Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Product news (13 December 2008)

SPC changes: Rapamune; Sebivo; Simulect / Prescription products: Buprenorphine

SPC changes


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.


Prescription products


Buprenorphine sublingual tablets are now available from Arrow Generics.

Net price:
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

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Good Pharmacovigilance Practice Guide

    Good Pharmacovigilance Practice Guide

    An essential guide on pharmacovigilance of medicinal products for human use. Practical advice for developing effective pharmacovigilance systems.

    £38.00Buy now
  • Essentials of Nonprescription Medications and Devices

    Essentials of Nonprescription Medications and Devices

    Essentials of Nonprescription Medications and Devices provides a quick, comprehensive reference of products available for self-care.

    £33.00Buy now
  • Non-prescription Medicines

    Non-prescription Medicines

    Reviews over-the-counter medicines, arranged by the conditions they are licensed to treat. Includes product recommendations.

    £38.00Buy now
  • Dale and Appelbe's Pharmacy and Medicines Law

    Dale and Appelbe's Pharmacy and Medicines Law

    This new edition of Dale and Appelbe's Pharmacy and Medicines Law is the definitive guide to law and ethics for pharmacy practice in the UK. It covers law and professional regulation and is firmly established as the definitive student textbook and reference work on this subject in the UK. Fully updated to include changes to pharmacy laws and regulation.

    £57.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.