SANCUSO Transdermal patch Ref.[8214] Active ingredients: Granisetron

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.

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.

There is no specific antidote for granisetron. In the event of overdose, the transdermal patch should be removed. Symptomatic treatment should be given.

3 years.

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

Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.

Each carton contains 1 transdermal patch.

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.