Aloxi label

Aloxi

Aloxi Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Prevention of Chemotherapy-Induced Nausea and Vomiting

ALOXI Capsules are indicated for:

  • Moderately emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses

History

There is currently no drug history available for this drug.

Other Information

ALOXI (palonosetron HCl) Capsules is an antiemetic and antinauseant agent. It is a serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:

Structural Formula

Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol.

Each light beige opaque soft gelatin ALOXI Capsule contains 0.56 mg of palonosetron HCl equivalent to palonosetron 0.5 mg. Inactive ingredients are: mono- and di-glycerides of capryl/capric acid, glycerin, polyglyceryl oleate, water, and butylated hydroxyanisole.

Aloxi Manufacturers

  • Eisai
    Aloxi | Eisai Inc.
    No Recall

    Aloxi | Eisai Inc.

    Aloxi | Eisai Inc.
    2.1 Recommended Dosing

    Dosage for Adults - one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. ALOXI can be taken with or without food.

  • Mgi Pharma
    Aloxi | Mgi Pharma
    No Recall

    Aloxi | Mgi Pharma

    Aloxi | Mgi Pharma
    2.1 Recommended Dosing

    Chemotherapy Induced Nausea and Vomiting

    Dosage for Adults - a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy.

    Postoperative Nausea and Vomiting

    Dosage for Adults - a single 0.075 mg I.V. dose administered over 10 seconds immediately before induction of anesthesia.

    2.2 Instructions for I.V. Administration

    ALOXI is supplied ready for intravenous injection. ALOXI should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of ALOXI.

    Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

  • Eisai Inc.
    Aloxi | Eisai Inc.
    No Recall

    Aloxi | Eisai Inc.

    Aloxi | Eisai Inc.
    2.1 Recommended Dosing

    Chemotherapy-Induced Nausea and Vomiting

    Age Dose* Infusion Time Adults 0.25 mg x 1

    Infuse over 30 seconds beginning approx.
    30 min before the start of chemo

    Pediatrics
    (1 month to less than 17 years)

    20 micrograms per
    kilogram (max 1.5 mg) x 1

    Infuse over 15 minutes beginning approx.
    30 min before the start of chemo

    *Note different dosing units in pediatrics

    Postoperative Nausea and Vomiting
    Dosage for Adults - a single 0.075 mg intravenous dose administered over 10 seconds immediately before the induction of anesthesia.

    2.2 Instructions for Intravenous Administration

    ALOXI is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/ mL). ALOXI should not be mixed with other drugs. The infusion line should be flushed with normal saline before and after administration of ALOXI. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.