Sancuso

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



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1. NAME OF THE MEDICINAL PRODUCT 
 
SANCUSO 3.1 mg/24 hours transdermal patch 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each 52 cm2 transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 
24 hours. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Transdermal patch. 
 
Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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). 
 
4.2 Posology and method of administration 
 
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. In the pivotal 
SANCUSO study, the concomitant use of corticosteroids, e.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. 
 



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Special populations 
Elderly 
Dosing as for adults (see sections 4.4 and 5.2). 
 
Renal or hepatic impairment 
No dose adjustment is necessary. Dosing as for adults (see sections 4.4 and 5.2). 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). 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. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients 
listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
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. If severe reactions, or a generalised skin reaction 
occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal 
patch must be removed. 
 
Gastrointestinal disorders 
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction 
should be monitored following its administration. 
 
Cardiac disorders 
5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG 
abnormalities. This potentially may have clinical significance in patients with pre-existing arrhythmias 
or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-- 
blockers. No clinically relevant effects have been observed in clinical studies with SANCUSO. 
 



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Exposure to sunlight 
Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further 
information. Patients must be advised to cover the transdermal patch application site, e.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). Appropriate 
observation of patients for serotonin syndrome-like symptoms is advised. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin 
syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products 
(including SSRIs and SNRIs). 
 
Co-administration of intravenous 5-HT3 receptor antagonists with oral paracetamol in human subjects 
has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism. 
 
As granisetron is metabolised by hepatic cytochrome P450 active substance-metabolising enzymes 
(CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and, 
hence, the half-life of granisetron. 
 
In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma 
clearance (approximately 25%) following intravenous administration of granisetron. 
 
In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the 
cytochrome P450 3A isoenzyme family. The clinical significance of this is unknown. 
 
In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the 
cytochrome P450 enzyme system. 
 
In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron 
and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products 
(cimetidine). 
 
No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have 
been seen. Furthermore, no interaction has been observed between granisetron and emetogenic cancer 
therapies. In agreement with these data, no clinically relevant interactions have been reported in 
clinical studies with SANCUSO. In clinical interaction studies, aprepitant did not have clinically 
important effects on the pharmacokinetics of granisetron. 



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Paediatric population 
Interaction studies have only been performed in adults. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are limited amount of data (less than 300 pregnancy outcomes) from the use of granisetron in 
pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to 
reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of 
SANCUSO during pregnancy. 
 
Breast-feeding 
It is unknown whether granisetron or its metabolites are excreted in human milk. Breast-feeding 
should be discontinued during treatment with SANCUSO. 
 
Fertility 
There are no data on the effect of granisetron on human fertility. Fertility was unaffected following 
granisetron treatment in rats. 
 
4.7 Effects on ability to drive and use machines 
 
SANCUSO has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing 
experience. The most commonly reported adverse reaction in clinical studies was constipation, 
occurring in approximately 8.7% 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. 
 
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 
Ear and labyrinth disorders Vertigo Uncommon 
Vascular disorders Flushing Uncommon 
Gastrointestinal disorders Constipation Common 

Dry mouth, nausea, retching Uncommon 



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Hepatobiliary disorders Alanine aminotransferase 
increased, aspartate 
aminotransferase increased, 
gamma-glutamyltransferase 
increased 

Uncommon 

Skin and subcutaneous tissue 
disorders 

Application site irritation 
Application site reactions 
(application site pain, 
application site pruritus, 
application site erythema, 
application site rash, 
application site irritation) * 

Uncommon 
Not known 

Musculoskeletal and connective 
tissue disorders 

Arthralgia Uncommon 

General disorders and 
administration site conditions 

Generalised oedema Uncommon 

*Spontaneous reports 
 
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. 
 
Class effects 
Class effects for granisetron seen with other formulations (oral and intravenous) include the following: 
 
- Hypersensitivity reactions, e.g. anaphylaxis, urticaria 
- Insomnia 
- Headache 
- Extrapyramidal reactions 
- Somnolence 
- Dizziness 
- QT prolongation 
- Constipation 
- Diarrhoea 
- Elevated hepatic transaminases 
- Rash 
- Asthenia 
 
Reporting of suspected adverse reactions 
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. 
 
