Exparel liposomal

Exparel liposomal is injected either around the edges of small to medium sized surgical wounds or around the nerve supplying the operation site in the leg or shoulder area. The dose depends on the size of the operation site and the area that needs to be numbed, and the patient’s physical condition.

Exparel liposomal should be given in a setting where trained personnel and appropriate resuscitation equipment are available to promptly treat patients in case they develop side effects of the heart and nervous system.

The medicine can only be obtained with a prescription. For more information about using Exparel liposomal, see the package leaflet or contact your doctor or pharmacist.

The active substance in Exparel liposomal, bupivacaine, is an anaesthetic that temporarily numbs the area to which it has been applied by blocking pain signals to the brain.

Bupivacaine has been available since the 1960s. In Exparel liposomal, it is enclosed in ‘liposomes’ (tiny fat particles) which release bupivacaine slowly.

Four studies in 703 patients have shown that Exparel liposomal is effective at reducing pain scores when used for local pain relief around small to medium sized surgical wound sites and for regional pain relief in the surgery of the knee and around the shoulders.

For local pain relief, patients given Exparel after an operation for haemorrhoids (piles) had a total pain score for a 3-day period of 142, compared with 203 for patients given placebo (a dummy treatment). In patients who had an operation to remove bunions, the total pain score for a 1-day period was 124 for Exparel compared with 146 for placebo.

For regional pain relief, patients given Exparel after knee-replacement operation had a total pain score for a 3-day period of 419, compared with 516 for patients given placebo. In patients who had a shoulder joint replacement operation, the total pain score for a 2-day period was 136 for Exparel compared with 254 for placebo.

The most common side effects with Exparel liposomal (which may affect more than 1 in 20 people) are dysgeusia (taste disturbances) and oral hypoaesthesia (reduced sensation in the mouth).

The most important serious side effects are convulsions (fits), serious dysrhythmia (irregular heartbeat), serious hypotension (low blood pressure) and cardiac arrest.

Exparel liposomal must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a chemical structure related to the active ingredients (amide-type local anaesthetics). It must not be used as obstetrical paracervical block anaesthesia (local anaesthetic injected at the top of the vagina) and must not be given by injection into a blood vessel or into a joint.

For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Exparel liposomal’s benefits are greater than its risks and it can be authorised for use in the EU. Studies had shown that Exparel liposomal was effective at managing pain after different surgical procedures. The safety profile was considered acceptable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exparel liposomal have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Exparel liposomal are continuously monitored. Side effects reported with Exparel liposomal are carefully evaluated and any necessary action taken to protect patients.

Exparel liposomal received a marketing authorisation valid throughout the EU on 16 November 2020.