New contraindications and monitoring advice for Prexige

New restrictions on the prescribing of Prexige (lumiracoxib) have been enforced following consultation between the manufacturer, the MHRA and other European regulators.

This follows concern raised worldwide after rare reports of serious liver reactions mostly relating to daily doses higher than the licensed daily dose of 100mg in the EU.

The new prescribing advice states that lumiracoxib is now contraindicated in patients with:

  • Current hepatic disease.
  • Prior drug-induced significant (>3xULN) elevations of transaminases.
  • Liver transaminases >1.5xULN before treatment, or >3xULN during treatment (see below).
  • Taking other medicines associated with clinically significant hepatotoxicity.

    New liver function test (LFT) monitoring advice states:
  • Perform baseline LFTs before starting treatment (lumiracoxib is contraindicated if transaminases >1.5xULN).
  • Where treatment is needed for longer than one month, repeat LFTs on monthly basis.
  • Stop treatment if transaminases >3xULN, repeat in seven days if transaminases >2xULN.
  • Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib.

Patients already taking lumiracoxib should be reviewed at their next routine appointment. If continued treatment is considered appropriate after consideration of overall benefit and risks, and after taking new contraindications into account, then LFTs should be performed.

The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis is currently being evaluated by european regulatory authorities and any updated advice will be issued following the evaluation.

Further information:

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases