posfrea palonosetron .25 mg/5mL Injection, Solution — NDC 83831-105-01 (Billing 83831-0105-01)
This is a package of posfrea palonosetron .25 mg/5mL Injection, Solution from Avyxa Pharma, LLC, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 052943
- GCN: 20228
- GPI-14 (Medi-Span): 50250070102020
- HICL (First Databank): 025512
- AHFS class code: 56:22.20.00
- RxCUI (RxNorm): 1728050
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Serotonin-3 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Palonosetron injection is used to prevent nausea and vomiting that may occur after receiving cancer chemotherapy or surgery. Palonosetron injection is in a class of medications called 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Read the full MedlinePlus article ↗- It's used to prevent nausea and vomiting — not to treat it once it's already started. For adults, it's given before cancer chemotherapy to stop both the immediate nausea (within th...
- What exactly is palonosetron injection used for?
- No, palonosetron injection is given directly into a vein (intravenously) by a nurse or doctor — you won't be managing this at home. For chemotherapy nausea, you'll get a single inf...
- How is it given — do I take it as a pill?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Palonosetron — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $81.04 | $405.21 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2468 | $55.230 / J2468 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 83831-0105-01 You're viewing this Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE | 2024-09-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Palonosetron Hydrochloride .25 mg/5mL 00703-4094-01 | Teva | 1 vial | — | — | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 00781-3312-75 | Sandoz | 1 vial | — | AP | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 00781-3415-75 | Sandoz | 1 vial | — | AP | Discontinued | — |
| Palonosetron .05 mg/mL 16714-0834-01 | NorthStar | 1 vial | — | AP | FDA listed | — |
| palonosetron hydrochloride .05 mg/mL 25021-0783-05 | Sagent | 1 vial | — | AP | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 36000-0326-02 | Baxter | 1 vial | — | — | FDA listed | — |
| Palonosetron .05 mg/mL 55111-0694-07 | Dr.Reddy's | 1 vial | — | AP | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 55150-0186-05 | Eugia | 1 vial | — | AP | FDA listed | — |
| Palonosetron .25 mg/5mL 60505-6193-01 | Apotex | 1 vial | — | — | FDA listed | — |
| Palonosetron .25 mg/5mL 60505-6439-01 | Apotex | 1 vial | — | — | FDA listed | — |
| Palonosetron .25 mg/5mL 63323-0673-05 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Palonosetron .25 mg/5mL 67184-0514-01 | Qilu | 1 vial | — | — | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 67457-0317-25 | Mylan | 1 vial | — | AP | FDA listed | — |
| Palonosetron .05 mg/mL 68001-0355-25 | BluePoint | 1 vial | — | AP | FDA listed | — |
| palonosetron hydrochloride .25 mg/5mL 69097-0927-35 | Cipla | 1 vial | — | — | FDA listed | — |
| Palonosetron Hydrochloride .25 mg/5mL 71288-0409-05 | Meitheal | 1 vial | — | AP | FDA listed | — |
| Palonosetron Hydrochloride .05 mg/mL 83634-0777-05 | Avenacy, | 1 vial | — | — | Discontinued | — |
| posfrea .25 mg/5mLthis 83831-0105-01 | Avyxa | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and 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 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 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1 ) 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 (HEC).
( 1 )
⏱️ Dosage and 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.
2.1Recommended 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 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 POSFREA in adults for PONV is 0.075 mg administered as a single intravenous dose over 10 seconds immediately before the induction of anesthesia.
2.2Instructions for Intravenous Administration POSFREA is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/mL). Do not mix POSFREA with other drugs. Flush the infusion line with 0.9% Sodium Chloride Injection before and after administration of POSFREA. Inspect POSFREA visually for particulate matter and discoloration before administration. Discard unused portion.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORM AND STRENGTHS POSFREA injection is sterile, clear, and colorless solution in a single-dose vial: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) 0.075 mg palonosetron in 1.5 mL (0.05 mg/mL) Injection: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial ( 3 ) 0.075 mg palonosetron in 1.5 mL (0.05 mg/mL) in a single-dose vial ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
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 POSFREA 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 )
5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with administration of palonosetron [see Adverse Reactions (6.2) ] . These reactions occurred in patients with or without known hypersensitivity to other 5-HT 3 receptor antagonists. If hypersensitivity reactions occur, discontinue POSFREA and initiate appropriate medical treatment.
Do not reinitiate POSFREA in patients who have previously experienced symptoms of hypersensitivity [see Contraindications (4) ] .
5.2Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 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-HT 3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 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 POSFREA and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue POSFREA and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if POSFREA is used concomitantly with other serotonergic drugs [see Drug Interactions (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 ) 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.
6.1Clinical 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. 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-Induced Nausea and Vomiting (CINV) Adults In double-blind randomized clinical trials for the prevention of nausea and vomiting induced by MEC or HEC, 1374 adult patients received a single dose of palonosetron, ondansetron (Studies 1 and 3) or dolasetron (Study 2) administered intravenously 30 minutes prior to chemotherapy [see Clinical Studies (14.1) ] . Adverse reactions were similar in frequency and severity in all three 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 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 any treatment group, in Studies 1, 2 and 3 were: Cardiac disorders : non-sustained tachycardia, bradycardia, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles.
Skin & subcutaneous tissue disorders : allergic dermatitis, rash. Ear &labyrinth disorders : motion sickness, tinnitus. Gastrointestinal disorders : diarrhea, dyspepsia, abdominal pain, dry mouth, hiccups and flatulence.
General disorders and administration site conditions : weakness, fatigue, fever, hot flash, flu-like syndrome. Investigations : QT prolongation, transient, asymptomatic increases in AST and/or ALT and bilirubin and these changes occurred predominantly in patients receiving HEC. Metabolism and nutrition disorders : hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, appetite decrease, anorexia.
Musculoskeletal and connective tissue disorders : arthralgia. Nervous System disorders : dizziness, somnolence, insomnia, hypersomnia, paresthesia. Psychiatric disorders : anxiety, euphoric mood.
Renal and urinary disorders : urinary retention, glycosuria. Vascular disorders : vein discoloration, vein distention, hypotension, hypertension. In other studies, two subjects experienced severe constipation following a single 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 eight years received a single 20 mcg/kg (maximum 1.5 mg) intravenous infusion of palonosetron 30 minutes before beginning the first cycle of emetogenic chemotherapy [see Clinical Studies (14.2) ] . Adverse reactions were evaluated in pediatric patients receiving palonosetron for u… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment ( 7.1 )
7.1Serotonergic 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) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on palonosetron use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
8.2Lactation Risk Summary There are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for POSFREA and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition.
8.4Pediatric Use Chemotherapy-Induced Nausea and Vomiting (CINV) Safety and effectiveness of POSFREA have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including HEC. Use is supported by a clinical trial where 165 pediatric patients aged two months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see Clinical Studies (14.2) ] .
While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see Adverse Reactions (6.1) ] . Safety and effectiveness of POSFREA in neonates (less than 1 month of age) have not been established. Postoperative Nausea and Vomiting Studies (PONV) Safety and effectiveness have not been established in pediatric patients for PONV.
Two pediatric trials were performed. Pediatric Study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). A total of 150 pediatric surgical patients participated, age range one month to less than 17 years.
No dose response was observed. Pediatric Study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. A total of 670 pediatric surgical patients participated, age 30 days to less than 17 years.
The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Adverse rea… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on palonosetron use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
🧒 Pediatric Use ▾
8.4Pediatric Use Chemotherapy-Induced Nausea and Vomiting (CINV) Safety and effectiveness of POSFREA have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including HEC. Use is supported by a clinical trial where 165 pediatric patients aged two months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see Clinical Studies (14.2) ] .
