MEKTOVI® Adverse Reactions

(binimetinib)

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

New Primary Malignancies [see Warnings and Precautions (5.1)]
Cardiomyopathy [see Warnings and Precautions (5.2)]
Venous Thromboembolism [see Warnings and Precautions (5.3)]
Ocular Toxicities [see Warnings and Precautions (5.4)]
Interstitial Lung Disease [see Warnings and Precautions (5.5)]
Hepatotoxicity [see Warnings and Precautions (5.6)]
Rhabdomyolysis [see Warnings and Precautions (5.7)]
Hemorrhage [see Warnings and Precautions (5.8)]
Embryo-Fetal Toxicity [see Warnings and Precautions (5.9)]
Risks Associated with Combination Treatment [see Warnings and Precautions (5.10)]

6.1 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 data described in WARNINGS AND PRECAUTIONS reflect exposure of 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma to MEKTOVI 45 mg twice daily in combination with encorafenib 450 mg once daily in a randomized open-label, active-controlled trial (COLUMBUS) [see Clinical Studies (14.1)] or, for rare events, exposure of 690 patients with BRAF V600 mutation-positive melanoma to MEKTOVI 45 mg twice daily in combination with encorafenib once daily across multiple clinical trials (NCT03915951, NCT01909453).

The pooled safety population described in the WARNINGS AND PRECAUTIONS also reflect exposure of 98 patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer to MEKTOVI 45 mg twice daily and encorafenib 450 mg once daily until disease progression or unacceptable toxicity in PHAROS [see Clinical Studies (14.2)].

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

The data described below reflect exposure of 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma to MEKTOVI (45 mg twice daily) in combination with encorafenib (450 mg once daily) in COLUMBUS.

The COLUMBUS trial [see Clinical Studies (14.1)] excluded patients with a history of Gilbert's syndrome, abnormal left ventricular ejection fraction, prolonged QTc (>480 msec), uncontrolled hypertension, and history or current evidence of retinal vein occlusion. The median duration of exposure was 11.8 months for patients treated with MEKTOVI in combination with encorafenib and 6.2 months for patients treated with vemurafenib.

The most common (≥25%) adverse reactions in patients receiving MEKTOVI in combination with encorafenib were fatigue, nausea, diarrhea, vomiting, and abdominal pain.

Adverse reactions leading to dose interruptions of MEKTOVI occurred in 33% of patients receiving MEKTOVI in combination with encorafenib; the most common were left ventricular dysfunction (6%) and serous retinopathy (5%). Adverse reactions leading to dose reductions of MEKTOVI occurred in 19% of patients receiving MEKTOVI in combination with encorafenib; the most common were left ventricular dysfunction (3%), serous retinopathy (3%), and colitis (2%). Five percent (5%) of patients receiving MEKTOVI in combination with encorafenib experienced an adverse reaction that resulted in permanent discontinuation of MEKTOVI. The most common adverse reactions resulting in permanent discontinuation of MEKTOVI were hemorrhage in 2% and headache in 1% of patients.

Table 3 and Table 4 present adverse drug reactions and laboratory abnormalities, respectively, identified in COLUMBUS. The COLUMBUS trial was not designed to demonstrate a statistically significant difference in adverse reaction rates for MEKTOVI in combination with encorafenib, as compared to vemurafenib, for any specific adverse reaction listed in Table 3.

Table 3: Adverse Reactions Occurring in ≥10% of Patients Receiving MEKTOVI in Combination with Encorafenib in COLUMBUS*
Adverse ReactionMEKTOVI with
encorafenib
N=192
Vemurafenib
N=186
All
Grades
(%)
Grades
3 and 4
(%)
All
Grades
(%)
Grades
3 and 4
(%)
*
Grades per National Cancer Institute CTCAE v4.03.
Grade 4 adverse reactions limited to diarrhea (n=1) and hemorrhage (n=3) in the MEKTOVI with encorafenib arm and constipation (n=1) in the vemurafenib arm.
Represents a composite of multiple, related preferred terms.

