PALONOSETRON injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)

Dostupné z:

BluePoint Laboratories

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Palonosetron hydrochloride injection 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 course of 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. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see  Warning and Precautions   Error! Hyperlink reference not valid. )] Risk Summary There are no available data on palonosetron HCl 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 HCl 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). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron HCl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral dosed up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. Risk Summary There are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. Chemotherapy-Induced Nausea and Vomiting Safety and effectiveness of palonosetron hydrochloride injection 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. Use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see Clinical Studies ( 14.2) ]. While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see Adverse Reactions ( 6.1) ]. Safety and effectiveness of palonosetron hydrochloride injection in neonates (less than 1 month of age) have not been established. Postoperative Nausea and Vomiting Studies Safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. Two pediatric trials were performed. Pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). A total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. No dose responses were observed. Pediatric study 2, a multicenter, double-blind double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron HCl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. A total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. Adverse reactions to palonosetron were similar to those reported in adults. Of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron HCl, 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 HCl, 73 (5%) were at least 65 years old [ see Clinical Studies ( 14.1, 14.3]. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. Population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see Clinical Pharmacology ( 12.3)]. No dose adjustment is required for geriatric patients.

Prehľad produktov:

Palonosetron hydrochloride injection is supplied as a sterile, clear and colorless solution: Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-dose vial packaged in a carton containing 1 vial. NDC 68001-355-25 Storage • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. • Protect from freezing. • Protect from light.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PALONOSETRON- PALONOSETRON INJECTION, SOLUTION
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PALONOSETRON
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PALONOSETRON HYDROCHLORIDE INJECTION.
PALONOSETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Palonosetron hydrochloride injection is a serotonin-3 (5-HT
) receptor antagonist indicated in: (1)
Adults for prevention of: (1)
• acute and delayed nausea and vomiting associated with initial and
repeat courses of moderately
emetogenic cancer chemotherapy (MEC). ERROR! HYPERLINK REFERENCE NOT
VALID. (1)
• acute nausea and vomiting associated with initial and repeat
course of highly emetogenic cancer
chemotherapy (HEC). ERROR! HYPERLINK REFERENCE NOT VALID. (1)
• postoperative nausea and vomiting (PONV) for up to 24 hours
following surgery. Efficacy beyond 24
hours has not been demonstrated. ERROR! HYPERLINK REFERENCE NOT VALID.
(1)
Pediatric patients aged 1 month to less than 17 years for prevention
of: (1)
acute nausea and vomiting associated with initial and repeat courses
of emetogenic cancer
chemotherapy, including highly emetogenic cancer chemotherapy (HEC).(
ERROR! HYPERLINK
REFERENCE NOT VALID.)
DOSAGE AND ADMINISTRATION
CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING(2.1)
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 1.5mg) as a
single dose
Infuse over 15 MINUTES beginning
approximately 30 minutes before
the start of chemotherapy
* Note different dosing units in pediatrics
POSTOPERATIVE NAUSEA AND VOMITING( 2.1)
• The recommended adult dosage is 0.075 mg as a single intravenous
dose administered over
10 seconds immediately before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
Injection:
0.25 mg pa