Sunitinib Side Effects

Some side effects of sunitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sunitinib: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking sunitinib: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sunitinib and call your doctor at once if you have a serious side effect such as:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• feeling short of breath (even with mild exertion), swelling in your ankles or feet;

• sudden numbness or weakness, problems with vision, speech, or balance;

• numbness or tingly feeling around your mouth;

• slow heart rate, weak pulse, confusion;

• muscle weakness, tightness, or contraction, overactive reflexes;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• lower back pain, blood in your urine;

• urinating less than usual or not at all;

• pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• missed menstrual periods;

• feeling depressed or very tired, loss of appetite, diarrhea, weight gain or loss, hair loss, sweating, increased sensitivity to heat.

• fever, white patches or sores inside your mouth or on your lips; or

• redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet.

Less serious side effects of sunitinib may include:

• unusual or unpleasant taste in the mouth;

• cough;

• mild nausea, vomiting, upset stomach;

• constipation;

• dry skin, changes in skin or hair color; or

• joint pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sunitinib: oral capsule

General

General side effects including fatigue (up to 74%), anorexia (up to 48%), asthenia (up to 34%), fever (up to 18%), and dehydration (up to 11%) have been reported. Cases of serious infection, some with fatal outcome, have also been reported.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 66%), nausea (up to 58%), mucositis/stomatitis (up to 53%), dyspepsia (up to 46%), vomiting (up to 39%), abdominal pain (up to 39%), constipation (up to 34%), flatulence (up to 14%), and glossodynia (up to 11%). Laboratory abnormalities have included increased lipase (up to 56%) and increased amylase (up to 35%).

Hematologic

Hematologic side effects have included bleeding events (up to 37%) and epistaxis (up to 21%). Hematologic laboratory abnormalities have included neutropenia (up to 77%), lymphocytopenia (up to 68%), thrombocytopenia (up to 68%), anemia (up to 79%) and leukopenia (up to 78%). Fatal hemorrhage has also been reported.

Four patients (2%) in the two RCC studies had venous thromboembolic events reported. Two of the patients had pulmonary embolism (both grade 4) and two patients had deep venous thrombosis (DVT) (both grade 3). Dose interruption occurred in one of these cases. Seven patients (3%) on sunitinib in GIST Study A experienced venous thromboembolic events. Five of the seven were grade 3 DVTs, and two were grade 1 or 2. Four of these seven GIST patients discontinued treatment following first observation of DVT. Cases of erythrocytosis and macrocytosis have also been reported.

Postmarketing reports have included arterial thromboembolic events, some with fatal outcomes. The most frequent events included cerebrovascular accident, transient ischemic attack and cerebral infarction. Other postmarketing reports have included pulmonary embolism and pulmonary hemorrhage, some with fatal outcomes, cases of fatal hemorrhage associated with thrombocytopenia, and thrombotic microangiopathy.

Nervous system

Patients with seizures and signs and symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness should be controlled with medical management including control of hypertension. Temporary suspension of sunitinib is recommended. Following resolution, treatment may be resumed at the discretion of the treating physician.

Nervous system side effects have included altered taste (up to 47%), headache (up to 23%), and dizziness (up to 11%).

In clinical studies of sunitinib, seizures have been observed in subjects with radiological evidence of brain metastases. There have also been rare (less than 1%) reports of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS). None of these subjects had a fatal outcome to the event. A case of transient sunitinib-induced coma has also been reported.

Postmarketing case reports of hyperammonemic encephalopathy have been received.

Hepatic

Hepatic side effects have included liver failure (0.3%), including fatalities. Laboratory abnormalities have included elevated AST (up to 72%), elevated ALT (up to 61%), elevated total bilirubin (up to 37%), and elevated indirect bilirubin (13%).

Hypersensitivity

Hypersensitivity reactions have included angioedema and fistula formation.

Dermatologic

Dermatologic side effects have included skin discoloration (up to 30%), rash (up to 29%), hand-foot syndrome (up to 29%), hair color changes (up to 29%), dry skin (up to 23%), alopecia (up to 14%), erythema (up to 12%), and pruritus (up to 12%). A case of periodic hair depigmentation has also been reported. Other possible dermatologic side effects may include thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet. Postmarketing reports of pyoderma gangrenosum have been received.

Cardiovascular

Cardiovascular side effects have included hypertension (up to 34%) and peripheral edema (up to 24%). Heart failure including fatalities have been reported. Laboratory abnormalities have included decreased left ventricular ejection fraction (up to 16%).

Cardiovascular events, including heart failure, myocardial disorders and cardiomyopathy, some of which were fatal, have been reported through postmarketing experience.

Data from nonclinical (in vitro and in vivo) studies indicate that sunitinib has the potential to inhibit the cardiac action potential repolarization process (e.g., prolongation of QT interval). In GIST Study A, 23 patients (11%) on sunitinib versus 12 (12%) on placebo had observed QT prolongation greater than 20 milliseconds from baseline. No consistent, clinically significant QTc prolongation has been observed in completed clinical studies.

Musculoskeletal

Musculoskeletal side effects including pain in extremity, limb pain, limb discomfort or myalgia (up to 40%), arthralgia (up to 30%), and back pain (up to 28%) have been reported. Cases of myopathy and/or rhabdomyolysis have also been reported. Postmarketing reports of osteonecrosis of the jaw have been received.

Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.

Respiratory

Respiratory side effects have included cough (up to 27%), dyspnea (up to 26%), nasopharyngitis (up to 14%), oropharyngeal pain (up to 14%), and upper respiratory tract infection (up to 11%).

Renal

Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated. Sunitinib should be discontinued in patients with nephrotic syndrome.

Renal side effects have included laboratory abnormalities in creatinine (up to 70%). Postmarketing reports have included cases of proteinuria, rare cases of nephrotic syndrome, and renal failure, including fatalities.

Metabolic

Metabolic side effects have included laboratory abnormalities such as hyperglycemia (up to 71%), elevated creatine kinase (up to 49%), uric acid (up to 46%), hypoalbuminemia (up to 41%), hypophosphatemia (up to 36%), hypocalcemia (up to 42%), hyponatremia (up to 29%), hypoglycemia (up to 22%), hypokalemia (up to 21%), hypomagnesemia (up to 19%), hyperkalemia (up to 18%), and hypernatremia (up to 13%). Postmarketing reports of hyperammonemia and tumor lysis syndrome have been received.

Other

Other side effects including appetite disturbance (up to 9%) have been reported. Postmarketing reports of necrotizing fascitis have been received.

Ocular

Ocular side effects including periorbital edema (up to 7%) and increased lacrimation (up to 7%) have been reported.

Endocrine

Endocrine side effects including hyperparathyroidism (up to 62%), hypothyroidism (up to 16%) and TSH elevations (up to 2%) have been reported.

Severe fatigue has been reported to be a result of the onset of hypothyroidism.

Patients with symptoms suggestive of hypothyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.

Three medical doctors stated in a letter to the New England Journal of Medicine that for their group of 65 patients treated with sunitinib, the incidence of laboratory evidence of thyroid dysfunction was 60% to 70%. They made a general recommendation for monitoring thyroid dysfunction in patients receiving sunitinib or similar compounds.

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