menu
Home   |   Drugs   |   Ingredients   |   Pharma Companies   |   ATC   |   ICD
Share on Facebook Tweet

Granisteron

When are you taking this medicine?
advertisement

Granisteron uses


1 INDICATIONS AND USAGE

Granisteron® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.

Granisteron is a serotonin -3 (5-HT3) receptor antagonist indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. (1)

2 DOSAGE AND ADMINISTRATION

The transdermal system should be applied to clean, dry, intact healthy skin on the upper outer arm. Granisteron should not be placed on skin that is red, irritated, or damaged.

Each patch is packed in a pouch and should be applied directly after the pouch has been opened.

The patch should not be cut into pieces.

Apply a single transdermal system (patch) to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. (2)

2.1 Adults

Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

3 DOSAGE FORMS AND STRENGTHS

Granisteron is a 52 cm2 patch containing 34.3 mg of Granisteron. The patch releases 3.1 mg of Granisteron per 24 hours for up to 7 days.

Transdermal System: 52 cm2 patch containing 34.3 mg of Granisteron delivering 3.1 mg per 24 hours (3)

advertisement

4 CONTRAINDICATIONS

Granisteron is contraindicated in patients with known hypersensitivity to Granisteron or to any of the components of the patch.

Known hypersensitivity to Granisteron or to any of the components of the patch (4)

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal

The use of Granisteron in patients may mask a progressive ileus and/or gastric distention caused by the underlying condition.

5.2 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, 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 Granisteron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Granisteron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Granisteron is used concomitantly with other serotonergic drugs. .

5.3 Skin Reactions

In clinical trials with Granisteron, 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), the patch must be removed.

5.4 External Heat Sources

A heat pad should not be applied over or in vicinity of Granisteron patch. Patients should avoid prolonged exposure to heat as plasma concentration continues increasing during the period of heat exposure .

5.5 Exposure to Sunlight

Granisteron may be affected by direct natural or artificial sunlight. Patients must be advised to cover the 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 because of a potential skin reaction .

advertisement

6 ADVERSE REACTIONS

The most common adverse reaction is constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc. at 1-800-SANCUSO (1-800-726-2876) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical 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 Granisteron was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with patch 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 Granisteron, for 1 to 5 days.

Adverse reactions occurred in 8.7% (35/404) of patients receiving Granisteron and 7.1% (29/406) of patients receiving oral Granisteron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Granisteron group and 3.0% of patients in the oral Granisteron group.

Table 1 lists the adverse reactions that occurred in at least 3% of patients treated with Granisteron or oral Granisteron.

Body System

Preferred Term

 Granisteron TDS

N=404

(%)

 Oral Granisteron

N=406

(%)
Gastrointestinal disorders
Constipation 5.4 3.0
Nervous system disorders
Headache 0.7 3.0

5-HT3 receptor antagonists, such as Granisteron, 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 Granisteron, 8 (2.7%) on oral Granisteron, and 3 (1.1%) on the patch. 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 Granisteron 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.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Granisteron. 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); patch non-adhesion.

Cardiac Disorders: bradycardia, chest pain, palpitations, sick sinus syndrome

advertisement

7 DRUG INTERACTIONS

Granisteron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro. There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs. However, in humans, Granisteron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisteron 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 Granisteron.

Because Granisteron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Granisteron. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by Granisteron hydrochloride in vitro. In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of Granisteron hydrochloride. However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous Granisteron hydrochloride. The clinical significance of this change is not known.

Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) .

No clinically relevant drug interactions have been reported in clinical studies with Granisteron. (7)

advertisement

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

Reproduction studies with Granisteron 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 Granisteron patch, 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 Granisteron 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 Granisteron 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 Granisteron based on body surface area). These studies did not reveal any evidence of impaired fertility or harm to the fetus due to Granisteron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Granisteron should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Granisteron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Granisteron is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Granisteron have not been established in pediatric patients.

8.5 Geriatric Use

Clinical studies of Granisteron 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.

8.6 Renal Impairment or Hepatic Impairment

Although no studies have been performed to investigate the pharmacokinetics of Granisteron in patients with renal or hepatic impairment, pharmacokinetic information is available for intravenous Granisteron .

10 OVERDOSAGE

There is no specific antidote for Granisteron overdosage. In the case of overdosage, symptomatic treatment should be given.

Overdosage of up to 38.5 mg of Granisteron hydrochloride, as a single intravenous injection, has been reported without symptoms or only the occurrence of a slight headache.

In clinical trials there were no reported cases of overdosage with Granisteron.

