GRANISETRON HYDROCHLORIDE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

GRANISETRON HYDROCHLORIDE

Skład:

GRANISETRON 1 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: - The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Granisetron Hydrochloride Injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. Teratogenic Effects Pregnancy Category B Reproduction  studies  have  been  performed  in  pregnant  rats  at  intravenous  doses  up  to  9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Benzyl alcohol may cross the placenta. Granisetron Hydrochloride Injection 1 mg/mL is preserved with benzyl alcohol and should be used in pregnancy only if the benefit outweighs the potential risk. It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Granisetron Hydrochloride Injection is administered to a nursing woman. Benzyl alcohol, a component of Granisetron Hydrochloride Injection 1 mg/mL, has been associated with serious adverse reactions and death, particularly in neonates [see Warnings and Precautions (5.4)] . Chemotherapy-Induced Nausea and Vomiting [See Dosage and Administration (2)] for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. Safety and effectiveness in pediatric patients under 2 years of age have not been established. Postoperative Nausea and Vomiting Safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (PONV). Granisetron has been evaluated in a pediatric patient clinical trial for use in the prevention of PONV. Due to the lack of efficacy and the QT prolongation observed in this trial, use of granisetron for the prevention of PONV in children is not recommended. The trial was a prospective, multicenter, randomized, double-blind, parallel-group trial that evaluated 157 children aged 2 to 16 years who were undergoing elective surgery for tonsillectomy or adenotonsillectomy. The purpose of the trial was to assess two dose levels (20 mcg/kg and 40 mcg/kg) of intravenous granisetron in the prevention of PONV. There was no active comparator or placebo. The primary endpoint was total control of nausea and vomiting (defined as no nausea, vomiting/retching, or use of rescue medication) in the 24 hours following surgery. Efficacy was not established due to lack of a dose response. The trial also included standard 12 lead ECGs performed pre-dose and after the induction of anesthesia. ECGs were repeated at the end of surgery after the administration of granisetron and just prior to reversal of anesthesia. QT prolongation was seen at both dose levels. Five patients in this trial experienced an increase of ≥ 60 msec in QTcF. In addition, there were two patients whose QTcF was ≥ 500 msec. Interpretation of the QTcF prolongation was confounded by multiple factors, including the use of concomitant medication and the lack of either a placebo or active control. A thorough QT trial in adults has not been performed. Other adverse events that occurred in the study included: vomiting (5 to 8%), post-procedural hemorrhage (3 to 5%), and dehydration (0 to 5%). Pediatric patients under 2 years of age have not been studied. During chemotherapy clinical trials, 713 patients 65 years of age or older received Granisetron Hydrochloride Injection. The safety and effectiveness were similar in patients of various ages.

Podsumowanie produktu:

Granisetron Hydrochloride Injection, USP 1 mg/mL (free base), is supplied in 1 mL Single Dose Vials and 4 mL Multiple Dose Vials. CONTAINS BENZYL ALCOHOL. NDC 0143-9744-10 (Carton of 10 x 1 mL Single Dose Vials) NDC 0143-9745-10 (Carton of 10 x 4 mL Multiple Dose Vials) NDC 0143-9745-05 (Carton of 5 x 4 mL Multiple Dose Vials) Store single dose vials and multiple dose vials at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Discard unused portion for the single dose vials. Once the multiple dose vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light. Retain in carton until time of use.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON
HYDROCHLORIDE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
GRANISETRON HYDROCHLORIDE INJECTION, USP.
GRANISETRON HYDROCHLORIDE INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT )
receptor antagonist indicated for:
Prevention of nausea and/or vomiting associated with initial and
repeat courses of emetogenic cancer
therapy, including high-dose cisplatin. (1)
DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
Recommended dosage is 10 mcg/kg intravenously within 30 minutes before
initiation of chemotherapy
Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg
DOSAGE FORMS AND STRENGTHS
Injection 1 mg/mL (free base). (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron or to any of its components. (4)
WARNINGS AND PRECAUTIONS
Granisetron hydrochloride does not stimulate gastric or intestinal
peristalsis and should not be used
instead of nasogastric suction. (5.1)
QT prolongation has been reported with granisetron hydrochloride. Use
with caution in patients with pre-
existing arrhythmias or cardiac conduction disorders. (5.2)
Hypersensitivity reactions, such as anaphylaxis, shortness of breath,
hypotension, and urticaria, may
occur in patients with known hypersensitivity to other selective 5-HT
receptor antagonists. (5.3)
Contains benzyl alcohol. (5.4)
Serotonin syndrome has been reported with granisetron products, alone
but particularly with
concomitant use of serotonergic drugs. (5.5)
ADVERSE REACTIONS
Most common adverse reactions:
Chemotherapy-induced nausea and vomiting (≥3%): Headache, and
constipation (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
877-845-0689 OR FDA AT 1-