While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see Adverse Reactions (6.1) ] . Safety and effectiveness of POSFREA in neonates (less than 1 month of age) have not been established. Postoperative Nausea and Vomiting Studies (PONV) Safety and effectiveness have not been established in pediatric patients for PONV.
Two pediatric trials were performed. Pediatric Study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). A total of 150 pediatric surgical patients participated, age range one month to less than 17 years.
No dose response was observed. Pediatric Study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. A total of 670 pediatric surgical patients participated, age 30 days to less than 17 years.
The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Adverse reactions to palonosetron were similar to those reported in adults.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron for CINV, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. Of the 1520 adult patients in clinical studies of intravenously administered palonosetron for PONV, 73 (5%) were at least 65 years old [see Clinical Studies (14.1, 14.3) ] . No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out.
Population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see Clinical Pharmacology (12.3) ] . No dosage adjustment is required for geriatric patients.
🆘 Overdosage ▾
10 OVERDOSAGE There is no known antidote to palonosetron. Overdose should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose.
A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Palonosetron is a 5-HT 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT 3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.
It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT 3 receptors located on vagal afferents to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factors and is triggered by release of 5-HT in a cascade of neuronal events involving both the central nervous system and the gastrointestinal tract.
The 5-HT 3 receptor has been demonstrated to selectively participate in the emetic response.
12.2Pharmacodynamics Cardiac Electrophysiology The effect of intravenous palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to intravenous ondansetron and dolasetron in CINV clinical trials. In PONV clinical trials the effect of palonosetron on the QTc interval was no different from placebo. In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarization and to prolong action potential duration.
At a dose of 9 times the maximum recommended adult dose, POSFREA does not prolong the QT interval to any clinically relevant extent.
12.3Pharmacokinetics After intravenous dosing of palonosetron in healthy subjects and cancer patients, an initial decline in palonosetron plasma concentrations is followed by a slow elimination from the body. Mean maximum plasma concentration (C max ) and area under the concentration-time curve (AUC 0-∞ ) are generally dose proportional over the dose range of 0.3 to 90 mcg/kg in healthy subjects and in cancer patients. Following a single intravenous dose of palonosetron at 3 mcg/kg (or 0.21 mg/70 kg) to six cancer patients, mean (±SD) maximum plasma concentration was estimated to be 5630 ± 5480 ng/L and mean AUC was 35.8 ± 20.9 h•mcg/L.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 cancer patients, the mean increase in plasma palonosetron concentration from Day 1 to Day 5 was 42±34%. Following intravenous administration of palonosetron 0.25 mg once daily for three days in 12 healthy subjects, the mean (±SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110±45%. After intravenous dosing of palonosetron in patients undergoing surgery (abdominal surgery or vaginal hysterectomy), the pharmacokinetic characteristics of palonosetron were similar to those observed in cancer patients.
Distribution Palonosetron has a volume of distribution of approximately 8.3 ±
2.5L/kg. Approximately 62% of palonosetron is bound to plasma proteins. Elimination After a single intravenous dose of 10 mcg/kg [ 14 C]-palonosetron, approximately 80% of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40% of the administered dose.
In healthy subjects, the total body clearance of palonosetron was 0.160 ± 0.035 L/h/kg and renal clearance was 0.067± 0.018 L/h/kg. Mean terminal elimination half-life is approximately 40 hours. Metabolism Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron.
These metabolites each have less than 1% of the 5-HT 3 receptor antagonist activity of palonosetron. In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Palonosetron is a 5-HT 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT 3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.
It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT 3 receptors located on vagal afferents to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factors and is triggered by release of 5-HT in a cascade of neuronal events involving both the central nervous system and the gastrointestinal tract.
