessary (ritonavir may be given concurrently or 6 hr after).
• P-gp inducers, including carbamazepine, phenobarbital, phenytoin, or rifampin may ↓ levels and effectiveness; dosage adjustment may be necessary.

• Tablets: 20 mg; 30 mg; 40 mg;

• PO (Adults): 40 mg once daily until disease progression or unacceptable toxicity. Concurrent use of P-gp inhibitors: ↓ dose by 10 mg/day if necessary. Concurrent use of P-gp inducers: ↑ dose by 10 mg/day if necessary.

Gilotrif

• Inhibits tyrosine kinases which results in slowed proliferation of specific tumor cell lines.

• Decreased spread of NSCLC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: Well absorbed (92%) following oral administration; absorption is ↓ by high-fat meal.

Distribution: Unknown.

Metabolism/Excretion: Metabolites occur partly as protein-bound products. Excretion is primarily fecal (85%) as parent drug; 4% excreted in urine.

Half-life: 37 hr.

Giotrif

(improved progression-free survival)

• Instruct patient to take afatinib as directed. Take missed dose as soon as remembered unless within 12 hr of next dose, then omit and take next dose at scheduled time; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Caution patient to notify health care professional if signs and symptoms of keratitis (acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye) occur. Withhold if symptoms occur; if ulcerative keratitis is confirmed, discontinue afatinib. Advise patient that use of contact lenses is also a risk factor.
• Advise patient to wear sunscreen and protective clothing during therapy to minimize risk of skin disorders.
• Inform patient that diarrhea occurs in most patients and may cause dehydration and renal impairment. Notify health care professional if diarrhea is severe or persistent, if new or worsening lung symptoms (difficulty breathing, shortness of breath, cough, fever), symptoms of liver problems (yellow skin or whites of eyes, dark brown urine, pain on right side of abdomen, unusual bleeding or bruising, lethargy), severe abdominal pain, or if symptoms of left ventricular dysfunction (shortness of breath, exercise intolerance, cough, fatigue, swelling or ankles or feet, palpitations, sudden weight gain) occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May be teratogenic. Advise females of reproductive potential to use highly effective contraception and to avoid breast feeding during and for at least 2 wk after last dose. If pregnancy occurs, instruct patient to notify health care professional immediately. May impair fertility in males and females.

a-FA-ti-nib

NDC Code^*

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0137- Gilotrif
    • 0597-0137-30- 1 BOTTLE in 1 CARTON (0597-0137-30) > 30 TABLET, FILM COATED in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0137- Gilotrif
    • 0597-0137-90- 1 BOTTLE in 1 CARTON (0597-0137-90) > 30 TABLET, FILM COATED in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0138- Gilotrif
    • 0597-0138-30- 1 BOTTLE in 1 CARTON (0597-0138-30) > 30 TABLET, FILM COATED in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0138- Gilotrif
    • 0597-0138-95- 1 BOTTLE in 1 CARTON (0597-0138-95) > 30 TABLET, FILM COATED in 1 BOTTLE

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0141- Gilotrif
    • 0597-0141-30- 1 BOTTLE in 1 CARTON (0597-0141-30) > 30 TABLET, FILM COATED in 1 BOTTLE