Trametinib
Trametinib (Mekinist) is a targeted cancer medicine used to treat certain melanoma, non-small cell lung cancer, anaplastic thyroid cancer, low-grade glioma, and other solid tumors that carry a specific BRAF gene mutation.
🧬 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 →
📖 Trametinib: Patient Information Guide
A plain-language walkthrough of Trametinib — 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▾
Trametinib (Mekinist) is a targeted cancer medicine approved for several BRAF V600E or V600K mutation-positive cancers. A confirmed mutation is required before starting treatment.
- Mekinist as a single agent: unresectable or metastatic melanoma in patients who have not previously received a BRAF inhibitor
- Mekinist with dabrafenib: unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Mekinist with dabrafenib: adjuvant (post-surgery) treatment of melanoma with lymph node involvement, following complete tumor removal
- Mekinist with dabrafenib: metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation
- Mekinist with dabrafenib: locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600E mutation, when no satisfactory local treatment options exist
- Mekinist with dabrafenib: unresectable or metastatic BRAF V600E-positive solid tumors in adults and children 1 year and older who have progressed on prior treatment and have no satisfactory alternatives (approved under accelerated approval)
- Mekinist with dabrafenib: low-grade glioma (a type of brain tumor) with a BRAF V600E mutation in children 1 year and older who need systemic therapy
- Not for colorectal cancer — cancers of the colon and rectum have built-in resistance to BRAF-blocking medicines, so Mekinist is not used for them
⚙️How it works▾
Cancer cells with a BRAF V600E or V600K mutation carry a permanently switched-on signal in a growth pathway called RAS/RAF/MEK/ERK. Trametinib blocks two proteins in that pathway — MEK1 and MEK2 — interrupting the instructions telling cancer cells to keep dividing. When dabrafenib is added, it targets the upstream BRAF protein, so both drugs are hitting the same runaway signaling chain at different steps, producing a stronger, longer-lasting tumor-suppressing effect than either medicine alone.
In colorectal cancer carrying a BRAF mutation, a different receptor (EGFR) can reactivate the growth pathway around the blockade — meaning the brakes don't hold — which is why trametinib does not work for that cancer type.
💊How it's taken▾
Trametinib is taken once daily by mouth. Adults receive a fixed dose; children's doses are calculated by body weight. Both the tablet and oral solution are taken at roughly the same time every day, about 24 hours apart.
- Mekinist tablets: taken on an empty stomach — at least 1 hour before or 2 hours after eating; do not crush or break tablets
- Mekinist oral solution: when used alone, may be taken with a low-fat meal or on an empty stomach; when used with dabrafenib, must be taken on an empty stomach; given by oral syringe or feeding tube
- If you miss a dose and the next one is fewer than 12 hours away, skip the missed dose and continue on schedule
- If you vomit after a dose, do not take a replacement — wait for the next scheduled dose
🤒Side effects — in detail▾
The most common side effects depend on whether Mekinist is used alone or with dabrafenib, but generally include:
- Fever (pyrexia) — affects the majority of patients on the combination
- Rash, acne-like skin changes, or dry skin
- Nausea, vomiting, and diarrhea
- Fatigue
- Chills
- Swelling in the limbs or body (edema or lymphedema)
- High blood pressure
- Headache and muscle or joint pain
Seek care right away for signs of serious reactions: unusual or heavy bleeding, sudden vision changes, severe shortness of breath, chest pain, leg swelling, high fever, blistering skin, or severe abdominal pain — these can signal life-threatening complications that require prompt medical attention.
⚠️Warnings & precautions▾
- Heart problems (cardiomyopathy): Trametinib can weaken heart muscle and reduce the heart's pumping efficiency. Heart function is monitored by echocardiogram before and regularly during treatment.
- Serious bleeding: Major bleeding events, including fatal brain and gastrointestinal hemorrhages, have occurred. Report any unusual bleeding immediately.
- Blood clots (DVT/PE): Deep vein thrombosis and pulmonary embolism can develop. Seek emergency care for sudden leg swelling, chest pain, or trouble breathing.
- Eye problems: Retinal vein occlusion (RVO) and retinal pigment epithelial detachment (RPED) can cause vision loss. Any visual disturbance needs urgent eye evaluation within 24 hours. RVO requires permanent discontinuation.
