GEMCITABINE- gemcitabine hydrochloride injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)

Доступна с:

Athenex Pharmaceutical Division, LLC.

ИНН (Международная Имя):

gemcitabine hydrochloride

состав:

gemcitabine 200 mg in 5 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Gemcitabine for Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine for Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. Gemcitabine for Injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Gemcitabine for Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection is indicated for patients previously treated with fluorouracil. Gemcitabine for Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions ( 6.1)]. Risk Summary Based on animal data and its mechanism of action, Gemcitabine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1)] . There are no available data on the use of Gemcitabine for Injection in pregnant women. In animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data) . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations ( 8.3)] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data Gemcitabine is embryotoxic in mice. Daily dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day [approximately 0.005 times the 1000 mg/m 2 clinical dose based on body surface area (BSA)]. Gemcitabine was embryotoxic and fetotoxic in rabbits. Daily dosing of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and developmental delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day (approximately 0.002 times the 1000 mg/m 2 clinical dose based on BSA). Risk Summary There is no information regarding the presence of Gemcitabine for Injection or its metabolites in human milk, or their effects on the breastfed infant or on milk production. Due to the potential for serious adverse reactions in breastfed infants from Gemcitabine for Injection, advise women not to breastfeed during treatment with Gemcitabine for Injection and for at least one week following the last dose. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating Gemcitabine for Injection [see Use in Specific Populations ( 8.1)] . Contraception Gemcitabine for Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)]. Females Because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with Gemcitabine for Injection and for 6 months after the final dose of Gemcitabine for Injection. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Gemcitabine for Injection and for 3 months after the final dose [see Nonclinical Toxicology ( 13.1)] . Infertility Males Based on animal studies, Gemcitabine for Injection may impair fertility in males of reproductive potential [see Nonclinical Toxicology ( 13.1)] . It is not known whether these effects on fertility are reversible. The safety and effectiveness of Gemcitabine for Injection have not been established in pediatric patients. The safety and pharmacokinetics of gemcitabine were evaluated in a trial in pediatric patients with refractory leukemia. The maximum tolerated dose was 10 mg/m 2 /min for 360 minutes weekly for three weeks followed by a one-week rest period. The safety and activity of Gemcitabine for Injection were evaluated in a trial of pediatric patients with relapsed acute lymphoblastic leukemia (22 patients) and acute myelogenous leukemia (10 patients) at a dose of 10 mg/m 2 /min administered over 360 minutes weekly for three weeks followed by a one-week rest period. Patients with M1 or M2 bone marrow on Day 28 who did not experience unacceptable toxicity were eligible to receive a maximum of one additional four-week course. Toxicities observed included myelosuppression, febrile neutropenia, increased serum transaminases, nausea, and rash/desquamation. No meaningful clinical activity was observed in this trial. In clinical studies which enrolled 979 patients with various malignancies who received single agent Gemcitabine for Injection, no overall differences in safety were observed between patients aged 65 and older and younger patients, with the exception of a higher rate of Grade 3-4 thrombocytopenia in older patients as compared to younger patients. In a randomized trial in women with ovarian cancer (Study 1), 175 women received Gemcitabine for Injection with carboplatin, of which 29% were age 65 years or older. Similar effectiveness was observed between older and younger women. There was significantly higher Grade 3-4 neutropenia in women 65 years of age or older [see Dosage and Administration ( 2.1)] . Gemcitabine for Injection clearance is affected by age; however, there are no recommended dose adjustments based on patients' age [see Clinical Pharmacology ( 12.3)]. Gemcitabine for Injection clearance is decreased in females [see Clinical Pharmacology ( 12.3)] . In single agent studies of Gemcitabine for Injection, women, especially older women, were more likely not to proceed to a subsequent cycle and to experience Grade 3-4 neutropenia and thrombocytopenia [see Dosage and Administration ( 2.1, 2.2, 2.3, 2.4)] .

Обзор продуктов:

Gemcitabine for Injection, USP is supplied as follows: Gemcitabine for Injection, USP is a sterile white to off-white lyophilized powder. Gemcitabine for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, Lyophilized. The container closure is not made with natural rubber latex.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

GEMCITABINE- GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, LLC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GEMCITABINE FOR
INJECTION.
GEMCITABINE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Hemolytic Uremic Syndrome ( 5.4)
5/2019
INDICATIONS AND USAGE
Gemcitabine for Injection is a nucleoside metabolic inhibitor
indicated:
in combination with carboplatin, for the treatment of advanced ovarian
cancer that has relapsed at
least 6 months after completion of platinum-based therapy. ( 1.1)
in combination with paclitaxel, for first-line treatment of metastatic
breast cancer after failure of prior
anthracycline-containing adjuvant chemotherapy, unless anthracyclines
were clinically contraindicated.
( 1.2)
in combination with cisplatin, for the treatment of non-small cell
lung cancer. ( 1.3)
as a single agent for the treatment of pancreatic cancer. ( 1.4)
DOSAGE AND ADMINISTRATION
Gemcitabine for Injection is for intravenous use only.
Ovarian Cancer: 1000 mg/m
over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1)
Breast Cancer: 1250 mg/m
over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2)
Non-Small Cell Lung Cancer: 1000 mg/m
over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or
1250 mg/m
over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3)
Pancreatic Cancer: 1000 mg/m
over 30 minutes once weekly for the first 7 weeks, then one week rest,
then once weekly for 3 weeks of each 28-day cycle. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Gemcitabine for Injection, USP is a white to off-white lyophilized
powder available in sterile single-dose vials
containing 200 mg or 1 gram gemcitabine. ( 3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. ( 4)
WARNINGS AND PRECAUTIONS
Schedule-Dependent Toxicity: Incre