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 AdministrationALOXI 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.
3 DOSAGE FORM AND STRENGTHS
ALOXI is supplied as a single-use sterile, clear, colorless solution in glass vials that provide:
0.25 mg (free base) per 5 mL (concentration: 0.05 mg/mL, 50 mcg/mL)
0.075 mg (free base) per 1.5 mL (concentration: 0.05 mg/mL, 50 mcg/mL)
4 CONTRAINDICATIONS
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see Adverse Reactions (6.2)].
5 WARNINGS AND PRECAUTIONS
5.1 HypersensitivityHypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists.
5.2 Serotonin SyndromeThe development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ALOXIand other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ALOXI and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs [see Drug Interactions (7), Patient Counseling Information (17)].
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
6.1 Chemotherapy-Induced Nausea and VomitingAdults
In clinical tria |
