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Pemetrexed
Pemetrexed disodium · Injection, Powder, Lyophilized, for Solution
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Pemetrexed Disodium | 1 g/40mL | 1728072 | View |
| Pemetrexed Disodium | 100 mg/4mL | 1728072 | View |
| Pemetrexed Disodium | 1000 mg/40mL | 1728072 | View |
| Pemetrexed Disodium | 500 mg/20mL | 1728072 | View |
| Pemetrexed Disodium | 750 mg/30mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 1 g/40mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 100 mg/10mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 100 mg/4.2mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 100 mg/4mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 1000 mg/40mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 500 mg/20mL | 1728072 | View |
| Pemetrexed Disodium Hemipentahydrate | 500 mg/50mL | 1728072 | View |
| Pemetrexed Disodium Heptahydrate | 1 g/40mL | 1728072 | View |
| Pemetrexed Disodium Heptahydrate | 100 mg/4.2mL | 1728072 | View |
| Pemetrexed Disodium Heptahydrate | 100 mg/4mL | 1728072 | View |
| Pemetrexed Disodium Heptahydrate | 500 mg/20mL | 1728072 | View |
| Pemetrexed Disodium Heptahydrate | 750 mg/30mL | 1728072 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Folate Analog Metabolic Inhibitor [EPC] | EPC | All 21 members |
| Folic Acid Metabolism Inhibitors [MoA] | MoA | All 19 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208696-001 | PEMETREXED DISODIUM | POWDER | PEMETREXED DISODIUM | Prescription | AP | ||
| 208696-002 | PEMETREXED DISODIUM | POWDER | PEMETREXED DISODIUM | Prescription | AP |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | May 25, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250831). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingIndications and Usage ( 1.1 ) 01/2019 Dosage and Administration ( 2.1 ) 01/2019
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Pemetrexed for injection, USP 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, USP 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 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed for injection, USP 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, USP is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies ( 14.1 )]. 1.2 Mesothelioma Pemetrexed for injection, USP 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.
Dosage and Administration
openFDA Drug Labeling2 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 2 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 creatinine clearance of 45 mL/minute or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. ( 2.1 , 2.2 ) Initiate folic acid 400 mcg to 1000 mcg orally, once daily, beginning 7 days prior to the first dose of pemetrexed for injection and continue until 21 days after the last dose of pemetrexed for injection. ( 2.4 ) Administer vitamin B 12 , 1 mg intramuscularly, 1 week prior to the first dose of pemetrexed for injection and every 3 cycles. ( 2.4 ) Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after pemetrexed for injection administration. ( 2.4 ) 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 metastatic non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes administered after pembrolizumab and prior to carboplatin or cisplatin on Day 1 of each 21-day cycle for 4 cycles. Following completion of platinum-based therapy, treatment with pemetrexed for injection with or without pembrolizumab is administered until disease progression or unacceptable toxicity. Please refer to the full prescribing information for pembrolizumab and for carboplatin or cisplatin. The recommended dose of pemetrexed for injection when administered with cisplatin for initial treatment of locally advanced or metastatic non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity. The recommended dose of pemetrexed for injection for maintenance treatment of non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy. The recommended dose of pemetrexed for injection for treatment of recurrent non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. 2.2 Recommended Dosage for Mesothelioma The recommended dose of pemetrexed for injection when administered with cisplatin in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m 2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. 2.3 Renal Impairment Pemetrexed for injection dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater [see Dosage and Administration ( 2.1 , 2.2 )] . There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min [see Use in Specific Populations ( 8.6 )] . 2.4 Premedication and Concomitant Medications to Mitigate Toxicity Vitamin Supplementation Initiate folic aci …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg, 500 mg or 1000 mg pemetrexed as a white to either light-yellow or green-yellow lyophilized powder or cake in single-dose vials for reconstitution. For Injection: 100 mg, 500 mg or 1000 mg lyophilized powder or cake in single-dose vial.
