Mekinist

Last updated on RxList: 7/8/2020
Mekinist Side Effects Center

What Is Mekinist?

Mekinist (trametinib) is a kinase inhibitor used to treat patients with melanoma with BRAF V600E or V600K mutations that are metastatic or unable to be removed by surgery (unresectable).

What Are Side Effects of Mekinist?

Common side effects of Mekinist include:

Dosage for Mekinist

The recommended dose of Mekinist is 2 mg orally once daily. Take at least 1 hour before or 2 hours after a meal.

What Drugs, Substances, or Supplements Interact with Mekinist?

Mekinist may interact with other drugs. Tell your doctor all medications and supplements you use.

Mekinist During Pregnancy and Breastfeeding

Mekinist can cause fetal harm and is not recommended during pregnancy. Tell your doctor if you become pregnant during treatment. It is unknown if this drug is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants, consult your doctor before breastfeeding.

Additional Information

Our Mekinist (trametinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Mekinist Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take trametinib and dabrafenib together. Call your doctor at once if you have:

  • cough, feeling short of breath;
  • fever, chills, feeling light-headed;
  • little or no urination;
  • severe headache, blurred vision, and dizziness;
  • nausea, stomach pain, severe diarrhea;
  • increased thirst or urination;
  • eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;
  • severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;
  • signs of bleeding--weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of a blood clot--chest pain, sudden cough or trouble breathing, pain or swelling in an arm or leg, pale skin, cold feeling in an arm or leg; or
  • signs of a heart problem--shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;
  • fever, chills, tiredness;
  • headache;
  • bleeding;
  • increased blood pressure;
  • muscle or joint pain;
  • cough, shortness of breath;
  • swelling in your arms, face, and legs; or
  • rash, dry skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mekinist (Trametinib Tablets)

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SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • New Primary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Colitis and Gastrointestinal Perforation [see WARNINGS AND PRECAUTIONS]
  • Venous Thromboembolism [see WARNINGS AND PRECAUTIONS]
  • Cardiomyopathy [see WARNINGS AND PRECAUTIONS]
  • Ocular Toxicities [see WARNINGS AND PRECAUTIONS]
  • Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
  • Serious Febrile Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Toxicities [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia [see WARNINGS AND PRECAUTIONS]

There are additional adverse reactions associated with dabrafenib. Refer to the dabrafenib prescribing information for additional information.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The pooled safety populations described in the WARNINGS and PRECAUTIONS reflect exposure to MEKINIST as a single agent in 329 patients with various solid tumors enrolled in METRIC, MEK113583, and MEK111054, and to MEKINIST administered with dabrafenib in 1087 patients enrolled in COMBI-d, COMBI-v, COMBI-AD, and BRF113928 with unresectable or metastatic melanoma, adjuvant melanoma or NSCLC. Among the 329 patients who received MEKINIST as a single agent, 33% were exposed for 6 months or longer and 9% were exposed for at least one year. Among the 1087 patients who received MEKINIST administered with dabrafenib, 70% were exposed for 6 months or longer and 21% were exposed for greater than one year.

Unresectable Or Metastatic BRAF V600E Or V600K Mutation-Positive Melanoma

MEKINIST As A Single Agent

The safety of MEKINIST was evaluated in the METRIC study, a randomized, open-label trial of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma who received MEKINIST (N = 211) 2 mg orally once daily or chemotherapy (N = 99) (either dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² every 3 weeks) [see Clinical Studies]. Patients with abnormal LVEF, history of acute coronary syndrome within 6 months, or current evidence of Class II or greater congestive heart failure (New York Heart Association) were excluded. The median duration of treatment with MEKINIST was 4.3 months.

In this study, 9% of patients who received MEKINIST experienced adverse reactions resulting in permanent discontinuation of trial medication. The most frequent adverse reactions resulting in permanent discontinuation of MEKINIST were decreased LVEF, pneumonitis, renal failure, diarrhea, and rash. Adverse reactions led to dose reductions in 27% of patients treated with MEKINIST. Rash and decreased LVEF were the most frequent reasons cited for dose reductions of MEKINIST. Tables 3 and 4 present adverse reactions and laboratory abnormalities, respectively, of MEKINIST as a single agent in the METRIC study.

