FDA-filed SPL labeling · retrieved through openFDA

Palonosetron Injection

Palonosetron injection is a serotonin-blocking medicine used to prevent nausea and vomiting caused by cancer chemotherapy and to prevent postoperative nausea and vomiting after surgery.

Brand names Aloxiposfrea
Drug class ⓘ Serotonin-3 Receptor Antagonist
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 29, 2025
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ2003
FDA-listed product records ⓘ45
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Palonosetron Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Palonosetron injection (Posfrea) is a highly targeted anti-nausea medicine that blocks serotonin receptors to prevent chemotherapy-induced and postoperative nausea and vomiting. It is given by intravenous infusion by your healthcare team, so you don't manage the dose yourself. The most important things to know are the small risk of serious allergic reactions and, if you take serotonin-raising medicines, the risk of serotonin syndrome — report any unusual symptoms to your care team right away.
How we write & review this content — our editorial policy →

📖 Palonosetron Injection: Patient Information Guide

A plain-language walkthrough of Palonosetron Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Palonosetron injection is approved for preventing nausea and vomiting in specific clinical situations. Here is the full list of supported uses:

  • Adults — moderately emetogenic chemotherapy (MEC): Prevents both acute (within 24 hours) and delayed (days later) nausea and vomiting with initial and repeat chemotherapy courses.
  • Adults — highly emetogenic chemotherapy (HEC): Prevents acute nausea and vomiting with initial and repeat courses of the most nausea-causing chemotherapy agents.
  • Adults — postoperative nausea and vomiting (PONV): Prevents nausea and vomiting for up to 24 hours after surgery; given immediately before anesthesia is started. Efficacy beyond 24 hours has not been demonstrated.
  • Children aged 1 month to less than 17 years — emetogenic chemotherapy including HEC: Prevents acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. Not approved for postoperative nausea and vomiting in children.
  • Note: Palonosetron has not been studied in newborns under 1 month of age.
⚙️How it works▾

Palonosetron is a 5-HT3 receptor antagonist — meaning it blocks a specific type of serotonin receptor found both in the gut and in the brain's vomiting-control center. When chemotherapy drugs or surgery-related anesthesia trigger the release of serotonin in the small intestine, that serotonin normally binds to these receptors and kicks off the vomiting reflex. Palonosetron binds very tightly to those receptors, blocking the signal before it can start the cascade. It has little to no effect on other receptor types, which helps limit unrelated side effects.

💊How it's taken▾

Palonosetron injection is given intravenously (directly into a vein) by a trained healthcare professional in a clinical setting such as a hospital, infusion center, or surgical suite. It is not taken by mouth and not self-administered. For chemotherapy prevention, it is given as a single dose approximately 30 minutes before chemotherapy begins — infusion time differs between adults and children, so the care team will manage this. For postoperative nausea prevention in adults, it is given as a single quick injection immediately before anesthesia is started. In both settings, a single dose per treatment session is the standard approach; your prescriber will determine all details of your regimen.

🤒Side effects — in detail▾

Like all medicines, palonosetron can cause side effects, though most people tolerate it well. The most commonly reported reactions include:

  • Headache
  • Constipation
  • Diarrhea
  • Dizziness
  • Fatigue or weakness
  • QT prolongation (a subtle electrical change in the heart, seen on an ECG) — reported in postoperative use
  • Bradycardia (a slower-than-normal heartbeat) — reported in postoperative use
  • Injection site reactions: pain, burning, induration (hardening), or discomfort

Serious but less common reactions include severe allergic reactions (anaphylaxis) and serotonin syndrome — both require immediate medical attention. Tell your care team right away if you feel unwell after receiving this medicine.

⚠️Warnings & precautions▾
  • Severe allergic reactions (including anaphylaxis): Life-threatening allergic reactions have been reported, even in patients without a known allergy to similar medicines. Signs include difficulty breathing, swelling, hives, and a sudden drop in blood pressure. If this happens, the medicine must be stopped immediately. Anyone who has previously had a hypersensitivity reaction to palonosetron should not receive it again.
  • Serotonin syndrome: This dangerous condition can occur when palonosetron is combined with other medicines that raise serotonin levels — including certain antidepressants (SSRIs, SNRIs), MAO inhibitors, tramadol, fentanyl, lithium, mirtazapine, and intravenous methylene blue. Warning signs include confusion, agitation, rapid heartbeat, high fever, heavy sweating, muscle twitching or rigidity, and seizures. Some cases have been fatal. Your care team should know about all medicines you take before you receive palonosetron.
🔀What it interacts with▾