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Pemetrexed for Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions ( 6.1 )] . History of severe hypersensitivity reaction to pemetrexed. ( 4 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer pemetrexed for injection when the absolute neutrophil count is less than 1,500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed for injection. ( 2.4 , 5.1 ) Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min. ( 2.3 , 5.2 ) Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity. ( 5.3 ) Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed. ( 5.4 ) Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall. ( 5.5 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation Pemetrexed for Injection can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection. The risk of myelosuppression is increased in patients who do not receive vitamin supplementation. In Study JMCH, incidences of Grade 3 to 4 neutropenia (38% versus 23%), thrombocytopenia (9% versus 5%), febrile neutropenia (9% versus 0.6%), and neutropenic infection (6% versus 0) were higher in patients who received pemetrexed for injection plus cisplatin without vitamin supplementation as compared to patients who were fully supplemented with folic acid and vitamin B 12 prior to and throughout pemetrexed for injection plus cisplatin treatment. Initiate supplementation with oral folic acid and intramuscular vitamin B 12 prior to the first dose of pemetrexed for injection; continue vitamin supplementation during treatment and for 21 days after the last dose of pemetrexed for injection to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed for injection [see Dosage and Administration ( 2.4 )] . Obtain a complete blood count at the beginning of each cycle. Do not administer pemetrexed for injection until the ANC is at least 1,500 cells/mm 3 and platelet count is at least 100,000 cells/mm 3 . Permanently reduce pemetrexed for injection in patients with an ANC of less than 500 cells/mm 3 or platelet count of less than 50,000 cells/mm 3 in previous cycles [see Dosage and Administration ( 2.6 )] . In Studies JMDB and JMCH, among patients who received vitamin supplementation, incidence of Grade 3 to 4 neutropenia was 15% and 23%, the incidence of Grade 3 to 4 anemia was 6% and 4%, and incidence of Grade 3 to 4 thrombocytopenia was 4% and 5%, respectively. In Study JMCH, 18% of patients in the pemetrexed for injection arm required red blood cell transfusions compared to 7% of patients in the cisplatin arm [see Adverse Reactions ( 6.1 )]. In Studies JMEN, PARAMOUNT, and JMEI, where all patients received vitamin supplementation, incidence of Grade 3 to 4 neutropenia ranged from 3% to 5%, and incidence of Grade 3 to 4 anemia ranged from 3% to 5%. 5.2 Renal Failure Pemetrexed for Injection can cause severe, and sometimes fatal, renal toxicity. The incidences of renal failure in clinical studies in which patients received pemetrexed for injection with cisplatin were: 2.1% in Study JMDB and 2.2% in Study JMCH. The incidence of renal failure in clinical studies in which patients received pemetrexed for injection as a single agent ranged from 0.4% to 0.6% (Studies JMEN, PARAMOUNT, and JMEI [see Adverse Reactions ( 6.1 )] . Determine creatinine clea …
Adverse Reactions
openFDA Drug Labeling6 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 [see Warnings and Precautions ( 5.2 )] Bullous and exfoliative skin toxicity [see Warning and Precautions ( 5.3 )] Interstitial pneumonitis [see Warnings and Precautions ( 5.4 )] Radiation recall [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence ≥20%) of pemetrexed for injection, when administered as a single agent are fatigue, nausea, and anorexia. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed for injection when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed for injection when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. In clinical trials, the most common adverse reactions (incidence ≥20%) of pemetrexed for injection, when administered as a single agent, are fatigue, nausea, and anorexia. The most common adverse reactions (incidence ≥20%) of pemetrexed for injection, when administered in combination with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. The most common adverse reactions (incidence ≥20%) of pemetrexed for injection, when administered in combination with pembrolizumab and platinum chemotherapy, are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia. Non-Squamous NSCLC First-line Treatment of Metastatic Non-squamous NSCLC with Pembrolizumab and Platinum Chemotherapy The safety of pemetrexed for injection, in combination with pembrolizumab and investigator's choice of platinum (either carboplatin or cisplatin), was investigated in Study KEYNOTE-189, a multicenter, double-blind, randomized (2:1), active-controlled trial in patients with previously untreated, metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. A total of 607 patients received pemetrexed for injection, pembrolizumab, and platinum every 3 weeks for 4 cycles followed by pemetrexed for injection and pembrolizumab (n=405), or placebo, pemetrexed for injection, and platinum every 3 weeks for 4 cycles followed by placebo and pemetrexed for injection (n=202). Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible [see Clinical Studies ( 14.1 )] . The median duration of exposure to pemetrexed for injection was 7.2 months (range: 1 day to 1.7 years). Seventy-two percent of patients received carboplatin. The study population characteristics were: median age of 64 years (range: 34 to 84), 49% age 65 years or older, 59% male, 94% White and 3% Asian, and 18% with history of brain metastases at baseline. Pemetrexed for Injection was discontinued for adverse reactions in 23% of patients in the pemetrexed for injection, pembrolizumab, and platinum arm. The most common adverse reactions resulting in discontinuation of pemetrexed for injection in this arm were acute kidney injury (3%) and pneumonitis (2%). Adverse reactions leading to interruption of pemetrexed for injection occurred in 49% of patients in the …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Ibuprofen increased risk of pemetrexed for injection toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage as recommended for patients with a creatinine clearance between 45 mL/min and 79 mL/min. ( 2.5 , 5.6 , 7 ) 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 and 79 mL/min: • Avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of pemetrexed for injection [see Dosage and Administration ( 2.5 )] . • Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy 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/m 2 [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/m 2 . At doses, based on BSA, greater than or equal to 0.0012 times the 500 mg/m 2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). 8.2 Lactation 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. 8.3 Females and Males of Reproductive Potential 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 )] . Infertilit y 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 )] . 8.4 Pediatric Use 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/m 2 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/m 2 (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 B 12 and folic acid supplementation and dexamethasone. No tumor responses were observed. Adverse reactions observed in pediatric patients wer …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Pemetrexed for injection is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication. In vitro studies show that pemetrexed inhibits thymidylate synthase (TS), dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase (GARFT), which are folate- dependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Pemetrexed is taken into cells by membrane carriers such as the reduced folate carrier and membrane folate binding protein transport systems. Once in the cell, pemetrexed is converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase. The polyglutamate forms are retained in cells and are inhibitors of TS and GARFT.
Description
openFDA Drug Labeling11 DESCRIPTION Pemetrexed for Injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium heptahydrate, has the chemical name L-glutamic acid, N -[4-[2-(2-amino-4,7-dihydro-4-oxo-1 H -pyrrolo[2,3- d ]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 •7H 2 O and a molecular weight of 597.49. The structural formula is as follows: Pemetrexed for Injection, USP is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100 mg vial of Pemetrexed for Injection, USP contains 100 mg pemetrexed (equivalent to 139.8 mg pemetrexed disodium heptahydrate) and 106 mg mannitol. Each 500 mg vial of Pemetrexed for Injection, USP contains 500 mg pemetrexed (equivalent to 699 mg pemetrexed disodium heptahydrate) and 500 mg mannitol. Each 750 mg vial of Pemetrexed for Injection, USP contains 750 mg pemetrexed (equivalent to 1,048.5 mg pemetrexed disodium heptahydrate) and 750 mg mannitol. Each 1 gram vial of Pemetrexed for Injection, USP contains 1 gram pemetrexed (equivalent to 1,398 mg pemetrexed disodium heptahydrate) and 1 gram mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. structural formula
Overdosage
openFDA Drug Labeling10 OVERDOSAGE No drugs are approved for the treatment of pemetrexed for injection overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of pemetrexed for injection overdosage. It is not known whether pemetrexed is dialyzable.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Pemetrexed for injection, USP is a white to either light yellow or greenish yellow lyophilized powder supplied in single-dose vials for reconstitution for intravenous infusion. NDC 16729-229-03: Carton containing one (1) single-dose vial of 100 mg pemetrexed. NDC 16729-230-11: Carton containing one (1) single-dose vial of 500 mg pemetrexed. NDC 16729-244-38: Carton containing one (1) single-dose vial of 1 gram pemetrexed. Storage and Handling Store at 25°C (77°F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F)[see USP Controlled Room Temperature]. Pemetrexed for injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Discard unused portion.