Table 3: Select Adverse Reactions Occurring in ≥ 10% of Patients Who Received MEKINIST and at a Higher Incidence (≥ 5%) Than in the Chemotherapy Arm or ≥ 2% (Grades 3 or 4) Adverse Reactions in METRIC

Adverse ReactionsMEKINIST
N = 211
Chemotherapy
N = 99
All GradesaGrades 3 and 4bAll GradesaGrades 3 and 4b
Skin and subcutaneous tissue
Rash578100
Acneiform dermatitis19< 110
Dry skin11000
Pruritus10210
Paronychia10010
Gastrointestinal
Diarrhea430162
Stomatitisc15220
Abdominal paind13151
Vascular
Lymphedemae32140
Hypertension151273
Hemorrhagef13< 100
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
b Grade 4 adverse reactions limited to rash (n = 1) in trametinib arm and diarrhea (n = 1) in chemotherapy arm.
cIncludes stomatitis, aphthous stomatitis, mouth ulceration, and mucosal inflammation.
d Includes abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness.
e Includes lymphedema, edema, and peripheral edema.
f Includes epistaxis, gingival bleeding, hematochezia, rectal hemorrhage, melena, vaginal hemorrhage, hemorrhoidal hemorrhage, hematuria, and conjunctival hemorrhage.

Other clinically important adverse reactions observed in ≤ 10% of patients (N = 329) who received MEKINIST were:

Cardiac: Bradycardia

Gastrointestinal: Dry mouth

Infections: Folliculitis, rash pustular, cellulitis

Musculoskeletal and Connective Tissue: Rhabdomyolysis

Nervous System: Dizziness, dysgeusia

Ocular: Blurred vision, dry eye

Table 4: Laboratory Abnormalities Occurring at a Higher Incidence in Patients Who Received MEKINIST in the METRIC Study [Between-arm Difference of ≥ 5% (All Grades) or ≥ 2% (Grades 3 or 4)a]

Laboratory AbnormalityMEKINIST
N = 211
Chemotherapy
N = 99
All GradesGrades 3 and 4All GradesGrades 3 and 4
Increased aspartate aminotransferase (AST)602161
Hypoalbuminemia422231
Increased alanine aminotransferase (ALT)393203
Anemia382263
Increased alkaline phosphatase242183
a Only Grade 3 adverse reactions were reported in either treatment arm.

MEKINIST With Dabrafenib

The safety of MEKINIST, administered with dabrafenib, was evaluated in 559 patients with previously untreated, unresectable or metastatic, BRAF V600 mutation-positive melanoma who received MEKINIST in two trials, the COMBI-d study (n = 209), a multicenter, double-blind, randomized (1:1), active-controlled trial and the COMBI-v study (n = 350), a multicenter, open-label, randomized (1:1), active-controlled trial. In both trials, patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity. The trials excluded patients with abnormal LVEF, history of acute coronary syndrome within 6 months, history of Class II or greater congestive heart failure (New York Heart Association), history of RVO or RPED, QTcB interval ≥ 480 msec, uncontrolled hypertension, uncontrolled arrhythmias, active brain metastases, or known history of glucose-6-phosphate dehydrogenase deficiency.

Among these 559 patients, 197 (35%) were exposed to MEKINIST for > 6 months to 12 months, while 185 (33%) were exposed to MEKINIST for > 1 year. The median age was 55 years (range: 18 to 91), 57% were male, and 98% were white, 72% had baseline ECOG performance status 0 and 28% had ECOG performance status 1, 64% had M1c stage disease, 35% had elevated lactate dehydrogenase (LDH) at baseline, and 0.5% had a history of brain metastases.

The most common adverse reactions (≥ 20%) for MEKINIST in patients who received MEKINIST plus dabrafenib were: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.

The demographics and baseline tumor characteristics of patients enrolled in the COMBI-d study are summarized in Clinical Studies [see Clinical Studies]. Patients who received MEKINIST plus dabrafenib had a median duration of exposure of 11 months (range: 3 days to 30 months) to MEKINIST. Among the 209 patients who received MEKINIST plus dabrafenib, 26% were exposed to MEKINIST for > 6 months to 12 months while 46% were exposed to MEKINIST for > 1 year.

In the COMBI-d study, adverse reactions leading to discontinuation of MEKINIST occurred in 11% of patients who received MEKINIST plus dabrafenib; the most frequent were pyrexia (1.4%) and decreased ejection fraction (1.4%). Adverse reactions leading to dose reductions of MEKINIST occurred in 18% of patients who received MEKINIST plus dabrafenib; the most frequent were pyrexia (2.9%), neutropenia (1.9%), decreased ejection fraction (1.9%), and rash (1.9%). Adverse reactions leading to dose interruptions of MEKINIST occurred in 46% of patients who received MEKINIST plus dabrafenib; the most frequent were pyrexia (18%), chills (7%), vomiting (6%), and decreased ejection fraction (4.8%).

