Afatinib
Afatinib is a kinase inhibitor (a targeted cancer medicine) used to treat certain types of metastatic non-small cell lung cancer (NSCLC), including EGFR mutation-positive tumors and squamous NSCLC that has progressed after platinum-based chemotherapy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Afatinib (Gilotrif) is a targeted medicine for non-small cell lung cancer that has spread, permanently blocking EGFR, HER2 and HER4 growth signals. Available since about 2013 and now as a generic, it is a first-line option for tumors with certain EGFR mutations and also treats squamous lung cancer after platinum chemotherapy. It is tougher to tolerate than some other EGFR medicines, and most people notice diarrhea and an acne-like rash, plus mouth sores or nail infections. The thing to watch is diarrhea, so start loperamide at the first loose stool and call your care team if it persists, because the dehydration it causes can damage the kidneys and has proved fatal.
Clinical pearls
- Take it on an empty stomach, at least 1 hour before or 2 hours after eating, because food cuts absorption.
- If your next dose is less than 12 hours away, skip the missed one rather than doubling up.
- Ritonavir, cyclosporine, verapamil, amiodarone, rifampicin, carbamazepine and St. John's wort all change afatinib levels, so tell every prescriber you take it.
- Check before using ibuprofen, naproxen or steroids, which raise the risk of a hole in the digestive tract with afatinib.
Patient information guide A plain-language walkthrough of Afatinib, written from its FDA label.
What Afatinib is used for
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Afatinib treats certain types of metastatic non-small cell lung cancer (NSCLC).
- First-line treatment of metastatic NSCLC whose tumors have non-resistant EGFR mutations, as detected by an FDA-approved test (Gilotrif and afatinib tablets). The afatinib tablets label names exon 19 deletions and exon 21 (L858R) substitutions.
- Metastatic squamous NSCLC that has progressed after platinum-based chemotherapy (Gilotrif and afatinib tablets).
- Safety and effectiveness have not been established for tumors with resistant EGFR mutations.
How Afatinib works
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Afatinib is a kinase inhibitor. It attaches permanently to EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4), which are proteins that send growth signals inside cells. This turns down their signaling.
Certain EGFR mutations keep the receptor overactive and help lung cancer cells multiply. Blocking that signal helps slow tumor growth.
Afatinib dosage
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Afatinib is taken by mouth as a tablet once daily, at least 1 hour before or 2 hours after a meal. Treatment continues until the disease progresses or you can't tolerate it. Your prescriber may adjust the dose for side effects, kidney function or interacting medicines.
- Do not take a missed dose within 12 hours of your next dose.
- Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Afatinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Non-resistant EGFR mutation-positive metastatic NSCLC (first-line treatment); recommended dosage
- 40 mg orally once daily until disease progression or no longer tolerated by the patient
- Take at least 1 hour before or 2 hours after a meal; do not take a missed dose within 12 hours of the next dose
- Pre-existing severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2)
- 30 mg orally once daily
- Use the MDRD formula to estimate eGFR
- Adverse reactions (Grade 3 or higher; Grade 2 diarrhea persisting 2 or more consecutive days on anti-diarrheal medication; Grade 2 cutaneous reactions lasting more than 7 days or intolerable)
- Withhold
- Resume when the reaction fully resolves, returns to baseline, or improves to Grade 1, at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred
- Permanently discontinue for a severe or intolerable adverse reaction occurring at a dose of 20 mg per day
- Patients requiring therapy with a P-glycoprotein (P-gp) inhibitor
- Reduce daily dose by 10 mg if not tolerated
- Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated
- Patients requiring chronic therapy with a P-gp inducer
- Increase daily dose by 10 mg as tolerated
- Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Recommended dosage : 40 mg orally once daily ( 2.2 ) • Renal impairment : 30 mg orally once daily in patients with severe renal impairment ( 2.4 , 8.6 , 12.3 ) • Instruct patients to take afatinib tablets at least 1 hour before or 2 hours after a meal ( 2.2 ) 2.1 Patient Selection for Non-Resistant EGFR Mutation-Positive Metastatic NSCLC Select patients for first-line treatment of metastatic NSCLC with afatinib tablets based on the presence of non-resistant EGFR mutations in tumor specimens [ see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.1 )]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of afatinib tablets is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take afatinib tablets at least 1 hour before or 2 hours after a meal. Do not take a missed dose within 12 hours of the next dose. 2.3 Dosage Modifications for Adverse Reactions Withhold afatinib tablets for: • Grade* 3 or higher adverse reactions • Diarrhea of Grade 2 persisting for 2 or more consecutive days while taking anti-diarrheal medication [ see Warnings and Precautions ( 5.1 ) ] • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable [ see Warnings and Precautions ( 5.2 ) ] *National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v 3.0 Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute afatinib tablets at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Afatinib side effects
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The most common side effects are:
Common side effects
- Diarrhea
- Rash or acne-like skin reaction
- Mouth sores or inflammation (stomatitis)
- Nail infection around the nail (paronychia)
- Dry skin
- Itching
- Decreased appetite
- Nausea and vomiting
When to get medical help
- Call your doctor right away for severe or ongoing diarrhea, especially if it doesn't improve with anti-diarrheal medicine, because it can cause dehydration and kidney problems.