The main drug interaction concern with palonosetron is the risk of serotonin syndrome when it is combined with other medicines that increase serotonin activity. Key medicines to flag for your care team include:

  • SSRIs (selective serotonin reuptake inhibitors, e.g., fluoxetine, sertraline, escitalopram) — commonly used antidepressants that raise serotonin levels
  • SNRIs (serotonin-norepinephrine reuptake inhibitors, e.g., venlafaxine, duloxetine) — another class of antidepressants with serotonin effects
  • MAO inhibitors (monoamine oxidase inhibitors, e.g., phenelzine, selegiline) — antidepressants or Parkinson's medicines with strong serotonin interactions
  • Mirtazapine — an antidepressant with serotonergic activity
  • Fentanyl and tramadol — opioid pain medicines that also affect serotonin
  • Lithium — used for bipolar disorder; has serotonergic effects
  • Intravenous methylene blue — a dye used in some medical procedures that potently inhibits MAO

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not receive palonosetron if you have had a confirmed allergic reaction to palonosetron or any ingredient in the injection.
  • Tell your doctor if you are pregnant. Human data on the safety of palonosetron during pregnancy is not available; animal studies did not show harm to developing fetuses, but this does not guarantee safety in humans.
  • Tell your doctor if you are breastfeeding. It is not known whether palonosetron passes into breast milk or affects a nursing infant. Discuss the risks and benefits with your care team.
  • Children under 1 month of age: safety and effectiveness have not been established for any use.
  • Children of any age: palonosetron injection is not approved for preventing postoperative nausea and vomiting in pediatric patients — this use is for adults only.
  • Older adults (65 and over): no dose adjustment is needed based on age alone, and clinical studies showed no overall difference in safety or effectiveness compared to younger adults, though individual sensitivity can vary.
  • Kidney impairment: mild to moderate kidney disease does not meaningfully change how the body handles palonosetron. Even in severe kidney disease, the increase in drug exposure is not considered clinically significant.
  • Liver impairment: liver disease does not significantly affect how the body clears palonosetron.
🚑If you take too much▾

There is no specific antidote if someone receives too much palonosetron. Overdose is managed with supportive medical care. Because palonosetron distributes widely throughout the body, dialysis is unlikely to remove it effectively and is not expected to help in an overdose situation. If you suspect an overdose, seek emergency medical attention immediately.

📡Pharmacodynamics — effects in the body▾

Palonosetron's most clinically relevant effect is blocking serotonin-3 (5-HT3) receptors to prevent nausea and vomiting signals from reaching the brain. Studies of its effect on the heart show that, at recommended doses, it does not meaningfully prolong the QT interval (a measure of heart electrical activity) — a concern with some similar medicines. In surgical patients, its effect on heart rhythm was no different from placebo. At very high doses (nine times the maximum adult dose), no clinically relevant QT prolongation was seen.

🔬Pharmacokinetics — how your body processes it▾

After intravenous administration, palonosetron spreads widely through the body (volume of distribution roughly 8.3 L/kg) and about 62% binds to plasma proteins. It is eliminated slowly, with a half-life of approximately 40 hours in adults — meaning it stays active in the body for a long time after a single dose. About half of the drug is broken down by liver enzymes (primarily CYP2D6, with minor involvement of CYP3A4 and CYP1A2) into inactive metabolites, while roughly 40% is excreted unchanged in the urine. In children, the half-life is somewhat shorter (around 20–30 hours depending on age), and younger children tend to clear the drug faster, which is why the pediatric dose is calculated by body weight.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Do not freeze. Protect from light.

📄 Written from Palonosetron Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

21

Supplements & herbs that interact with Palonosetron Injection

21 supplements and herbal products have documented interactions with Palonosetron Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 18
  • Minor · 2
LITHIUM Major 5-HTP Moderate ACETYL-L-CARNITINE Moderate AYAHUASCA Moderate BLACK COHOSH Moderate BLACK SEED Moderate ERGOT Moderate FERMENTED WHEAT GERM EXTRACT Moderate +13 more
Every supplement checked against Palonosetron Injection — ranked by severity The full interaction hub: 1 major · 18 moderate · 2 minor · every one linked to its full report. Check Palonosetron Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Palonosetron Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What is palonosetron injection (Posfrea) actually used for? ▾
It's an anti-nausea medicine given through an IV by your healthcare team. It's used to prevent nausea and vomiting that chemotherapy can cause — both the kind that hits within the first day and the kind that can linger for several days after treatment. In adults, it's also used to prevent nausea and vomiting after surgery, given right before anesthesia. It doesn't treat nausea you already have — it works best when given before the trigger happens.
Will I receive this at home, or does it have to be given by a healthcare provider? ▾
You'll always receive this in a clinical setting — a hospital, infusion center, or surgical suite. A nurse or other healthcare professional gives it as an IV infusion or injection. There's no at-home version of this medicine, so you don't need to worry about managing it yourself.
What side effects should I watch out for after getting this injection? ▾
Most people handle it well. The most common reactions are headache and constipation — worth knowing about, but not usually a reason to worry. Some people notice dizziness or fatigue. More serious signs to report right away include any signs of an allergic reaction (trouble breathing, swelling, hives, or feeling faint) or unusual symptoms like confusion, racing heart, muscle twitching, or a high fever — these could point to a rare but serious condition called serotonin syndrome. Tell your care team immediately if anything feels off after you receive it.
I take an antidepressant. Is that a problem with this medicine? ▾
It's really important that your doctor and care team know about every medicine you take — especially antidepressants. Some antidepressants (like SSRIs such as sertraline or fluoxetine, and SNRIs like venlafaxine) raise serotonin levels, and combining them with palonosetron can increase the risk of serotonin syndrome, a serious condition. Your team will weigh the risks and monitor you closely if there's any concern. Don't skip mentioning it — this is exactly the kind of thing they need to know.
Is this safe for my child who is going through chemotherapy? ▾
Yes — palonosetron injection is approved for children aged 1 month and older to prevent nausea and vomiting from cancer chemotherapy, including the most intense regimens. Kids actually need a higher weight-based dose than adults, but that's taken care of by your child's care team. One thing to note: it is not approved for preventing postoperative (post-surgery) nausea and vomiting in children — that use is only for adults.
I'm pregnant. Is palonosetron safe to use? ▾
There isn't enough human data yet to say with certainty how palonosetron affects pregnancy. Animal studies at very high doses didn't show harm to developing fetuses, but animal results don't always translate directly to humans. If you're pregnant or could become pregnant, be upfront with your doctor so they can weigh the potential benefits — like preventing severe chemotherapy-related nausea — against the unknowns. The same goes for breastfeeding: it's not known whether this medicine passes into breast milk, so your care team will help you make the most informed choice.
Is Palonosetron Injection available over the counter? ▾
Palonosetron Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Palonosetron Injection first available? ▾
Palonosetron Injection has been available in the United States since at least 2003, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Palonosetron Injection? ▾
Palonosetron Injection is supplied by 23 manufacturers listed in the FDA NDC Directory, including Sandoz Inc, BluePoint Laboratories, Apotex Corp..

💬 Answers drafted from Palonosetron Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Palonosetron Injection supplement interactions21 checked — ranked by severity 🌿Drug & Supplement CheckerPalonosetron Injection vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Palonosetron Injection NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Palonosetron Injection comes

Palonosetron Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Posfrea
How this form is used
What it may be used for
  • Posfrea is used in adults to prevent both acute and delayed nausea and vomiting from moderately emetogenic cancer chemotherapy
  • Posfrea is used in adults to prevent acute nausea and vomiting from highly emetogenic cancer chemotherapy
  • Posfrea is used in adults to prevent postoperative nausea and vomiting for up to 24 hours after surgery
  • Posfrea is used in children aged 1 month to less than 17 years to prevent acute nausea and vomiting from emetogenic cancer chemotherapy, including highly emetogenic regimens
Important instructions
  • Posfrea is given intravenously (into a vein) by a healthcare professional — not self-administered at home
  • For chemotherapy use in adults, Posfrea is infused over 30 seconds beginning approximately 30 minutes before chemotherapy starts; in children, it is infused over 15 minutes beginning approximately 30 minutes before chemotherapy
  • For postoperative nausea and vomiting in adults, Posfrea is injected over 10 seconds immediately before anesthesia is induced
  • Flush the IV line with normal saline before and after administering Posfrea; do not mix it with other drugs in the same line
Available strengths 4 strengths
0.05 mg/mL 0.075 mg/1.5 mL 0.25 mg/2 mL 0.25 mg/5 mL
45 FDA-listed product records ⓘ

