Palonosetron Hydrochloride (Page 5 of 6)

14.3 Prevention of Postoperative Nausea and Vomiting in Adults

In a multicenter, randomized, stratified, double-blind, parallel-group, clinical trial, palonosetron hydrochloride injection was compared to placebo for PONV in 546 patients undergoing abdominal and gynecological surgery. All patients received general anesthesia. The trial was conducted predominantly in the US in the out-patient setting for patients undergoing elective gynecologic or abdominal laparoscopic surgery and stratified at randomization for the following risk factors: gender, non-smoking status, history of PONV and/or motion sickness.

Patients were randomized to receive a single dose of palonosetron hydrochloride injection 0.025 mg, 0.050 mg or 0.075 mg or placebo, each given intravenously immediately prior to induction of anesthesia. Antiemetic activity of was evaluated during the 0 to 72-hour time period after surgery.

Of the 138 patients treated with palonosetron hydrochloride injection 0.075 mg and evaluated for efficacy, 96% were women; 66% had a history of PONV or motion sickness; 85% were non-smokers. As for race, 63% were White, 20% were Black, 15% were Hispanic, and 1% were Asian. The age of patients ranged from 21 to 74 years, with a mean age of 38years. Three patients were greater than 65 years of age.

Co-primary efficacy measures were Complete Response (CR) defined as no emetic episode and no use of rescue medication in 0 to 24 hours and 24 to 72 hours postoperatively.

Secondary efficacy endpoints included:

  • Complete Response (CR) 0 to 48 hours and 0 to 72 hours
  • Complete Control (CC) defined as CR and no more than mild nausea
  • Severity of nausea (none, mild, moderate, severe)

The primary hypothesis was that at least one of the three palonosetron doses were superior to placebo.

Complete Response Rates for palonosetron hydrochloride injection 0.075 mg and placebo in this trial are described in the Table 9.

Table 9: Prevention of Postoperative Nausea and Vomiting in Adults: Complete Response Rates

Treatment

n/N (%)

Palonosetron Hydrochloride Injection vs Placebo

Δ

p-value a

Co-primary Endpoints

Complete Response Rate (0 to 24 hours)

Palonosetron Hydrochloride Injection 0.075 mg intravenously

59/138 (42.8%)

16.8%

0.004

Placebo

35/135 (25.9%)

Complete Response Rate (24 to 72 hours)

Palonosetron Hydrochloride Injection 0.075 mg intravenously

67/138 (48.6%)

7.8%

0.188

Placebo

55/135 (40.7%)

  1. To reach statistical significance for each co-primary endpoint, the required significance limit for the lowest p-value was p<0.017.

Δ Difference (%): palonosetron 0.075 mg minus placebo

Palonosetron hydrochloride injection as a single dose of 0.075 mg reduced the severity of nausea compared to placebo. Analyses of other secondary endpoints indicate that palonosetron hydrochloride injection 0.075 mg was numerically better than placebo, however, statistical significance was not formally demonstrated.

A randomized, double-blind, multicenter, placebo-controlled, dose ranging study was performed to evaluate palonosetron hydrochloride injection for PONV following abdominal or vaginal hysterectomy. Five intravenous doses (0.1, 0.3, 1.0, 3.0 and 30 mcg/kg) were evaluated in a total of 381 intent-to-treat patients. The primary efficacy measure was the proportion of patients with CR in the first 24 hours after recovery from surgery. The lowest effective dose was palonosetron hydrochloride injection 1 mcg/kg (approximately 0.075 mg) which had a CR rate of 44% versus 19% for placebo, p=0.004 and significantly reduced the severity of nausea versus placebo, p=0.009.

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC 0703-4094-01, Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-dose vial individually packaged in a carton.

Storage

  • Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
  • Protect from freezing.
  • Protect from light.
  • Discard unused portion.

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-HT3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of palonosetron hydrochloride injection [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of palonosetron hydrochloride injection 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 In Israel By:
Teva Pharmaceutical Ind. Ltd.
Kfar Saba, 4410202, Israel

Manufactured For:
Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054

Rev. B 4/2020

PATIENT INFORMATION

Palonosetron Hydrochloride (pal”oh noe’se tron hye”droe klor’ide)

Injection, for intravenous use

Read this Patient Information before you receive palonosetron hydrochloride injection and each time you receive palonosetron hydrochloride injection. 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 palonosetron hydrochloride injection?

Palonosetron hydrochloride injection is a prescription medicine called an “antiemetic.”

Palonosetron hydrochloride injection 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

    Palonosetron hydrochloride injection 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 palonosetron hydrochloride injection is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
  • It is not known if palonosetron hydrochloride injection is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.

Who should not receive palonosetron hydrochloride injection?

Do not receive palonosetron hydrochloride injection if you are allergic to palonosetron hydrochloride or any of the ingredients in palonosetron hydrochloride injection. See the end of this leaflet for a complete list of ingredients in palonosetron hydrochloride injection.

What should I tell my doctor before receiving palonosetron hydrochloride injection?

Before receiving palonosetron hydrochloride injection, 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 palonosetron hydrochloride injection will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if palonosetron hydrochloride 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 palonosetron hydrochloride injection.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Palonosetron hydrochloride injection and certain other medicines can affect each other, causing serious side effects.

How will I receive palonosetron hydrochloride injection?

  • Palonosetron hydrochloride injection will be given to you in your vein by intravenous (I.V.) injection.
  • Palonosetron hydrochloride injection 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 palonosetron hydrochloride injection?

Palonosetron hydrochloride injection 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 palonosetron hydrochloride injection, 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 ○ fast heartbeat or unusual and frequent changes in (hallucinations), confusion, or coma 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 palonosetron hydrochloride injection 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 palonosetron hydrochloride injection 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 from palonosetron hydrochloride injection.

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 palonosetron hydrochloride injection.

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 palonosetron hydrochloride injection that is written for health professionals.

What are the ingredients in palonosetron hydrochloride injection?

Active ingredient: palonosetron hydrochloride

Inactive ingredients: mannitol, edetate disodium, trisodium citrate and citric acid in water

Manufactured In Israel By:Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel

Manufactured For:Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054

For more information, go to www.tevagenerics.com or call 1-888-838-2872.

This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. B 4/2020

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.