4.9 Overdose 
 
There is no specific antidote for granisetron. In the event of overdose, the transdermal patch should be 
removed. Symptomatic treatment should be given. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC 
code: A04AA02. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 
receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea and 
vomiting as a result of cytostatic therapy. Radioligand binding studies have demonstrated that 
granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine 
D2 binding sites. 
 
A pivotal, randomised, double-blind, double-dummy, multinational Phase III study compared the 
efficacy, tolerability and safety of SANCUSO with that of 2 mg oral granisetron once daily in the 
prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy. The 
study was designed to show non-inferiority of SANCUSO to oral granisetron. 
 
The population randomised into the trial included 48% males and 52% females aged 16 to 86 years 
receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy. 78% of 
patients were white, with 12% Asian and 10% Hispanic/Latino. 
 
The granisetron transdermal patch was applied 24 to 48 hours prior to the first dose of chemotherapy, 
and kept in place for 7 days. Oral granisetron was administered daily for the duration of the 
chemotherapy regimen, one hour prior to each dose of chemotherapy. Anti-emetic activity was 
assessed from the first administration until 24 hours after the start of the last day’s administration of 
the ME or HE chemotherapy regimen. 
 
Non-inferiority of SANCUSO versus oral granisetron was confirmed, with complete control (CC) 
achieved in 60.2% of patients in the SANCUSO arm and 64.8% of patients receiving oral granisetron 
in the per protocol set (difference -4.89%; 95% confidence interval –12.91% to +3.13%; n=284 
transdermal patch, n=298 oral). CC was defined as no vomiting and/or retching, no more than mild 
nausea and no rescue medicine from the first administration until 24 hours after the start of the last 
day’s administration of multi-day chemotherapy. 
 
Due to the gradual increase in plasma levels of granisetron following application of the transdermal 
patch, initial plasma levels at the start of chemotherapy may be lower than 2 mg oral granisetron and a 
slower onset of efficacy may therefore be observed. Consequently, SANCUSO is indicated for use in 
patients where oral anti-emetic administration is complicated by factors making swallowing difficult. 
 
Complete control by day is illustrated below. 
 



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In clinical trials with SANCUSO, there were no treatment-related effects on heart rate or blood 
pressure. Assessment of serial ECGs in patients showed no QT prolongation and no change in ECG 
morphology. The effect of SANCUSO on QTc interval was specifically evaluated in a blinded, 
randomised, parallel, placebo and positive (moxifloxacin) controlled thorough QTc trial with 
SANCUSO in 240 adult male and female subjects. No significant effect on QTc prolongation was 
observed for SANCUSO. 
 
An assessment of transdermal patch adhesion in 621 patients receiving either active or placebo 
transdermal patches showed that less than 1% of transdermal patches became detached over the course 
of the 7 day period of transdermal patch application. 
 
There is no clinical trial experience with SANCUSO and patients on chemotherapy for less than 
3 consecutive days, or over multiple cycles of chemotherapy, or with high-dose chemotherapy prior to 
stem-cell transplantation. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Granisetron crosses intact skin into the systemic circulation by a passive diffusion process. Following 
SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 
24 and 48 hours. 
 
Based on the measure of residual content of the transdermal patch after removal, approximately 65% 
of granisetron is delivered resulting in an average daily dose of 3.1 mg per day. 
 
Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at 
the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects. An 
initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 
10 minutes post-administration. The known pharmacokinetic profile of the transdermal patch over the 
period of wear (7 days) was not affected. 
 



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Following consecutive application of two SANCUSO transdermal patches in healthy subjects, each for 
seven days, granisetron levels were maintained over the study period with evidence of minimal 
accumulation. 
 
In a study designed to assess the effect of heat on the transdermal delivery of granisetron from 
SANCUSO in healthy subjects, a heat pad generating an average temperature of 42°C was applied over 
the transdermal patch for 4 hours each day over the 5 day period of wear. While application of the heat 
pad was associated with a minor and transient increase in the transdermal patch flux during the period 
of heat pad application, no overall increase in granisetron exposure was observed when compared to a 
control group. 
 
In a pharmacokinetic study in healthy volunteers, where SANCUSO was applied for a period of 
7 days, mean total exposure (AUC0-infinity) was 416 ng h/ml (range 55 – 1192 ng h/ml), with a between 
subject variability of 89%. Mean Cmax was 3.9 ng/ml (range 0.7 – 9.5 ng/ml), with a between subject 
variability of 77%. This variability is similar to the known high variability in granisetron 
pharmacokinetics after oral or intravenous administration. 
 