How Supplied Pemetrexed for injection, USP is a white to either light yellow or greenish yellow lyophilized powder supplied in single-dose vials for reconstitution for intravenous infusion. NDC 16729-229-03: Carton containing one (1) single-dose vial of 100 mg pemetrexed. NDC 16729-230-11: Carton containing one (1) single-dose vial of 500 mg pemetrexed. NDC 16729-244-38: Carton containing one (1) single-dose vial of 1 gram pemetrexed.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: PEMETREXED DISODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 16729-229-03 | 16729-229 | Accord Healthcare Inc. | 1 VIAL in 1 CARTON (16729-229-03) / 4 mL in 1 VIAL | May 25, 2022 |
| 16729-230-11 | 16729-230 | Accord Healthcare Inc. | 1 VIAL in 1 CARTON (16729-230-11) / 20 mL in 1 VIAL | May 25, 2022 |
| 16729-244-38 | 16729-244 | Accord Healthcare Inc. | 1 VIAL in 1 CARTON (16729-244-38) / 40 mL in 1 VIAL | May 25, 2022 |
| 68001-535-41 | 68001-535 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-535-41) / 4 mL in 1 VIAL | July 4, 2022 |
| 68001-536-41 | 68001-536 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-536-41) / 20 mL in 1 VIAL | July 4, 2022 |
| 68001-538-41 | 68001-538 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-538-41) / 4 mL in 1 VIAL | June 24, 2022 |
| 68001-539-41 | 68001-539 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-539-41) / 20 mL in 1 VIAL | June 24, 2022 |
| 68001-543-41 | 68001-543 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-543-41) / 4 mL in 1 VIAL | September 1, 2022 |
| 68001-544-41 | 68001-544 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-544-41) / 20 mL in 1 VIAL | September 1, 2022 |
| 68001-545-41 | 68001-545 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-545-41) / 30 mL in 1 VIAL | September 1, 2023 |
| 68001-546-41 | 68001-546 | BluePoint Laboratories | 1 VIAL in 1 CARTON (68001-546-41) / 40 mL in 1 VIAL | September 1, 2023 |
| 31722-336-31 | 31722-336 | Camber Pharmaceuticals, Inc. | 1 VIAL in 1 CARTON (31722-336-31) / 4 mL in 1 VIAL | June 14, 2024 |
| 31722-337-31 | 31722-337 | Camber Pharmaceuticals, Inc. | 1 VIAL in 1 CARTON (31722-337-31) / 20 mL in 1 VIAL | June 14, 2024 |
| 55150-381-01 | 55150-381 | Eugia US LLC | 1 VIAL in 1 CARTON (55150-381-01) / 4 mL in 1 VIAL | May 25, 2022 |
| 55150-382-01 | 55150-382 | Eugia US LLC | 1 VIAL in 1 CARTON (55150-382-01) / 20 mL in 1 VIAL | May 25, 2022 |
| 55150-383-01 | 55150-383 | Eugia US LLC | 1 VIAL in 1 CARTON (55150-383-01) / 40 mL in 1 VIAL | May 25, 2022 |
| 63323-134-10 | 63323-134 | Fresenius Kabi USA, LLC | 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE | May 25, 2022 |
| 63323-450-50 | 63323-450 | Fresenius Kabi USA, LLC | 1 VIAL, SINGLE-USE in 1 CARTON (63323-450-50) / 20 mL in 1 VIAL, SINGLE-USE | May 25, 2022 |
| 63323-621-00 | 63323-621 | Fresenius Kabi USA, LLC | 1 VIAL, SINGLE-USE in 1 CARTON (63323-621-00) / 30 mL in 1 VIAL, SINGLE-USE | May 25, 2022 |
| 63323-622-00 | 63323-622 | Fresenius Kabi USA, LLC | 1 VIAL, SINGLE-USE in 1 CARTON (63323-622-00) / 40 mL in 1 VIAL, SINGLE-USE | May 25, 2022 |
