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Mekinist

TRAMETINIB

Manufacturer: Novartis Pharmaceuticals Corporation

Score: 141.0

Quick Summary

Mekinist (Trametinib) is a kinase inhibitor used for the treatment of various cancers, including melanoma, non-small cell lung cancer (NSCLC), and anaplastic thyroid cancer (ATC), in patients with specific genetic mutations. It is often used in combination with dabrafenib. Key clinical findings indicate its efficacy in improving survival rates and reducing tumor growth in these patient populations. Important safety information includes warnings about potential fetal harm, cardiomyopathy, and ocular toxicities. The main dosing recommendations vary based on the condition being treated and the patient's age and weight. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, each with specific guidelines and precautions.

Key Clinical Findings and Indications

  • Treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations
  • Adjuvant treatment of melanoma with BRAF V600E or V600K mutations and involvement of lymph node(s) following complete resection
  • Treatment of metastatic NSCLC with BRAF V600E mutation
  • Treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation
  • Treatment of adult and pediatric patients with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options

Important Safety Information

Warning

Mekinist can cause fetal harm when administered to a pregnant woman and has warnings regarding cardiomyopathy, ocular toxicities, and other serious adverse reactions

Contraindications

  • None

Adverse Reactions

  • 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

Dosing Recommendations

General Guidance

Dose reductions for adverse reactions associated with MEKINIST are presented in Tables 3 and 4

Melanoma

Adult Dose

2 mg orally once daily

Pediatric Dose

Based on body weight (Table 1)

NSCLC

Adult Dose

2 mg orally once daily

Pediatric Dose

Not established

ATC

Adult Dose

2 mg orally once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Mekinist can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to a fetus

Nursing Mothers

  • It is not known whether trametinib is present in human milk

Pediatric Use

  • The safety and effectiveness of MEKINIST in combination with dabrafenib have been established in pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation

Geriatric Use

  • No overall differences in the effectiveness of MEKINIST plus dabrafenib were observed in geriatric patients as compared to younger adults
  • The incidences of peripheral edema and anorexia increased in geriatric patients as compared to younger adults