Distribution 
Granisetron is distributed with a mean volume of distribution of approximately 3 l/kg. Plasma protein 
binding is approximately 65%. Granisetron distributes freely between plasma and red blood cells. 
 
Biotransformation 
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal 
uses. 
 
Granisetron is mainly metabolised to 7-hydroxygranisetron and 9’N-desmethylgranisetron. In vitro 
studies using human liver microsomes indicate that CYP1A1 is the major enzyme responsible for the 
7-hydroxylation of granisetron, whereas CYP3A4 contributes to 9’desmethylation. 
 
Elimination 
Granisetron is cleared primarily by hepatic metabolism. After intravenous dosing, the mean plasma 
clearance ranged from 33.4 to 75.7 l/h in healthy subjects and from 14.7 to 33.6 l/h in patients with 
wide inter-subject variability. The mean plasma half-life in healthy subjects is 4-6 hours and in patients 
is 9-12 hours. After transdermal patch application, the apparent granisetron plasma half-life in healthy 
subjects was prolonged to approximately 36 hours due to the slow absorption rate of granisetron 
through the skin. 
 
In clinical studies conducted with SANCUSO, clearance in cancer patients was shown to be 
approximately half that of healthy subjects. 
 
After intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of 
healthy subjects in 48 hours. The remainder of the dose is excreted as metabolites, with 49% in the 
urine and 34% in the faeces. 
 
Pharmacokinetics in special populations 
The effects of gender on the pharmacokinetics of SANCUSO have not been specifically studied. No 
consistent gender effects on pharmacokinetics were observed in clinical studies with SANCUSO, with 
a large inter-individual variability reported in both sexes. Population PK modelling has confirmed the 
absence of a gender effect on the pharmacokinetics of SANCUSO. 
 
Elderly 
In a clinical study no differences were seen in the plasma pharmacokinetics of SANCUSO in male and 
female elderly subjects (≥ 65 years) compared with younger subjects (aged 18-45 years inclusive). 
 



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Renal or hepatic impairment 
No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO 
in patients with renal or hepatic impairment. No clear relationship between renal function (as measured 
by creatinine clearance) and granisetron clearance was identified in population PK modelling. In 
patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined 
following a single 40 µg/kg intravenous dose of granisetron hydrochloride. 
 
Hepatic impairment 
In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance was 
approximately halved compared to patients without hepatic impairment. Given the wide variability in 
pharmacokinetic parameters of granisetron and the good tolerance well above the recommended dose, 
dose adjustment in patients with functional hepatic impairment is not necessary. 
 
Renal impairment 
No correlation between creatinine clearance and total clearance was observed in cancer patients, 
indicating no influence of renal impairment on the pharmacokinetics of granisetron. 
 
Body Mass Index (BMI) 
In a clinical study designed to assess granisetron exposure from SANCUSO in subjects with differing 
levels of body fat, using BMI as a surrogate measure for body fat, no differences were seen in the 
plasma pharmacokinetics of SANCUSO in male and female subjects with a low BMI [<19.5 kg/m2 
(males), <18.5 kg/m2 (females)] and a high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control 
group (BMI 20.0 to 24.9 kg/m2inclusive). 
 
Paediatric population 
There are limited data available in patients <18 years of age. No studies have been performed to 
investigate the pharmacokinetics of SANCUSO in paediatric patients <13 years of age. 
 
5.3 Preclinical safety data 
 
Preclinical data did not reveal any special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity. Carcinogenicity studies 
showed no special hazard for humans when used at the recommended dose. However, when 
administered in higher doses and over a prolonged period of time, the risk of carcinogenicity cannot be 
ruled out but with the short application period recommended for the transdermal delivery system, a 
carcinogenic risk for humans is not expected. 
 
SANCUSO transdermal patches did not show any potential for photoirritation or photosensitivity when 
tested in vivo in guinea-pigs. Granisetron was not phototoxic when tested in vitro in a mouse fibroblast 
cell line. When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell 
line, granisetron increased the percentage of cells with chromosome damage following 
photoirradiation. Although, the clinical relevance of this finding is not completely clear, patients 
should be advised to cover the transdermal patch application site if there is a risk of exposure to 
sunlight throughout the period of wear and for 10 days following its removal (see section 4.4). 
 