| 71288-145-10 | 71288-145 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-145-10) / 4.2 mL in 1 VIAL, SINGLE-DOSE | December 13, 2022 |
| 71288-146-50 | 71288-146 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-146-50) / 20 mL in 1 VIAL, SINGLE-DOSE | December 13, 2022 |
| 71288-147-50 | 71288-147 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-147-50) / 30 mL in 1 VIAL, SINGLE-DOSE | December 13, 2022 |
| 71288-148-51 | 71288-148 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-148-51) / 40 mL in 1 VIAL, SINGLE-DOSE | December 13, 2022 |
| 71288-166-10 | 71288-166 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-10) / 10 mL in 1 VIAL, SINGLE-DOSE | May 25, 2022 |
| 71288-166-91 | 71288-166 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91) / 10 mL in 1 VIAL, SINGLE-DOSE | May 25, 2022 |
| 71288-167-50 | 71288-167 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-167-50) / 50 mL in 1 VIAL, SINGLE-DOSE | May 25, 2022 |
| 71288-167-95 | 71288-167 | Meitheal Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-167-95) / 50 mL in 1 VIAL, SINGLE-DOSE | May 25, 2022 |
| 72603-325-01 | 72603-325 | NorthStar RxLLC | 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-325-01) / 10 mL in 1 VIAL, SINGLE-DOSE | October 1, 2024 |
| 72603-425-01 | 72603-425 | NorthStar RxLLC | 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-425-01) / 50 mL in 1 VIAL, SINGLE-DOSE | October 1, 2024 |
| 67184-0503-1 | 67184-0503 | Qilu Pharmaceutical Co., Ltd. | 1 VIAL in 1 CARTON (67184-0503-1) / 4 mL in 1 VIAL | May 25, 2022 |
| 67184-0504-1 | 67184-0504 | Qilu Pharmaceutical Co., Ltd. | 1 VIAL in 1 CARTON (67184-0504-1) / 20 mL in 1 VIAL | May 25, 2022 |
| 25021-260-10 | 25021-260 | Sagent Pharmaceuticals | 1 VIAL in 1 CARTON (25021-260-10) / 4.2 mL in 1 VIAL | December 15, 2024 |
| 25021-261-50 | 25021-261 | Sagent Pharmaceuticals | 1 VIAL in 1 CARTON (25021-261-50) / 20 mL in 1 VIAL | December 15, 2024 |
| 70069-834-01 | 70069-834 | Somerset Therapeutics LLC | 1 VIAL in 1 CARTON (70069-834-01) / 4 mL in 1 VIAL | April 15, 2025 |
| 70069-835-01 | 70069-835 | Somerset Therapeutics LLC | 1 VIAL in 1 CARTON (70069-835-01) / 20 mL in 1 VIAL | April 15, 2025 |
| 72338-100-01 | 72338-100 | Waverley Pharma Inc | 1 VIAL in 1 CARTON (72338-100-01) / 4 mL in 1 VIAL | June 4, 2018 |
| 72338-101-01 | 72338-101 | Waverley Pharma Inc | 1 VIAL in 1 CARTON (72338-101-01) / 20 mL in 1 VIAL | June 4, 2018 |
| 70771-1691-1 | 70771-1691 | Zydus Lifesciences Limited | 1 VIAL in 1 CARTON (70771-1691-1) / 4 mL in 1 VIAL | May 26, 2022 |
| 70771-1692-1 | 70771-1692 | Zydus Lifesciences Limited | 1 VIAL in 1 CARTON (70771-1692-1) / 20 mL in 1 VIAL | May 26, 2022 |
| 70771-1693-1 | 70771-1693 | Zydus Lifesciences Limited | 1 VIAL in 1 CARTON (70771-1693-1) / 40 mL in 1 VIAL | May 26, 2022 |
| 70710-1654-1 | 70710-1654 | Zydus Pharmaceuticals USA Inc. | 1 VIAL in 1 CARTON (70710-1654-1) / 4 mL in 1 VIAL | May 26, 2022 |
| 70710-1655-1 | 70710-1655 | Zydus Pharmaceuticals USA Inc. | 1 VIAL in 1 CARTON (70710-1655-1) / 20 mL in 1 VIAL | May 26, 2022 |
| 70710-1674-1 | 70710-1674 | Zydus Pharmaceuticals USA Inc. | 1 VIAL in 1 CARTON (70710-1674-1) / 40 mL in 1 VIAL | May 26, 2022 |