General Disorders and Administration Site Conditions

  Fatigue

43

3

46

6

  Pyrexia

18

4

30

0

  Peripheral edema

13

1

15

1

Gastrointestinal Disorders

  Nausea

41

2

34

2

  Diarrhea

36

3

34

2

  Vomiting

30

2

16

1

  Abdominal pain

28

4

16

1

  Constipation

22

0

6

1

Skin and Subcutaneous Tissue Disorders

  Rash

22

1

53

13

Nervous System Disorders

  Dizziness

15

3

4

0

Visual Disorders

  Visual impairment

20

0

4

0

  Serous retinopathy/RPED

20

3

2

0

Vascular Disorders

  Hemorrhage

19

3

9

2

  Hypertension

11

6

11

3

Other clinically important adverse reactions occurring in <10% of patients who received MEKTOVI in combination with encorafenib were:

Gastrointestinal disorders: Colitis

Skin and subcutaneous tissue disorders: Panniculitis

Immune system disorders: Drug hypersensitivity

Table 4: Laboratory Abnormalities Occurring in ≥10% (All grades) of Patients Receiving MEKTOVI in Combination with Encorafenib in COLUMBUS*
Laboratory AbnormalityMEKTOVI
with encorafenib
N=192
Vemurafenib
N=186
All
Grades
(%)
Grades
3 and 4
(%)
All
Grades
(%)
Grades
3 and 4
(%)
*
Grades per National Cancer Institute CTCAE v4.03.

Hematology

  Anemia

36

3.6

34

2.2

  Leukopenia

13

0

10

0.5

  Lymphopenia

13

2.1

30

7

  Neutropenia

13

3.1

4.8

0.5

Chemistry

  Increased Creatinine

93

3.6

92

1.1

  Increased Creatine Phosphokinase

58

5

3.8

0

  Increased Gamma Glutamyl Transferase

45

11

34

4.8

  Increased ALT

29

6

27

2.2

  Increased AST

27

2.6

24

1.6

  Increased Alkaline Phosphatase

21

0.5

35

2.2

  Hyponatremia

18

3.6

15

0.5

BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

The safety of MEKTOVI in combination with encorafenib is described in 98 patients with BRAF V600E mutation-positive metastatic NSCLC who received MEKTOVI (45 mg twice daily) in combination with encorafenib (450 mg once daily) in an open-label, single-arm trial (PHAROS).

The PHAROS trial [see Clinical Studies (14.2)] excluded patients with abnormal LVEF, prolonged QTc (>480 ms), uncontrolled hypertension, and history or current evidence of retinal vein occlusion. The median duration of treatment for MEKTOVI and encorafenib was 8.4 and 9.2 months respectively.

The most common (≥25%) adverse reactions in patients receiving MEKTOVI were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.

Adverse reactions leading to dose interruptions of MEKTOVI occurred in 62% of patients receiving MEKTOVI; the most common (≥5%) were diarrhea (17%); nausea (15%); fatigue (9%); AST increased (7%); ALT increased, anemia, musculoskeletal pain, vomiting (6% each); and acute kidney injury, hemorrhage, and LV dysfunction/cardiomyopathy (5% each). Adverse reactions leading to dose reductions of MEKTOVI occurred in 33% of patients receiving MEKTOVI; the most common (≥5%) were diarrhea (8%), nausea (6%), and AST increased (5%). A total of 17% of patients receiving MEKTOVI experienced an adverse reaction that resulted in permanent discontinuation of MEKTOVI; the most common (≥2%) were diarrhea (3.1%); musculoskeletal pain, LV dysfunction/cardiomyopathy, fatigue, nausea, rash, visual impairment, and vomiting (2% each). None of the other adverse reactions leading to permanent discontinuation of MEKTOVI occurred in more than 1 patient.

Serious adverse reactions occurred in 38% of patients who received MEKTOVI in combination with encorafenib. Serious adverse reactions in ≥2% of patients included hemorrhage (6%); diarrhea (4.1%); anemia, dyspnea, pneumonia (3.1% each); arrhythmia, device related infection, edema, myocardial infarction, and pleural effusion (2% each). Fatal adverse reactions occurred in 2% of patients who received MEKTOVI (45 mg twice-daily) in combination with encorafenib, including intracranial hemorrhage and myocardial infarction (1% each).

Table 5 and Table 6 present adverse drug reactions and laboratory abnormalities, respectively, identified in PHAROS.