The 5-HT 3 receptor has been demonstrated to selectively participate in the emetic response.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING POSFREA TM injection is supplied as a sterile, clear and colorless solution in single-dose vials as follows: NDC Number Strength Package 83831-105-01 0.25 mg palonosetron in 5 mL (0.05 mg/mL) 1 vial/carton 83831-104-05 0.075 mg palonosetron in 1.5 mL (0.05 mg/mL) 5 vials/carton Storage Store at 20°C to 25°C (68°F to 77°F); [Excursions permitted to 15°C to 30°C (59°F to 86°F)]. Protect from freezing. Protect from light.
📋 Description ▾
11 DESCRIPTION POSFREA Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3a S )-2-[ (S)- 1-Azabicyclo [2.2.2]oct 3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H benz[ de ]isoquinoline hydrochloride.
The empirical formula is C 19 H 24 N 2 O . HCl, with a molecular weight of 332.87. Palonosetron HCl exists as a single isomer and has the following structural formula: Palonosetron HCl is a white to off-white crystalline powder.
It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. POSFREA Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. POSFREA Injection is available as a 5 mL or 1.5 mL single-dose vial.
Each mL of aqueous solution contains 0.05 mg palonosetron (equivalent to 0.056 mg palonosetron hydrochloride). Each mL also contains 41.5 mg mannitol, 3.0 mg sodium acetate trihydrate, and water for injection (q.s. to 1.0 mL). The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5.
Hydrochloric acid or sodium hydroxide may have been added to adjust pH. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT 3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of POSFREA [see Warnings and Precautions (5.1) ] .
Serotonin Syndrome Advise patients of the possibility of serotonin syndrome, especially with concomitant use of POSFREA and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.2) ]. Manufactured for: Avyxa Pharma, LLC New Jersey 07054, USA Image
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics After intravenous dosing of palonosetron in healthy subjects and cancer patients, an initial decline in palonosetron plasma concentrations is followed by a slow elimination from the body. Mean maximum plasma concentration (C max ) and area under the concentration-time curve (AUC 0-∞ ) are generally dose proportional over the dose range of 0.3 to 90 mcg/kg in healthy subjects and in cancer patients. Following a single intravenous dose of palonosetron at 3 mcg/kg (or 0.21 mg/70 kg) to six cancer patients, mean (±SD) maximum plasma concentration was estimated to be 5630 ± 5480 ng/L and mean AUC was 35.8 ± 20.9 h•mcg/L.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 cancer patients, the mean increase in plasma palonosetron concentration from Day 1 to Day 5 was 42±34%. Following intravenous administration of palonosetron 0.25 mg once daily for three days in 12 healthy subjects, the mean (±SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110±45%. After intravenous dosing of palonosetron in patients undergoing surgery (abdominal surgery or vaginal hysterectomy), the pharmacokinetic characteristics of palonosetron were similar to those observed in cancer patients.
Distribution Palonosetron has a volume of distribution of approximately 8.3 ±
2.5L/kg. Approximately 62% of palonosetron is bound to plasma proteins. Elimination After a single intravenous dose of 10 mcg/kg [ 14 C]-palonosetron, approximately 80% of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40% of the administered dose.
In healthy subjects, the total body clearance of palonosetron was 0.160 ± 0.035 L/h/kg and renal clearance was 0.067± 0.018 L/h/kg. Mean terminal elimination half-life is approximately 40 hours. Metabolism Palonosetron is eliminated by multiple routes with approximately 50% metabolized to form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron.
These metabolites each have less than 1% of the 5-HT 3 receptor antagonist activity of palonosetron. In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron. However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.
Specific Populations Pediatric Patients Pharmacokinetic data was obtained from a subset of pediatric cancer patients that received 10 mcg/kg or 20 mcg/kg as a single intravenous dose of palonosetron. When the dose was increased from 10 mcg/kg to 20 mcg/kg a dose-proportional increase in mean AUC was observed. Peak plasma concentrations (CT) reported at the end of the 15-minute infusion of 20 mcg/kg were highly variable in all age groups and tended to be lower in patients less than six years than in older patients as shown in Table 4.
