XOVOLTIB (Afatinib) 50mg is indicated for the 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.
Limitation of Use: Safety and efficacy of XOVOLTIB (Afatinib) 50mg have not been established in patients whose tumors have resistant EGFR mutations
XOVOLTIB (Afatinib) 50mg is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum‑based chemotherapy.
XOVOLTIB DOSAGE AND ADMINISTRATION
The recommended dose of XOVOLTIB is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.
Severe Renal Impairment The recommended dose of XOVOLTIB in patients with severe renal impairment (estimated glomerular filtration rate [eGFR* ] 15 to 29 mL/min /1.73 m2 ) is 30 mg orally, once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
* Use the Modification of Diet in Renal Disease [MDRD] formula to estimate eGFR.
Take XOVOLTIB at least 1 hour before or 2 hours after a meal.
Do not take a missed dose within 12 hours of the next dose.
XOVOLTIB Side Effect:
1.Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold Lucifa (Xovoltib) for severe and prolonged diarrhea not responsive to antidiarrheal agents.
2.Bullous and exfoliative skin disorders: Severe bullous, blistering, and exfoliating lesions occurred in 0.2% of patients. Discontinue for life threatening cutaneous reactions. Withhold LUCIFA (GILOTRIF) for severe and prolonged cutaneous reactions.
3.Interstitial lung disease (ILD): Occurs in 1.6% of patients. Withhold LUCIFA (GILOTRIF) for acute onset or worsening of pulmonary symptoms. Discontinue LUCIFA (GILOTRIF) if ILD is diagnosed.
4.Hepatic toxicity: Fatal hepatic impairment occurs in 0.2% of patients. Monitor with periodic liver testing. Withhold or discontinue LUCIFA (GILOTRIF) for severe or worsening liver tests.
5.Keratitis: Occurs in 0.7% of patients. Withhold LUCIFA (GILOTRIF) for keratitis evaluation. Withhold or discontinue LUCIFA (GILOTRIF) for confirmed ulcerative keratitis.