Table 5: Adverse Reactions Occurring in ≥10% of Patients Receiving MEKTOVI in Combination with Encorafenib in PHAROS*
*
Grades per National Cancer Institute CTCAE v4.03.
One Grade 5 adverse reaction of hemorrhage occurred.
Fatigue includes fatigue, asthenia.
§
Edema includes edema peripheral, generalized edema, swelling, localized edema, face edema.
Diarrhea includes diarrhea, colitis.
#
Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort.
Þ
Visual impairment includes vision blurred, visual impairment, vitreous floaters, photophobia, visual acuity reduced, photopsia.
ß
Musculoskeletal pain includes back pain, arthralgia, pain in extremity, myalgia, musculoskeletal chest pain, non-cardiac chest pain, neck pain.
à
Rash includes rash, rash macular, rash maculo-papular, rash papular, rash pustular,dermatitis acneiform, palmar-plantar erythrodysesthesia syndrome, eczema, skin exfoliation.
è
Pruritis includes pruritus, pruritus genital.
ð
Dyspnea includes dyspnea, dyspnea exertional.
ø
Cough includes cough, productive cough.
ý
Dizziness includes dizziness, balance disorder.
£
Hemorrhage includes anal hemorrhage, hemothorax, gastrointestinal hemorrhage, hematochezia, hematuria, hemoptysis, hemorrhage intracranial, hyphema, small intestinal hemorrhage, upper gastrointestinal hemorrhage, vaginal hemorrhage.
¥
Left ventricular dysfunction/cardiomyopathy includes ejection fraction decreased, cardiac failure, cardiac failure congestive.

 

 

Adverse Reaction

MEKTOVI

with encorafenib

N=98

All

Grades

(%)

Grade 3 and 4

(%)

General Disorders and Administration Site Conditions

   Fatigue

61

8

   Edema§

23

1

   Pyrexia

22

0

Gastrointestinal Disorders

   Nausea

58

3.1

   Diarrhea

52

7

   Vomiting

37

1

   Abdominal pain#

32

1

   Constipation

27

0

Eye Disorders

   Visual impairmentÞ

29

2

Musculoskeletal and Connective Tissue Disorders

   Musculoskeletal painß

48

4.1

Skin and Subcutaneous Tissue Disorders

   Rashà

27

3.1

   Pruritisè

16

0

   Dry skin

13

0

   Alopecia

12

0

Respiratory, Thoracic and Mediastinal Disorders

   Dyspneað

27

8

   Coughø

26

0

Nervous System Disorders

   Dizzinessý

17

1

   Headache

11

0

Metabolism and Nutrition Disorders

   Decreased appetite

14

1

Vascular Disorders

   Hemorrhage£

12

4.1

   Hypertension

10

5

Cardiac Disorders

   Left ventricular dysfunction/cardiomyopathy¥

11

1

Investigations

   Weight increased

11

1

Psychiatric Disorders

   Insomnia

10

0

Other clinically important adverse reactions occurring in <10% of patients who received MEKTOVI in combination with encorafenib were:

Nervous system disorders: Peripheral neuropathy, Dysgeusia, Facial paresis

Gastrointestinal disorders: Pancreatitis

Skin and subcutaneous tissue disorders: Hyperkeratosis, Erythema

Immune system disorders: Drug hypersensitivity

Table 6: Laboratory Abnormalities Occurring in ≥10% (All Grades) of Patients Receiving MEKTOVI with Encorafenib in PHAROS*
*
Grades per National Cancer Institute CTCAE v4.03.
Based on the number of patients with available baseline and at least one on-treatment laboratory test.

 

 

Laboratory Abnormality

MEKTOVI with encorafenib

All

Grades

(%)

Grades

3 and 4

(%)

Hematology

    Anemia

47

11

    Lymphopenia

24

6

    Thrombocytopenia

20

1.1

    Leukopenia

12

0

    Neutropenia

12

1.1

Chemistry

    Increased creatinine

91

3.2

    Hyperglycemia

48

6

    Increased creatine kinase

41

3.3

    Lipase increased

40

14

    Increased ALT

34

9

    Hypoalbuminemia

32

0

    Increased AST

31

10

    Increased alkaline phosphatase

31

3.2

    Hyperkalemia

31

2.1

    Hyponatremia

26

11

    Serum amylase increased

22

1.1

    Hypocalcemia

12

2.1

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Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