The median half-life was 30 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 mcg/kg. The total body clearance (L/h/kg) in patients 12 to 17 years old was similar to that in healthy adults. There are no apparent differences in volume of distribution when expressed as L/kg.
Table 4: Pharmacokinetics Parameters in Pediatric Cancer Patients following Intravenous Infusion of 20 mcg/kg Palonosetron Over 15 minutes a Geometric Mean (CV) except for t1/2 which is median values b C T is the plasma palonosetron concentration at the end of the 15-minute infusion c Clearance and Vss calculated from 10 and 20 mcg/kg and are weight adjusted PK Parameter a Pediatric Age Group Less than 2 years 2 years to less than 6 years 6 years to less than 12 years 12 years to less than 17 years N=12 N=42 N=38 N=44 C T b , ng/L 9025 (197) 9414 (252) 16275 (203) 11831 (176) N=5 N=7 N=10 AUC 0- ∞, h·mcg/L 103.5 (40.4) 98.7 (47.7) 124.5 (19.1) N=6 N=14 N=13 N=19 Clearance c , L/h/kg 0.31 (34.7) 0.23 (51.3)… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Cardiac Electrophysiology The effect of intravenous palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to intravenous ondansetron and dolasetron in CINV clinical trials. In PONV clinical trials the effect of palonosetron on the QTc interval was no different from placebo. In non-clinical studies palonosetron possesses the ability to block ion channels involved in ventricular de- and re-polarization and to prolong action potential duration.
At a dose of 9 times the maximum recommended adult dose, POSFREA does not prolong the QT interval to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of POSFREA have been established based on adequate and well-controlled adult studies of another intravenous formulation of palonosetron in CINV and PONV. Below is a display of the results of these adequate and well-controlled studies of palonosetron in these conditions.
14.1Prevention of Nausea and Vomiting Associated with MEC and HEC in Adults Efficacy of a single intravenous dose of palonosetron in preventing acute and delayed nausea and vomiting associated with MEC or HEC were studied in four trials. In these double-blind studies, complete response rates (no emetic episodes and no rescue medication) and other efficacy parameters were assessed through at least 120 hours after administration of chemotherapy. The safety and efficacy of palonosetron in repeated courses of chemotherapy was also assessed.
Moderately Emetogenic Chemotherapy Two double-blind trials (Study 1 and Study 2) involving 1132 patients compared a single dose of palonosetron with either a single-dose of ondansetron (Study 1) or dolasetron (Study 2) given 30 minutes prior to MEC, including carboplatin, cisplatin ≤ 50 mg/m 2 , cyclophosphamide <1500 mg/m 2 , doxorubicin > 25 mg/m 2 , epirubicin, irinotecan, and methotrexate >250 mg/m 2 . Concomitant corticosteroids were not administered prophylactically in Study 1 and were only used by 4 to 6% of patients in Study 2.
The majority of patients in these studies were women (77%), White (65%) and naïve to previous chemotherapy (54%). The mean age was 55 years. Highly Emetogenic Chemotherapy A double-blind, dose-ranging trial evaluated the efficacy of a single intravenous dose of palonosetron from 0.3 to 90 mcg/kg (equivalent to < 0.1 mg to 6 mg fixed dose) in 161 chemotherapy-naïve adult cancer patients receiving HEC, either cisplatin ≥ 70 mg/m 2 or cyclophosphamide > 1100 mg/m 2 .
Concomitant corticosteroids were not administered prophylactically. Analysis of data from this trial indicates that 0.25 mg is the lowest effective dose in preventing acute nausea and vomiting associated with HEC. A double-blind trial involving 667 patients compared a single intravenous dose of palonosetron with a single intravenous dose of ondansetron (Study 3) given 30 minutes prior to HEC, including cisplatin ≥ 60 mg/m 2 , cyclophosphamide > 1500 mg/m 2 , and dacarbazine.
