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Palonosetron Hydrochloride (Palonosetron Hydrochloride)

Trade Name : Palonosetron Hydrochloride

West-Ward Pharmaceuticals Corp

INJECTION

Strength 0.25 mg/2mL

PALONOSETRON HYDROCHLORIDE Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Palonosetron Hydrochloride (Palonosetron Hydrochloride) which is also known as Palonosetron Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 0.25 mg/2mL per ml. Read more

Palonosetron Hydrochloride (Palonosetron Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Palonosetron Hydrochloride (HCl) Injection is indicated for:
  • u2022u00a0u00a0u00a0u00a0 Moderately emetogenic cancer chemotherapy u2013 prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
  • u2022u00a0u00a0u00a0u00a0 Highly emetogenic cancer chemotherapy u2013 prevention of acute nausea and vomiting associated with initial and repeat courses
  • Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT) receptor antagonist indicated in adults for:
  • u2022 Moderately emetogenic cancer chemotherapy u2013 prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ()
  • u2022u00a0 Highly emetogenic cancer chemotherapy u2013 prevention of acute nausea and vomiting associated with initial and repeat courses ()
  • Chemotherapy-Induced Nausea and Vomiting ()
  • u2022 The recommended adult dosage is 0.25 mg as a single intravenous dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy.
  • Palonosetron Hydrochloride Injection is sterile, clear, and colorless:
  • u2022u00a0 u00a00.25 mg palonosetron in 2 mL (0.125 mg/mL) in a single-dose vial
  • Injection:u00a0 0.25 mg palonosetron u00a0in 2 mL (0.125 mg/mL) in a single-dose vial ()
  • Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components .
  • Hypersensitivity to the drug or any of its components ()
  • u2022u00a0 Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT receptor antagonists ()
  • u2022u00a0 Serotoninu00a0 syndrome has beenu00a0 reportedu00a0 with 5-HTu00a0 u00a0receptor antagonists alone but particularly with concomitant use of serotonergic drugs (, )
  • The most common adverse reactions in chemotherapy-induced nausea and vomiting (u22655%) are headache and constipation ()
  • Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).u00a0 Monitor for the emergence of serotonin syndrome. u00a0If symptoms occur, discontinue Palonosetron HCl Injection and initiate supportive treatment .
  • Serotonergic Drugs: u00a0Monitor for serotonin syndrome; if symptoms occur, discontinue Palonosetron HCl Injection and initiate supportive treatment ()
  • No data
  • There is no known antidote to palonosetron HCl. 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 HCl overdose. A single intravenous dose of palonosetron HCl 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.
  • Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6u00ad hexahydro-1-oxo-1benz[]isoquinoline hydrochloride. The empirical formula is CHNOu2022HCl, 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.
  • Palonosetron HCl Injection is a sterile, clear, colorless, non-pyrogenic, non-buffered, hypotonic solution for intravenous administration.u00a0 Palonosetron HCl Injection contains no preservative or chelating agent. Palonosetron HCl Injection is available as 2 mL single-dose vial.
  • Each 2 mL vial contains 0.25 mg palonosetron base equivalent to 0.28 mg palonosetron HCl, and water for intravenous administration.
  • The pH of the solution in the 2 mL vial is 6.5 to 8.5.
  • No data
  • In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral doses of palonosetron HCl at 10, 30 and 60 mg/kg/day. Treatment with palonosetron was not tumorigenic. The highest tested dose produced a systemic exposure to palonosetron (plasma AUC) of about 150 to 289 times the human exposure (AUC = 29.8 hu2022mcg/L) at the recommended intravenous dose of 0.25 mg. In a 104-week carcinogenicity study in Sprague-Dawley rats, male and female rats were treated with oral doses of 15, 30 and 60 mg/kg/day and 15, 45 and 90 mg/kg/day, respectively. The highest doses produced a systemic exposure to palonosetron (plasma AUC) of 137 and 308 times the human exposure at the recommended dose. Treatment with palonosetron HCl produced increased incidences of adrenal benign pheochromocytoma and combined benign and malignant pheochromocytoma, increased incidences of pancreatic Islet cell adenoma and combined adenoma and carcinoma and pituitary adenoma in male rats. In female rats, it produced hepatocellular adenoma and carcinoma and increased the incidences of thyroid C-cell adenoma and combined adenoma and carcinoma.
