Dacomitinib
Dacomitinib is a targeted cancer medicine used as a first-line treatment for metastatic non-small cell lung cancer with specific 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: Patient Information Guide
A plain-language walkthrough of Dacomitinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Dacomitinib is a targeted cancer medicine approved for a specific type of advanced lung cancer. Below is the full set of supported uses based on the available product evidence.
- Vizimpro is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors carry an EGFR exon 19 deletion or exon 21 L858R substitution mutation, as confirmed by an FDA-approved diagnostic test
⚙️How it works▾
Dacomitinib is an irreversible kinase inhibitor — it permanently binds to and shuts off a group of proteins called the EGFR (epidermal growth factor receptor) family, specifically HER1, HER2, and HER4. In certain lung cancers, mutations in the EGFR gene cause these proteins to be constantly switched on, driving uncontrolled tumor growth. By blocking these mutated proteins, dacomitinib disrupts the signals cancer cells use to grow and divide.
Because dacomitinib binds irreversibly, it stays locked onto its targets rather than detaching and reattaching. This permanent blockade is key to its effectiveness against EGFR-mutated tumors.
💊How it's taken▾
Vizimpro tablets are taken once daily by mouth, with or without food — food does not meaningfully affect how the medicine works. It should be taken at the same time each day. If a dose is missed or vomited, skip it and continue with the next scheduled dose; never take a double dose to make up for one missed.
- Avoid proton pump inhibitors (PPIs) — they reduce dacomitinib levels; use antacids or an H2-blocker as an alternative
- If using an H2-blocker, take Vizimpro at least 6 hours before or 10 hours after the H2-blocker dose
- Your doctor may reduce or pause your dose if certain side effects occur; follow their instructions exactly
🤒Side effects — in detail▾
Most people taking Vizimpro experience some side effects. The most common ones include:
- Diarrhea — very common; can be severe and needs prompt treatment
- Skin rash or acne-like breakouts
- Paronychia (painful nail and skin infections around the nails)
- Mouth sores (stomatitis)
- Decreased appetite and weight loss
- Dry skin
- Hair loss (alopecia)
- Itching (pruritus)
- Conjunctivitis (red, irritated eyes)
- Nausea and fatigue (asthenia)
Contact your doctor right away if you develop severe or persistent diarrhea, difficulty breathing, a worsening cough, fever, or severe skin reactions such as blistering or peeling — these can be signs of serious complications requiring prompt attention.
⚠️Warnings & precautions▾
- Interstitial lung disease (ILD): A serious, potentially fatal inflammation of the lungs occurred in a small number of patients. If you develop new or worsening shortness of breath, cough, or fever, contact your doctor immediately. Vizimpro must be permanently stopped if ILD is confirmed.
- Severe diarrhea: Diarrhea was very common and was life-threatening in rare cases. Start anti-diarrheal medicine at the first sign and contact your care team if it doesn't improve quickly.
- Skin reactions: Rash and skin peeling were common and sometimes severe. Sun exposure worsens these reactions — use sunscreen and protective clothing from the start of treatment. Moisturizers and topical treatments can help manage milder rash early on.
- Embryo-fetal toxicity: Dacomitinib can cause serious harm or loss of a pregnancy. Women who could become pregnant must use effective contraception during treatment and for at least 17 days after the last dose. Pregnancy status should be confirmed before starting therapy.
🔀What it interacts with▾
Vizimpro can interact with certain medicines in clinically important ways. Key interactions to know about:
- Proton pump inhibitors (PPIs) — such as omeprazole, lansoprazole, and pantoprazole — reduce dacomitinib absorption and can make Vizimpro less effective; avoid using them together
- H2-receptor antagonists — such as famotidine — also affect absorption; if needed, take Vizimpro at least 6 hours before or 10 hours after the H2-blocker
- CYP2D6 substrates — medicines broken down by the CYP2D6 liver enzyme (certain antidepressants, antipsychotics, and heart medicines) — dacomitinib raises their blood levels, which could increase the risk of their side effects; your doctor may need to avoid or adjust those medicines
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Vizimpro can harm or end a pregnancy — confirm you are not pregnant before starting, use effective contraception during treatment, and for at least 17 days afterward
- Breastfeeding: Do not breastfeed during treatment or for at least 17 days after the last dose, as the medicine could harm a nursing infant
- Children: Safety and effectiveness in patients under 18 have not been established
- Older adults (65+): More likely to experience severe side effects, need dose pauses, or need to stop treatment — your care team will monitor you closely
- Lung or breathing problems: Tell your doctor about any prior history of lung disease or breathing issues before starting
- Mild to moderate kidney impairment: No dose adjustment is needed; the recommended dose has not been established for severe kidney impairment
- All other medicines: Share a complete list of all your medicines — including heartburn drugs, supplements, and over-the-counter products — with your doctor and pharmacist before starting
📡Pharmacodynamics — effects in the body▾
At the doses used clinically, Vizimpro does not cause a large or dangerous effect on the heart's electrical rhythm (specifically, the QTc interval). However, higher drug exposures are linked to a greater chance of serious skin reactions and diarrhea, so your doctor may adjust your dose based on how your body responds.
🔬Pharmacokinetics — how your body processes it▾
After swallowing a Vizimpro tablet, about 80% of the drug is absorbed into the bloodstream, with peak levels reached around 6 hours after a dose. Food does not meaningfully change how much is absorbed. Dacomitinib has a long half-life of about 70 hours — meaning it takes nearly three days for the body to clear half a dose — and it takes roughly two weeks of daily dosing to reach stable levels in the blood. The liver is the main route of processing, primarily through the CYP2D6 enzyme, and most of the drug leaves the body through the stool.
📦How to store it▾
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 Dacomitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.
🩺 Pharmacist Counseling Corner
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 exactly is Vizimpro used for? ▾
How do I take this medication, and does it matter if I take it with food? ▾
What side effects should I be prepared for? ▾
When should I call my doctor or go to the hospital right away? ▾
Can I take my regular heartburn medicine while on Vizimpro? ▾
Is this medicine safe if I'm pregnant or trying to get pregnant? ▾
Is Dacomitinib available over the counter? ▾
When was Dacomitinib first available? ▾
Who makes Dacomitinib? ▾
💬 Answers drafted from Dacomitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Dacomitinib 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.
Tablet
How this form is used
- Vizimpro tablets are indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have an EGFR exon 19 deletion or exon 21 L858R substitution mutation, confirmed by an FDA-approved test
- Vizimpro tablets are taken by mouth once daily, with or without food
- Take Vizimpro at the same time each day
- If you vomit after a dose or miss a dose, skip it and take the next dose at the regular scheduled time — do not take an extra dose
- Avoid proton pump inhibitors (PPIs) while taking Vizimpro; if you need an H2-blocker for heartburn, take Vizimpro at least 6 hours before or 10 hours after the H2-blocker
📊 Dacomitinib across the U.S. market
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.
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 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 × 4 listings | NDA | View NDC → |
| 30 mg | Oral | Pfizer Laboratories Div Pfizer Inc × 4 listings | NDA | View NDC → |
| 45 mg | Oral | Pfizer Laboratories Div Pfizer Inc × 4 listings | NDA | View NDC → |
| 15 mg | Oral | U.S. Pharmaceuticals × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Pfizer Ireland Pharmaceuticals Unlimited Company | BULK INGREDIENT | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Dacomitinib NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Dacomitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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
-
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.