- Lung inflammation (ILD/pneumonitis): New or worsening cough, shortness of breath, or low oxygen levels should be reported right away.
- Severe fever: High fever is very common with the combination and can lead to dangerous dehydration, low blood pressure, or kidney injury. Stop the medicine and call your care team for any temperature ≥ 100.4°F.
- Serious skin reactions: Life-threatening reactions including Stevens-Johnson syndrome (SJS) and DRESS have been reported. Report blistering, peeling, or widespread rash — especially with mouth or eye sores.
- New cancers: When used with dabrafenib, new skin cancers and other malignancies can occur; regular skin checks are required during and for 6 months after treatment.
- Fetal harm: Trametinib can cause serious harm to a developing baby. Effective contraception is required during treatment and for 4 months after the last dose.
🔀What it interacts with▾
The main drug interaction to be aware of involves the combination therapy itself and its partner medicine.
- Dabrafenib: Trametinib is frequently prescribed together with dabrafenib. Taking both together does not change trametinib's blood levels, but the combination carries additional risks documented in dabrafenib's prescribing information — review both before starting treatment.
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: Trametinib can cause fetal harm, including pregnancy loss in animal studies. A pregnancy test is required before starting. Do not use if pregnant unless the risks are clearly discussed with your doctor.
- Breastfeeding: Do not breastfeed during treatment or for 4 months after the last dose.
- Contraception (women): Use effective birth control during treatment and for 4 months after the last dose.
- Contraception (men): Use condoms during treatment and for 4 months after the last dose if your partner could become pregnant, even if you have had a vasectomy.
- Fertility: Trametinib may impair fertility in women; discuss family planning with your doctor before starting.
- Children under 1 year: Safety and effectiveness have not been established for patients younger than 1 year of age.
- Older adults: Older patients may experience more swelling and decreased appetite, especially on the combination with dabrafenib.
- Diabetes or high blood sugar: Blood sugar should be monitored closely; additional diabetes medications may be needed.
- Heart conditions: Patients with abnormal heart function or recent heart events require special caution; heart function is assessed before and during treatment.
- Liver impairment: No dose adjustment is needed for mild liver impairment; there is no established dose for moderate or severe liver impairment — the risk-benefit balance must be discussed with your doctor.
🚑If you take too much▾
The highest doses tested in clinical trials were well above the approved amount, and serious eye problems — specifically retinal pigment epithelial detachment (a type of retinal separation) — occurred in a significant portion of patients at those doses. Because trametinib binds very tightly to proteins in the blood, hemodialysis (a kidney-filtering procedure sometimes used in overdose) is unlikely to remove it effectively. If an overdose is suspected, contact a poison control center or seek emergency care immediately.
📡Pharmacodynamics — effects in the body▾
In patients with BRAF V600-positive melanoma, Mekinist tablets produced measurable, dose-dependent changes in tumor tissue, including reduced activity of ERK (a key growth-signaling protein), less cell proliferation, and increased markers of cell death (apoptosis). Trametinib also slows the heart rate modestly and can cause small changes in the heart's electrical conduction (PR interval on an ECG). At standard doses, it does not appear to cause large, dangerous changes in the QT interval (a measure of heart electrical rhythm), though a small percentage of patients on the combination with dabrafenib showed meaningful QTc prolongation.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, trametinib reaches its peak blood level in about 1.5 hours. It is very highly protein-bound (about 97%) and stays in the body for several days — the half-life (the time it takes blood levels to fall by half) is roughly 4 to 5 days. The drug is broken down mainly in the liver through an enzyme process called deacetylation, and most of it leaves the body in the stool, with a small amount in the urine. Food has an important effect on the tablet form: a high-fat meal significantly reduces and delays absorption, which is why tablets must be taken on an empty stomach. The oral solution, by contrast, is not meaningfully affected by a low-fat meal.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Dispense in original bottle. Protect from moisture and light.
📄 Written from Trametinib’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 Trametinib
17 supplements and herbal products have documented interactions with Trametinib 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 · 7
- 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 Trametinib — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need a genetic test before starting this medicine? ▾
Does it matter when I take it or whether I eat first? ▾
Fever seems to happen a lot — should I just take Tylenol and push through it? ▾
What side effects should I actually call my doctor about right away? ▾
Is this safe if I want to have children someday? ▾
How will my doctors monitor me while I'm on this medication? ▾
Is Trametinib available over the counter? ▾
When was Trametinib first available? ▾
Who makes Trametinib? ▾
💬 Answers drafted from Trametinib’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 Trametinib comes
Trametinib is available in 2 forms. 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
- Mekinist tablets are used to treat BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, alone or with dabrafenib
- Mekinist tablets, with dabrafenib, are used for adjuvant treatment of melanoma after complete surgical removal when lymph nodes are involved
- Mekinist tablets, with dabrafenib, are used for metastatic NSCLC, anaplastic thyroid cancer, certain other BRAF V600E-positive solid tumors, and low-grade glioma
- Mekinist tablets must be taken on an empty stomach — at least 1 hour before or 2 hours after a meal
- Mekinist tablets are taken once daily at the same time each day
- Do not crush or break Mekinist tablets
- If you vomit after taking a Mekinist tablet, do not take an extra dose — take the next dose at its scheduled time
Oral solution
How this form is used
- Mekinist oral solution is used for adults and pediatric patients 1 year of age and older across the same BRAF V600E mutation-positive indications as the tablet, with dosing based on body weight
- Mekinist oral solution is the formulation used for younger or lower-weight pediatric patients who may not be able to take the tablet form
- Mekinist oral solution must be prepared (reconstituted) by a pharmacist or healthcare provider before it is dispensed; caregivers should receive training on how to measure and give each dose
- When given as a single agent, Mekinist oral solution can be taken with a low-fat meal or on an empty stomach; when given with dabrafenib, it must be taken on an empty stomach (at least 1 hour before or 2 hours after a meal)
- Mekinist oral solution is given once daily using an oral syringe or feeding tube and should be stored in the original bottle below 25°C (77°F) — do not freeze; once mixed, use within 35 days
- If a pediatric patient cannot tolerate fasting, breastfeeding or baby formula may be given on demand
📊 Trametinib across the U.S. market
How Trametinib 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.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (8) — 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 Trametinib is used
A general measure of how commonly Trametinib 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 Trametinib 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 Trametinib prescribed? Of the 1,596 medications we measure, Trametinib ranks #1,042 by Medicaid prescriptions — more than 35% of them.
Utilization by Trametinib 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.
trametinib 2 MG Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1425116
trametinib 0.5 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1425104
trametinib 0.05 MG/ML Oral Solution
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2632560
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 Trametinib, 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 3 of 10 listed Trametinib NDCs with Medicaid activity.
🔍 Compare Trametinib products
A representative set of FDA-listed product records for Trametinib — 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 |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 0.05 mg/mL | Oral | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
| 💊Tablet | ||||
| 0.5 mg | — | GlaxoSmithKline Manufacturing SpA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 2 mg | — | GlaxoSmithKline Manufacturing SpA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 0.5 mg | Oral | Novartis Pharmaceuticals Corporation × 4 listings | NDA | View NDC → |
| 2 mg | Oral | Novartis Pharmaceuticals Corporation × 5 listings | NDA | View NDC → |
| 0.5 mg | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 2 mg | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | AX Pharmaceutical Corp | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Biocon Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Glaxo Wellcome Manufacturing Pte. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Novartis Pharma Schweizerhalle AG | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Valary Lab Private Limited | BULK INGREDIENT | View NDC → |
Showing 23 of 23 products — FDA National Drug Code Directory. See every product, package size and price: browse all 23 Trametinib 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 Trametinib — 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 Trametinib 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 Trametinib 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 1425099 2 dose forms · 3 strengths
-
Dose form (SCDF) Oral Solution RxCUI 2632559In current FDA listingsClinical drug / strength (SCD) 0.05 MG/MLRxCUI 2632560 -
Dose form (SCDF) Oral Tablet RxCUI 1425103In current FDA listings
Look up RxCUI 1425099 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 Trametinib 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
Trametinib 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.
🔬 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. Novartis Pharmaceuticals Corporation 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.