Binimetinib: uses, dosing, side effects & brands
Binimetinib is a medicine sold in the U.S. under one brand, for melanoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Melanoma
- Available as
- Tablet
- Sold as
- Mektovi
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How binimetinib is dosed
From the FDA label for Mektovi (application NDA210498). Other binimetinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Melanoma • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of MEKTOVI. ( 2.1 ) • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. ( 2.2 ) • For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily. ( 2.4 , 8.6 ) NSCLC • Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI. ( 2.1 ) • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. ( 2.2 ) 2.1 Patient Selection BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating MEKTOVI [see Clinical Studies (14) ] . Information on FDA-approved tests for the detection of BRAF V600E and V600K mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics . BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) Confirm the presence of a BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI [see Clinical Studies (14.2) ] . If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at:…
Binimetinib side effects
The following adverse reactions are described elsewhere in the labeling: • New Primary Malignancies [see Warnings and Precautions (5.1) ] • Cardiomyopathy [see Warnings and Precautions (5.2) ] • Venous Thromboembolism [see Warnings and Precautions (5.3) ] • Ocular Toxicities [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease [see Warnings and Precautions (5.5) ] • Hepatotoxicity [see Warnings and Precautions (5.6) ] • Rhabdomyolysis [see Warnings and Precautions (5.7) ] • Hemorrhage [see Warnings and Precautions (5.8) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.9) ] • Risks Associated with Combination Treatment [see Warnings and Precautions (5.10) ] Melanoma: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. ( 6.1 ) NSCLC: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly…
Who shouldn’t take binimetinib
None. None. ( 4 )
Binimetinib drug interactions
No clinically important drug interactions have been observed with MEKTOVI.
Every binimetinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Mektovi.
What binimetinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| A;15 | 15 mg | yellow | oval | — |
Binimetinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for binimetinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of binimetinib during breastfeeding. Because binimetinib is 97% bound to plasma proteins, and the half-life of the drug is 3.5 hours, the amount in milk is likely to be low. However, the manufacturer recommends that breastfeeding be discontinued during binimetinib therapy and for at least 3 days after the final dose. For patients taking the combination with encorafenib, the manufacturer recommends that breastfeeding be discontinued during binimetinib therapy and for at least 2 weeks after the final dose.
National Institute of Child Health and Human Development, record revised July 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about binimetinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,557 reports naming binimetinib, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea122 reports
- nausea120 reports
- pyrexia110 reports
- fatigue93 reports
- acute kidney injury71 reports
- colitis59 reports
- vomiting58 reports
- anaemia56 reports
Read these as a signal, not a rate. A report does not mean binimetinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is binimetinib?
Mektovi (Binimetinib) is a medication used to treat Melanoma.
Can you take binimetinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run binimetinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does binimetinib come in?
Across the brands we track, binimetinib is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic binimetinib?
We do not currently list a generic-labelled binimetinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Binimetinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/binimetinib
- MLA
- “Binimetinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/binimetinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for binimetinib on DailyMed (NIH) ↗.