- Get help for severe blistering, peeling or exfoliating skin, which can be life-threatening.
- Report new or worsening cough, shortness of breath or other lung symptoms, which could signal interstitial lung disease.
- Tell your doctor about signs of liver problems; liver tests are done regularly during treatment.
- Seek urgent care for severe stomach pain, which could signal a perforation (a hole) in the digestive tract.
- Report eye redness, pain, tearing, light sensitivity or blurred vision, which could be keratitis (inflamed cornea).
- Tell your doctor about heart-related symptoms, since left ventricular dysfunction may require stopping treatment.
Afatinib warnings and precautions
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- Diarrhea: can cause dehydration and kidney problems, and some cases were fatal.
- Severe skin reactions: including blistering, peeling, toxic epidermal necrolysis and Stevens-Johnson syndrome.
- Interstitial lung disease: occurred in 1.6% of patients in trials, and some cases were fatal. It appeared more often in Asian patients.
- Liver toxicity: periodic liver tests are needed.
- Digestive tract perforation: risk may be higher with corticosteroids, NSAIDs, anti-angiogenic drugs, older age, ulcers, diverticular disease or bowel metastases.
- Keratitis: use caution with a history of keratitis or severe dry eye, or if you wear contact lenses.
- Pregnancy: can cause fetal harm.
Afatinib interactions
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Some medicines change afatinib levels in your body.
- P-gp inhibitors (ritonavir, cyclosporine, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, amiodarone) can raise afatinib exposure.
- P-gp inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort) can lower afatinib exposure.
- Corticosteroids, NSAIDs and anti-angiogenic drugs may raise perforation risk.
- Food, especially a high-fat meal, lowers absorption.
Interactions listed in the FDA-approved label
From the Afatinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone): Concomitant taking can increase exposure to afatinib. Reduce afatinib by 10 mg per day if not tolerated; resume the previous dose after the inhibitor is discontinued as tolerated.
- P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort): Concomitant taking can decrease exposure to afatinib. Increase afatinib by 10 mg per day as tolerated; resume the previous dose 2 to 3 days after the inducer is discontinued.
Read the label’s full interactions text
7 DRUG INTERACTIONS Effect of P-glycoprotein (P-gp) Inhibitors and Inducers Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with afatinib can increase exposure to afatinib [ see Clinical Pharmacology ( 12.3 ) ]. Reduce afatinib daily dose as recommended [ see Dosage and Administration ( 2.5 ) ]. Concomitant taking of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with afatinib can decrease exposure to afatinib [see Clinical Pharmacology ( 12.3 ) ]. Increase afatinib daily dose as recommended [s ee Dosage and Administration ( 2.5 ) ]. • P-glycoprotein (P-gp) Inhibitors : Co-administration of P-gp inhibitors can increase afatinib exposure. Reduce afatinib by 10 mg per day if not tolerated. ( 2.5 , 7 ) • P-gp Inducers : Co-administration of chronic P-gp inducers orally can decrease afatinib exposure. Increase afatinib by 10 mg per day as tolerated. ( 2.5 , 7 )
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Afatinib
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- Pregnancy: afatinib can harm a fetus. Use effective contraception during treatment and for at least 2 weeks after the last dose.
