Posfrea

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 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.
• 2.2 Instructions 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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-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 up to four chemotherapy cycles.
• The following adverse reactions were reported in less than 1% of palonosetron-treated patients:
• Nervous System disorders :
• headache, dizziness, dyskinesia.
• General disorders and administration site conditions : infusion site pain.
• Skin and subcutaneous tissue disorders : allergic dermatitis, skin disorder.
• Postoperative Nausea and Vomiting (PONV) The most common adverse reactions reported in at least 2% of
• adults receiving palonosetron 0.075 mg intravenously immediately before induction of anesthesia in three randomized placebo-controlled trials [see Clinical Studies (14.3) ] are shown in Table 3.
• Rates of adverse reactions between palonosetron and placebo groups were similar.
• Some events are known to be associated with, or may be exacerbated by, concomitant perioperative and intraoperative medications administered in this surgical population.
• A thorough QT/QTc study demonstrated palonosetron does not prolong the QT interval to any clinically relevant extent [see Clinical Pharmacology (12.2) ] .
• Table 3:
• Common Adverse Reactions* in Trials of
• Adults with Postoperative Nausea and Vomiting *Reported in at least 2% of patients in any treatment group Adverse Reaction Palonosetron 0.075 mg intravenously (N=336) Placebo (N=369) Electrocardiogram QT prolongation 5% 3% Bradycardia 4% 4% Headache 3% 4% Constipation 2% 3% Less common adverse reactions, reported in 1% or less of patients, in these PONV clinical trials were:
• Cardiac disorders :
• sinus bradycardia, tachycardia, arrhythmia, ventricular extrasystoles.
• The frequency of these adverse effects did not appear to be different from placebo.
• Skin and subcutaneous tissue disorders : pruritus.
• Gastrointestinal disorders :
• flatulence, dry mouth, upper abdominal pain, salivary hypersecretion, dyspepsia, diarrhea, intestinal hypomotility.
• General disorders and administration site conditions : chills, generalized edema.
• Investigations :
• increases in AST and/or ALT, hepatic enzyme increased, QTc prolongation, blood pressure decreased, platelet count decreased, T wave amplitude decreased.
• Metabolism and nutrition disorders : hypokalemia, anorexia.
• Nervous System disorders : dizziness.
• Respiratory, thoracic and mediastinal disorders : hypoventilation, laryngospasm.
• Renal and urinary disorders : Urinary retention.
• Vascular disorders : Hypotension, Hypertension.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of palonosetron.
• 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

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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.

Quoted from the official label, section “How Supplied”.

What is in it

• 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Palonosetron