  • Palonosetron was not genotoxic in the Ames test, the Chinese hamster ovarian cell (CHO/HGPRT) forward mutation test, the hepatocyte unscheduled DNA synthesis (UDS) test or the mouse micronucleus test. It was, however, positive for clastogenic effects in the Chinese hamster ovarian (CHO) cell chromosomal aberration test.
  • Palonosetron HCl at oral doses up to 60 mg/kg/day (about 1894 times the recommended human intravenous dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
  • The safety and efficacy of Palonosetron HCl Injection have been established based on adequate and well-controlled adult studies of another intravenous formulation of palonosetron HCl in chemotherapy induced nausea and vomiting. Below is a display of the results of these adequate and well-controlled studies of palonosetron HCl.
  • Efficacy of a single intravenous dose of palonosetron HCl in preventing acute and delayed nausea and vomiting induced by both moderately and highly emetogenic chemotherapy was studied in 4 trials. In these double-blind trials, complete response rates (no emetic episodes and no rescue medication) and other efficacy parameters were assessed through at least 120 hours after administration of chemotherapy. The safety and efficacy of palonosetron HCl in repeated courses of chemotherapy was also assessed.
  • Moderately Emetogenic Chemotherapy:
  • Two double-blind trials (Study 1 and Study 2) involving 1132 patients compared a single intravenous dose of palonosetron HCl with either a single intravenous dose of ondansetron (Study 1) or dolasetron (Study 2) given 30 minutes prior to moderately emetogenic chemotherapy including carboplatin, cisplatin u2264 50 mg/mu00b2, cyclophosphamide < 1500 mg/mu00b2, doxorubicin > 25 mg/mu00b2, epirubicin, irinotecan, and methotrexate > 250 mg/mu00b2. Concomitant corticosteroids were not administered prophylactically in Study 1 and were only used by 4 to 6% of patients in Study 2. The majority of patients in these studies were women (77%), White (65%) and nau00efve to previous chemotherapy (54%). The mean age was 55 years.
  • H
  • i
  • g
  • hly Emetogenic Chemotherapy:
  • A double-blind, dose-ranging trial evaluated the efficacy of single-dose intravenous palonosetron from 0.3 to 90 mcg/kg (equivalent to < 0.1 mg to 6 mg fixed dose) in 161 chemotherapy-nau00efve adult cancer patients receiving highly emetogenic chemotherapy (either cisplatin u2265 70 mg/mu00b2 or cyclophosphamide >1100 mg/mu00b2). Concomitant corticosteroids were not administered prophylactically. Analysis of data from this trial indicates that 0.25 mg is the lowest effective dose in preventing acute nausea and vomiting induced by highly emetogenic chemotherapy.
  • A double-blind trial involving 667 patients compared a single intravenous dose of palonosetron HCl with a single intravenous dose of ondansetron (Study 3) given 30 minutes prior to highly emetogenic chemotherapy including cisplatin u2265 60 mg/mu00b2, cyclophosphamide > 1500 mg/mu00b2, and dacarbazine. Corticosteroids were co-administered prophylactically before chemotherapy in 67% of patients. Of the 667 patients, 51% were women, 60% White, and 59% nau00efve to previous chemotherapy. The mean age was 52 years.
  • Efficacy Results:
  • The antiemetic activity of palonosetron HCl was evaluated during the acute phase (0-24 hours) [Table 3], delayed phase (24-120 hours) [Table 4], and overall phase (0-120 hours) [Table 5] post-chemotherapy in Studies 1, 2 and 3.
  • T
  • able 3: Prevention of Acute Nausea and Vomiting (0-24 hours): Complete Response Rates
  • These trials show that palonosetron HCl was effective in the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.
  • In Study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly. Clinical superiority over other 5-HT receptor antagonists has not been adequately demonstrated in the acute phase.
  • T
  • able 4: Prevention of Delayed Nausea and Vomiting (24-120 hours): Complete Response Rates
  • These trials show that palonosetron HCl was effective in the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.
  • T
  • able 5: Prevention of Overall Nausea and Vomiting (0-120 hours): Complete Response Rates
  • These trials show that palonosetron HCl was effective in the prevention of nausea and vomiting throughout the 120 hours (5 days) following initial and repeat courses of moderately emetogenic cancer chemotherapy.