New Primary Malignancies [see Warnings and Precautions (5.1)]
Cardiomyopathy [see Warnings and Precautions (5.2)]
Venous Thromboembolism [see Warnings and Precautions (5.3)]
Ocular Toxicities [see Warnings and Precautions (5.4)]
Interstitial Lung Disease [see Warnings and Precautions (5.5)]
Hepatotoxicity [see Warnings and Precautions (5.6)]
Rhabdomyolysis [see Warnings and Precautions (5.7)]
Hemorrhage [see Warnings and Precautions (5.8)]
Embryo-Fetal Toxicity [see Warnings and Precautions (5.9)]
Risks Associated with Combination Treatment [see Warnings and Precautions (5.10)]

6.1 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 data described in WARNINGS AND PRECAUTIONS reflect exposure of 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma to MEKTOVI 45 mg twice daily in combination with encorafenib 450 mg once daily in a randomized open-label, active-controlled trial (COLUMBUS) [see Clinical Studies (14.1)] or, for rare events, exposure of 690 patients with BRAF V600 mutation-positive melanoma to MEKTOVI 45 mg twice daily in combination with encorafenib once daily across multiple clinical trials (NCT03915951, NCT01909453).

The pooled safety population described in the WARNINGS AND PRECAUTIONS also reflect exposure of 98 patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer to MEKTOVI 45 mg twice daily and encorafenib 450 mg once daily until disease progression or unacceptable toxicity in PHAROS [see Clinical Studies (14.2)].

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

The data described below reflect exposure of 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma to MEKTOVI (45 mg twice daily) in combination with encorafenib (450 mg once daily) in COLUMBUS.

The COLUMBUS trial [see Clinical Studies (14.1)] excluded patients with a history of Gilbert's syndrome, abnormal left ventricular ejection fraction, prolonged QTc (>480 msec), uncontrolled hypertension, and history or current evidence of retinal vein occlusion. The median duration of exposure was 11.8 months for patients treated with MEKTOVI in combination with encorafenib and 6.2 months for patients treated with vemurafenib.

The most common (≥25%) adverse reactions in patients receiving MEKTOVI in combination with encorafenib were fatigue, nausea, diarrhea, vomiting, and abdominal pain.

Adverse reactions leading to dose interruptions of MEKTOVI occurred in 33% of patients receiving MEKTOVI in combination with encorafenib; the most common were left ventricular dysfunction (6%) and serous retinopathy (5%). Adverse reactions leading to dose reductions of MEKTOVI occurred in 19% of patients receiving MEKTOVI in combination with encorafenib; the most common were left ventricular dysfunction (3%), serous retinopathy (3%), and colitis (2%). Five percent (5%) of patients receiving MEKTOVI in combination with encorafenib experienced an adverse reaction that resulted in permanent discontinuation of MEKTOVI. The most common adverse reactions resulting in permanent discontinuation of MEKTOVI were hemorrhage in 2% and headache in 1% of patients.

Table 3 and Table 4 present adverse drug reactions and laboratory abnormalities, respectively, identified in COLUMBUS. The COLUMBUS trial was not designed to demonstrate a statistically significant difference in adverse reaction rates for MEKTOVI in combination with encorafenib, as compared to vemurafenib, for any specific adverse reaction listed in Table 3.

Table 3: Adverse Reactions Occurring in ≥10% of Patients Receiving MEKTOVI in Combination with Encorafenib in COLUMBUS*
Adverse ReactionMEKTOVI with
encorafenib
N=192
Vemurafenib
N=186
All
Grades
(%)
Grades
3 and 4
(%)
All
Grades
(%)
Grades
3 and 4
(%)
*
Grades per National Cancer Institute CTCAE v4.03.
Grade 4 adverse reactions limited to diarrhea (n=1) and hemorrhage (n=3) in the MEKTOVI with encorafenib arm and constipation (n=1) in the vemurafenib arm.
Represents a composite of multiple, related preferred terms.

