Sancuso
(granisetron)Dosage & Administration
The recommended dosage is a single transdermal system applied to the upper outer arm a minimum of 24 hours, up to a maximum of 48 hours, before chemotherapy. The transdermal system should be worn at minimum, 24 hours after chemotherapy is finished. The transdermal system can be worn for up to 7 days.
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Sancuso Prescribing Information
Sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.
The recommended dosage is a single transdermal system applied to the upper outer arm a minimum of 24 hours, up to a maximum of 48 hours, before chemotherapy. The transdermal system should be worn at minimum, 24 hours after chemotherapy is finished. The transdermal system can be worn for up to 7 days.
Application and Removal Instructions
- Each transdermal system releases 3.1 mg of granisetron per 24 hours for up to 7 days.
- Each transdermal system is packed in a pouch and should be applied directly after the pouch has been opened.
- Only wear one transdermal system at any time.
- Do not cut the transdermal system.
- Open the pouch and apply the transdermal system to clean, dry, nearly hairless, intact healthy skin on the upper outer arm.
- Do not place Sancuso transdermal system on skin that is red, irritated, or damaged.
- Do not apply a heat pad or heat lamp over or in vicinity of the transdermal system and avoid extended exposure to heat [see Warnings and Precautions (5.4)].
- Cover the application site of the transdermal system with clothing, if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal [see Warnings and Precautions (5.5)].
- After the transdermal system is applied, wash hands thoroughly.
- Remove the transdermal system by peeling off gently from the skin.
- Upon removal, fold the transdermal system in half with the sticky side together, and discard in the household trash in a manner that prevents accidental contact or ingestion by children, pets or others.
- Sancuso contains granisetron. Do not use other granisetron-containing products with Sancuso.
Transdermal System: a 52 cm2 thin, translucent, rectangular-shaped transdermal system with rounded corners imprinted on one side with "Granisetron 3.1 mg/24 hours". The transdermal system releases 3.1 mg of granisetron per 24 hours for up to 7 days.
Pregnancy
Risk Summary
Available published data and postmarketing reports with granisetron use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In a published ex vivo human placental perfusion model, no transplacental passage of granisetron was detected at a concentration (5 ng/mL) that mimics the plasma concentration achieved following transdermal application of Sancuso. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 24 times and 16 times, respectively, the maximum recommended human dose delivered by the Sancuso transdermal system, based on body surface area (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride at intravenous doses up to 24 times and 16 times, respectively, the maximum recommended human dose delivered by the Sancuso transdermal system, based on body surface area (see Data).
Data
Animal Data
Reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2/day, about 24 times the recommended human dose delivered by the Sancuso transdermal system, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m2/day, about 326 times the recommended human dose with Sancuso based on body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m2/day, about 16 times the human dose with Sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m2/day, about 167 times the human dose with Sancuso based on body surface area). These studies did not reveal any harm to the fetus due to granisetron.
Lactation
Risk Summary
There are no data on the presence of granisetron in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Sancuso and any potential adverse effects on the breastfed child from Sancuso or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness of Sancuso have not been established in pediatric patients.
Geriatric Use
Clinical studies of Sancuso did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, cautious treatment selection for an elderly patient is prudent because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment or Hepatic Impairment
Although no studies have been performed to investigate the pharmacokinetics of Sancuso in patients with renal or hepatic impairment, pharmacokinetic information is available for intravenous granisetron [see Clinical Pharmacology (12.3)]. No dosage adjustment is recommended for renal or hepatic impairment.
Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system [see Description (10)].
Progressive Ileus and Gastric Distention
Sancuso may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of Sancuso in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
Serotonin Syndrome
The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post- anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Sancuso and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Sancuso and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Sancuso is used concomitantly with other serotonergic drugs. [see Drug Interactions (7)].
Skin Reactions
In clinical trials with Sancuso, application site reactions were reported that were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo.
If severe reactions, or a generalized skin reaction occur (e.g., allergic rash, including erythematous, macular, papular rash or pruritus), remove the Sancuso transdermal system.
Increased Drug Exposure with Use of External Heat Sources
Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure [see Clinical Pharmacology (12.3)]. Do not apply a heat pad or heat lamp over or in the vicinity of the Sancuso transdermal system and avoid extended exposure to heat [see Dosage and Administration (2)].
Phototoxicity with Ultraviolet Light Exposure
Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. An in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity [see Nonclinical Toxicology (13.3)]. To avoid a potential skin reaction, advise patients to cover the application site of the transdermal system with clothing if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal.