SANCUSO granisetron 3.1 mg/24h Patch, 168-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Serotonin-3 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- The Sancuso patch prevents nausea and vomiting caused by chemotherapy by blocking a specific set of signals that chemo triggers in your gut and brain. It needs to be on your skin a...
- What exactly does this patch do, and why do I need it before chemo even starts?
- Apply Sancuso to the upper outer arm — somewhere with clean, dry, nearly hairless skin that isn't red, broken, or irritated. Open the pouch and apply it right away; don't cut or tr...
- Where do I put the patch, and is there anything I need to watch out for when applying it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Granisetron — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $750.43 | $126,071.53 / 168 hs |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sancuso 3.1 mg/24hthis 66220-0637-72 | Cumberland | 168 hs | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 66220-0637-31 | 168 h in 1 POUCH (66220-637-31) | $686.50 / ea | $115,332.67 | 2024-07-16 | Active |
| 66220-0637-72 You're viewing this | 168 h in 1 POUCH (66220-637-72) | — | — | 2024-07-16 | Active |
This pack shows little to no recent Medicaid volume — the 168 hs pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 66220-0637-72?
What is the difference between NDC 66220-0637-72 and NDC 66220-0637-31?
What NDC number is used to bill for this package of SANCUSO granisetron 3.1 mg/24h Patch?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. SANCUSO is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND 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.
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. 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. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Transdermal System: a 52 cm 2 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. Transdermal System: 3.1 mg per 24 hours. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS SANCUSO is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system [see Description ( 11 )] . Known hypersensitivity to granisetron or to any of the components of the transdermal system ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Progressive Ileus and Gastric Distention : Granisetron may mask a progressive ileus and/or gastric distention; consider before use in patients with abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. ( 5.1 ) Serotonin Syndrome : Serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.
If such symptoms occur, discontinue SANCUSO and initiate supportive treatment. If concomitant use of SANCUSO with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk of serotonin syndrome. ( 5.2 , 7.1 ) Skin Reactions : Mild application site reactions have occurred; remove SANCUSO transdermal system if severe reactions or a generalized skin reaction occur.
( 5.3 ) Increased Drug Exposure with Use of External Heat Sources: Avoid exposing SANCUSO transdermal system and surrounding area to direct external heat sources, such as heating pads ( 5.4 ). Phototoxicity with Ultraviolet Light Exposure : Avoid direct exposure of application site to natural or artificial sunlight, including sunlamps, by covering with clothing throughout the period of wear and for 10 days after removal. ( 5.5 )
5.1Progressive 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.
5.2Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 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-HT 3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 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 )].
5.3Skin 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.
5.4Increased 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 exte…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Progressive ileus and gastric distention [see Warnings and Precautions ( 5.1 )] Serotonin syndrome [see Warnings and Precautions ( 5.2 )] Skin reactions [see Warnings and Precautions ( 5.3 )] Increased drug exposure with use of external heat sources [see Warnings and Precautions ( 5.4 )] Phototoxicity with ultraviolet light exposure [se Warnings and Precautions ( 5.5 )] The most common adverse reaction (≥ 3%) is constipation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 (X 225) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of SANCUSO was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with transdermal system treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.
Adverse reactions occurred in 9% (35/404) of patients receiving SANCUSO and 7% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5% of patients in the SANCUSO group and 3% of patients in the oral granisetron group. Table 1 lists the adverse reactions that occurred in at least 3% of patients treated with SANCUSO or oral granisetron.
Table 1: Incidence of Adverse Reactions in Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving Chemotherapy (³ 3% in either group) SANCUSO Transdermal System Oral granisetron Body System N=404 N=406 Preferred Term (%) (%) Gastrointestinal disorders Constipation 5 3 Nervous system disorders Headache 1 3 5-HT 3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 patients in a randomized, parallel group, double-blind, double-dummy study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy.
QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron, and 3 (1.1%) on the transdermal system. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.
Adverse reactions reported in clinical trials with other formulations of granisetron include the following: Gastrointestinal: abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting Cardiovascular: hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely Central Nervous System: dizziness, insomnia, headache, anxiety, somnolence and asthenia Hypersensitivity: rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported Other: fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia, thrombocytopenia.
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of SANCUSO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Disorders and Administration Site Conditions: Application site reactions (pain, pruritus, erythema, rash, irritation, vesicles, burn, discoloration, urticaria) [see Warnings and Precautions…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue SANCUSO and initiate supportive treatment [see Warnings and Precautions ( 5.4 )] .
7.2Concomitant Use Medications There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs. However, in humans, granisetron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisetron hydrochloride injection also does not appear to interact with emetogenic cancer therapies.
In agreement with these data, no clinically relevant drug interactions have been reported in clinical studies with SANCUSO.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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/m 2 /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/m 2 /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/m 2 /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/m 2 /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.
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness of SANCUSO have not been established in pediatric patients.
8.5Geriatric 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.
8.6Renal 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.
🤰 Pregnancy ▾
8.1Pregnancy 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/m 2 /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/m 2 /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/m 2 /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/m 2 /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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of SANCUSO have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🆘 Overdosage ▾
10 OVERDOSAGE There is no specific antidote for granisetron overdosage. In the case of overdosage, symptomatic treatment should be given.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Granisetron is a selective 5-hydroxytryptamine 3 (5-HT 3 ) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT 1, 5-HT 1A , 5-HT 1B/C , 5-HT 2 ; for alpha 1 -, alpha 2 -, or beta-adrenoreceptors; for dopamine-D 2 ; or for histamine-H 1 ; benzodiazepine; picrotoxin or opioid receptors. Serotonin receptors of the 5-HT 3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT 3 receptors.
This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT 3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
12.2Pharmacodynamics The effect of granisetron on QTc prolongation was evaluated in a randomized, single-blind, positive (moxifloxacin 400 mg) - and placebo controlled parallel study in healthy subjects. A total of 120 subjects were administered SANCUSO transdermal system (n=60) or intravenous granisetron (10 mcg/kg over 30 seconds; n=60). In a study with demonstrated ability to detect small effects, the upper bound of the 90% confidence interval for the largest placebo adjusted, baseline corrected QTc based on Fridericia correction method (QTcF) for SANCUSO was below 10 ms.
This study suggests that SANCUSO does not have significant effects on QT prolongation. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in studies using granisetron. The effect on oro-cecal transit time following application of SANCUSO has not been studied.
Granisetron hydrochloride injection exhibited no effect on oro-cecal transit time in healthy subjects given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses of granisetron hydrochloride slowed colonic transit in healthy subjects.
12.3Pharmacokinetics Absorption Granisetron crosses intact skin into the systemic circulation by a passive diffusion process. Following a 7-day application of SANCUSO transdermal system in 24 healthy subjects, high inter- subject variability in systemic exposure was observed. Maximal concentration was reached at approximately 48 hours (range: 24-168 hours) following application.
Mean C max was 5 ng/mL (CV: 170%) and mean AUC 0-168hr was 527 ng-hr/mL (CV: 173%). Mean Plasma Concentration of Granisetron (mean ± SD) Based on the measure of residual content of the transdermal system after removal, approximately 66% (SD: ± 10.9) of granisetron is delivered following transdermal system application for 7 days. Following consecutive application of two SANCUSO transdermal systems, each for seven days, granisetron plasma concentrations were maintained over the study period with evidence of minimal accumulation.
The mean plasma concentration at 24 hours after the second transdermal system application was 1.5-fold higher due to residual granisetron from the first transdermal system. As the plasma concentration increased after the second transdermal system application, the difference decreased and the mean plasma concentration at 48 hours was 1.3-fold higher after application of the second transdermal system compared to that after application of the first transdermal system. 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 (107.6°F) was applied over the transdermal system for 4 hours each day over the 5 day period of wear.
The application of the heat pad was associated with an increase in plasma granisetron concentrations during the period of heat pad appli…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Granisetron is a selective 5-hydroxytryptamine 3 (5-HT 3 ) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT 1, 5-HT 1A , 5-HT 1B/C , 5-HT 2 ; for alpha 1 -, alpha 2 -, or beta-adrenoreceptors; for dopamine-D 2 ; or for histamine-H 1 ; benzodiazepine; picrotoxin or opioid receptors. Serotonin receptors of the 5-HT 3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT 3 receptors.
This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT 3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING SANCUSO (granisetron transdermal system) is a 52 cm 2 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. Each SANCUSO transdermal system is packaged in a separate sealed foil-lined plastic pouch supplied in packages of 1 (NDC 66220-637-31) transdermal system.
Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. SANCUSO should be stored in the original packaging.
📋 Description ▾
11 DESCRIPTION SANCUSO contains granisetron, which is a serotonin-3 (5-HT 3 ) receptor antagonist. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C 18 H 24 N 4 O, while its chemical structure is: Granisetron is a white to off-white solid that is insoluble in water.
The inactive ingredients are acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax. SANCUSO is a 52 cm 2 thin, translucent, matrix-type transdermal system that is rectangular- shaped with rounded corners, consisting of a backing (polyester), the drug matrix (acrylate- vinylacetate copolymer) and a release liner (siliconized polyester). Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Progressive Ileus and Gastric Distention Advise the patient to report new or worsening constipation to their healthcare provider and seek immediate medical care if symptoms of an ileus (pain or swelling in their abdomen) occur [see Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Advise the patient of the possibility of serotonin syndrome with concomitant use of SANCUSO and another serotonergic agent such as medications to treat depression and migraines.
Advise the patient to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms [see Warnings and Precautions ( 5.2 )] . Skin Reactions Instruct the patient remove the transdermal system if they have a severe skin reaction, or a generalized skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) [see Warnings and Precautions ( 5.3 )] . Increased Drug Exposure with Use of External Heat Sources Advise the patient to avoid prolonged exposure to heat and not to apply a heat pad or heat lamp over or near the SANCUSO transdermal system and avoid extended exposure to heat [see Warnings and Precautions ( 5.4 )] .
Phototoxicity with Ultraviolet Light Exposure Advise the patient to avoid direct sunlight or exposure to sunlamps and to cover the application site of the transdermal system with clothing, if there is a risk of exposure to sunlight or sunlamps throughout the period of wear and for 10 days following its removal [see Warnings and Precautions ( 5.5 )] . Application and Removal Instructions Instruct the patient on how to apply and remove the transdermal system: Only wear one transdermal system at any time. Do not cut the transdermal system.
Apply the transdermal system to clean, dry, nearly hairless, intact healthy skin on the upper outer arm. After the transdermal system is applied, wash hands thoroughly. Remove the transdermal system by peeling off gently from the skin.
Upon removal, fold the used transdermal system in half with the sticky side together, and discard in 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 [see Dosage and Administration ( 2 )] .
Manufactured by: Kindeva Drug Delivery L.P. Northridge, CA 91324 Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN 37203 US Patent Number 7608282 SANCUSO ® is a registered trademark of Cumberland Pharmaceuticals Inc.