• Treatment of metastatic/unresectable melanoma with the BRAF V600E or V600K mutation.
• Treatment of metastatic/unresectable melanoma in patients with the BRAF V600E or V600K mutation (in combination with dabrafenib).

Contraindicated in:

• OB: May cause fetal harm
• Lactation: Breastfeeding should be avoided.

Use Cautiously in:

• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established.

CNS: dizziness.

EENT: blurred vision, dry eyes, retinal pigment epithelial detachment, retinal vein occlusion.

Resp: INTERSTITIAL LUNG DISEASE.

CV: CARDIOMYOPATHY, VENOUS THROMBOEMBOLISM, hypertension.

GI: GI PERFORATION, abdominal pain, diarrhea, ↑liver enzymes, stomatitis, colitis, dysgeusia.

Derm: acneiform dermatitis, rash, skin toxicity, cellulitis, dry skin, folliculitis, palmar-plantar erythrodysesthesia syndrome, paranychia, pruritus.

Endo: hyperglycemia.

Hemat: bleeding.

MS: rhabdomyolysis.

Misc: fever, lymphedema.

Drug-Drug:

• None noted

• Tablets: 0.5 mg; 2 mg;

• PO (Adults): 2 mg once daily continued until disease progression or unacceptable toxicity.

Mekinist

• Inhibits the activity of kinases, enzymes that promote cellular proliferation.

• Decreased progression of melanoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 97.4%.

Metabolism/Excretion: 50% metabolized, 80% eliminated in feces (metabolites and parent compound), 20% excreted in urine (mostly as metabolites).

Half-life: 3.9–4.8 days.

(response)

• Instruct patient to take trametinib as directed at least 1 hr before or 2 hrs after meals. Take missed doses as soon as remembered unless within 12 hrs of next dose, then skip missed dose and take regularly scheduled dose. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Inform patient of potential side effects. Advise patient to notify health care professional if signs and symptoms of heart failure (pounding or racing heart, shortness of breath, swelling of feet or ankles, lightheadedness), visual disturbances (blurred vision, loss of vision, seeing colored dots, seeing a blurred outline or halo around objects, other visual changes), dyspnea, progressive or intolerable rash (acne; redness, swelling, peeling, or tenderness of hands or feet), hypertension (severe headache, lightheadedness, dizziness), bleeding problems (headaches, dizziness, or feeling weak, coughing up blood or blood clots, vomit blood or vomit looks like “coffee grounds”, red or black stools that look like tar), skin changes (new wart, sore or reddish bump that bleeds or does not heal, change in size or color of a mole), hyperglycemia (increased thirst, urinating more often than normal or urinating an increased amount of urine), or severe diarrhea occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Advise female patient to use a highly effective form of contraception during and for at least 4 mo after treatment. Use a non-hormonal form of contraception; trametinib may decrease effectiveness of hormonal contraceptives. Advise patient to notify health care professional if pregnancy is suspected and to avoid breastfeeding during and for 4 mo following therapy. May impair fertility in females.

tra-ME-ti-nib

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0666- Mekinist
    • 0078-0666-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0668- Mekinist
    • 0078-0668-15- 30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15)