📊 Palonosetron Injection across the U.S. market

How Palonosetron Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
23
Manufacturers
3
Brand names
45
FDA-listed product records ⓘ
2003
First marketed ⓘ
Sandoz Inc11%
BluePoint Laboratories11%
Apotex Corp.9%
Baxter Healthcare Corporation7%
NorthStar Rx LLC7%
Fresenius Kabi USA, LLC4%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Palonosetron Injection is used

A general measure of how commonly Palonosetron Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Palonosetron Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

116,599
Medicaid prescriptions filled (Q1–Q4 2025)
$16M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Palonosetron Injection prescribed? Of the 1,596 medications we measure, Palonosetron Injection ranks #489 by Medicaid prescriptions — more than 69% of them.

Where Palonosetron Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #489 of 1,596
#484 Azathioprine 118,943 Rx #485 Clonidine Transdermal... 118,585 Rx #486 Pseudoephedrine 118,552 Rx #487 Rifaximin 118,294 Rx #488 Modafinil 117,062 Rx #489 Palonosetron Injection 116,599 Rx #490 Cefpodoxime 115,402 Rx #491 Magnesium Sulfate Hept... 113,083 Rx #492 Nystatin and Triamcino... 112,193 Rx #493 Vancomycin Injection 112,053 Rx #494 Atropine 111,807 Rx

Utilization by Palonosetron Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mL / 0.05 mg/mL injection is the most-dispensed Palonosetron Injection product — about 88% of these Medicaid prescriptions.

5 ML palonosetron 0.05 MG/ML Injection Most dispensed

102,945 Medicaid prescriptions (Q1–Q4 2025) 88% of Palonosetron Injection prescriptions shown $15.4M gross reimbursement (before rebates) ≈ $150 per prescription (gross)

Summed across the 16 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1728055

5 ML palonosetron 0.05 MG/ML Prefilled Syringe

13,654 Medicaid prescriptions (Q1–Q4 2025) 12% of Palonosetron Injection prescriptions shown $581,627 gross reimbursement (before rebates) ≈ $43 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2056929

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Palonosetron Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 17 of 30 listed Palonosetron Injection NDCs with Medicaid activity.

🔍 Compare Palonosetron Injection products

A representative set of FDA-listed product records for Palonosetron Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 45 of 45 products — FDA National Drug Code Directory. See every product, package size and price: browse all 45 Palonosetron Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Palonosetron Injection RxCUI 70561 2 dose forms · 4 strengths
  2. Dose form (SCDF) Prefilled Syringe RxCUI 2056926 No current FDA listing
    Clinical drug / strength (SCD) 5 ML palonosetron 0.05 MG/ML RxCUI 2056929

Look up RxCUI 70561 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Aloxi posfrea

🏭 Manufacturers & labelers

Sandoz Inc 5 BluePoint Laboratories 5 Apotex Corp. 4 Baxter Healthcare Corporation 3 NorthStar Rx LLC 3 Fresenius Kabi USA, LLC 2 Virtus Pharmaceuticals, LLC 2 Teva Parenteral Medicines, Inc. 2 Sagent Pharmaceuticals 2 Qilu Pharmaceutical Co., Ltd. 2 Eugia US LLC 2 Athenex Pharmaceutical Division, LLC. 2 Accord Healthcare, Inc. 1 Hospira, Inc. 1 Ingenus Pharmaceuticals, LLC 1 Meitheal Pharmaceuticals Inc. 1 Mylan Institutional LLC 1 Dr.Reddy's Laboratories Limited 1 Cipla USA Inc. 1 Avyxa Pharma, LLC 1 Avenacy, Inc. 1 AuroMedics Pharma LLC 1 West-Ward Pharmaceuticals Corp 1

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 29, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Palonosetron Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Palonosetron Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
NDC products indexed
45
Distinct labelers/manufacturers represented
23
Linked representative label ⓘ
Avyxa Pharma, LLC
Linked label effective
Apr 29, 2025
Composite sections available
23
Linked SPL Set ID
13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7
Linked SPL Document ID
2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Avyxa Pharma, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.