When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for 
irritancy. 
 
A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect 
cardiac repolarisation via blockade of hERG potassium channels. Granisetron has been shown to block 
both sodium and potassium channels, which could affect cardiac depolarisation and repolarisation and 
therefore PR, QRS, and QT intervals. These data help to clarify the mechanisms by which some of the 
ECG changes (particularly QT and QRS prolongation) associated with this class of substance can 
occur. However, no clinically relevant effects on ECG have been observed in clinical studies with 
SANCUSO, including a through QT study in 240 healthy subjects (section 5.1). 
 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing layer 
Polyester 
 
Matrix layer 
Acrylate-vinylacetate copolymer 
 
Release liner  
Siliconised polyester 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from light. 
 
6.5 Nature and contents of container 
 
Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated 
paper/aluminium/LLDPE. 
 
Each carton contains 1 transdermal patch. 
 
6.6 Special precautions for disposal 
 
The transdermal patch will still contain active substance following use. After removal, the used 
transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the 
reach of children. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands  
Tel: +31 (0) 237200822 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/766/001 
 
 



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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 April 2012 
Date of latest renewal: 9 January 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  

http://www.ema.europa.eu/


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ANNEX II 
 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
 AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
 EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
  



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
PHARBIL Waltrop GmbH(a subsidiary of NextPharma) 
Im Wirrigen 25 
45731 Waltrop  
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
 AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
 EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and 
interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and 
any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency: 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as a result of an 
important (pharmacovigilance or risk minimisation) milestone being reached. 

  



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

  



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A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 

 
 
1. NAME OF THE MEDICINAL PRODUCT 

 
SANCUSO 3.1 mg/24 hours transdermal patch  
granisetron 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron per 
24 hours. 
 
 
3. LIST OF EXCIPIENTS 

 
Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 

 
1 transdermal patch 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Read the package leaflet before use.  
Transdermal use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
 OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 
 
8. EXPIRY DATE 

 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 

 
Store in the original package in order to protect from light. 
 
 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS 

 
EU/1/12/766/001 
 
 
13. BATCH NUMBER 

 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
15. INSTRUCTIONS ON USE 

 
 
16. INFORMATION IN BRAILLE 

 
Sancuso 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC:  
SN:  
NN:   
 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SANCUSO 3.1 mg/24 h transdermal patch  
granisetron 
Transdermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 transdermal patch 
 
 
6. OTHER 
 
Store in the original package in order to protect from light.  
Keep out of the sight and reach of children. 
 
Kyowa Kirin 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
  



21 

Package Leaflet: Information for the patient 
 

SANCUSO 3.1 mg/24 hours transdermal patch 
granisetron 

 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What SANCUSO is and what it is used for 
2. What you need to know before you use SANCUSO 
3. How to use SANCUSO 
4. Possible side effects 
5. How to store SANCUSO 
6. Contents of the pack and other information 
 
 
1. What SANCUSO is and what it is used for 
 
The active substance in SANCUSO is granisetron, which belongs to a group of medicines called 
antiemetics and antinauseants. 
 
SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being 
sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and 
who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the 
mouth or throat). 
 
You must talk to a doctor if you do not feel better or if you feel worse after the first day of 
chemotherapy. 
 
 
2. What you need to know before you use SANCUSO 
 
Do not use SANCUSO: 
- if you are allergic to granisetron or any of the other ingredients of this medicine (listed in 

section 6) 
- if you are allergic to any other anti-sickness medicines whose name ends in “setron” e.g. 

ondansetron. 
 
Warnings and precautions 
Tell your doctor or nurse before using this treatment if any of the following applies to you: 
 
- if you have been told you have a heart disorder or disease 
- if you have pain in your stomach or your stomach is swollen 
- if you have problems with your kidneys or liver. 
 



22 

This medicine may not work as well and/or may affect your skin if exposed to direct sunlight or the 
light from sunlamps or tanning beds. It is important to do the following: 
- while you wear the transdermal patch, keep it covered with clothing if you will be in sunlight or 

near a sunlamp, including tanning beds 
- keep the skin where this medicine was applied covered for another 10 days after the  transdermal 

patch is taken off to protect from exposure to direct sunlight. 
 
