Trametinib Mekinist 2mg

[Treatment]

Treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

The combination of trametinib and dabrafenib is used to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation.

[Dosage and Administration]

(1) Confirm the presence of BRAF V600E and V600K mutations in tumor specimens prior to initiating treatment with MEKINIST.

(2) The recommended dosage regimen for MEKINIST is 2 mg orally once daily as a single agent, or in combination with dabrafenib 150 mg orally twice daily. MEKINIST should be taken at least 1 hour before a meal or at least 2 hours after a meal.

[Adverse Reactions]

(1) The most common adverse reactions (≥20%) associated with MEKINIST as a single agent include rash, diarrhea, and lymphedema.

(2) The most common adverse reactions (≥20%) associated with MEKINIST in combination with dabrafenib include fever, chills, fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, arthralgia, night sweats, decreased appetite, constipation, and myalgia.

[Drug Interactions]

(1) When MEKINIST is used in combination with dabrafenib, avoid the concomitant administration of strong inhibitors of CYP3A4 and CYP2C8.

(2) When MEKINIST is used in combination with dabrafenib, avoid the concomitant administration of strong inducers of CYP3A4 and CYP2C8.

(3) When MEKINIST is used in combination with dabrafenib, the concomitant use of drugs that are sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, and CYP2B6 may result in a loss of efficacy for these drugs.

[Use in Specific Populations]

(1) Nursing Mothers: Discontinue the drug or discontinue nursing.

(2) Females and Males of Reproductive Potential: Counsel female patients regarding pregnancy planning and prevention. May impair fertility.

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**Product Specifications**

**Product Name:** Mekinist (Trametinib) 2mg

**Common Name:** Mekinist

**Active Ingredient:** Trametinib 2mg

**Dosage Form:** Tablets

**Specification:** 30 Tablets

**Manufacturer:** Novartis International AG

**Indications:** Used for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

Trametinib, in combination with dabrafenib, is used to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation.

**Dosage and Administration:** (1) Confirm the presence of BRAF V600E or V600K mutations in tumor samples prior to initiating treatment with MEKINIST.

(2) The recommended dosage regimen for MEKINIST is 2 mg taken orally once daily as a monotherapy, or in combination with dabrafenib (150 mg orally twice daily). MEKINIST should be taken at least 1 hour before a meal or at least 2 hours after a meal.