What is NEVANAC?
NEVANAC is a yellow suspension (eye drops) that contains the active substance nepafenac.
What is NEVANAC used for?
NEVANAC is used for the prevention and treatment of pain and inflammation that can
arise after surgery to remove a cataract from the eye.
The medicine can only be obtained with a prescription.
How is NEVANAC used?
The dose of NEVANAC is one drop in the affected eye (s) three times a day, starting the day before the cataract surgery. Treatment is continued for two to three weeks after the operation. An additional drop should be administered between 30 and 120 minutes prior to the start of the operation. If other eye medications are also used, an interval should be observed. at least five minutes between administering one medicine and the other.
How does NEVANAC work?
The active substance in NEVANAC, nepafenac, is a 'prodrug' of amfenac. This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
It works by blocking an enzyme called cyclooxygenase that produces prostaglandins, substances involved in the inflammatory process. By reducing the production of prostaglandins in the eye, NEVANAC is able to reduce the inflammation and pain caused by the eye surgery.
How has NEVANAC been studied?
The effects of NEVANAC were first tested in experimental models before being studied in humans. The efficacy of NEVANAC was tested in four main studies involving a total of 1 201 patients undergoing cataract surgery. One study compared NEVANAC used once, twice or three times a day with placebo (sham eye drops) in 220 patients. The other three studies, involving a total of 981 patients, compared NEVANAC used three times a day with placebo, ketorolac eye drops (another NSAID) or with both placebo and ketorolac. The main measure of effectiveness was alternatively the percentage of patients in whom the treatment had the desired effect (with no or few signs of inflammation of the eye) or the percentage of patients in whom the treatment had not had the expected outcome (with signs of moderate or severe inflammation of the eye). These percentages were measured two weeks after surgery.
What benefit has NEVANAC shown during the studies?
NEVANAC has been shown to be more effective than placebo and equivalent to ketorolac in reducing the signs of inflammation. In the study comparing different doses, patients using NEVANAC three times a day had the lowest rate of treatment failure. When NEVANAC was compared with placebo, approximately 70% of the patients using NEVANAC had no signs of "inflammation after two weeks, compared to between 17% and 59% of those using the placebo. In the study comparing NEVANAC with ketorolac, approximately 65% of both patient groups showed no or few signs of inflammation.
What is the risk associated with NEVANAC?
The most common side effects of NEVANAC (seen in between 1 and 10 patients in 100) are headache, punctate keratitis (spots from inflammation of the cornea, the transparent layer in front of the pupil), pain in the eye, blurred vision , itchy eye, dry eye, foreign body sensation in the eye and crusting on the edge of the eyelid.
Similar side effects were seen in patients using placebo or ketorolac eye drops. For the full list of side effects reported with NEVANAC, see the Package Leaflet.
NEVANAC should not be used in people who may be hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs. Like other NSAIDs, NEVANAC should not be used in patients who have had an attack of asthma, hives or inflammation of the nasal passages in the past when taking aspirin or other NSAIDs. NEVANAC contains benzalkonium chloride, which causes the discoloration of soft contact lenses. Therefore, people who wear soft contact lenses need to be careful.
Why has NEVANAC been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NEVANAC's benefits are greater than its risks for the prevention and treatment of postoperative pain and inflammation associated with cataract surgery. The Committee recommended that it be released. marketing authorization for NEVANAC.
Other information about NEVANAC:
On 11 December 2007, the European Commission granted Alcon Laboratories (UK) Ltd. a "Marketing Authorization" for NEVANAC valid throughout the European Union.
For the complete version of the NEVANAC EPAR click here.
Last update of this summary: 11-2007
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