Sunitinib Side Effects

Brand Names: Sutent

Please note - some side effects for Sunitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sunitinib - for the Consumer

Sunitinib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sunitinib:

Changes in taste; constipation; decreased appetite; diarrhea; dry, thick, or cracked skin; headache; indigestion; mouth pain or irritation; nausea; nosebleed; skin or hair discoloration; stomach pain or upset; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blistering or rash on the palms of hands and soles of feet; calf swelling or tenderness; chest pain; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, confusion, decreased alertness, depression, irritability, nervousness); muscle pain, tenderness, or weakness; numbness of an arm or leg; numbness or tingling of the hands or feet; pale stools; seizures; severe or persistent headache, dizziness, stomach pain, back pain, tiredness, or weakness; shortness of breath; swelling of the hands or legs; symptoms of thyroid problems (eg, changes in menstrual period, excessive sweating, increased appetite, increased sensitivity to hot or cold conditions, sudden weight changes, tremors, trouble sleeping); unusual or severe bruising or bleeding (eg, bleeding gums, nosebleeds); vision changes or vision loss; vomit that looks like coffee grounds; yellowing of the eyes or skin.

Side Effects by Body System

General

General side effects including fatigue (up to 74%), anorexia (up to 33%), asthenia (up to 22%), 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 including diarrhea (up to 55%), nausea (up to 54%), mucositis/stomatitis (up to 53%), dyspepsia (up to 46%), vomiting (up to 37%), constipation (up to 34%), abdominal pain (up to 33%), glossodynia (up to 15%), and flatulence (up to 14%) have been reported.

Hematologic

Hematologic side effects have been reported including bleeding from all sites (up to 26%). Treatment-emergent laboratory abnormalities from Study A on gastrointestinal stromal tumor (GIST) patients have included neutropenia (up to 53%), lymphopenia (up to 38%), thrombocytopenia (up to 38%), and anemia (up to 26%). Common treatment-emergent grade 3 and 4 chemistry laboratory abnormalities in the metastatic renal cell carcinoma (MRCC) studies included increased lipase (16%), increased amylase (5%), hypophosphatemia (10%), and hyperuricemia (10%). Grade 3 leukopenia (7%) has also been reported by the MRCC studies.

Four patients (2%) in the two MRCC 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 reports of thrombotic microangiopathy.

Nervous system

Nervous system side effects including altered taste (up to 43%), headache (up to 25%), dizziness (up to 16%), and peripheral neuropathy (10%) have been reported.

In clinical studies of sunitinib, seizures have been observed in subjects with radiological evidence of brain metastases. There have also been rare (<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.

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.

Hepatic

Hepatic side effects have included treatment-emergent laboratory abnormalities in AST/ALT (39%), lipase (25%), alkaline phosphatase (24%), amylase (17%), total bilirubin (16%), and indirect bilirubin (10%) as reported by Study A on gastrointestinal stromal tumor (GIST) patients. A case of sunitinib-related fulminant hepatic failure has also been reported.

Dermatologic

Dermatologic side effects including rash (up to 38%), skin discoloration (up to 33%), dry skin (up to 17%), hair color changes (up to 17%), hand-foot syndrome (up to 14%), alopecia (up to 12%), and blistering of the skin (up to 7%) have been reported. 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.

Cardiovascular

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.

Cardiovascular side effects including hypertension (up to 28%) and peripheral edema (up to 17%) have been reported. Treatment-emergent laboratory abnormalities have included decreased left ventricular ejection fraction (up to 11%) reported by Study A on gastrointestinal stromal tumor (GIST) patients. Six cases of heart failure have been reported. Two patients with metastatic renal cell carcinoma experienced grade 3 myocardial ischemia, one had grade 2 "cardiovascular toxicity" reported as an adverse event, and one patient experienced a fatal myocardial infarction while on treatment.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 28%), limb pain (up to 18%), back pain (up to 17%), and myalgia (up to 17%) have been reported. Cases of myopathy and/or rhabdomyolysis have also been reported.

Respiratory

Respiratory side effects including dyspnea (up to 28%) and cough (up to 17%) have been reported.

Renal

Renal side effects have included treatment-emergent laboratory abnormalities in uric acid (15%) and creatinine (12%) reported by Study A on gastrointestinal stromal tumor (GIST) patients. Postmarketing reports have included cases of proteinuria and rare cases of nephrotic syndrome.

Metabolic

Metabolic side effects have included treatment-emergent laboratory abnormalities such as hypokalemia (12%) and hypernatremia (10%) reported by Study A on gastrointestinal stromal tumor (GIST) patients.

Other

Other side effects including appetite disturbance (up to 9%) have been reported.

Ocular

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

Endocrine

Endocrine side effects including hypothyroidism (up to 4%) 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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