| 16729-229 | 16729-229 | Accord Healthcare Inc. | — | May 25, 2022 |
| 16729-230 | 16729-230 | Accord Healthcare Inc. | — | May 25, 2022 |
| 16729-244 | 16729-244 | Accord Healthcare Inc. | — | May 25, 2022 |
| 68001-535 | 68001-535 | BluePoint Laboratories | — | July 4, 2022 |
| 68001-536 | 68001-536 | BluePoint Laboratories | — | July 4, 2022 |
| 68001-538 | 68001-538 | BluePoint Laboratories | — | June 24, 2022 |
| 68001-539 | 68001-539 | BluePoint Laboratories | — | June 24, 2022 |
| 68001-543 | 68001-543 | BluePoint Laboratories | — | May 25, 2022 |
| 68001-544 | 68001-544 | BluePoint Laboratories | — | September 1, 2022 |
| 68001-545 | 68001-545 | BluePoint Laboratories | — | February 28, 2023 |
| 68001-546 | 68001-546 | BluePoint Laboratories | — | February 28, 2023 |
| 31722-336 | 31722-336 | Camber Pharmaceuticals, Inc. | — | June 14, 2024 |
| 31722-337 | 31722-337 | Camber Pharmaceuticals, Inc. | — | June 14, 2024 |
| 55150-381 | 55150-381 | Eugia US LLC | — | May 25, 2022 |
| 55150-382 | 55150-382 | Eugia US LLC | — | May 25, 2022 |
| 55150-383 | 55150-383 | Eugia US LLC | — | May 25, 2022 |
| 63323-134 | 63323-134 | Fresenius Kabi USA, LLC | — | May 25, 2022 |
| 63323-450 | 63323-450 | Fresenius Kabi USA, LLC | — | May 25, 2022 |
| 63323-621 | 63323-621 | Fresenius Kabi USA, LLC | — | May 25, 2022 |
| 63323-622 | 63323-622 | Fresenius Kabi USA, LLC | — | May 25, 2022 |
| 71288-145 | 71288-145 | Meitheal Pharmaceuticals Inc. | — | December 13, 2022 |
| 71288-146 | 71288-146 | Meitheal Pharmaceuticals Inc. | — | December 13, 2022 |
| 71288-147 | 71288-147 | Meitheal Pharmaceuticals Inc. | — | December 13, 2022 |
| 71288-148 | 71288-148 | Meitheal Pharmaceuticals Inc. | — | December 13, 2022 |
| 71288-166 | 71288-166 | Meitheal Pharmaceuticals Inc. | — | May 25, 2022 |
| 71288-167 | 71288-167 | Meitheal Pharmaceuticals Inc. | — | May 25, 2022 |
| 72603-325 | 72603-325 | NorthStar RxLLC | — | October 1, 2024 |
| 72603-425 | 72603-425 | NorthStar RxLLC | — | October 1, 2024 |
| 67184-0503 | 67184-0503 | Qilu Pharmaceutical Co., Ltd. | — | May 25, 2022 |
| 67184-0504 | 67184-0504 | Qilu Pharmaceutical Co., Ltd. | — | May 25, 2022 |
| 25021-260 | 25021-260 | Sagent Pharmaceuticals | — | December 15, 2024 |
| 25021-261 | 25021-261 | Sagent Pharmaceuticals | — | December 15, 2024 |
| 70069-834 | 70069-834 | Somerset Therapeutics LLC | — | April 15, 2025 |
| 70069-835 | 70069-835 | Somerset Therapeutics LLC | — | April 15, 2025 |
| 72338-100 | 72338-100 | Waverley Pharma Inc | — | June 4, 2018 |
| 72338-101 | 72338-101 | Waverley Pharma Inc | — | June 4, 2018 |
| 70771-1691 | 70771-1691 | Zydus Lifesciences Limited | — | May 26, 2022 |
| 70771-1692 | 70771-1692 | Zydus Lifesciences Limited | — | May 26, 2022 |
| 70771-1693 | 70771-1693 | Zydus Lifesciences Limited | — | May 26, 2022 |
| 70710-1654 | 70710-1654 | Zydus Pharmaceuticals USA Inc. | — | May 26, 2022 |
| 70710-1655 | 70710-1655 | Zydus Pharmaceuticals USA Inc. | — | May 26, 2022 |
| 70710-1674 | 70710-1674 | Zydus Pharmaceuticals USA Inc. | — | May 26, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.