- Breastfeeding: do not breastfeed during treatment and for 2 weeks after the last dose.
- Fertility may be reduced in women and men.
- Severe kidney impairment: a lower dose is used.
- History of keratitis, severe dry eye or contact lens use: use caution.
- Children: safety and effectiveness have not been established.
- No contraindications are listed on the label.
Afatinib overdose
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In the label's report, two healthy adolescents took a very large amount of Gilotrif as part of a mixed-drug ingestion. They had nausea, vomiting, weakness, dizziness, headache, abdominal pain and raised amylase. If you suspect an overdose, seek medical help or call poison control right away.
What Afatinib does in the body
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Afatinib reduces signaling through EGFR, HER2 and HER4, which slows growth of cells driven by those pathways. In a study of people with advanced solid tumors, it did not cause large changes in the QTc interval, a measure of heart rhythm timing.
How your body processes Afatinib
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After you swallow afatinib, blood levels peak in about 2 to 5 hours. A high-fat meal lowers absorption, which is why it's taken away from meals. Steady levels build within about 8 days, and the half-life is about 37 hours.
Very little is broken down by enzymes. Most is cleared in the stool, with a small amount in urine. Levels are higher in people with moderate or severe kidney impairment.
How to store Afatinib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . protect from exposure to high humidity and light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Afatinib
54 supplements and herbal products have documented interactions with Afatinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 35
- Minor · 17
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Afatinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Afatinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is afatinib used for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor?
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Can I take other medicines with it?
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Is it safe in pregnancy?
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Is Afatinib available over the counter?
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When was Afatinib first available?
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Who makes Afatinib?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Afatinib on HelloPharmacist
Afatinib forms and strengths (how it comes)
Afatinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Gilotrif is used for first-line treatment of metastatic NSCLC with non-resistant EGFR mutations.
- Gilotrif is used for metastatic squamous NSCLC that progressed after platinum-based chemotherapy.
- Afatinib tablets are used for first-line treatment of metastatic NSCLC with non-resistant EGFR mutations.
- Afatinib tablets are used for metastatic squamous NSCLC that progressed after platinum-based chemotherapy.
- Gilotrif is taken by mouth once daily, at least 1 hour before or 2 hours after a meal.
- Afatinib tablets are taken by mouth once daily, at least 1 hour before or 2 hours after a meal.
- Gilotrif: do not take a missed dose within 12 hours of the next dose.
- Afatinib tablets: do not take a missed dose within 12 hours of the next dose.
Afatinib on the U.S. market: products, makers and brands
How Afatinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 6 Afatinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Gilotrif; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Afatinib is used (Medicaid data)
A general measure of how commonly Afatinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Afatinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Afatinib prescribed? Of the 1,601 medications we measure, Afatinib ranks #1,572 by Medicaid prescriptions — more than 2% of them.
Utilization by Afatinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
afatinib 40 MG Oral Tablet Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1430455
afatinib 20 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1430446
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Afatinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 3 listed Afatinib NDCs with Medicaid activity.
Compare Afatinib products
A representative set of FDA-listed product records for Afatinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 20 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| 30 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| 40 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| 20 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Afatinib NDCs →
Afatinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Afatinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Afatinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Afatinib FDA approval history
How Afatinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Afatinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Afatinib recalls since July 2021.
✅No Afatinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1430438 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1430445In current FDA listings
Look up RxCUI 1430438 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Afatinib supply and shortage status
Whether Afatinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Afatinib brand names
Afatinib is sold under one brand name in the FDA directory — Gilotrif. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Afatinib: manufacturers and labelers
2 companies list Afatinib products with the FDA. By number of product records, the largest are Boehringer Ingelheim Pharmaceuticals, Inc., Camber Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Afatinib drug class (RxNorm)
Afatinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Afatinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Boehringer Ingelheim Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →