Monthly lists of letters for healthcare professionals on the safety of medicines

Copies of letters sent to healthcare professionals in June 2014, to inform of new safety information and advice.

Date sent                         

Medicine

Safety information

16 July 2014

Velcade (bortezomib) powder for solution for injectionPDF file (opens in new window) (115Kb)

The licence-holder has received reports of cracked or broken vials. When dispensing or preparing Velcade for injection:

  • always wear protective gloves, eye protection, face protection, and other protective clothing

  • inspect vial for any cracks or other damage

  • if you discover a compromised vial, do not use it

  • place any compromised vials in a secure sealed container and contact Janssen Customer Service centre on 0800-7315550

25 July 2014

▼ Arzerra (ofatumumab)PDF file (opens in new window) (169Kb)

Ofatumumab can cause serious or fatal infusion reactions. It should only be given under the supervision of a physician experienced in the use of cancer therapy and where facilities to monitor and treat infusion reactions are available. Give a corticosteroid, analgesic, and antihistamine 30 minutes to 2 hours before each infusion according to the protocol in the ofatumumab summary of product characteristics (SmPC). Infusion reactions may still occur despite this measure, particularly during the first infusion. In cases of severe infusion reaction, interrupt ofatumumab infusion immediately and treat the reaction.



See also the following MHRA letters for healthcare professionals:

• Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight

 

 

Posted on the UK MHRA website on 31 July 2014