FDA

Palonosetron Hydrochloride

Approved 19 Sept 2018IntravenousInjectable

The FDA lists this product in 26 strengths and forms.

Indications

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 highly emetogenic cancer chemotherapy (HEC). 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.

Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) Pediatric patients aged 1 month to less than 17 years for prevention of : acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC).

( 1 )

Contraindications

4. CONTRAINDICATIONS Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to palonosetron [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to palonosetron or any of its components ( 4 )

Warnings and precautions

5. WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis and anaphylactic shock : reported in patients with or without known hypersensitivity to other selective 5-HT 3 receptor antagonists. If symptoms occur, discontinue Palonosetron Hydrochloride Injection and initiate appropriate medical treatment. ( 5.1 ) Serotonin syndrome : reported with 5-HT 3 receptor antagonists alone, but particularly with concomitant use of serotonergic drugs.

( 5.2 , 7.1 )

Indications

( 1 )

Warnings and precautions

( 5.2 , 7.1 )

Adverse reactions

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 )] Most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (≥5%) are: headache and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 Adults In double-blind randomized clinical trials for the prevention of nausea and vomiting induced by MEC or HEC, 1,374 adult patients received a single dose of Palonosetron Hydrochloride Injection, ondansetron (Studies 1 and 3) or dolasetron (Study 2) administered 30 minutes prior to chemotherapy [see Clinical Studies ( 14.1 )] .

Adverse reactions were similar in frequency and severity in all 3 treatment groups. Common adverse reactions reported in at least 2% of patients in these trials are shown in Table 2 . Table 2: Common Adverse Reactions* in Adults with Receiving MEC (Studies 1 and 2) or HEC (Study 3) * Reported in at least 2% of patients in any treatment group Adverse Reaction Palonosetron Hydrochloride Injection 0.25 mg intravenously (N=633) Ondansetron 32 mg intravenously (N=410) Dolasetron 100 mg intravenously (N=194) Headache 9% 8% 16% Constipation 5% 2% 6% Diarrhea 1% 2% 2% Dizziness 1% 2% 2% Fatigue < 1% 1% 2% Abdominal Pain < 1% < 1% 2% Insomnia < 1% 1% 2% Less common adverse reactions, reported in 1% or less of patients, in Studies 1, 2 and 3 were: Cardiovascular: non-sustained tachycardia, bradycardia, hypotension, hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation.

Dermatological: allergic dermatitis, rash Hearing and Vision: motion sickness, tinnitus, eye irritation and amblyopia Gastrointestinal System: diarrhea, dyspepsia, abdominal pain, dry mouth, hiccups and flatulence General: weakness, fatigue, fever, hot flash, flu-like syndrome Liver: transient, asymptomatic increases in AST and/or ALT and bilirubin. These changes occurred predominantly in patients receiving highly emetogenic chemotherapy Metabolic: hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, glycosuria, appetite decrease, anorexia Musculoskeletal: arthralgia Nervous System: dizziness, somnolence, insomnia, hypersomnia, paresthesia Psychiatric: anxiety, euphoric mood Urinary System: urinary retention Vascular: vein discoloration, vein distention In other studies, 2 subjects experienced severe constipation following a single Palonosetron Hydrochloride Injection dose of approximately 0.75 mg (three times the recommended dose).

Pediatrics Aged 2 Months to 17 Years In a pediatric clinical trial, 163 pediatric cancer patients with a mean age of 8 years received a single 20 mcg/kg (maximum 1.5 mg) intravenous infusion of Palonosetron Hydrochloride Injection 30 minutes before beginning the first cycle of emetogenic chemotherapy [see Clinical Studies ( 14.2 )] . Adverse reactions were evaluated in pediatric patients receiving Palonosetron Hydrochloride Injection for up to 4 chemotherapy cycles.

The following adverse reactions were reported in less than 1% of patients: Nervous System: headache, dizziness, dyskinesia. General: infusion site pain. Dermatological: allergic dermatitis, skin disorder.

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of palonosetron HCl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions: including dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticaria, anaphylaxis and anaphylactic shock [see Warnings and Precautions ( 5.1 )] Injection site reactions: including burning, induration, discomfort and pain

Palonosetron Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Palonosetron Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Hypersensitivity Reactions

5.2Serotonin Syndrome

Interactions

7.1Serotonergic Drugs

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance