Dacomitinib
Dacomitinib is a targeted kinase inhibitor pill used as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) with certain EGFR gene mutations.
🧬 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 1 clinical label set 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 →
Dacomitinib (Vizimpro) is a once-daily first treatment for metastatic non-small cell lung cancer with an EGFR exon 19 deletion or L858R mutation; it permanently blocks the EGFR family of proteins that can drive tumor growth and, on the U.S. market since the late 2010s, is one of several EGFR options rather than the usual first pick. Most people get diarrhea and rash, and sore nail folds and mouth sores are common, so it is tougher to tolerate than some other EGFR medicines. Call right away for new or worsening shortness of breath, cough or fever, which can signal interstitial lung disease, an uncommon but sometimes fatal lung inflammation.
Clinical pearls
- Avoid PPIs like omeprazole; with an H2 blocker like famotidine, take Vizimpro at least 6 hours before or 10 hours after.
- Keep an anti-diarrhea medicine at home and start it at the first loose stool, as your oncology team directs.
- Begin moisturizer and sun protection on day one, since sunlight makes the rash from this drug worse.
- It raises levels of drugs cleared by the CYP2D6 enzyme, so have every new prescription checked against it.
Patient information guide A plain-language walkthrough of Dacomitinib, written from its FDA label.
What Dacomitinib is used for
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Dacomitinib is used for one cancer type:
- Vizimpro (oral tablet) is used as first-line treatment of metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation, detected by an FDA-approved test.
How Dacomitinib works
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Dacomitinib is a kinase inhibitor. It irreversibly blocks the EGFR family of proteins (EGFR/HER1, HER2 and HER4), including certain EGFR mutations that drive tumor growth.
In lab and animal studies, it slowed the growth of tumors driven by these proteins.
Dacomitinib dosage
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Vizimpro is a tablet taken by mouth once a day, at the same time each day, with or without food. Treatment continues until the cancer progresses or side effects become unacceptable.
- If you vomit or miss a dose, do not take extra or make it up.
- Your doctor may pause treatment or lower your dose if side effects occur.
- Follow your prescriber and the label for your exact dose.
Dosing details from the FDA-approved label
From the Dacomitinib 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.
- First-line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutation
- 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs
- With or without food
- Take at the same time each day
- If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose; continue with the next scheduled dose
- Dose reductions for adverse reactions
- First dose reduction 30 mg once daily
- Second dose reduction 15 mg once daily
- Interstitial lung disease (any grade): permanently discontinue. Grade 2 diarrhea or dermatologic reactions: withhold until recovery to Grade 1 or less, then resume at the same dose level (reduced dose if recurrent). Grade 3 or 4 diarrhea or dermatologic reactions: withhold until Grade 1 or less, then resume at reduced dose
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended Dosage: 45 mg orally once daily with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens. 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 VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. VIZIMPRO can be taken with or without food [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . Take VIZIMPRO the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions Reduce the dose of VIZIMPRO for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2. Table 1. VIZIMPRO Recommended Dose Reductions for Adverse Reactions Dose Level Dose (Once Daily) First dose reduction 30 mg Second dose reduction 15 mg Table 2. VIZIMPRO Dosage Modifications for Adverse Reactions Adverse Reaction Severity National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03. Dosage Modification Interstitial lung disease (ILD) [see Warnings and Precautions (5.1) ] Any Grade • Permanently discontinue VIZIMPRO. Diarrhea [see Warnings and Precautions (5.2) ] Grade 2 • Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at the same dose level. • For recurrent Grade 2 diarrhea, withhold until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose. Grade 3 or 4 • Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose. Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Grade 2 • Withhold VIZIMPRO for persistent dermatologic adverse reactions; upon recovery to less than or equal to Grade 1, resume VIZIMPRO at the same dose level. • For recurrent persistent Grade 2 dermatologic adverse reactions, withhold until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dacomitinib side effects
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The most common side effects are:
Common side effects
- Diarrhea
- Rash
- Paronychia (nail-fold infection or inflammation)
- Stomatitis (mouth sores and inflammation)
- Decreased appetite
- Dry skin
- Weight loss
- Hair loss, cough and itching
When to get medical help
- Call your doctor right away if you have new or worsening shortness of breath, cough or fever. These can be signs of interstitial lung disease (ILD), a serious and sometimes fatal lung problem.
- Tell your care team promptly about diarrhea. It can be severe or even fatal, and it needs anti-diarrheal treatment early.
- Report severe rash, peeling or blistering skin, or a rash that does not go away. Serious skin reactions can happen.
- Contact your doctor if you think you may be pregnant while taking this medicine.
Dacomitinib warnings and precautions
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- Interstitial lung disease (ILD): can be severe or fatal. Worsening breathlessness, cough or fever needs prompt attention. Treatment is permanently stopped if ILD is confirmed.
- Diarrhea: very common and sometimes severe or fatal. Anti-diarrheal treatment should start promptly, and the drug may be paused or reduced.
- Skin reactions: rash and peeling skin can occur and may worsen with sun. Use moisturizers and limit sun exposure from the start.
- Pregnancy: can cause fetal harm.
Dacomitinib interactions
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Some medicines change how Vizimpro works, or how it affects other drugs.
- PPIs (acid reducers): lower dacomitinib levels and may reduce its effect, so avoid them.
- Locally-acting antacids: an alternative to PPIs.
- H2-receptor antagonists: take Vizimpro at least 6 hours before or 10 hours after them.
- CYP2D6 substrates: dacomitinib raises their levels, which may increase their toxicity. Avoid when small increases could be dangerous.
Interactions listed in the FDA-approved label
From the Dacomitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Proton pump inhibitors (PPIs): Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid concomitant use of PPIs with VIZIMPRO; as an alternative use locally-acting antacids.
- H2-receptor antagonists: The label gives H2-receptor antagonists as an alternative to PPIs, with timing of administration specified. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist.
- CYP2D6 substrates: Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates, which may increase the risk of toxicities of these drugs. Avoid concomitant use with CYP2D6 substrates where minimal increases in concentration may lead to serious or life-threatening toxicities.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Proton Pump Inhibitors (PPIs): Avoid use with VIZIMPRO; use locally-acting antacids or H2-receptor antagonist; administer VIZIMPRO at least 6 hours before or 10 hours after H2-receptor antagonist. ( 2.4 , 7.1 ) • CYP2D6 Substrates: Avoid concomitant use with VIZIMPRO where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities. ( 7.2 ) 7.1 Effect of Other Drugs on VIZIMPRO Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . 7.2 Effect of VIZIMPRO on CYP2D6 Substrates Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates [see Clinical Pharmacology (12.3) ] which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.
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 Dacomitinib
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- Your tumor must have a qualifying EGFR mutation.
- Pregnancy status should be checked before starting. Use effective contraception during treatment and for at least 17 days after the last dose.
- Do not breastfeed during treatment and for at least 17 days after the last dose.
- Safety in children has not been established.
- Adults 65 and older had more serious side effects and more treatment stops.
- No dose change is recommended for mild or moderate kidney impairment.
What Dacomitinib does in the body
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In a study of 32 patients with advanced NSCLC, dacomitinib had no large effect on the heart's QT interval (an electrical timing measure on an ECG). Higher drug levels were linked to a greater chance of severe skin problems and diarrhea.
How your body processes Dacomitinib
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About 80% of dacomitinib is absorbed after you swallow it, and a high-fat meal does not meaningfully change this. It reaches peak levels about 6 hours after a dose. Its half-life is about 70 hours, and steady levels build up within 14 days. The liver breaks it down, and most of it leaves in the stool.
How to store Dacomitinib
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Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dacomitinib
20 supplements and herbal products have documented interactions with Dacomitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 10
- Minor · 9
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.
Dacomitinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dacomitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Vizimpro for?
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How do 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 heartburn medicine with it?
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What about pregnancy and breastfeeding?
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Is Dacomitinib available over the counter?
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When was Dacomitinib first available?
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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 Dacomitinib on HelloPharmacist
Dacomitinib forms and strengths (how it comes)
Dacomitinib 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Dacomitinib inactive ingredients by manufacturer.
Tablet
How this form is used
- Vizimpro is used as first-line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations.
- Vizimpro is taken by mouth once daily at the same time each day.
- Vizimpro can be taken with or without food.
- If you vomit or miss a dose of Vizimpro, do not take an extra dose or make it up.
Dacomitinib on the U.S. market: products, makers and brands
How Dacomitinib 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.
1 company lists 3 Dacomitinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2016. Brand names on the directory include Vizimpro; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Dacomitinib products
A representative set of FDA-listed product records for Dacomitinib — 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 | ||||
| 15 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 30 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 45 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Dacomitinib NDCs →
Dacomitinib 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 Dacomitinib — 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 Dacomitinib 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.
Dacomitinib FDA approval history
How Dacomitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dacomitinib 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 Dacomitinib recalls since July 2021.
✅No Dacomitinib 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 2058849 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2058914In current FDA listings
Look up RxCUI 2058849 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.
Dacomitinib supply and shortage status
Whether Dacomitinib 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.
Dacomitinib brand names
Dacomitinib is sold under one brand name in the FDA directory — Vizimpro. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dacomitinib: manufacturers and labelers
One company lists Dacomitinib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dacomitinib drug class (RxNorm)
Dacomitinib belongs to the Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors 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 Dacomitinib 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. Pfizer Laboratories Div Pfizer 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 →