From the official label (Apr 2025). Your prescription and pharmacist come first.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
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. …
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 )
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) ] . …
Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment ( 7.1 ) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue POSFREA and initiate supportive treatment [see Warnings and Precautions (5.2) ] .
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 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with administration of palonosetron [see Adverse Reactions (6.2) ] . …
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. …
8.1 Pregnancy 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). …
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.
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
Products with Palonosetron as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
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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 demons (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: 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 beginni…
Usually yes. Palonosetron is a prescription medicine in most countries. Rules differ by country.
Palonosetron is sold under names such as Akynzeo, Posfrea. Brand names differ between countries.
The official label lists: 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 vo… Tell your doctor about any side effect that bothers you or does not go away.
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. … Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy 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… Ask your doctor or midwife first.
Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue POSFREA and initiate supportive treatment ( 7.1 ) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including… Use the free interaction checker before combining medicines.
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 palonoset… Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.