11 DESCRIPTION

Granisteron contains Granisteron, which is a serotonin-3 (5-HT3) 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 C18H24N4O, while its chemical structure is:

Granisteron

Granisteron is a white to off-white solid that is insoluble in water. Granisteron is a thin, translucent, matrix-type transdermal patch that is rectangular-shaped with rounded corners, consisting of a backing, the drug matrix and a release liner.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Granisteron is a selective 5-hydroxytryptamine3 receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2; for alpha1-, alpha2-, or beta-adrenoreceptors; for dopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioid receptors.

Serotonin receptors of the 5-HT3 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-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, Granisteron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single Granisteron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

12.2 Pharmacodynamics

The effect of Granisteron 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 Granisteron patch (n=60) or intravenous Granisteron (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 Granisteron was below 10 ms. This study suggests that Granisteron 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 Granisteron.

The effect on oro-cecal transit time following application of Granisteron has not been studied. Granisteron 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 Granisteron hydrochloride slowed colonic transit in healthy subjects.

12.3 Pharmacokinetics

Absorption

Granisteron crosses intact skin into the systemic circulation by a passive diffusion process.

Following a 7-day application of Granisteron 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 patch application. Mean Cmax was 5.0 ng/mL (CV: 170%) and mean AUC0-168hr was 527 ng-hr/mL (CV: 173%).

Mean Plasma Concentration of Granisteron (mean ± SD)

Based on the measure of residual content of the patch after removal, approximately 66% (SD: ± 10.9) of Granisteron is delivered following patch application for 7 days.

Following consecutive application of two Granisteron patches, each for seven days, Granisteron levels were maintained over the study period with evidence of minimal accumulation. The mean plasma concentration at 24 hours after the second patch application was 1.5-fold higher due to residual Granisteron from the first patch. As the plasma concentration increased after the second patch application, the difference decreased and the mean plasma concentration at 48 hours was 1.3-fold higher after the second patch compared to that after the first patch.

In a study designed to assess the effect of heat on the transdermal delivery of Granisteron from Granisteron in healthy subjects, a heat pad generating an average temperature of 42°C (107.6°F) was applied over the patch 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 Granisteron concentrations during the period of heat pad application. The elevated plasma concentration declined after removal of the heat pad. Mean Cmax with intermittent heat exposure was 6% higher than without heat. Mean partial AUCs over 6 hours with 4 hour of heat application (AUC0-6, AUC24-30, and AUC48-54) were 4.9, 1.4, and 1.1 folds higher, respectively, with heat pad than without heat pad. A heat pad should not be applied over or in the near vicinity of the Granisteron patch.

Image

Distribution

Plasma protein binding is approximately 65%. Granisteron distributes freely between plasma and red blood cells.

Metabolism

Granisteron metabolism involves N-demethylation and aromatic ring oxidation followed by conjugation. In vitro liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily. Animal studies suggest that some of the metabolites may also have 5-HT3 receptor antagonist activity.

Elimination

Clearance is predominantly by hepatic metabolism. Based on a study with 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, 49% in the urine, and 34% in the feces.

Subpopulations

Gender

There is evidence to suggest that female subjects had higher Granisteron concentrations than males following patch application. However, no statistically significant difference in clinical efficacy outcome was observed between genders.

Pediatrics

No studies have been performed to investigate the pharmacokinetics of Granisteron in pediatrics.

Elderly

Following application of Granisteron patch in healthy subjects, mean AUC0-z, Cmax, and Cavg were 17%, 15%, and 16% higher, respectively in male and female elderly subjects (≥ 65 years) compared to younger subjects (aged 18-45 years inclusive). These pharmacokinetic parameters were largely overlapped between the two age groups with high variability (CV: >50%).

Following a single 40 mcg/kg intravenous dose of Granisteron hydrochloride in elderly volunteers (mean age 71 years), lower clearance and longer half-life were observed compared to younger healthy volunteers.

Renal Impairment

Total clearance of Granisteron was not affected in patients with severe renal failure who received a single 40 mcg/kg intravenous dose of Granisteron hydrochloride.

Hepatic Impairment

In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance following a single 40 mcg/kg intravenous dose of Granisteron hydrochloride was approximately halved compared to patients without hepatic impairment. Given the wide variability in pharmacokinetic parameters of Granisteron and the good tolerance of doses well above the recommended dose, dose adjustment in patients with hepatic functional impairment is not necessary.

Body Mass Index

In a clinical study designed to assess Granisteron exposure from Granisteron in subjects with differing levels of body fat, using body mass index (BMI) as a surrogate measure for subcutaneous fat, no significant differences were seen in the plasma pharmacokinetics of Granisteron in male and female subjects with low BMI [<19.5 kg/m2 (males), <18.5 kg/m2 (females)] and high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control group (BMI 20.0 to 24.9 kg/m2 inclusive).

