PEMETREXED- pemetrexed disodium injection, powder, lyophilized, for solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Pemetrexed disodium heptahydrate (UNII: 9T47E4OM16) (Pemetrexed - UNII:04Q9AIZ7NO)

থেকে পাওয়া:

Waverley Pharma Inc

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Pemetrexed for Injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies 14.1]. Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. Pemetrexed for Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions (6.1)]. Risk Summary Based on findings from animal studies and its mechanism of action, Pemetrexed for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on Pemetrexed for Injection use in pregnant women. In animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m2 [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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Pemetrexed was teratogenic in mice. Daily dosing of pemetrexed by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on BSA) 0.03 times the human dose of 500 mg/m2 . At doses, based on BSA, greater than or equal to 0.0012 times the 500 mg/m2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). Risk Summary There is no information regarding the presence of pemetrexed or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pemetrexed for Injection, advise women not to breastfeed during treatment with Pemetrexed for Injection and for one week after last dose. Contraception Females Pemetrexed for Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with Pemetrexed for Injection for at least 6 months after the final dose of Pemetrexed for Injection. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Pemetrexed for Injection and for 3 months after the final dose [see Nonclinical Toxicology (13.1)] . Infertility Males Pemetrexed for Injection may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible [see Nonclinical Toxicology (13.1)] . The safety and effectiveness of Pemetrexed for Injection in pediatric patients have not been established. The safety and pharmacokinetics of Pemetrexed for Injection were evaluated in two clinical studies conducted in pediatric patients with recurrent solid tumors. Pemetrexed for Injection was administered at doses ranging from 400 to 2480 mg/m2 intravenously over 10 minutes on Day 1 of a 21-day cycle to 32 pediatric patients with recurrent solid tumors in a dose-finding study. The maximum tolerated dose (MTD) was determined to be 1910 mg/m2 (60 mg/kg for patients <12 months old). Pemetrexed for Injection was administered at the MTD every 21 days in an activity-estimating study enrolling 72 patients with relapsed or refractory osteosarcoma, Ewing sarcoma/peripheral primitive neural ectodermal tumor (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET, or non-brainstem high grade glioma. Patients in both studies received concomitant vitamin B12 and folic acid supplementation and dexamethasone. No tumor responses were observed. Adverse reactions observed in pediatric patients were similar to those observed in adults. Single-dose pharmacokinetics of Pemetrexed for Injection administered at doses ranging from 400 to 2480 mg/m2 were evaluated in 22 patients (13 males and 9 females) age 4 to 18 years (average age 12 years). Pemetrexed exposure (AUC and Cmax ) appeared to increase proportionally with dose. Average clearance (2.30 L/h/m2 ) and half-life (2.3 hours) were similar in pediatric patients compared to adults. Of the 3,946 patients enrolled in clinical studies of Pemetrexed for Injection, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials. [see Adverse Reactions (6.1) and Clinical Studies (14.1, 14.2)]. Pemetrexed for Injection is primarily excreted by the kidneys. Decreased renal function results in reduced clearance and greater exposure (AUC) to Pemetrexed for Injection compared with patients with normal renal function [Warnings and Precautions (5.2, 5.6) and Clinical Pharmacology (12.3)] . No dose is recommended for patients with creatinine clearance less than 45 mL/min [see Dosage and Administration (2.3)].

পণ্য সারাংশ:

How Supplied Pemetrexed for Injection USP, is a white-to-light yellow or green-yellow lyophilized powder supplied in single-dose vials for reconstitution for intravenous infusion. NDC 72338-100-01: Carton containing one (1) single-dose vial of 100 mg pemetrexed. NDC 72338-101-01: Carton containing one (1) single-dose vial of 500 mg pemetrexed. Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Discard unused portion. Pemetrexed for Injection USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PEMETREXED- PEMETREXED DISODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
WAVERLEY PHARMA INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEMETREXED FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PEMETREXED FOR
INJECTION.PEMETREXED FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Pemetrexed for Injection is a folate analog metabolic inhibitor
indicated:
in combination with pembrolizumab and platinum chemotherapy, for the
initial treatment of patients
with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor
aberrations. (1.1)
in combination with cisplatin for the initial treatment of patients
with locally advanced or metastatic,
non-squamous, non-small cell lung cancer (NSCLC). (1.1)
as a single agent for the maintenance treatment of patients with
locally advanced or metastatic, non-
squamous NSCLC whose disease has not progressed after four cycles of
platinum-based first-line
chemotherapy. (1.1)
as a single agent for the treatment of patients with recurrent,
metastatic non-squamous, NSCLC after
prior chemotherapy. (1.1) Limitations of Use: Pemetrexed for Injection
is not indicated for the
treatment of patients with squamous cell, non-small cell lung cancer.
(1.1)
initial treatment, in combination with cisplatin, of patients with
malignant pleural mesothelioma whose
disease is unresectable or who are otherwise not candidates for
curative surgery. (1.2)
DOSAGE AND ADMINISTRATION
The recommended dose of Pemetrexed for Injection administered with
pembrolizumab and platinum
chemotherapy in patients with a creatinine clearance (calculated by
Cockcroft-Gault equation) of 45
mL/min or greater is 500 mg/m as an intravenous infusion over 10
minutes, administered after
pembrolizumab and prior to platinum chemotherapy, on Day 1 of each
21-day cycle. (2.1)
The recommended dose of Pemetrexed for Injection, administered as a
single agent or with cisplatin, in
patients with creati