General Disorders and Administration Site Conditions

  Fatigue

43

3

46

6

  Pyrexia

18

4

30

0

  Peripheral edema

13

1

15

1

Gastrointestinal Disorders

  Nausea

41

2

34

2

  Diarrhea

36

3

34

2

  Vomiting

30

2

16

1

  Abdominal pain

28

4

16

1

  Constipation

22

0

6

1

Skin and Subcutaneous Tissue Disorders

  Rash

22

1

53

13

Nervous System Disorders

  Dizziness

15

3

4

0

Visual Disorders

  Visual impairment

20

0

4

0

  Serous retinopathy/RPED

20

3

2

0

Vascular Disorders

  Hemorrhage

19

3

9

2

  Hypertension

11

6

11

3

Other clinically important adverse reactions occurring in <10% of patients who received MEKTOVI in combination with encorafenib were:

Gastrointestinal disorders: Colitis

Skin and subcutaneous tissue disorders: Panniculitis

Immune system disorders: Drug hypersensitivity

Table 4: Laboratory Abnormalities Occurring in ≥10% (All grades) of Patients Receiving MEKTOVI in Combination with Encorafenib in COLUMBUS*
Laboratory AbnormalityMEKTOVI
with encorafenib
N=192
Vemurafenib
N=186
All
Grades
(%)
Grades
3 and 4
(%)
All
Grades
(%)
Grades
3 and 4
(%)
*
Grades per National Cancer Institute CTCAE v4.03.

Hematology

  Anemia

36

3.6

34

2.2

  Leukopenia

13

0

10

0.5

  Lymphopenia

13

2.1

30

7

  Neutropenia

13

3.1

4.8

0.5

Chemistry

  Increased Creatinine

93

3.6

92

1.1

  Increased Creatine Phosphokinase

58

5

3.8

0

  Increased Gamma Glutamyl Transferase

45

11

34

4.8

  Increased ALT

29

6

27

2.2

  Increased AST

27

2.6

24

1.6

  Increased Alkaline Phosphatase

21

0.5

35

2.2

  Hyponatremia

18

3.6

15

0.5

BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

The safety of MEKTOVI in combination with encorafenib is described in 98 patients with BRAF V600E mutation-positive metastatic NSCLC who received MEKTOVI (45 mg twice daily) in combination with encorafenib (450 mg once daily) in an open-label, single-arm trial (PHAROS).

The PHAROS trial [see Clinical Studies (14.2)] excluded patients with abnormal LVEF, prolonged QTc (>480 ms), uncontrolled hypertension, and history or current evidence of retinal vein occlusion. The median duration of treatment for MEKTOVI and encorafenib was 8.4 and 9.2 months respectively.

The most common (≥25%) adverse reactions in patients receiving MEKTOVI were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.

Adverse reactions leading to dose interruptions of MEKTOVI occurred in 62% of patients receiving MEKTOVI; the most common (≥5%) were diarrhea (17%); nausea (15%); fatigue (9%); AST increased (7%); ALT increased, anemia, musculoskeletal pain, vomiting (6% each); and acute kidney injury, hemorrhage, and LV dysfunction/cardiomyopathy (5% each). Adverse reactions leading to dose reductions of MEKTOVI occurred in 33% of patients receiving MEKTOVI; the most common (≥5%) were diarrhea (8%), nausea (6%), and AST increased (5%). A total of 17% of patients receiving MEKTOVI experienced an adverse reaction that resulted in permanent discontinuation of MEKTOVI; the most common (≥2%) were diarrhea (3.1%); musculoskeletal pain, LV dysfunction/cardiomyopathy, fatigue, nausea, rash, visual impairment, and vomiting (2% each). None of the other adverse reactions leading to permanent discontinuation of MEKTOVI occurred in more than 1 patient.

Serious adverse reactions occurred in 38% of patients who received MEKTOVI in combination with encorafenib. Serious adverse reactions in ≥2% of patients included hemorrhage (6%); diarrhea (4.1%); anemia, dyspnea, pneumonia (3.1% each); arrhythmia, device related infection, edema, myocardial infarction, and pleural effusion (2% each). Fatal adverse reactions occurred in 2% of patients who received MEKTOVI (45 mg twice-daily) in combination with encorafenib, including intracranial hemorrhage and myocardial infarction (1% each).

Table 5 and Table 6 present adverse drug reactions and laboratory abnormalities, respectively, identified in PHAROS.