Race

The pharmacokinetic profile of Granisteron from Granisteron was assessed in healthy Japanese males. Following the application of a single 6-day Granisteron 52 cm2, in healthy male Japanese subjects, mean Cmax, AUC(0-144), and AUC(0-∞) values were 5.02 ng/mL (CV: 66%), 492 ng.hr/mL (CV: 72%), and 562 ng.hr/mL (CV: 60%), respectively, and a median tmax value was 48 hours.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month carcinogenicity study, rats were treated orally with Granisteron 1, 5 or 50 mg/kg/day. The 50 mg/kg/day dose was reduced to 25 mg/kg/day (150 mg/m2/day) during week 59 due to toxicity. For a 50 kg person of average height (1.46 m2 body surface area), these doses represent about 2.6, 13, and 65 times the recommended clinical dose (3.1 mg/day, 2.3 mg/m2/day, delivered by the Granisteron patch, on a body surface area basis). There was a statistically significant increase in the incidence of hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m2/day, about 13 times the recommended human dose with Granisteron, on a body surface area basis) and above, and in females treated with 25 mg/kg/day (150 mg/m2/day, about 65 times the recommended human dose with Granisteron, on a body surface area basis). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m2/day, about 2.6 times the recommended human dose with Granisteron, on a body surface area basis) in males and 5 mg/kg/day (30 mg/m2/day, about 13 times the recommended human dose with Granisteron, on a body surface area basis) in females.

In a 12-month oral toxicity study, treatment with Granisteron 100 mg/kg/day (600 mg/m2/day, about 261 times the recommended human dose with Granisteron, on a body surface area basis) produced hepatocellular adenomas in male and female rats while no such tumors were found in the control rats. A 24-month mouse carcinogenicity study of Granisteron did not show a statistically significant increase in tumor incidence, but the study was not conclusive.

Because of the tumor findings in rat studies, Granisteron should be prescribed only at the dose and for the indication recommended .

Granisteron was not mutagenic in an in vitro Ames test and mouse lymphoma cell forward mutation assay, and in vivo mouse micronucleus test and in vitro and ex vivo rat hepatocyte UDS assays. It, however, produced a significant increase in UDS in HeLa cells in vitro and a significant increased incidence of cells with polyploidy in an in vitro human lymphocyte chromosomal aberration test.

Granisteron at subcutaneous doses up to 6 mg/kg/day (36 mg/m2/day, about 16 times the recommended human dose of Granisteron, on a body surface area basis), and oral doses up to 100 mg/kg/day (600 mg/m2/day, about 261 times the recommended human dose of Granisteron, on a body surface area basis) was found to have no effect on fertility and reproductive performance of male and female rats.

13.3 Phototoxicity

When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, at 200 and 300 mcg/mL, Granisteron increased the percentage of cells with chromosomal aberration following photoirradiation.

Granisteron was not phototoxic when tested in vitro in a mouse fibroblast cell line. When tested in vivo in guinea-pigs, Granisteron patches did not show any potential for photoirritation or photosensitivity. No phototoxicity studies have been performed in humans.

14 CLINICAL STUDIES

The effectiveness of Granisteron in the prevention of chemotherapy-induced nausea and vomiting (CINV) was evaluated in a randomized, parallel group, double-blind, double-dummy study conducted in the U.S. and abroad. The study compared the efficacy, tolerability and safety of Granisteron with that of 2 mg oral Granisteron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.

The population randomized 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. Seventy-eight (78%) of patients were White, 12% Asian, 10% Hispanic/Latino and 0% Black.

The Granisteron patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral Granisteron was administered daily for the duration of the chemotherapy regimen, 1 hour before each dose of chemotherapy. Efficacy was assessed from the first administration until 24 hours after the start of the last day's administration of the chemotherapy regimen.

The primary endpoint of the trial was the proportion of patients achieving no vomiting and/or retching, no more than mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy. Using this definition, the effect of Granisteron was established in 60.2% of patients in the Granisteron arm and 64.8% of patients receiving oral Granisteron (difference -4.89%; 95% confidence interval –12.91% to +3.13%).

An assessment of patch adhesion in 621 patients receiving either active or placebo patches showed that less than 1% of patches became detached over the course of the 7 day period of patch application.

16 HOW SUPPLIED/STORAGE AND HANDLING

Granisteron (Granisetron Transdermal System) is supplied as a 52 cm2 patch containing 34.3 mg of Granisteron. Each patch is printed on one side with the words "Granisetron 3.1 mg/24 hours". Each patch is packaged in a separate sealed foil-lined plastic pouch.

Granisteron is available in packages of 1 (NDC 42747-726-01) patch.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)..

Granisteron should be stored in the original packaging.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling

17.1 Gastrointestinal

Because the use of Granisteron may mask a progressive ileus and/or gastric distention caused by the underlying condition, patients should be instructed to tell their physician if they have pain or swelling in their abdomen.

17.2 Skin Reactions

Patients should be instructed to remove the patch if they have a severe skin reaction, or a generalized skin reaction.

