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Granisetron

    DEA Class; Rx

    Common Brand Names; Sustol, Sancuso, Granisol Oral Solution

    • Antiemetics, Selective 5-HT3 Antagonist

    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

    Indicated for the treatment of Cancer Chemotherapy Induced Nausea & Vomiting
    For chemotherapy-induced nausea/vomiting (CINV) and chemotherapy-induced nausea/vomiting prophylaxis.
    For radiation-induced nausea/vomiting prophylaxis.
    For the treatment of post-operative nausea/vomiting (PONV).
    For post-operative nausea/vomiting (PONV) prophylaxis.

    Hypersensitivity to drug or excipients

    • Headache (10-21%)
    • Diarrhea (1-9%)
    • Constipation (3-18%)
    • Asthenia (5%)
    • Somnolence (10%)
    • Sedation (10%)
    • Drowsiness (10%)

    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

    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

    Adults

    40 mcg/kg IV; 2 mg PO; 1 transdermal patch; 10 mg subcutaneously.

    Geriatric

    40 mcg/kg IV; 2 mg PO; 1 transdermal patch; 10 mg subcutaneously.

    Adolescents

    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.

    Children

    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.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    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)