  • Hn- ow Supplied
  • Palonosetron Hydrochloride Injection is clear and colorless and is supplied in single-dose vials as follows:
  • NDCn- Numberu00a0n- Strengthn- Pn- ackage
  • 0143-9513-01u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a00.25 mg/2 mL (0.125 mg/mL)u00a0u00a0u00a0u00a0u00a0u00a0u00a01 vial/carton
  • Storage
  • Advise patients to read the FDA-approved patient labeling ().
  • Hn- yn- persensitivity Reactions
  • Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients with or without known hypersensitivity to other 5-HT receptor antagonists.u00a0 Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron HCl Injection .
  • Serotonin Syndrome
  • Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonsetron HCl 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: u00a0changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms n .
  • Manufactured by:n
  • Distributed by:n
  • 9513-0617-00
  • Issued June 2017
  • Pn- atient Informationn n- Pn- alonosetron Hydrochloride Injection (PAL-oh-NOE-se-tron HYE-droe-KLOR-ide)n n- fon- r 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.
  • Wn- hn- at is Palonosetron Hydrochloride Injection?
  • Palonosetron Hydrochloride Injection is a prescription medicine called an u201cantiemetic.u201d
  • 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).
  • This product has not been approved for use in children to help prevent nausea and vomiting after chemotherapy.
  • Wn- hn- o 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.
  • Wn- hn- at 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:
  • u2022 have had an allergic reaction to another medicine for nausea or vomiting
  • u2022 are pregnant or plan to become pregnant. It is not known if Palonosetron Hydrochloride Injection will
  • harm your unborn baby.
  • u2022
  • Tn- ell your doctor about all of the medicines you take
  • Palonosetron Hydrochloride Injection and certain other medicines can affect each other, causing serious side effects.
  • How will I receive Palonosetron Hydrochloride Injection?
  • u2022 Palonosetron Hydrochloride Injection will be given to you in your vein by I.V. (intravenous) injection.
  • u2022 Palonosetron Hydrochloride Injection is usually given about 30 minutes before you receive your antiu00ad-cancer medicine (chemotherapy).
  • Wn- hn- at are the possible side effects of Palonosetron Hydrochloride Injection?
  • Palonosetron Hydrochloride Injection may cause serious side effects, including:
  • u2022 n Palonosetron Hydrochloride Injection can cause allergic reactions that can sometimes be serious. Tell your doctor or nurse right away if you have any of the following symptoms of a serious allergic reaction with Palonosetron Hydrochloride Injection:
  • u00a0u00a0u00a0 o hives
  • u00a0u00a0u00a0 o swollen face
  • u00a0u00a0u00a0 o breathing trouble
  • u00a0u00a0u00a0 o chest pain
  • u2022 n A possible life-threatening problem called serotonin syndrome can happen with medicines called 5-HT 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:
  • u00a0u00a0u00a0 o agitation, seeing things that are not there (hallucinations), confusion, or coma
  • u00a0u00a0u00a0 o fast heartbeat or unusual and frequent changes in your blood pressure
  • u00a0u00a0u00a0 o dizziness, sweating, flushing, or fever
  • u00a0u00a0u00a0 o tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination
  • u00a0u00a0u00a0 o seizures
  • u00a0u00a0u00a0 o nausea, vomiting, or diarrhea
  • The most common side effects of Palonosetron Hydrochloride Injection in adults are headache and constipation.
  • These are not all the possible side effects of Palonosetron Hydrochloride Injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Gn- eneral information about the safe and effective use of Palonosetron Hydrochloride Injection
  • Wn- hn- at are the ingredients in Palonosetron Hydrochloride Injection?
  • Active ingredient:
  • Inactive ingredient:
  • Rx Only
  • Manufactured by:
  • Distributed by:
  • For Product Inquiry call 1-877-845-0689.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • 9513-0617-00
  • Issued June 2017
  • NDC 0143-9513-01u00a0u00a0 u00a0n n n n n
  • Arrayn- Array
  • u00a0
  • u00a0
  • NDC 0143-9513-01u00a0u00a0 u00a0n n n n
  • Check concentration prior to n n- preparation. n- See package insertn n- for complete instructions.
  • u00a0
  • Arrayn- Array
  • No data

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