When patients remove the patch, they should be instructed to peel it off gently.

17.3 Exposure to Sunlight

Granisteron may be degraded by direct sunlight or exposure to sunlamps. In addition, an in vitro study using Chinese hamster ovary cells suggests that Granisteron has the potential for photogenotoxicity .

Patients must be advised to cover the patch application site, e.g. 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.

17.4 Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome with concomitant use of Granisteron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms.

17.5 External Heat Sources

Patients should be advised not to apply a heat pad over or near the Granisteron patch. Patients should avoid prolonged exposure to heat as plasma concentration continues increasing during the period of heat exposure.

Rx Only

Manufactured by:

3M Delivery Systems

St. Paul, MN 55107

Manufactured for:

Kyowa Kirin, Inc.

Bedminster, NJ 07921

Rev. 01/2017

Copyright © 2017, Kyowa Kirin, Inc. All rights reserved.

Granisteron and Kyowa Kirin are trademarks owned by the Kyowa Kirin group of companies

Patient Information

Granisteron® [san-KOO-so]

(granisetron transdermal system)

IMPORTANT: For skin use only

Read the Patient Information that comes with Granisteron before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about Granisteron, ask your healthcare provider.

What is Granisteron?

Granisteron is a prescription medicine used to prevent nausea and vomiting in people receiving some types of chemotherapy treatment. Granisteron is a skin patch that slowly releases the medicine contained in the adhesive (glue), through clean and intact skin areas into your bloodstream while you wear the patch.

Important: Granisteron contains Granisteron, the same medicine in Kytril. Do not take Kytril at the same time you use Granisteron unless your healthcare provider tells you it is alright.

Who should not use Granisteron?

Do not use Granisteron if you are allergic to any of the ingredients in Granisteron. See the end of this leaflet for a list of ingredients in Granisteron.

What should I tell my healthcare provider before using Granisteron?

Tell your healthcare provider about all your medical conditions, including if you:


Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Other medicines may affect how Granisteron works. Granisteron may also affect how other medicines work.

How should Granisteron be used?

Use Granisteron exactly as prescribed. See the detailed Patient Instructions for Applying Granisteron at the end of this Patient Information leaflet.

What should I avoid while using Granisteron?

Do not apply any heat source over or near the Granisteron patch. For example,


Avoid sunlight. The medicine in Granisteron (granisetron) 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:


What are the possible side effects of Granisteron?

Granisteron can cause serious side effects:


Common side effects of Granisteron are:


Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Granisteron. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Granisteron?


Keep Granisteron out of the reach of children.

General information about Granisteron

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Granisteron for a condition for which it is not prescribed. Do not give Granisteron to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Granisteron. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Granisteron that is written for health professionals.

For more information, go to www.sancuso.com or call 1-800-SANCUSO.

Patient Instructions for Applying Granisteron

When do I apply the Granisteron patch?


Where do I apply the Granisteron patch?


How do I apply the Granisteron patch?

The Granisteron patch comes inside a pouch which is inside the carton.


What to do if the Granisteron patch does not stick well?

If the patch does not stick well, you may use surgical bandages or medical adhesive tape to keep the patch in place. Place tape or bandages on the edges of the patch. Do not completely cover the patch with bandages or tape and do not wrap completely around your arm. If the patch comes more than half off or it becomes damaged see your healthcare provider.

Can I bathe or shower while wearing Granisteron?

You can continue to shower and wash normally while wearing the Granisteron patch. It is not known how other activities, for example swimming, strenuous exercise or using a sauna or whirlpool, may affect Granisteron. Avoid these activities while wearing Granisteron.

How do I remove and dispose of Granisteron?


What are the ingredients in Granisteron?

Active ingredient: Granisteron.

Inactive ingredients: acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax.

Manufactured by:

3M Drug Delivery Systems, St. Paul, MN 55107

Manufactured for:

Kyowa Kirin, Inc., Bedminster, NJ 07921

Copyright © 2017 Kyowa Kirin, Inc. All rights reserved.

Granisteron and Kyowa Kirin are trademarks owned by the Kyowa Kirin group of companies

Revised: 09/2017

Image Image Image Image Image Image

Granisteron pharmaceutical active ingredients containing related brand and generic drugs:


Granisteron available forms, composition, doses:


Granisteron destination | category:


Granisteron Anatomical Therapeutic Chemical codes:


Granisteron pharmaceutical companies:


advertisement

References

  1. Dailymed."GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."GRANISETRON: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "granisetron". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Granisteron?

Depending on the reaction of the Granisteron after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Granisteron not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Granisteron addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sdrugs.com conducted a study on Granisteron, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Granisteron consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 16 here

The information was verified by Dr. Rachana Salvi, MD Pharmacology


| About | Privacy Policy
© 2002 - 2024 "sdrugs.com". All Rights Reserved