Can sunitinib (Sunitinib Malate) be given with impaired renal function, specifically elevated Creatinine (CRE) levels of 156 micromoles per liter (μmol/L)?

From the Guidelines

Sunitinib can be given with caution when creatinine is 156 μmol/L, but close monitoring of kidney function and potential side effects is essential. According to the NCCN clinical practice guidelines in oncology: kidney cancer 1, sunitinib malate is a multikinase inhibitor that has shown antitumor activity in patients with metastatic RCC. The guidelines recommend sunitinib as a first-line treatment for patients with relapsed or medically unresectable stage IV renal cancer with predominant clear cell histology.

When considering the administration of sunitinib in patients with renal impairment, it is crucial to monitor kidney function, blood pressure, and potential side effects closely. Although sunitinib is primarily metabolized by the liver with minimal renal excretion, patients with impaired kidney function may be at higher risk for adverse effects like hypertension, proteinuria, and fluid retention.

Key considerations for administering sunitinib in this context include:

• Close monitoring of renal function during treatment
• Regular assessment of blood pressure and potential side effects
• Consultation with both oncology and nephrology specialists for optimal management
• Potential dose reduction to 37.5 mg daily or even 25 mg daily if renal function worsens significantly during therapy.

It is essential to weigh the benefits of sunitinib treatment against the potential risks in patients with moderate renal impairment, as indicated by a creatinine level of 156 μmol/L. By carefully monitoring patients and adjusting the treatment plan as needed, healthcare providers can optimize outcomes and minimize adverse effects.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Sunitinib Administration with Elevated Creatinine Levels

• The decision to administer sunitinib with creatinine levels of 156 μmol/L should be made with caution, as sunitinib can cause renal adverse effects, including renal insufficiency and proteinuria 2, 3.
• Studies have shown that sunitinib can cause hypertension, which can exacerbate renal dysfunction 2, 4.
• However, the incidence of renal adverse effects associated with sunitinib is generally lower than previously reported, and the severity of these effects is often mild to moderate and partially reversible after cessation of the drug 2.
• It is essential to monitor blood pressure, urinalysis, and renal function closely in patients receiving sunitinib, especially those with pre-existing renal impairment or hypertension 2, 4.

Renal Adverse Effects of Sunitinib

• Sunitinib has been associated with various renal adverse effects, including proteinuria, renal insufficiency, thrombotic microangiopathy, and acute and chronic kidney injury 2, 3.
• Risk factors for renal adverse effects include hypertension, dyslipidemia, and chronic kidney disease 2.
• Older age is also a risk factor for renal insufficiency 2.

Management of Sunitinib-Related Side Effects

• Fatigue, diarrhea, anorexia, oral changes, skin toxicity, and hypertension are common side effects of sunitinib that require monitoring and management 4.
• Hypertension can be treated with standard antihypertensive therapy, and rarely requires treatment discontinuation 4.
• Knowledge about side effects and proactive assessment and management of sunitinib-related side effects are critical to ensure optimal benefit from sunitinib treatment 4.