Label:
PEMETREXED- pemetrexed disodium injection, powder, lyophilized, for solution
PEMETREXED- pemetrexed disodium injection, p...
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  • NDC Code(s): 31722-336-31, 31722-337-31
  • Packager: Camber Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 1, 2025

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  • 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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed for injection is indicated: • in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage for Non-Squamous NSCLC - • The recommended dose of pemetrexed for injection when administered with pembrolizumab and platinum chemotherapy for the initial treatment of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    For injection: 100 mg or 500 mg pemetrexed as a white to light-yellow or green-yellow lyophilized cake in single-dose vials for reconstitution.
  • 4 CONTRAINDICATIONS
    Pemetrexed for injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed - [see - Adverse Reactions (6.1)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation - Pemetrexed can cause severe myelosuppression resulting in a requirement for transfusions and which ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression - [see - Warnings and Precautions (5.1)] • Renal failure ...
  • 7 DRUG INTERACTIONS
    Effects of Ibuprofen on Pemetrexed - Ibuprofen increases exposure (AUC) of pemetrexed - [see - Clinical Pharmacology (12.3)]. In patients with creatinine clearance between 45 mL/min ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal studies and its mechanism of action, pemetrexed can cause fetal harm when administered to a pregnant woman - [see - Clinical ...
  • 10 OVERDOSAGE
    No drugs are approved for the treatment of pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of pemetrexed overdosage. It is not known ...
  • 11 DESCRIPTION
    Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium hemipentahydrate, has the chemical name ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Pemetrexed is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication. In vitrostudies show that ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was clastogenic in an - in vivo - micronucleus assay ...
  • 14 CLINICAL STUDIES
    14.1 Non-Squamous NSCLC - Initial Treatment in Combination with Pembrolizumab and Platinum - The efficacy of pemetrexed in combination with pembrolizumab and platinum chemotherapy was ...
  • 15 REFERENCES
    1. “OSHA Hazardous Drugs.” OSHA. [https://www.osha.gov /hazardous-drugs]
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Pemetrexed for injection, USP is a white to light-yellow or green-yellow lyophilized cake supplied in single-dose vials for reconstitution for intravenous infusion. Carton ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Premedication and Concomitant Medication:Instruct patients to take folic acid as directed and to keep ...
  • PATIENT INFORMATION
    PATIENT INFORMATION - Pemetrexed for Injection - (pem-e-TREX-ed) for Intravenous Use - What is pemetrexed for injection? Pemetrexed for ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Pemetrexed for Injection USP, 100 mg-Carton label - Pemetrexed for Injection USP, 100 mg-Vial label - Pemetrexed for Injection USP, 500 mg-Carton label - Pemetrexed for Injection USP, 500 mg-Vial ...
  • INGREDIENTS AND APPEARANCE
    Product Information