Palonosetron Hydrochloride

PALONOSETRON HYDROCHLORIDE- palonosetron hydrochloride injection, solution
Mylan Institutional LLC

1 INDICATIONS AND USAGE

Palonosetron hydrochloride injection is indicated in adults for prevention of:

acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC).
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, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:

acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Prevention of Chemotherapy-Induced Nausea and Vomiting

The recommended dosage of palonosetron hydrochloride injection for prevention of nausea and vomiting associated with HEC and MEC in adults and associated with emetogenic chemotherapy, including HEC in pediatric patients 1 month to less than 17 years of age is shown in Table 1.

Table 1: Recommended Dosage of Palonosetron Hydrochloride Injection for the Prevention of Nausea and Vomiting Associated with Chemotherapy in Adults and Pediatric Patients 1 Month to Less than 17 Years
*
Note different dosing units in pediatrics

Age

Dose *

Infusion Time

Adults

0.25 mg as a single dose

Infuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy

Pediatrics (1 month to less than 17 years)

20 micrograms per kilogram (max 1.5 mg) as a single dose

Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy

Postoperative Nausea and Vomiting

The recommended dosage of palonosetron hydrochloride injection in adults for PONV is 0.075 mg administered as a single intravenous dose over 10 seconds immediately before the induction of anesthesia.

2.2 Instructions for Intravenous Administration

Palonosetron hydrochloride injection is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/mL).
Do not mix palonosetron hydrochloride injection with other drugs.
Flush the infusion line with normal saline before and after administration of palonosetron hydrochloride injection.
Inspect palonosetron hydrochloride injection visually for particulate matter and discoloration before administration.
Discard unused portion.

3 DOSAGE FORMS AND STRENGTHS

Palonosetron hydrochloride injection is sterile, clear, and colorless solution.

0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial

4 CONTRAINDICATIONS

Palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with administration of palonosetron hydrochloride injection [see Adverse Reactions (6.2)]. These reactions occurred in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. If hypersensitivity reactions occur, discontinue palonosetron hydrochloride injection and initiate appropriate medical treatment. Do not reinitiate palonosetron hydrochloride injection in patients who have previously experienced symptoms of hypersensitivity [see Contraindications (4)].

5.2 Serotonin Syndrome

The 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 palonosetron hydrochloride and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue palonosetron hydrochloride and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if palonosetron hydrochloride is used concomitantly with other serotonergic drugs [see Drug Interactions (7.1)].

6 ADVERSE REACTIONS

Serious or otherwise clinically significant adverse reactions reported in other sections of labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Serotonin Syndrome [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

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.

Chemotherapy-Induced Nausea and Vomiting

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