It is not known how activities such as swimming, strenuous exercise or using a sauna or whirlpool, 
may affect this medicine. Avoid these activities while wearing this transdermal patch. You can continue 
to shower and wash normally while wearing the transdermal patch. 
 
External heat, for example from hot water bottles or heat pads, should be avoided on the area of the 
transdermal patch. 
 
Children and adolescents 
This medicine should not be used by children or adolescents under 18 years. 
 
Other medicines and SANCUSO 
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
SANCUSO can affect the way some medicines work. Also, some other medicines can affect the way 
SANCUSO works. In particular, tell your doctor or nurse if you are taking the following medicines: 
- Paracetamol, used to treat pain. 
- Phenobarbital, used to treat epilepsy. 
- Ketoconazole, used to treat fungal infections. 
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including 
 fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram. 
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety 
 including venlafaxine, duloxetine. 
 
Pregnancy and breast-feeding 
Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. 
 
Stop breast-feeding while wearing the patch. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before using this medicine. 
 
Driving and using machines 
SANCUSO has no or negligible effect on your ability to drive or use any machines. 
 
 
3. How to use SANCUSO 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or nurse if you 
are not sure. 
 
The recommended dose is one single transdermal patch. The medicine in the transdermal patch passes 
gradually through your skin into your body and, therefore, the patch is applied 1 to 2 days (24 to 
48 hours) before the start of chemotherapy treatment. 
 
This medicine is for transdermal use. This medicine delivers the active substance slowly and 
constantly through your skin and into your blood stream for the duration that you are wearing the 
transdermal patch. 
 



23 

Things to remember when using the transdermal patch 
- Do not keep or store the transdermal patch outside the sealed sachet. 
- Do not cut the transdermal patch into smaller pieces. 
- Use only one transdermal patch at a time. 
- When you remove the transdermal patch, check your skin and tell your doctor if you notice a 

serious skin reaction (if your skin is very red, itchy or you notice any blisters). 
- The transdermal patch may be affected by direct sunlight or exposure to sunlamps. While you 

are wearing the transdermal patch you must keep it covered, e.g. under clothing, if there is a risk 
of exposure to sunlight or sunlamps. Continue to keep the application site covered for a further 
10 days after removing the transdermal patch. 

- Contact with water during bathing or showering will not change the way SANCUSO works. 
- However, the transdermal patch may become partially unstuck. Try to avoid wearing the 

transdermal patch in water for long periods of time. 
- There is no information on the effect on the transdermal patch of activities such as strenuous 

exercise or the use of sauna or whirlpools; therefore, you should avoid these activities while 
wearing this transdermal patch. 

- You should avoid external heat (for example hot water bottles or heat pads) on the area of the 
transdermal patch. 

 
When to apply and remove the transdermal patch 
Do not remove the transdermal patch from the sachet until you are ready to use it. Apply a transdermal 
patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment. The 
transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy. Wear 
the transdermal patch all the time during your chemotherapy. The transdermal patch can be worn for 
up to 7 days depending on the duration of your chemotherapy treatment. Remove the transdermal 
patch at least 1 day (24 hours) after completing your chemotherapy. 
 
Where to apply the transdermal patch 
Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm. If 
your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on 
your abdomen. The area you choose should not be oily, recently shaved or have any skin problems 
such as being injured (cut or scraped) or irritated (redness or a rash). Do not put SANCUSO on areas 
that have been treated with creams, oils, lotions, powders or other skin products that could keep the 
transdermal patch from sticking well to your skin. 
 
How to apply the transdermal patch 
1. Remove a sachet from the box and tear it open using the slit provided. Each sachet contains one 

transdermal patch stuck onto a rigid plastic film. 
2. Take the transdermal patch out of the sachet. 

 
3. The sticky side of the transdermal patch is covered by a two-piece rigid plastic film. Bend the 

transdermal patch in the middle and remove one half of the rigid plastic film. Be careful not to 
stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch. 

4. While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin 
on the outside part of your upper arm. 



24 

5. Remove the second half of the rigid plastic film and press the whole transdermal patch firmly in 
place with your fingers and smooth down. Press firmly making sure there is good contact with 
the skin, especially around the edges. 

6. Wash your hands after applying the transdermal patch. 
7. Keep the transdermal patch in place for the whole time you are having chemotherapy. 
8. Do not re-use the transdermal patch after removal, see below for instructions on transdermal 

patch removal and disposal (see section 5). 
 
