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Molecule

Trametinib dimethyl sulfoxide

Kinase Inhibitor
Available on requestOrphanCold chain
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Trametinib dimethyl sulfoxide is a kinase inhibitor. It is available as tablets and powder for oral solution. MedsAcross supplies Trametinib dimethyl sulfoxide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Kinase Inhibitor, Protein Kinase Inhibitors
US FDA first approval
29 May 2013
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Powder for oral solution
Identifiers
UNII BSB9VJ5TUTRxCUI 1425098CAS 1187431-43-1DrugBank DBSALT001947Q27145671

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Source: US FDA prescribing information

How it works

Trametinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 activation and of MEK1 and MEK2 kinase activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF V600E mutations result in constitutive activation of the BRAF pathway which includes MEK1 and MEK2. Trametinib inhibits cell growth of various BRAF V600 mutation-positive tumors in vitro and in vivo. Trametinib and dabrafenib target two different kinases in the RAS/RAF/MEK/ERK pathway. Use of trametinib and dabrafenib in combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines in vitro and prolonged inhibition of tumor growth in BRAF V600 mutation-positive tumor xenografts compared with either drug alone.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of MEKINIST in adult patients is 2 mg orally once daily. The recommended dosage for MEKINIST in pediatric patients is based on body weight.

Source: US FDA prescribing information

Warnings and precautions

New Primary Malignancies, Cutaneous and Non-Cutaneous: Can occur when MEKINIST is used with dabrafenib. Monitor patients for new malignancies prior to, or while on therapy, and following discontinuation of treatment. Hemorrhage: Major hemorrhagic events can occur. Monitor for signs and symptoms of bleeding. Colitis and Gastrointestinal Perforation: Colitis and gastrointestinal perforation can occur in patients receiving MEKINIST. Venous Thromboembolic Events: Deep vein thrombosis (DVT) and pulmonary embolism (PE) can occur in patients receiving MEKINIST. Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment, after one month of treatment, then every 2 to 3 months thereafter. Ocular Toxicities: Perform ophthalmological evaluation for any visual disturbances. For Retinal Vein Occlusion (RVO), permanently discontinue MEKINIST.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: New Primary Malignancies Hemorrhage Colitis and Gastrointestinal Perforation Venous Thromboembolic Events Cardiomyopathy Ocular Toxicities Interstitial Lung Disease/Pneumonitis Serious Febrile Reactions Serious Skin Toxicities Hyperglycemia Hemophagocytic Lymphohistiocytosis There are additional adverse reactions associated with dabrafenib. Refer to the dabrafenib prescribing information for additional information. Most common adverse reactions (≥ 20%) for MEKINIST as a single agent include rash, diarrhea, and lymphedema. Most common adverse reactions (≥ 20%) for MEKINIST in combination with dabrafenib include: Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.

Source: US FDA prescribing information

Interactions

MEKINIST is indicated for use in combination with dabrafenib. Refer to the dabrafenib prescribing information for additional risk information that applies to combination use treatment.

Source: US FDA prescribing information

Storage

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). Store refrigerated at 2°C to 8°C (36°F to 46°F). Protect from moisture and light. Store in the original carton to protect from light and moisture. After reconstitution, store in the original bottle below 25°C (77°F) and do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Trametinib dimethyl sulfoxide, sorted by availability.

MedicineManufacturerRegisterAvailability
Mekinist 0.05 mg/mL powder for oral solutionOral Cold chainNovartis PharmaceuticalsUS FDAAvailable on request
Mekinist 0.5 mg tabletOral Cold chainNovartis PharmaceuticalsUS FDAAvailable on request
Mekinist 2 mg tabletOral Cold chainNovartis PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 May 2013Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Trametinib dimethyl sulfoxide available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Trametinib dimethyl sulfoxide and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Trametinib dimethyl sulfoxide have?

The catalogue lists 1 brand names for Trametinib dimethyl sulfoxide, including Mekinist.

Is Trametinib dimethyl sulfoxide approved by the US FDA?

Yes. The US FDA first approved Trametinib dimethyl sulfoxide on 29 May 2013, according to Drugs@FDA.

Does Trametinib dimethyl sulfoxide need cold chain shipping?

At least one listed presentation of Trametinib dimethyl sulfoxide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Mekinist prescribing information (Novartis Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 7 May 2026

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