MEKINIST (trametinib) for oral solution

Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called ‘BRAF V600’. It is used for the treatment of: melanoma (a skin cancer) that has spread or cannot be removed surgically. Brand Name: MEKINIST (trametinib) for oral solution Initial U.S. Approval: 2013

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MEKINIST (trametinib) for oral solution

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MEKINIST (trametinib) for oral solution

Trametinib, sold under the brand name Mekinist among others, is an anticancer medication used for the treatment of melanoma. It is a MEK inhibitor drug with anti-cancer activity. It inhibits MEK1 and MEK2.

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 FDAapproved test.
MEKINIST is indicated, in combination with dabrafenib, for:
• the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
• the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
• the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
• the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
• the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation
who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
• the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.

Trametinib is an anticancer medication used for the treatment of melanoma. It is a MEK inhibitor drug with anti-cancer activity. It inhibits MEK1 and MEK2.
Trametinib dimethyl sulfoxide is approved to be used alone or with dabrafenib mesylate to treat patients whose cancer has a certain mutation in the BRAF gene, including: Anaplastic thyroid cancer, Glioma, Melanoma, Non-small cell lung cancer, Solid tumors. Trametinib dimethyl sulfoxide is also being studied in the treatment of other types of cancer.

Drug (Brand / Generic): MEKINIST / letermovir
Current Indications: melanoma (a skin cancer)
Marketed by:: Novartis Pharmaceuticals Corporation
Approval Date: 2013

Dosage forms and strengths of MEKINIST (trametinib).
MEKINIST Tablets: 0.5 mg, 2 mg
MEKINIST for Oral Solution: 4.7 mg

For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here

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