After removing the transdermal patch 
1. The used transdermal patch will still contain some granisetron and should be disposed of 

immediately as described in section 5. 
2. After removing the transdermal patch you may find some sticky material is left on your skin. 

Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such 
as nail polish remover may cause skin irritation and should not be used. 

3. Wash your hands. 
4. You may see mild redness on the skin where the transdermal patch is removed. This redness 

should go away over time. If it does not, tell your doctor. 
 
If the transdermal patch becomes unstuck 
If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the 
same area of skin. If required, use surgical bandages or medical adhesive tape to keep the transdermal 
patch in place. If the transdermal patch is lost or becomes damaged go back to your doctor. 
 
If you use more SANCUSO than you should 
If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your 
doctor. 
 
If you forget to use SANCUSO 
It is important to use this medicinal product as instructed by your doctor to prevent you feeling sick or 
being sick following your chemotherapy. If you have forgotten to apply your transdermal patch at the 
right time, apply it as soon as you remember, and tell your doctor as soon as possible before your 
chemotherapy treatment. 
 
If you stop using SANCUSO 
It is important to use this medicine during the whole length of your chemotherapy (up to 7 days) to 
prevent you feeling sick or being sick following your chemotherapy. Talk to your doctor if you want 
to remove the patch before the end of your chemotherapy treatment course (up to 7 days). 
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
If you are being treated with chemotherapy that is moderately or highly capable of making you feel 
sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine. 
 
Tell your doctor immediately if you develop constipation or if your stomach becomes painful or 
swollen. Constipation is a common side effect and may affect up to 1 in 10 people. 
 
Remove the transdermal patch and tell your doctor if you notice a serious skin reaction (if your 
skin is very red, itchy or you notice any blisters). Skin reactions at the site of application, such as 
irritation, itching or redness are uncommon and may affect up to 1 in 100 people. 
 



25 

Other possible side effects: 
Uncommon side effects are: 
- headache, a feeling of “spinning” even when you are standing still (vertigo) 
- decreased appetite, weight loss 
- flushing (or redness) 
- feeling sick (nausea), retching, dry mouth 
- pain in your joints 
- swelling due to water retention (oedema) 
- changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you 
 have been given SANCUSO). 
 
Rare side effects (may affect up to 1 in 1,000 people) are: 
- abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions). 
 
Side effects with a frequency not known (cannot be estimated from available data): 
- allergic skin reactions. The signs may include red, raised itchy bumps 
 
Other possible side effects associated with granisetron products (frequency not known): 
- Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious 

allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the 
eyelids, face or lips, rash or itching) 

- Difficulty sleeping/disturbed sleep 
- Excessive sleepiness 
- Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart 

rhythm disorder) 
- Constipation 
- Diarrhoea 
- Lack of energy/weakness /Loss of strength 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store SANCUSO 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after 
‘EXP’. The expiry date refers to the last day of that month. 
 
Store in the original package in order to protect from light. 
 
Used transdermal patches still contain active ingredients, which may be harmful to others. Fold the 
used transdermal patch in half with the sticky side inwards and dispose of it safely, out of the reach of 
children. Do not throw away any medicines via wastewater or household waste.  
 
Ask your pharmacist how to throw away medicines you no longer use. These measures will help 
protect the environment. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


26 

6. Contents of the pack and other information  
 
What SANCUSO contains 
- The active substance is granisetron. Each 52 cm2 transdermal patch contains 34.3 mg of 

granisetron, releasing 3.1 mg of granisetron in 24 hours. 
- The other ingredients are: 
- Transdermal patch adhesive: acrylate-vinylacetate copolymer 
- Backing layer: polyester 
- Rigid plastic film: siliconised polyester 
 
What SANCUSO looks like and contents of the pack 
SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a 
rigid plastic film. The transdermal patch is contained in a sachet. Each carton contains one transdermal 
patch. 
 
Marketing Authorisation Holder and Manufacturer  
 
Marketing Authorisation Holder 
Kyowa Kirin Holdings B.V. 
Bloemlaan 2 
2132NP Hoofddorp 
The Netherlands  
Tel: +31 (0) 237200822 
 
Manufacturer 
Pharbil Waltrop GmbH (a subsidiary of NextPharma) 
Im Wirrigen 25 
45731 Waltrop 
Germany 
 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site:  
http://www.ema.europa.eu 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET