Classes
DEA Class; Rx
Common Brand Names; Sustol, Sancuso, Granisol Oral Solution
- Antiemetics, Selective 5-HT3 Antagonist
Description
Oral/intravenous/subcutaneous/transdermal 5-HT3 antagonist
Used to offset nausea/vomiting from moderately or highly emetogenic chemotherapy; also used for prevention of radiation-induced nausea/vomiting, and the immediate-release IV formulation is also approved for postoperative nausea/vomiting
Risk of dose-dependent QT prolongation and torsades de pointes
Indications
Contraindications
Hypersensitivity to drug or excipients
Adverse Effects
- Headache (10-21%)
- Diarrhea (1-9%)
- Constipation (3-18%)
- Asthenia (5%)
- Somnolence (10%)
- Sedation (10%)
- Drowsiness (10%)
Warnings
Liver disease
Protect patch from sunlight
May prolong QT interval; coadministration with drugs known to prolong QT interval may result in serious arrhythmias
Mild application site reactions have occurred; remove patch if severe reactions or generalized skin reaction occur
Avoid exposing granisetron patch and surrounding area to direct external heat sources, such as heating pads; plasma concentration continues to increase during period of heat exposure
Pregnancy and Lactation
There are no available data on use in pregnant women; limited published data on granisetron use during pregnancy are not sufficient to inform a drug-associated risk
There are no data on presence of the drug in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
40 mcg/kg IV; 2 mg PO; 1 transdermal patch; 10 mg subcutaneously.
40 mcg/kg IV; 2 mg PO; 1 transdermal patch; 10 mg subcutaneously.
10 mcg/kg IV is the FDA-approved dosage; up to 40 mcg/kg IV is used off-label. Safety and efficacy have not been established for oral, subcutaneous, or transdermal formulations; however, up to 40 mcg/kg PO twice daily has been used off-label for chemotherapy-induced nausea/vomiting.
2 years and older: 10 mcg/kg IV is the FDA-approved dosage; up to 40 mcg/kg IV is used off-label. Safety and efficacy have not been established for oral, subcutaneous, or transdermal formulations; however, up to 40 mcg/kg PO twice daily has been used off-label for chemotherapy-induced nausea/vomiting.
Younger than 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Granisetron hydrochloride
injectable solution
Avalailable as generics
0.1mg/mL
1mg/mL
extended relase SC injection
10mg/0.4mL single-dose prefilled syringe (Sustol)
patch
3.1mg/24hr (Sancuso)
tablets
1mg (generic)
oral solution (DSC)
1mg/5mL (Granisol)