Corticosteroids were co-administered prophylactically before chemotherapy in 67% of patients. Of the 667 patients, 51% were women, 60% White, and 59% naïve to previous chemotherapy. The mean age was 52 years.
Efficacy Results Studies 1, 2 and 3 show that palonosetron was effective in the prevention of nausea and vomiting associated with initial and repeat courses of MEC and HEC in the acute phase (0 to 24 hours) [Table 5]. Clinical superiority over other 5-HT 3 receptor antagonists has not been adequately demonstrated in the acute phase. In Study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly.
Studies 1 and 2 show that palonosetron was effective in the prevention of nausea and vomiting associated with initial and repeat course of MEC in the delayed phase (24 to 120 hours) [Table 6] and overall phase (0 to 120 hours) [Table 7]. Table 5: Prevention of Acute Nausea and Vomiting (0 to 24 Hours) in Adults with Nausea and Vomiting Associated with MEC or HEC in Studies 1, 2 and 3: Complete Response Rates a Intent-to-treat cohort b 2-sided Fisher's exact test. Significance level at α=0.025. c These studies were designed to show non-inferiority.
A lower bound greater than –15% demonstrates non-inferiority between palonosteron and comparator. d Ondansetron 32 mg intravenously was used in the clinical trial. Although this dose was used in the trial, it is no longer the currently recommended dose. Refer to the ondansetron prescribing information for the current recommended dose.
Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval Palonosetron mi… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral doses of palonosetron at 10, 30 and 60 mg/kg/day. Treatment with palonosetron was not tumorigenic. The highest tested dose produced a systemic exposure to palonosetron (plasma AUC) of about 150 to 289 times the human exposure (AUC= 29.8 h•mcg/L) at the recommended intravenous dose of 0.25 mg.
In a 104-week carcinogenicity study in Sprague-Dawley rats, male and female rats were treated with oral doses of 15, 30 and 60 mg/kg/day and 15, 45 and 90 mg/kg/day, respectively. The highest doses produced a systemic exposure to palonosetron (plasma AUC) of 137 and 308 times the human exposure at the recommended dose. Treatment with palonosetron produced increased incidences of adrenal benign pheochromocytoma and combined benign and malignant pheochromocytoma, increased incidences of pancreatic Islet cell adenoma and combined adenoma and carcinoma and pituitary adenoma in male rats.
In female rats, it produced hepatocellular adenoma and carcinoma and increased the incidences of thyroid C-cell adenoma and combined adenoma and carcinoma. Palonosetron was not genotoxic in the Ames test, the Chinese hamster ovarian cell (CHO/HGPRT) forward mutation test, the ex vivo hepatocyte unscheduled DNA synthesis (UDS) test or the mouse micronucleus test. It was, however, positive for clastogenic effects in the Chinese hamster ovarian (CHO) cell chromosomal aberration test.
Palonosetron at oral doses up to 60 mg/kg/day (about 1894 times the recommended human intravenous dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral doses of palonosetron at 10, 30 and 60 mg/kg/day. Treatment with palonosetron was not tumorigenic. The highest tested dose produced a systemic exposure to palonosetron (plasma AUC) of about 150 to 289 times the human exposure (AUC= 29.8 h•mcg/L) at the recommended intravenous dose of 0.25 mg.
In a 104-week carcinogenicity study in Sprague-Dawley rats, male and female rats were treated with oral doses of 15, 30 and 60 mg/kg/day and 15, 45 and 90 mg/kg/day, respectively. The highest doses produced a systemic exposure to palonosetron (plasma AUC) of 137 and 308 times the human exposure at the recommended dose. Treatment with palonosetron produced increased incidences of adrenal benign pheochromocytoma and combined benign and malignant pheochromocytoma, increased incidences of pancreatic Islet cell adenoma and combined adenoma and carcinoma and pituitary adenoma in male rats.
