What is Sancuso - Granisetron?
Sancuso is a medicine that contains the active substance granisetron. It is available as a transdermal patch (which allows the medicine to be administered through the skin). Each patch releases 3.1 mg of the active substance granisetron per 24 hours.
Sancuso is a 'hybrid generic medicine'. This means that Sancuso is similar to a 'reference medicine' which contains the same active substance, but the way it is given is different. The reference medicine for Sancuso is Kytril, which is given orally, while Sancuso is a patch that is applied to the skin.
What is Sancuso - Granisetron 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 induce moderate or severe nausea and vomiting. Sancuso is only indicated in adults who would have difficulty swallowing medicines and in cases where the chemotherapy treatment has an expected duration of 3-5 days.
The medicine can only be obtained with a prescription.
How is Sancuso - Granisetron 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 a minimum of 24 hours after completion of chemotherapy.The patch must not be cut into several parts.
How does Sancuso - Granisetron work?
The active substance in Sancuso, granisetron, is a "5HT3 antagonist". That is, it prevents a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from binding to 5HT3 receptors in the brain and intestines. When 5HT binds to these receptors, it usually 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.
How has Sancuso - Granisetron been studied?
As Sancuso is a hybrid generic medicine, the applicant submitted comparative data on the reference medicine in addition to the results of their studies.
The benefit of Sancuso in preventing chemotherapy-associated nausea and vomiting was investigated in one main study involving a total of 641 patients. These patients had undergone multiple days of chemotherapy that stimulated nausea and vomiting in The study compared the Sancuso transdermal patch worn for seven days and granisetron taken orally once daily for the duration of chemotherapy.
The main measure of effectiveness was the number of patients in whom nausea and vomiting could be controlled, i.e. no episodes of vomiting or retching (strong involuntary contractions of the stomach accompanied by the urge to vomit) were observed, but only mild nausea without the need to take other anti-emetic medicines to quickly relieve 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: 60.2% of patients treated with Sancuso transdermal patch (171 out of 284) were able to control nausea and vomiting compared to in 64.8% of subjects treated with granisetron administered orally (193 out of 298).
What is the risk associated with Sancuso?
The most common side effect with Sancuso (seen in 1 to 10 patients in 100) is constipation. Most of the adverse effects were mild to moderate. For the full list of side effects reported with Sancuso, see the brochure.
Sancuso must not be used in people who may be hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
Why has Sancuso - Granisetron 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 offer a benefit to patients with swallowing difficulties, who would otherwise need to be given intravenous anti-emetic medicines daily. Therefore, the CHMP decided that the benefits of medicine exceed the identified risks and recommended the granting of the "marketing authorization" for Sancuso.
More information about Sancuso - Granisetron
On April 20, 2012, the European Commission issued a "marketing authorization" for Sancuso, valid throughout the European Union.
For more information on Sancuso therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2012.
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