Rx Item-Aloxi 0.25Mg/5ml Vial 5ml By Helsinn Therapeutics (Esai)

ALOXI- palonosetron hydrochloride capsule, gelatin coated
DESCRIPTION
ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is serotonin subtype (5-HT3 receptor antagonist with strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S)-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 C19 H24 N2 O.HCl, with molecular weight of 332.87. Palonosetron hydrochloride exists as single isome
Mechanism of Action
Palonosetron is 5-HT3 receptor antagonist with strong binding affinity for this receptor and little or no affinity for other receptors

INDICATIONS AND USAGE
1.1 Chemotherapy Induced Nausea and Vomiting
ALOXI is indicated for:
? Moderately emetogenic cancer chemotherapy prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
? Highly emetogenic cancer chemotherapy prevention of acute nausea and vomiting associated with initial and repeat courses
1.2 Postoperative Nausea and Vomiting
ALOXI is indicated for:
? Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, ALOXI is recommended even where the incidence of postoperative nausea and/or vomiting is low.
2 DOSAGE AND ADMINISTRATION
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.
3 DOSAGE FORM AND STRENGTHS
Aloxi is supplied as single-use sterile, clear, colorless solution in glass vials that provide:
? 0.25 mg (free base) per mL
? 0.075 mg (free base) per 1.5 mL
4 CONTRAINDICATIONS
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see Adverse Reactions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists.
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 58063-797-25, ALOXI Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in carton.
NDC 58063-797-37, ALOXI Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in carton containing vials.
Storage
? Store at controlled temperature of 20-25?C (68?F-77?F). Excursions permitted to 15-30?C (59-86?F).
? Protect from freezing.
? Protect from light.

Rx Item-Aloxi 0.25Mg/5ml Vial 5ml By Hel
NDC No. 62856-0797-01 62856-797-01 UPC/GTIN No.3-62856-79701-6 MPN No. 79701 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, P

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Eisai Inc.

PALONOSETRON HCL INTRAVEN
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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