Sunitinib

Red

Brand Name(s):Sutent

Indication:Pancreatic neuroendocrine tumours

Rationale:1,2,3

Considered:Nov-10

Review Date:Jan-21

Comments:
Advice for healthcare professionals:
* Treatment with bevacizumab or sunitinib may be a risk factor for the development of ONJ
* Patients treated who have previously received, or are treated concurrently with, bisphosphonates may be particularly at risk
* Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib. Invasive dental procedures should be avoided, if possible, in patients treated with bevacizumab or sunitinib who have previously received, or who are receiving, intravenous bisphosphonates

MHRA Drug safety update Volume 4 Issue 6 January 2011

Cases of osteonecrosis of the jaw have been reported in cancer patients in association with sunitinib (Sutent) treatment, the majority of whom had received prior or concomitant treatment with i.v. bisphosphonates.

Sutent treatment may be an additional risk factor for the development of osteonecrosis of the jaw.

This potential risk should be particularly considered when Sutent and bisphosphonates are administered simultaneously or sequentially.

Dental examination and appropriate preventitive dentistry should be considered prior to treatment with Sutent. In patients who have previously received or are receiving i.v. bisphosphonates invasive dental procedures should be avoided, if possible.

Osteonecrosis of the jaw in cancer patients in association with sunitinib (Sutent) and concomitant or previous use of bisphosphonates MHRA November 2010