posfrea .25 mg/5mL

palonosetron · INJECTION, SOLUTION · Avyxa Pharma, LLC

No Recall HistoryCurrently in Shortage

Plain English

posfrea is a injection, solution containing palonosetron at .25 mg/5mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.

Key Facts

Brand Name: posfrea
Generic Name: palonosetron
NDC Code (Product): 83831-105
Manufacturer: Avyxa Pharma, LLC
Strength: .25 mg/5mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA203050
Marketing Start: 09/30/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea413 reports

diarrhoea253 reports

febrile neutropenia252 reports

vomiting252 reports

fatigue251 reports

neutropenia247 reports

alopecia223 reports

dyspnoea197 reports

anaemia191 reports

off label use182 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE POSFREA 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). 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, POSFREA is recommended even where the incidence of postoperative nausea and/or vomiting is low. POSFREA 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. POSFREA is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associate…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Chemotherapy-Induced Nausea and Vomiting (CINV) ( 2.1 ) *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 (maximum 1.5 mg) as a single dose Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy Postoperative Nausea and Vomiting ( 2.1 ) The recommended adult dosage is 0.075 mg as a single intravenous dose administered over 10 seconds immediately before the induction of anesthesia. 2.1 Recommended Dosage Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) The recommended dosage of POSFREA 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 POSFREA 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 ped…

Contraindications

4 CONTRAINDICATIONS POSFREA 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 )

Drug Interactions

7 DRUG INTERACTIONS Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment ( 7.1 ) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue POSFREA and initiate supportive treatment [see Warnings and Precautions (5.2) ] .

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 ) postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h. 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. The safety of POSFREA has been established from adequate and well-controlled studies of another intravenous formulation of palonosetron [see Clinical Studies (14) ] . Below is a display of the adverse reactions of palonosetron in these adequate and well-controlled studies. Chemotherapy-…

Frequently Asked Questions

What is posfrea used for?

posfrea contains palonosetron. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is posfrea a controlled substance?

posfrea is not classified as a controlled substance by the DEA.

What is the generic name for posfrea?

The generic name for posfrea is palonosetron. There are 11 other brand versions of palonosetron.

What is the NDC code for posfrea .25 mg/5mL?

The NDC (National Drug Code) for posfrea .25 mg/5mL is 83831-105, listed by Avyxa Pharma, LLC.

Product NDC

83831-105

Package NDC

83831-105-01

Other Palonosetron Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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