Gilotrif (afatinib dimaleate)
Boehringer Ingelheim · Second-Generation EGFR / ErbB Family Inhibitor
What is Gilotrif? Gilotrif (afatinib) is a second-generation, irreversible ErbB family inhibitor by Boehringer Ingelheim approved for first-line treatment of metastatic NSCLC with common EGFR mutations (exon 19 deletions or exon 21 L858R substitutions) and squamous NSCLC after platinum chemotherapy.
About Gilotrif
| Brand Name | Gilotrif |
| Generic / INN | afatinib dimaleate |
| Drug Class | Second-Generation EGFR / ErbB Family Inhibitor |
| Manufacturer | Boehringer Ingelheim |
| Administration | Oral tablet |
| FDA Approval | 2013 |
FDA-Approved Uses for Gilotrif
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Metastatic NSCLC — first-line treatment of patients with common EGFR mutations (exon 19 del or L858R)
- Metastatic squamous cell NSCLC — after platinum-based chemotherapy
How Does Gilotrif Work?
Afatinib irreversibly inhibits all ErbB family kinases — EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4 — by covalently binding to their intracellular kinase domains. This pan-ErbB inhibition distinguishes afatinib from first-generation reversible EGFR inhibitors (gefitinib, erlotinib).
Dosage & Administration
40 mg orally once daily on an empty stomach (no food 3 hours before or 1 hour after). Dose escalation to 50 mg if 40 mg tolerated. Dose reduction to 30 mg for toxicity. Avoid strong P-gp inhibitors (taken with meals increases absorption significantly).
Warnings, Precautions & Side Effects
General Warning
Diarrhea — can be severe; proactive management required. Dermatologic reactions (rash, acneiform dermatitis, paronychia). ILD/pneumonitis — can be fatal. Hepatic toxicity — monitor LFTs. Keratitis. Embryo-fetal toxicity. Left ventricular dysfunction.
Common Side Effects
- Diarrhea (very common)
- Acneiform rash
- Paronychia
- Dry skin
- Mucositis/stomatitis
- Nausea
- Decreased appetite
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Store below 25°C (77°F). Protect from high humidity and light. Keep in original bottle with desiccant.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Gilotrif is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Gilotrif. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Gilotrif
Gilotrif (afatinib) is a second-generation, irreversible pan-ErbB inhibitor approved for EGFR exon 19 del/L858R NSCLC (first-line) and squamous NSCLC after platinum chemotherapy.
Afatinib irreversibly and covalently inhibits all ErbB family members (EGFR, HER2, ErbB3, ErbB4), while gefitinib and erlotinib are reversible EGFR-selective inhibitors. Afatinib shows particular benefit in certain EGFR mutations uncommon in the L858R/exon 19 population.
Diarrhea is the most common and often dose-limiting side effect. Proactive management with loperamide from the onset of loose stools is strongly recommended.
Related Medications & Conditions
Related Medications
Tagrisso (osimertinib) · Rybrevant (amivantamab) · Brigatinib (Alunbrig — ALK) · Erlotinib (Tarceva)
Related Conditions
EGFR-mutant NSCLC · Squamous cell NSCLC · Non-small cell lung cancer