Table 5 and Table 6 present selected adverse reactions and laboratory abnormalities, respectively, of MEKINIST observed in the COMBI-d study.

Table 5: Adverse Reactions Occurring in ≥ 10% (All Grades) of Patients Who Received MEKINIST With Dabrafenib and at a Higher Incidence* Than in Patients Who Received Single-Agent Dabrafenib in COMBI-da

Adverse ReactionsPooled MEKINIST plus Dabrafenib
N = 559
COMBI-d Study
MEKINIST plus Dabrafenib
N = 209
Dabrafenib
N = 211
All Grades (%)Grades 3 and 4 (%)All Grades (%)Grades 3 and 4 (%)All Grades (%)Grades 3 and 4 (%)
General
Pyrexia545577331.9
Chills310.5310170.5
Peripheral edemab210.7251.4110.5
Gastrointestinal
Nausea350.4340.5271.4
Diarrhea311.3301.4160.9
Vomiting271.1251.0140.5
Abdominal painc180.9261.0142.4
Skin
Rashd321.1420271.4
Vascular
Hypertension2611256166
Hemorrhagee182.0191.9151.9
Nervous system
Dizziness110.214070
*≥ 5% for All Grades or ≥ 2% for Grades 3-4 incidence in patients who received MEKINIST with dabrafenib compared with patients who received dabrafenib as a single agent.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
b Includes peripheral edema, edema, lymphedema, localized edema, and generalized edema.
cIncludes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.
d Includes rash, generalized rash, pruritic rash, erythematous rash, papular rash, vesicular rash, macular rash, maculo-papular, and folliculitis rash.
e Most common events (≥ 1%) include epistaxis, hematochezia, decreased hemoglobin, purpura, and rectal hemorrhage. Grade 4 events were limited to hepatic hematoma and duodenal ulcer hemorrhage (each n = 1 in the pooled combination arm).

Other clinically important adverse reactions for MEKINIST observed in less than 10% of patients who received MEKINIST in combination with dabrafenib (N = 559) were:

Cardiac: Bradycardia

Musculoskeletal: Rhabdomyolysis

Table 6: Laboratory Abnormalities Worsening From Baseline Occurring at ≥ 10% (All Grades) of Patients Who Received MEKINIST With Dabrafenib and at a Higher Incidence* Than in Patients Who Received Single-Agent Dabrafenib in COMBI-d

Laboratory AbnormalityPooled MEKINIST plus Dabrafenib
N = 559a
COMBI-d Study
MEKINIST plus Dabrafenib
N = 209b
Dabrafenib
N = 211b
All Grades (%)Grades 3 and 4c (%)All Grades (%)Grades 3 and 4c (%)All Grades (%)Grades 3 and 4c (%)
Chemistry
Hyperglycemia604.7656574.3
Hypoalbuminemia481.1531.4270
Hyponatremia258246142.9
Hepatic
Increased AST594.1604.3211.0
Increased blood alkaline phosphatase492.7501.0250.5
Increased ALT484.5443.8281.0
Hematology
Neutropenia467506161.9
Anemia432.3432.4384.3
Lymphopenia328389287
Thrombocytopenia210.7190.5100.5
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase. *≥ 5% for All Grades or ≥ 2% for Grades 3-4 incidence in patients who received MEKINIST with dabrafenib compared with patients who received dabrafenib as a single agent.
a For these laboratory tests the denominator is 556.
b For these laboratory tests the denominator is 208 for the combination arm, 207-209 for the dabrafenib arm.
cGrade 4 adverse reactions limited to lymphopenia and hyperglycemia (each n = 4), increased ALT and increased AST (each n = 3), neutropenia (n = 2), and hyponatremia (n = 1), in the pooled combination arm; neutropenia, lymphopenia, increased ALT, increased AST, hyperglycemia (each n = 1) in the COMBI-d study combination arm; neutropenia, thrombocytopenia, increased ALT, and increased AST (each n = 1) in the dabrafenib arm.

