Guidelines for Use
Approval requires a diagnosis of non-small cell lung cancer (NSCLC) and one of the following:
- The patient has metastatic NSCLC that has progressed after platinum-based chemotherapy.
- The medication is being requested as first line treatment for tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Rationale
Promote appropriate utilization of AFATINIB (Gilotrif) based on its FDA approved indications.
Indications for Use
- Gilotrif is a kinase inhibitor 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.
Limitation of Use: Safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations.
- Gilotrif is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
The recommended dose of Gilotrif is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take Gilotrif at least 1 hour before or 2 hours after a meal. Do not take a missed dose within 12 hours of the next dose.
Withhold Gilotrif for any drug-related adverse reactions of:
- National Cancer Institute Common Terminology Criteria for Adverse Events Grade 3 or higher
- Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking anti-diarrheal medication
- Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable
- Renal dysfunction of Grade 2 or higher
Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute Gilotrif at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.
Permanently discontinue Gilotrif for:
- Life-threatening bullous, blistering, or exfoliative skin lesions
- Confirmed interstitial lung disease (ILD)
- Severe drug-induced hepatic impairment
- Persistent ulcerative keratitis
- Symptomatic left ventricular dysfunction
- Severe or intolerable adverse reaction occurring at a dose of 20 mg per day
References
Gilotrif [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. January 2018.