Riluzole Zentiva - Riluzole

What is Riluzole Zentiva - Riluzole?

Sancuso is a medicine containing the active substance granisetron. It is available as a transdermal patch (which allows the drug to be administered through the skin). Each patch releases 3.1 mg of the granisetron active ingredient in 24 hours.

Sancuso is a "generic hybrid medicine". This means that Sancuso is similar to a "reference medicine" that contains the same active ingredient, but the mode of administration is different. The reference medicine of Sancuso is Kytril, which is administered orally, while Sancuso is a patch that is applied to the skin.

What is Riluzole Zentiva - Riluzole used for?

Sancuso is an antiemetic (a medicine that prevents nausea and vomiting). It is used for the prevention of nausea and vomiting in patients undergoing certain types of chemotherapy treatments (anticancer medicines) that stimulate nausea and vomiting in a moderate or intense manner. Sancuso is indicated only in adults who would have difficulty in ingesting medicines and in the event that the chemotherapy treatment has an expected duration of 3-5 days.

The medicine can only be obtained with a prescription.

How is Riluzole Zentiva - Riluzole used?

The transdermal patch is applied 24 to 48 hours before chemotherapy. The patch should be applied to healthy, clean and dry skin on the outside of the upper arm or, if this is not possible, on the abdomen. The patch can be worn for up to seven days, depending on the duration of chemotherapy, and must be removed after a minimum of 24 hours after chemotherapy is completed. The patch should not be cut into parts.

How does Riluzole Zentiva - Riluzole work?

The active ingredient in Sancuso, granisetron, is a "5HT3 antagonist". That is, it prevents a chemical substance in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from binding to 5HT3 receptors in the brain and intestinal tract. When 5HT binds to these receptors, it normally causes nausea and vomiting. By blocking these receptors, Sancuso prevents the feeling of nausea and vomiting that are often associated with certain types of chemotherapy.

What studies have been performed on Riluzole Zentiva - Riluzole?

Because Sancuso is a generic hybrid medicine, the applicant submitted comparative data on the reference medicine in addition to the results of its studies.

The benefit of Sancuso in the prevention of nausea and vomiting associated with chemotherapy was examined in a main study involving a total of 641 patients. These patients had undergone chemotherapy for several days, stimulating nausea and vomiting in a moderate or intense manner. The study compared the Sancuso transdermal patch worn for seven days and granisetron taken orally once a day for the duration of the chemotherapy.

The main measure of effectiveness was the number of patients in whom nausea and vomiting could be controlled, ie where no vomiting or retching were observed (strong involuntary stomach contractions accompanied by the urge to vomit), but exclusively mild nausea without the need to take other anti-emetic medicines to quickly alleviate the effects of chemotherapy.

What benefit has Sancuso shown during the studies?

The Sancuso transdermal patch showed similar effects to granisetron taken orally in the prevention of vomiting and nausea after chemotherapy: in 60.2% of patients treated with Sancuso transdermal patch (171 out of 284) it was possible to control nausea and vomiting compared to to 64.8% of subjects treated with oral granisetron (193 out of 298).

What is the risk associated with Sancuso?

The most common side effect of Sancuso (seen in 1-10 patients in 100) is constipation. Most adverse effects were mild to moderate. For the full list of all side effects reported with Sancuso, see the package leaflet.

Sancuso must not be used in people who may be hypersensitive (allergic) to granisetron, to other 5HT3 antagonists or to any of the other ingredients.

Why has Riluzole Zentiva - Riluzole been approved?

The CHMP considered that Sancuso transdermal patch showed a similar benefit to granisetron taken orally. Although Sancuso has a later onset of action, the CHMP considered that it could benefit patients with swallowing difficulties, who would otherwise need to administer intravenous anti-emetic medicines daily. Therefore, the CHMP decided that the benefits of the medicine outweigh the identified risks and recommended that Sancuso be given marketing authorization.