Sutent

Serious Warnings

• Black Box Warning: Sunitinib is associated with several serious and potentially life-threatening adverse reactions that require careful monitoring and management, even in the absence of a formal FDA Black Box Warning. **Hepatotoxicity**, including severe and fatal hepatic failure, has been reported. Liver function tests (ALT, AST, bilirubin) should be monitored before the start of treatment and during each cycle, with dose modification or interruption recommended for significant abnormalities. **Cardiovascular events**, such as left ventricular dysfunction, congestive heart failure, and QT interval prolongation, can occur; baseline and periodic cardiac monitoring, including ECG and echocardiograms, are crucial, especially in patients with pre-existing cardiac risk factors. **Hypertension**, often severe, is common and requires strict blood pressure monitoring and control; treatment interruption or discontinuation may be necessary. **Hemorrhage**, including fatal events, can arise from various sites; patients on anticoagulants or with underlying bleeding diatheses require increased vigilance. Other serious risks include **thromboembolic events** (both arterial and venous), **adrenal dysfunction**, **thyroid dysfunction**, **proteinuria** (sometimes severe, requiring dose modification), and **renal dysfunction**. Patients must be closely monitored for these serious adverse events throughout the course of therapy to mitigate risks and ensure patient safety.
• Cardiovascular events (e.
• g.
• , congestive heart failure, decreased left ventricular ejection fraction, myocardial ischemia/infarction) have been reported; monitor for signs/symptoms.
• Severe, sometimes fatal, hepatotoxicity has been observed; monitor liver function tests.
• Hypertension can be severe and require treatment; monitor blood pressure.
• May cause serious or fatal hemorrhagic events.
• Thyroid dysfunction (hypothyroidism and hyperthyroidism) has been reported; monitor thyroid function.
• Adrenal insufficiency may occur.
• QT prolongation and Torsade de Pointes can occur; monitor ECG and electrolytes.
• Thrombotic microangiopathy (TMA) has been reported; monitor for signs/symptoms.
• Gastrointestinal perforation, sometimes fatal, has occurred.
• Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported.
• Osteonecrosis of the jaw (ONJ) has been observed; advise patients to maintain good oral hygiene.
• Impairment of wound healing; interrupt treatment prior to major surgery.
• Reversible posterior leukoencephalopathy syndrome (RPLS) has occurred; discontinue if diagnosed.
• Hypoglycemia may lead to loss of consciousness; monitor blood glucose, especially in diabetics.
• Proteinuria may develop or worsen; monitor urine protein.
• Embryo-fetal toxicity: Can cause fetal harm; advise females of reproductive potential of the potential risk.