Adjuvant Treatment Of BRAF V600E Or V600K Mutation-Positive Melanoma

The safety of MEKINIST when administered with dabrafenib was evaluated in 435 patients with Stage III melanoma with BRAF V600E or V600K mutations following complete resection who received at least one dose of study therapy in the COMBI-AD study [see Clinical Studies]. Patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily for 12 months. The trial excluded patients with abnormal LVEF; history of acute coronary syndromes, coronary angioplasty, or stenting within 6 months; Class II or greater congestive heart failure (New York Heart Association); QTc interval ≥ 480 msec; treatment refractory hypertension; uncontrolled arrhythmias; or history of RVO.

Patients who received MEKINIST in combination with dabrafenib had a median duration of exposure of 11 months (range: 0 to 12) to MEKINIST. Among the 435 patients who received MEKINIST in combination with dabrafenib, 72% were exposed to MEKINIST for > 6 months. The median age of patients who received MEKINIST in combination with dabrafenib was 50 years (range: 18 to 89), 56% were male, 99% were white, 92% had baseline ECOG performance status 0, and 8% had baseline ECOG performance status 1.

The most common adverse reactions (≥ 20%) in patients who received MEKINIST in combination with dabrafenib were: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.

Adverse reactions resulting in discontinuation and dose interruptions of MEKINIST occurred in 24% and 54% of patients, respectively; the most frequent for each were pyrexia and chills. Adverse reactions leading to dose reductions of MEKINIST occurred in 23% of patients; the most frequent were pyrexia and decreased ejection fraction.

Table 7 summarizes adverse reactions that occurred in at least 20% of the patients who received MEKINIST in combination with dabrafenib.

Table 7: Adverse Reactions Occurring in ≥ 20% of Patients in COMBI-ADa

Adverse ReactionsMEKINIST plus Dabrafenib
N = 435
Placebo
N = 432
All Grades (%)Grades 3 and 4 (%)All Grades (%)Grades 3 and 4 (%)
General
Pyrexiab63511< 1
Fatiguec59537< 1
Chills37140
Gastrointestinal
Nausea40< 1200
Diarrhea33<115<1
Vomiting28< 1100
Nervous system
Headached391240
Skin
Rashe37<116<1
Musculoskeletal
Arthralgia28< 1140
Myalgiaf20< 1140
a NCI CTCAE version 4.0.
b Includes pyrexia and hyperpyrexia.
cIncludes fatigue, asthenia, and malaise.
d Includes headache and tension headache.
e Includes rash, rash maculo-papular, rash macular, rash generalized, rash erythematous, rash papular, rash pruritic, nodular rash, rash vesicular, and rash pustular.
f Includes myalgia, musculoskeletal pain, and musculoskeletal chest pain.

Other clinically important adverse reactions observed in less than 20% of patients in the COMBI-AD study who received MEKINIST in combination with dabrafenib were: blurred vision (6%), decreased ejection fraction (5%), and rhabdomyolysis (< 1%).

The laboratory abnormalities are summarized in Table 8.

Table 8: Laboratory Abnormalities Worsening From Baseline Occurring in ≥ 20% of Patients in COMBI-AD

Laboratory AbnormalityMEKINIST plus Dabrafeniba
N = 435
Placebob
N = 432
All Grades (%)Grades 3 and 4 (%)All Grades (%)Grades 3 and 4 (%)
Chemistry
Hyperglycemia633472
Hypophosphatemia42710< 1
Hypoalbuminemia25< 1< 10
Hepatic
Increased AST57611< 1
Increased ALT48518< 1
Increased blood alkaline phosphatase3816< 1
Hematology
Neutropenia47612< 1
Lymphopenia2656< 1
Anemia25< 16< 1
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
a The incidence is based on the number of patients who had both a baseline and at least one on-study laboratory measurement: MEKINIST plus dabrafenib (range: 429 to 431) and placebo arm (range: 426 to 428).

Metastatic, BRAF V600E Mutation-Positive Non-Small Cell Lung Cancer

The safety of MEKINIST when administered with dabrafenib was evaluated in 93 patients with previously untreated (n = 36) and previously treated (n = 57) metastatic BRAF V600E mutation-positive NSCLC in a multicenter, multi-cohort, non-randomized, open-label trial (Study BRF113928). Patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity. The trial excluded patients with abnormal LVEF, history of acute coronary syndrome within 6 months, history of Class II or greater congestive heart failure (New York Heart Association), QTc interval ≥ 480 msec, treatment refractory hypertension, uncontrolled arrhythmias, active brain metastases, history of ILD or pneumonitis, or history or current RVO [see Clinical Studies].

