Note: This document contains side effect information about cobimetinib. Some dosage forms listed on this page may not apply to the brand name Cotellic.

Summary

Common side effects of Cotellic include: skin photosensitivity. Other side effects include: increased creatine phosphokinase in blood specimen. Continue reading for a comprehensive list of adverse effects.

Applies to cobimetinib: oral tablet.

Serious side effects of Cotellic

Along with its needed effects, cobimetinib (the active ingredient contained in Cotellic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cobimetinib:

More common

• Bleeding gums
• blue lips and fingernails
• blurred vision or any other change in vision
• chest discomfort or pain
• chills
• clay colored stools
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• dark urine
• decreased appetite
• difficulty in breathing or swallowing
• dizziness
• faintness
• fast irregular or pounding heartbeat
• fever
• headache
• increased menstrual flow or vaginal bleeding
• increased sensitivity of the skin to sunlight
• increased sweating
• itching or skin rash
• loss of appetite
• muscle cramps or spasms
• muscle pain or stiffness
• nausea and vomiting
• nervousness
• nosebleeds
• pale skin
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness or other discoloration of the skin
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• severe sunburn
• slow or fast heartbeat
• stomach pain or tenderness
• swelling of the feet or lower legs
• unusual tiredness or weakness
• yellow eyes or skin

Other side effects of Cotellic

Some side effects of cobimetinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• acne or pimples
• belching
• bladder pain
• bloody or cloudy urine
• diarrhea
• difficult, burning, or painful urination
• dry mouth
• frequent urge to urinate
• heartburn
• indigestion
• lower back or side pain
• nausea
• stomach discomfort or upset
• swelling or inflammation of the mouth
• vomiting

For Healthcare Professionals

Applies to cobimetinib: oral tablet.

Cardiovascular

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Decreased left ventricular ejection fraction (26%), hypertension (15%)^[Ref]

Dermatologic

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Acneiform dermatitis (16%), alopecia (15%), erythema (10%), hyperkeratosis (11%), maculopapular rash, photosensitivity reactions (46%)

-Histiocytic Neoplasms: Acneiform dermatitis (65%), dry skin (31%), maculo-papular rash (31%), pruritus (31%)^[Ref]

Gastrointestinal

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Diarrhea (60%), nausea (41%), stomatitis (14%), vomiting (24%)

-Histiocytic Neoplasms: Diarrhea (62%), dry mouth (15%), dyspepsia (27%), nausea (46%), oral pain (15%), stomatitis (12%), vomiting (27%)^[Ref]

General

The most commonly reported adverse reactions (more than 35%) in patients treated for melanoma were increased creatinine, increased CPK, lymphopenia, increased AST, increased alkaline phosphatase, increased ALT, hypophosphatemia, anemia, increased gamma-glutamyltransferase, diarrhea, photosensitivity reactions, hypoalbuminemia, nausea, and hyponatremia.^[Ref]

Hematologic

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Lymphopenia (73%), anemia (69%), thrombocytopenia (18%), hemorrhage (e.g., rectal, hemorrhoidal, GI tract, uterine, vaginal, pulmonary, cerebral, subarachnoid, ocular, eye, conjunctival, retinal, reproductive system, melena, hematemesis, hematochezia, gingival bleeding, metrorrhagia, hemorrhagic ovarian cyst, menometrorrhagia, menorrhagia, hemoptysis, subgaleal hematoma, hematuria, epistaxis, contusion, traumatic hematoma, ecchymosis, purpura, nail bed bleeding)

-Histiocytic Neoplasms: Hemorrhage (19%), hypertension (15%), lymphopenia (27%)

Common (1% to 10%):

-Histiocytic Neoplasms: Anemia, neutropenia, leukopenia^[Ref]

Hepatic

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Increased aspartate aminotransferase (AST) (73%), increased alkaline phosphatase (71%), increased alanine aminotransferase (ALT) (68%), increased gamma-glutamyltransferase (65%)

Common (1% to 10%):

-Histiocytic Neoplasms: Increased AST, increased ALT

Frequency not reported: Increased total bilirubin^[Ref]

Metabolic

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Dehydration, hypophosphatemia (68%), hypoalbuminemia (42%), hyponatremia (38%), hyperkalemia (26%), hypokalemia (25%), hypocalcemia (24%)

-Histiocytic Neoplasms: Hypokalemia (12%), hyponatremia (18%)

Common (1% to 10%):

-Histiocytic Neoplasms: Hypocalcemia^[Ref]

Musculoskeletal

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Increased creatine phosphokinase (CPK) (79%)

-Histiocytic Neoplasms: Increased CPK (27%)^[Ref]

Nervous system

Very common (10% or more):

-Histiocytic Neoplasms: Headache (12%)

Ocular

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Vision impaired (e.g., vision blurred, visual acuity reduced, visual impairment) (15%), chorioretinopathy (e.g., retinal detachment, detachment of retinal pigment epithelium, detachment of macular retinal pigment epithelium) (13%), retinal detachment (e.g., retinal detachment, detachment of retinal pigment epithelium, detachment of macular retinal pigment epithelium) (12%)

-Histiocytic Neoplasms: Vision blurred (12%)

Common (1% to 10%):

-Unresectable or Metastatic Melanoma: Serious retinopathy (chorioretinopathy, retinal detachment)

-Histiocytic Neoplasms: Retinal vascular disorder, retinopathy

Frequency not reported:

-Unresectable or Metastatic Melanoma: Retinal vein occlusion^[Ref]

Oncologic

Common (1% to 10%):

-Unresectable or Metastatic Melanoma: Cutaneous squamous cell carcinoma/keratoacanthoma, basal cell carcinoma

Uncommon (0.1% to 1%):

-Unresectable or Metastatic Melanoma: Second primary melanoma, non-cutaneous malignancies^[Ref]

Other

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Pyrexia (28%), hemorrhage (13%), chills (10%)

-Histiocytic Neoplasms: Decreased ejection fraction (19%), edema (42%), fall (15%), fatigue (42%), pain (15%)^[Ref]

Renal

Very common (10% or more):

-Unresectable or Metastatic Melanoma: Increased creatinine (99.6%)

-Histiocytic Neoplasms: Acute kidney injury (15%)^[Ref]

Respiratory

Very common (10% or more):

-Histiocytic Neoplasms: Cough (15%), dyspnea (27%), hypoxia (12%), pulmonary infections (19%)

Common (1% to 10%):

-Histiocytic Neoplasms: Pulmonary edema, respiratory failure