In female rats, it produced hepatocellular adenoma and carcinoma and increased the incidences of thyroid C-cell adenoma and combined adenoma and carcinoma. Palonosetron was not genotoxic in the Ames test, the Chinese hamster ovarian cell (CHO/HGPRT) forward mutation test, the ex vivo hepatocyte unscheduled DNA synthesis (UDS) test or the mouse micronucleus test. It was, however, positive for clastogenic effects in the Chinese hamster ovarian (CHO) cell chromosomal aberration test.
Palonosetron at oral doses up to 60 mg/kg/day (about 1894 times the recommended human intravenous dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
📄 Patient Package Insert ▾
SPL PATIENT PACKAGE INSERT This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 04/2025 PATIENT INFORMATION POSFREA TM (pos-FREE-uh) (palonosetron) injection, for intravenous use Read this Patient Information before you receive POSFREA and each time you receive POSFREA.
There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is POSFREA?
POSFREA is a prescription medicine called an "antiemetic." POSFREA is used in adults to help prevent the nausea and vomiting that happens: ● right away or later with certain anti-cancer medicines (chemotherapy) ● up to 24 hours while recovering from anesthesia after surgery POSFREA is used in children 1 month old to less than 17 years of age to help prevent the nausea and vomiting that happens right away with certain anti-cancer medicines (chemotherapy). ● It is not known if POSFREA is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy. ● It is not known if POSFREA is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.
Who should not receive POSFREA? Do not receive POSFREA if you are allergic to palonosetron hydrochloride or any of the ingredients in POSFREA. See the end of this leaflet for a complete list of ingredients in POSFREA.
What should I tell my doctor before receiving POSFREA? Before receiving POSFREA, tell your doctor about all of your medical conditions, including if you: ● have had an allergic reaction to another medicine for nausea or vomiting ● are pregnant or plan to become pregnant. It is not known if POSFREA will harm your unborn baby. ● are breastfeeding or plan to breastfeed.
It is not known if POSFREA passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you will receive POSFREA. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
POSFREA and certain other medicines can affect each other, causing serious side effects. How will I receive POSFREA? ● POSFREA will be given to you in your vein by intravenous (I.V.) injection. ● POSFREA is usually given about 30 minutes before you receive your anti- cancer medicine (chemotherapy) or right before anesthesia for surgery. What are the possible side effects of POSFREA?
POSFREA may cause serious side effects, including: ● Serious allergic reactions , such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms. ○ hives ○ swollen face ○ breathing trouble ○ chest pain ● Serotonin Syndrome. A possible life threatening problem called serotonin syndrome can happen with medicines called 5-HT 3 receptor antagonists, including POSFREA, especially when used with medicines used to treat depression and migraine headaches called serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines.
Tell your doctor or nurse right away if you have any of the following symptoms of serotonin syndrome: ○ agitation, seeing things that are not there (hallucinations), confusion, or coma ○ fast heartbeat or unusual and frequent changes in your blood pressure ○ dizziness, sweating, flushing, or fever ○ tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination ○ seizures ○ nausea, vomiting, or diarrhea The most common side effects in adults who receive POSFREA to help prevent nausea and vomiting that happens with certain anti-cancer medicine (chemotherapy) include: headache and constipation.
The most common side effects in adults who receive POSFREA to help prevent nausea and vomiting that happens while recovering from anesthesia after surgery include: serious or life… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
RECENT MAJOR CHANGES Indications and Usage ( 1 ) 4/2025 Dosage and Administration ( 2.1 ) 4/2025
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Posfrea (palonosetron) Injection, 0.25mg/5 mL -Container label Posfrea (palonosetron) Injection, 0.25mg/5 mL -Carton label Posfrea (palonosetron) Injection, 0.25mg/5 mL -Container label Posfrea (palonosetron) Injection, 0.25mg/5 mL -Carton label
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