Among these 93 patients, 53 (57%) were exposed to MEKINIST and dabrafenib for > 6 months and 27 (29%) were exposed to MEKINIST and dabrafenib for ≥ 1 year. The median age was 65 years (range: 41 to 91), 46% were male, 85% were white; 32% had baseline ECOG performance status 0 and 61% had ECOG performance status 1; 98% had non-squamous histology; and 12% were current smokers, 60% were former smokers, and 28% had never smoked.

The most common adverse reactions (≥ 20%) in these 93 patients were: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.

Adverse reactions resulting in discontinuation of MEKINIST occurred in 19% of patients; the most frequent were pyrexia (2.2%), decreased ejection fraction (2.2%), and respiratory distress (2.2%). Adverse reactions leading to dose reductions of MEKINIST occurred in 30% of patients who received MEKINIST plus dabrafenib; the most frequent were pyrexia (5%), nausea (4.3%), vomiting (4.3%), diarrhea (3.2%), and neutropenia (3.2%). Adverse reactions leading to dose interruptions of MEKINIST occurred in 57% of patients who received MEKINIST plus dabrafenib; the most frequent were pyrexia (16%), vomiting (10%), neutropenia (8%), nausea (5%), and decreased ejection fraction (5%).

Table 9 and Table 10 present adverse reactions and laboratory abnormalities, respectively, of MEKINIST in combination with dabrafenib in Study BRF113928.

Table 9: Adverse Reactions Occurring in ≥ 20% (All Grades) of Patients Treated With MEKINIST plus Dabrafenib in Study BRF113928a

Adverse ReactionsMEKINIST plus Dabrafenib
N = 93
All Grades (%)Grades 3 and 4b (%)
General
Pyrexia555
Fatigueb515
Edemac280
Chills231.1
Gastrointestinal
Nausea450
Vomiting333.2
Diarrhea322.2
Decreased appetite290
Skin
Dry skin311.1
Rashd283.2
Vascular
Hemorrhagee233.2
Respiratory system
Cough220
Dyspnea205
a NCI CTCAE version 4.0.
b Includes fatigue, malaise, and asthenia.
cIncludes peripheral edema, edema, and generalized edema.
d Includes rash, rash generalized, rash papular, rash macular, rash maculo-papular, and rash pustular.
e Includes hemoptysis, hematoma, epistaxis, purpura, hematuria, subarachnoid hemorrhage, gastric hemorrhage, urinary bladder hemorrhage, contusion, hematochezia, injection site hemorrhage, pulmonary hemorrhage, and retroperitoneal hemorrhage.

Table 10: Treatment-Emergent Laboratory Abnormalities Occurring in ≥ 20% (All Grades) of Patients Who Received MEKINIST plus Dabrafenib in Study BRF113928

Laboratory AbnormalityMEKINIST plus Dabrafenib
N = 93
All Grades (%)Grades 3 and 4 (%)
Chemistrya
Hyperglycemia719
Hyponatremia5717
Hypophosphatemia367
Increased creatinine211.1
Hepatica
Increased blood alkaline phosphatase640
Increased AST614.4
Increased ALT326
Hematologyb
Leukopenia488
Anemia4610
Neutropenia448
Lymphopenia4214
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
a For these laboratory tests the denominator is 90.
b For these laboratory tests the denominator is 91.

Locally Advanced Or Metastatic, BRAF V600E Mutation-Positive, Anaplastic Thyroid Cancer

The safety of MEKINIST when administered with dabrafenib was evaluated in a nine-cohort, multicenter, non-randomized, open-label study in patients with rare cancers with the BRAF V600E mutation, including locally advanced or metastatic ATC (Study BRF117019). At the time of the safety analysis, a total of 100 patients were enrolled in the trial, 16 of whom were enrolled in the ATC cohort. The primary safety population included all patients who received at least one dose of MEKINIST or dabrafenib. Patients received MEKINIST 2 mg orally once daily and dabrafenib 150 mg orally twice daily until disease progression or unacceptable toxicity.

Among these 100 patients, 46 (46%) were exposed to MEKINIST and dabrafenib for > 6 months and 23 (23%) were exposed to MEKINIST and dabrafenib for ≥ 1 year. The median age was 59.5 years (range: 18 to 85); 62% were male; 85% were white; and 31% had baseline ECOG performance status 0, and 59% had ECOG performance status 1.

The adverse reaction profile among all patients and among patients in the ATC cohort was similar to that observed in other approved indications.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of MEKINIST in combination with dabrafenib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: SCAR (including DRESS and SJS)

Read the entire FDA prescribing information for Mekinist (Trametinib Tablets)

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