Table 5: Adverse Reactions Occurring in ≥10% of Patients Receiving MEKTOVI in Combination with Encorafenib in PHAROS*
*
Grades per National Cancer Institute CTCAE v4.03.
One Grade 5 adverse reaction of hemorrhage occurred.
Fatigue includes fatigue, asthenia.
§
Edema includes edema peripheral, generalized edema, swelling, localized edema, face edema.
Diarrhea includes diarrhea, colitis.
#
Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort.
Þ
Visual impairment includes vision blurred, visual impairment, vitreous floaters, photophobia, visual acuity reduced, photopsia.
ß
Musculoskeletal pain includes back pain, arthralgia, pain in extremity, myalgia, musculoskeletal chest pain, non-cardiac chest pain, neck pain.
à
Rash includes rash, rash macular, rash maculo-papular, rash papular, rash pustular,dermatitis acneiform, palmar-plantar erythrodysesthesia syndrome, eczema, skin exfoliation.
è
Pruritis includes pruritus, pruritus genital.
ð
Dyspnea includes dyspnea, dyspnea exertional.
ø
Cough includes cough, productive cough.
ý
Dizziness includes dizziness, balance disorder.
£
Hemorrhage includes anal hemorrhage, hemothorax, gastrointestinal hemorrhage, hematochezia, hematuria, hemoptysis, hemorrhage intracranial, hyphema, small intestinal hemorrhage, upper gastrointestinal hemorrhage, vaginal hemorrhage.
¥
Left ventricular dysfunction/cardiomyopathy includes ejection fraction decreased, cardiac failure, cardiac failure congestive.

 

 

Adverse Reaction

MEKTOVI

with encorafenib

N=98

All

Grades

(%)

Grade 3 and 4

(%)

General Disorders and Administration Site Conditions

   Fatigue

61

8

   Edema§

23

1

   Pyrexia

22

0

Gastrointestinal Disorders

   Nausea

58

3.1

   Diarrhea

52

7

   Vomiting

37

1

   Abdominal pain#

32

1

   Constipation

27

0

Eye Disorders

   Visual impairmentÞ

29

2

Musculoskeletal and Connective Tissue Disorders

   Musculoskeletal painß

48

4.1

Skin and Subcutaneous Tissue Disorders

   Rashà

27

3.1

   Pruritisè

16

0

   Dry skin

13

0

   Alopecia

12

0

Respiratory, Thoracic and Mediastinal Disorders

   Dyspneað

27

8

   Coughø

26

0

Nervous System Disorders

   Dizzinessý

17

1

   Headache

11

0

Metabolism and Nutrition Disorders

   Decreased appetite

14

1

Vascular Disorders

   Hemorrhage£

12

4.1

   Hypertension

10

5

Cardiac Disorders

   Left ventricular dysfunction/cardiomyopathy¥

11

1

Investigations

   Weight increased

11

1

Psychiatric Disorders

   Insomnia

10

0

Other clinically important adverse reactions occurring in <10% of patients who received MEKTOVI in combination with encorafenib were:

Nervous system disorders: Peripheral neuropathy, Dysgeusia, Facial paresis

Gastrointestinal disorders: Pancreatitis

Skin and subcutaneous tissue disorders: Hyperkeratosis, Erythema

Immune system disorders: Drug hypersensitivity

Table 6: Laboratory Abnormalities Occurring in ≥10% (All Grades) of Patients Receiving MEKTOVI with Encorafenib in PHAROS*
*
Grades per National Cancer Institute CTCAE v4.03.
Based on the number of patients with available baseline and at least one on-treatment laboratory test.

 

 

Laboratory Abnormality

MEKTOVI with encorafenib

All

Grades

(%)

Grades

3 and 4

(%)

Hematology

    Anemia

47

11

    Lymphopenia

24

6

    Thrombocytopenia

20

1.1

    Leukopenia

12

0

    Neutropenia

12

1.1

Chemistry

    Increased creatinine

91

3.2

    Hyperglycemia

48

6

    Increased creatine kinase

41

3.3

    Lipase increased

40

14

    Increased ALT

34

9

    Hypoalbuminemia

32

0

    Increased AST

31

10

    Increased alkaline phosphatase

31

3.2

    Hyperkalemia

31

2.1

    Hyponatremia

26

11

    Serum amylase increased

22

1.1

    Hypocalcemia

12

2.1

Medication Guide

Health Professional Information

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