Loading…
Sancuso is a brand name for Granisetron. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate. Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy. The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron.
Use of concomitant corticosteroids The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy. g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
Any increase in corticosteroid use during the study was reported as rescue treatment. 2). Renal or hepatic impairment No dose adjustment is necessary. 2). Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Paediatric population The safety and efficacy of SANCUSO in children aged 0 to 18 years have not yet been established. No data are available. Method of administration The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen. The transdermal patch should not be placed on skin that is red, irritated or damaged. Each transdermal patch is packed in a sachet and should be applied directly after the sachet has been opened.
The release liner is removed prior to application. The transdermal patch should not be cut into pieces. In the event of a transdermal patch becoming completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary).
Summary of the safety profile The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience. 7% of patients. The majority of adverse reactions were mild or moderate in severity. Tabulated list of adverse reactions Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Adverse reactions are presented in order of decreasing seriousness within each frequency grouping. 6 Table 1: Adverse reactions reported for SANCUSO System Organ Class Adverse reaction Frequency Immune system disorder Hypersensitivity reactions Not known Metabolism and nutrition disorders Decreased appetite Uncommon Nervous system disorders Headache Uncommon Dystonia Rare Dyskinesia Rare Serotonin syndrome Unknown Ear and labyrinth disorders Vertigo Uncommon Vascular disorders Flushing Uncommon Gastrointestinal disorders Constipation Common Dry mouth, nausea, retching Uncommon Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased Uncommon Musculoskeletal and connective tissue disorders Arthralgia Uncommon General disorders and administration site conditions Generalised oedema Application site irritation* Application site reactions** Uncommon Uncommon Unknown * Application site irritation includes: Application site pruritus and Skin irritation (Spontaneous reports) **Application site reactions includes: Application site erythema, Application site rash, Application site pain, Application site hypersensitivity, Application site vesicles, Application site burn, Application site urticaria and Application site discolouration.
Application site reactions In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Gastrointestinal disorders Granisetron may mask a progressive ileus and/or gastric distension caused by an underlying condition. Patients with signs of sub-acute intestinal obstruction should be monitored following its administration, as granisetron may reduce lower bowel motility.
Cardiac disorders 5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. This may potentially have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders and/or treated with antiarrhythmics or beta blockers.
No clinically relevant effects have been observed in clinical studies with SANCUSO. 3 for further information. g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Showering or washing Showering or washing normally can be continued while wearing SANCUSO. Activities such as swimming, strenuous exercise or using a sauna should be avoided. External heat External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Special populations No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment. Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Serotonin syndrome There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch. If this is not possible, a new transdermal patch should be applied on the opposite arm.
The newly applied transdermal patch should be removed in line with the timing recommended above.
Description of selected adverse reactions Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO. Serotonin Syndrome There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Noradrenaline (norepinephrine) Reuptake Inhibitors (SNRIs)).
5). Appropriate observation of patients for serotonin syndrome-like symptoms is advised. g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia Reporting of suspected adverse reactions 7 Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
There have also been reports of possible drug-drug interactions between buprenorphine/Opioids and serotonergic medicinal products leading to serotonin syndrome. Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Skin Reactions In clinical studies with granisetron transdermal patch, application site reactions generally mild in intensity were reported and did not lead to discontinuation of use. g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Potential for drug abuse and dependence Granisetron has no known potential for abuse and dependence.