Granisetron
Generic Name: granisetron
Brand Names:
Sustol
11 DESCRIPTION SUSTOL (granisetron) extended-release injection, contains granisetron, a serotonin-3 (5-HT 3 ) receptor antagonist. Granisetron 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, with the following chemical structure: Granisetron is a white to off-white crystalline solid that is insoluble in water.
Overview
11 DESCRIPTION SUSTOL (granisetron) extended-release injection, contains granisetron, a serotonin-3 (5-HT 3 ) receptor antagonist. Granisetron 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, with the following chemical structure: Granisetron is a white to off-white crystalline solid that is insoluble in water.
Uses
1 INDICATIONS AND USAGE SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For subcutaneous injection only. Intended for administration by a healthcare provider. Administer in skin of the back of the upper arm or in the skin of the abdomen at least 1 inch away from the umbilicus. Do not administer anywhere the skin is burned, hardened, inflamed, swollen, or otherwise compromised. Due to the viscosity, administration requires a slow, sustained injection over 20 to 30 seconds. Recommended Dosage ( 2.2 ): The recommended dosage in adults is 10 mg administered as a single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on Day 1. Do not administer SUSTOL more frequently than once every 7 days. See full prescribing information for recommended dosage of concomitant dexamethasone.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Injection Site Reactions [see Warnings and Precautions ( 5.1 )] Gastrointestinal Disorders [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥ 3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Heron Therapeutics, Inc.
Interactions
7 DRUG INTERACTIONS 7.1 Serotonergic 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 SUSTOL and initiate supportive treatment [see Warnings and Precautions ( 5.4 )] .
Warnings
5 WARNINGS AND PRECAUTIONS Serious or severe injection site reactions (ISRs): Infection, prolonged bleeding, bruising, hematomas, nodules, pain, and tenderness have been reported. Patients who are neutropenic or receiving antiplatelet agents or anticoagulants may be at greater risk. Monitor for ISRs during treatment with SUSTOL. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. For ongoing ISRs, administer SUSTOL at a site away from the affected area and consider discontinuing SUSTOL for severe or persistent ISRs. ( 5.1 ) Gastrointestinal disorders: Monitor for constipation and consider optimizing patients' current bowel regimens used for managing preexisting constipation. 4 CONTRAINDICATIONS SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists [see Warnings and Precautions ( 5.3 ), Description ( 11 )] . Hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists. ( 4 , 5.3 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on the use of SUSTOL in pregnant women. Limited published data on granisetron use during pregnancy are not sufficient to inform a drug-associated risk. 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 61 times and 41 times respectively the maximum recommended human dose (MRHD) of SUSTOL 10 mg/week [see Data] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06) each kit contains: One sterile single-dose amber colored glass syringe which contains 10 mg granisetron/0.4 mL, One sterile 18 Ga 5/8" special thin walled administration needle, Two sodium acetate syringe warming pouches, One Point Lok needle protection device.
Frequently Asked Questions
What is Granisetron used for?▼
1 INDICATIONS AND USAGE SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. ( 1 )
What are the side effects of Granisetron?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Injection Site Reactions [see Warnings and Precautions ( 5.1 )] Gastrointestinal Disorders [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥ 3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Heron Therapeutics, Inc.
Can I take Granisetron during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on the use of SUSTOL in pregnant women. Limited published data on granisetron use during pregnancy are not sufficient to inform a drug-associated risk. 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 61 times and 41 times respectively the maximum recommended human dose (MRHD) of SUSTOL 10 mg/week [see Data] .
What are the important warnings for Granisetron?▼
5 WARNINGS AND PRECAUTIONS Serious or severe injection site reactions (ISRs): Infection, prolonged bleeding, bruising, hematomas, nodules, pain, and tenderness have been reported. Patients who are neutropenic or receiving antiplatelet agents or anticoagulants may be at greater risk. Monitor for ISRs during treatment with SUSTOL. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. For ongoing ISRs, administer SUSTOL at a site away from the affected area and consider discontinuing SUSTOL for severe or persistent ISRs. ( 5.1 ) Gastrointestinal disorders: Monitor for constipation and consider optimizing patients' current bowel regimens used for managing preexisting constipation. 4 CONTRAINDICATIONS SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists [see Warnings and Precautions ( 5.3 ), Description ( 11 )] . Hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists. ( 4 , 5.3 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.