Aloxi Palonosetron hydrochloride 100 mg for sale







Specifications for Aloxi Palonosetron hydrochloride 100 mg


Aloxi (palonosetron)
     Brand name-----------------Aloxi
     Generic name---------------palonosetron
     Dosage form----------------Injection
     Quantity-------------------1 Vial/5ml
     Drug Class-----------------VEGF/VEGFR inhibitors
     Manufacturer---------------Eisai Co., Ltd.


Aloxi (palonosetron) drug information
       NDC code----------------------62856-0797-01
       LOT NO------------------------34001557
       Expiry Date-------------------03 / 2019

Aloxi (palonosetron) Usage
      * The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy
      * the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
      * Prevention of nausea and vomiting associated with moderately emetogenic cancer  chemotherapy.
       

Aloxi (palonosetron) Price
      Price-------------------$5,400 .00 USD (Per unit $450.00 USD)
      Quantity----------------12 vial/5ml
      Dosage------------------0.25mg



ALOXI®
(palonosetron HCl) Injection

DESCRIPTION

ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:

Palonosetron hydrochloride 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.
ALOXI injection is a sterile, clear, colorless, nonpyrogenic, isotonic, buffered solution for intravenous administration. ALOXI injection is available as 5 mL single use vial or 1.5 mL single use vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration.
Each 1.5 mL vial contains 0.075 mg palonosetron base as 0.084 mg palonosetron hydrochloride, 83 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration.
The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5.

INDICATIONS

Chemotherapy-Induced Nausea And Vomiting In Adults

ALOXI is indicated for:
  • Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
  • Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses

Chemotherapy-Induced Nausea And Vomiting In Pediatric Patients Aged 1 Month To Less than 17 Years

ALOXI is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

Postoperative Nausea And Vomiting In Adults

ALOXI is indicated for prevention of 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. In patients where nausea and vomiting must be avoided during the postoperative period, ALOXI is recommended even where the incidence of postoperative nausea and/or vomiting is low.

DOSAGE AND ADMINISTRATION

Recommended Dosing

Chemotherapy-Induced Nausea and Vomiting
AgeDose*Infusion Time
Adults0.25 mg x 1Infuse over 30 seconds beginning approx. 30 min before the start of chemo
Pediatrics (1 month to less than 17 years)20 micrograms per kilogram (max 1.5 mg) x 1Infuse over 15 minutes beginning approx. 30 min before the start of chemo
*Note different dosing units in pediatrics
Postoperative Nausea And Vomiting
Dosage for Adults - a single 0.075 mg intravenous dose administered over 10 seconds immediately before the induction of anesthesia.

Instructions For Intravenous Administration

ALOXI is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/ mL). ALOXI should not be mixed with other drugs. The infusion line should be flushed with normal saline before and after administration of ALOXI. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

HOW SUPPLIED

Dosage Form And Strengths

ALOXI is supplied as a single-use sterile, clear, colorless solution in glass vials that provide:
  • 0.25 mg (free base) per 5 mL (concentration: 0.05 mg/mL, 50 mcg/mL)
  • 0.075 mg (free base) per 1.5 mL (concentration: 0.05 mg/mL, 50 mcg/mL)

Storage And Handling

NDC #62856-797-01, ALOXI Injection 0.25 mg/5 mL (free base)single-use vial individually packaged in a carton.
NDC #62856-798-01, ALOXI Injection 0.075 mg/1.5 mL (free base)single-use vial packaged in a carton containing5 vials.
Storage
  • Store at controlled temperature of 20–25°C (68°F–77°F).Excursions permitted to 15–30°C (59-86°F).
  • Protect from freezing.
  • Protect from light.

  • SIDE EFFECTS

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    Chemotherapy-Induced Nausea And Vomiting

    Adults
    In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in frequency and severity with ALOXI and ondansetron or dolasetron. Following is a listing of all adverse reactions reported by ≥ 2% of patients in these trials (Table 1).
    Table 1: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies ≥ 2% in any Treatment Group
    EventALOXI 0.25 mg
    (N=633)    		Ondansetron 32 mg I.V.
    (N=410)    		Dolasetron 100 mg I.V.
    (N=194)
    Headache60 (9%)34 (8%)32 (16%)
    Constipation29 (5%)8 (2%)12 (6%)
    Diarrhea8 (1%)7 (2%)4 (2%)
    Dizziness8 (1%)9 (2%)4 (2%)
    Fatigue3 ( < 1%)4 (1%)4 (2%)
    Abdominal Pain1 ( < 1%)2 ( < 1%)3 (2%)
    Insomnia1 ( < 1%)3 (1%)3 (2%)

    In other studies, 2 subjects experienced severe constipation following a single palonosetron dose of approximately 0.75 mg, three times the recommended dose. One patient received a 10 mcg/kg oral dose in a post-operative nausea and vomiting study and one healthy subject received a 0.75 mg I.V. dose in a pharmacokinetic study.
    In clinical trials, the following infrequently reported adverse reactions, assessed by investigators as treatment-related or causality unknown, occurred following administration of ALOXI to adult patients receiving concomitant cancer chemotherapy:
    Cardiovascular: 1%: non-sustained tachycardia, bradycardia, hypotension, < 1%: hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation. In many cases, the relationship to ALOXI was unclear.
    Dermatological: < 1%: allergic dermatitis, rash.
    Hearing and Vision: < 1%: motion sickness, tinnitus, eye irritation and amblyopia.
    Gastrointestinal System: 1%: diarrhea, < 1%: dyspepsia, abdominal pain, dry mouth, hiccups and flatulence.
    General: 1%: weakness, < 1%: fatigue, fever, hot flash, flu-like syndrome.
    Liver: < 1%: transient, asymptomatic increases in AST and/or ALT and bilirubin. These changes occurred predominantly in patients receiving highly emetogenic chemotherapy.
    Metabolic: 1%: hyperkalemia, < 1%: electrolyte fluctuations, hyperglycemia, metabolic acidosis, glycosuria, appetite decrease, anorexia.
    Musculoskeletal: < 1%: arthralgia.
    Nervous System: 1%: dizziness, < 1%: somnolence, insomnia, hypersomnia, paresthesia.
    Psychiatric: 1%: anxiety, < 1%: euphoric mood.
    Urinary System: < 1%: urinary retention.
    Vascular: < 1%: vein discoloration, vein distention.
    Pediatrics
    In a pediatric clinical trial for the prevention of chemotherapy-induced nausea and vomiting 163 cancer patients received a single 20 mcg/kg (maximum 1.5 mg) intravenous infusion of palonosetron 30 minutes before beginning the first cycle of emetogenic chemotherapy. Patients had a mean age of 8.4 years (range 2 months to 16.9 years) and were 46% male; and 93% white.
    The following adverse reactions were reported for palonosetron:
    Nervous System: < 1%: headache, dizziness, dyskinesia.
    General: < 1%: infusion site pain.
    Dermatological: < 1%: allergic dermatitis, skin disorder.
    In the trial, adverse reactions were evaluated in pediatric patients receiving palonosetron for up to 4 chemotherapy cycles.

    Postoperative Nausea And Vomiting

    The adverse reactions cited in Table 2 were reported in ≥ 2% of adults receiving I.V. ALOXI 0.075 mg immediately before induction of anesthesia in one phase 2 and two phase 3 randomized placebo-controlled trials. Rates of events between palonosetron and placebo groups were similar. Some events are known to be associated with, or may be exacerbated by concomitant perioperative and intraoperative medications administered in this surgical population. Please refer to Section 12.2, thorough QT/QTc study results, for data demonstrating the lack of palonosetron effect on QT/QTc.

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