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Posfrea: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
0.25 mg/5 mL, 0.075 mg/1.5 mL
Other brand names:
  • Aloxi
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Posfrea

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-HT3 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-threatening heart rhythm changes (QT prolongation), slow heartbeat, headache, and constipation.

These are not all the possible side effects of POSFREA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of POSFREA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about POSFREA that is written for health professionals.

What are the ingredients in POSFREA?

Active ingredient: palonosetron hydrochloride

Inactive ingredients: mannitol and sodium acetate trihydrate in water for intravenous administration.

Hydrochloric acid or sodium hydroxide may have been added to adjust pH.

Rx Only

Manufactured for:

Avyxa Pharma, LLC

New Jersey 07054, USA

For more information call 1-888-520-0954.

Made in India

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 203050 · View the label on DailyMed

Revision date stated in the text: April 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Posfrea

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Serotonin-3 Receptor Antagonist
Active ingredient Palonosetron hydrochloride
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) AVYXA HOLDINGS
FDA approval NDA 203050New Drug Application (NDA) Approved March 1, 2016
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.25 mg/5 mL – 5 ml in 1 vial, single-dose / 1 in 1 carton NDC 83831-105-01
0.075 mg/1.5 mL – 1.5 ml in 1 vial, single-use / 5 in 1 carton NDC 83831-104-05

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.