Product news (13 December 2008)
SPC changes: Rapamune; Sebivo; Simulect / Prescription products: Buprenorphine
The summary of product characteristics for Rapamune (sirolimus; Wyeth) has been updated.
Patients treated with immunosuppressants including Rapamune are at increased risk of opportunistic infections (bacterial, fungal, viral and protozoal) including BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy. These infections are often related to high total immunosuppressive burden and may lead to serious or fatal conditions.
Pyrexia, hypertension, pain, constipation, nausea, headache and increased blood creatinine are now listed as common (>10 per cent) undesirable effects.
The summary of product characteristics for Sebivo (telbivudine; Novartis) has been updated to include information on myositis. It is recommended that if symptoms of myositis are reported (defined as myopathy with histological evidence of muscle damage) a detailed muscle examination should be performed in order to evaluate muscle functions.
The SPC now has additional information about the duration of treatment in patients who are HBeAg-positive without cirrhosis.
The SPC also states serum alanine transaminase and hepatitis B virus DNA levels should be measured regularly after treatment discontinuation to detect any late virological relapse.
It is recommended regular reassessment should be carried out in patients who are HBeAg-negative without cirrhosis who have had prolonged treatment for more than two years to confirm that continuation of the selected therapy remains appropriate.
The summary of product characteristics for Simulect (basiliximab; Novartis) has been updated.
The SPC now states that immunosuppressive regimens involving combinations of medicines increase patients’ susceptibility to infection, including opportunistic infections, fatal infections and sepsis, and the risk increases with total immunosuppressive load.
Simulect must not be administered unless it is certain that the patient will receive the graft and concomitant immunosuppression.
Simulect has potentially hazardous immunosuppressive effects during pregnancy and to the neonate during breastfeeding.
Buprenorphine sublingual tablets are now available from Arrow Generics.
7 x 0.4mg, £1.57
7 x 2mg, £6.59
7 x 8mg, £19.76
Legal category: CD (schedule 3)
Citation: The Pharmaceutical Journal URI: 10041840
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