te renal failure, in some cases with fatal outcome, have been reported.
Risk factors associated with renal impairment/failure in patients receiving sunitinib included, in addition to underlying renal cell carcinoma, older age, diabetes mellitus, underlying renal insufficiency, cardiac failure, hypertension, sepsis, dehydration/hypovolemia, and rhabdomyolysis.
The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically eva luated.
Cases of proteinuria and rare cases of nephrotic syndrome have been reported. Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. Discontinue sunitinib in patients with nephrotic syndrome.
Fistula
If fistula formation occurs, sunitinib treatment should be interrupted. Limited information is available on the continued use of sunitinib in patients with fistulae.
Impaired wound healing
Cases of impaired wound healing have been reported during sunitinib therapy.
No formal clinical studies of the effect of sunitinib on wound healing have been conducted. Temporary interruption of sunitinib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention. Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Osteonecrosis of the Jaw (ONJ)
Cases of ONJ have been reported in patients treated with SUTENT. The majority of cases occurred in patients who had received prior or concomitant treatment with i.v. bisphosphonates, for which ONJ is an identified risk. Caution should therefore be exercised when SUTENT and i.v. bisphosphonates are used either simultaneously or sequentially.
Invasive dental procedures are also an identified risk factor. Prior to treatment with SUTENT, a dental examination and appropriate preventative dentistry should be considered. In patients who have previously received or are receiving i.v. bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
Hypersensitivity/Angioedema
If angioedema due to hypersensitivity occurs, sunitinib treatment should be interrupted and standard medical care provided.
Nervous system disorders
Taste disturbance
Dysgeusia was reported in approximately 28% of patients receiving sunitinib in clinical trials.
Seizures
In clinical studies of sunitinib and from post-marketing experience, seizures have been observed in subjects with or without radiological evidence of brain metastases. In addition, there have been few reports (<1%) of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS). Patients with seizures and signs/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.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction studi |
