o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/943194/2011

EMEA/H/C/000381

EPAR summary for the public

Dynastat

parecoxib

This document is a summary of the European public assessment report (EPAR) for Dynastat. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dynastat.

What is Dynastat?

Dynastat is a medicine that contains the active substance parecoxib. It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.

What is Dynastat used for?

Dynastat is used in adults for the short-term treatment of pain after an operation.

The medicine can only be obtained with a prescription.

How is Dynastat used?

Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day. The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle. Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).

As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with higher doses and longer durations of Dynastat treatment. The shortest duration possible and the lowest effective dose of Dynastat should be used.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg. Dynastat must not be used in patients with severe liver problems. In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient's kidneys should be monitored closely.

How does Dynastat work?

The active substance in Dynastat, parecoxib, is a 'prodrug' of valdecoxib. This means that it is converted to valdecoxib in the body. Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called 'cyclo-oxygenase-2 (COX-2) inhibitors'. It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.

How has Dynastat been studied?

Dynastat has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery. Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol. Some of the studies also looked at the impact of giving Dynastat on the patient's use of morphine for additional pain relief after surgery. The main measures of effectiveness were changes in pain scores as rated by the patients.

What benefit has Dynastat shown during the studies?

Dynastat was effective in relieving moderate to severe pain after an operation. It was generally more effective than placebo and as effective as other painkillers. Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.

What is the risk associated with Dynastat?

The most common side effect with Dynastat (seen in more than 1 patient in 10) is nausea (feeling sick). For the full list of all side effects reported with Dynastat, see the package leaflet.

Dynastat must not be used in people who are hypersensitive (allergic) to parecoxib or any of the other ingredients. Dynastat must not be used in patients with:

•    a history of serious allergic reactions to medicines, especially skin reactions;

•    stomach ulcers or bleeding in the stomach or gut;

•    allergic-type reactions such as bronchospasm (excessive and prolonged contraction of the airway muscles), cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;

•    severe liver disease;

•    inflammatory bowel disease;

•    heart failure (an inability of the heart to pump enough blood around the body), ischaemic heart disease (disease of the heart caused by failure in the blood supply), peripheral artery disease

Dynastat

EMA/943194/2011    Page 2/3

(obstruction of the arteries in the arms or legs), or cerebrovascular disease (problems affecting the blood vessels in the brain).

Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women. It must not be used after coronary bypass surgery.

Why has Dynastat been approved?

The CHMP decided that Dynastat's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Dynastat:

The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.

The full EPAR for Dynastat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Dynastat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 12-2011.

Dynastat

EMA/943194/2011