Pemetrexed
Generic Name: pemetrexed
Brand Names:
Pemfexy
11 DESCRIPTION Pemetrexed is a folate analog metabolic inhibitor. Pemetrexed diacid, the drug substance, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glumatic acid. The molecular formula is C 20 H 21 N 5 O 6 and the molecular weight is 427.41. The structural formula is as follows: PEMFEXY (pemetrexed injection) for intravenous use is a sterile, clear, colorless to yellow or green-yellow solution .
Overview
11 DESCRIPTION Pemetrexed is a folate analog metabolic inhibitor. Pemetrexed diacid, the drug substance, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glumatic acid. The molecular formula is C 20 H 21 N 5 O 6 and the molecular weight is 427.41. The structural formula is as follows: PEMFEXY (pemetrexed injection) for intravenous use is a sterile, clear, colorless to yellow or green-yellow solution .
Uses
1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: 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.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of PEMFEXY 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 dosage of PEMFEXY, 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.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Renal failure [see Warnings and Precautions ( 5.2 )] Bullous and exfoliative skin toxicity [see Warnings 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, when administered as a single agent are fatigue, nausea, and anorexia. ( 6.1 ) The most common adverse reactions (incidence ≥ 20%) of pemetrexed when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.
Interactions
7 DRUG INTERACTIONS Ibuprofen: 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 ) 7.1 Effect of Other Drugs on Pemetrexed Ibuprofen 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 PEMFEXY [see Dosage and Administration ( 2.5 )] . Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression : Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer PEMFEXY when the absolute neutrophil count is less than 1500 cells/mm 3 and platelets are less than 100,000 cells/mm 3 . Initiate supplementation with oral folic acid and intramuscular vitamin B 12 to reduce the severity of hematologic and gastrointestinal toxicity of PEMFEXY. ( 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. 4 CONTRAINDICATIONS PEMFEXY 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 )
Pregnancy
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 Pharmacology ( 12.1 )] . There are no available data on pemetrexed 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 ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PEMFEXY (pemetrexed injection) is a clear, colorless to yellow or green-yellow solution supplied in a multi-dose vial for intravenous use. NDC 42367-531-33: Carton containing one (1) multi-dose vial of 500 mg/20 mL (25 mg/mL). Store refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light until time of use. PEMFEXY is a hazardous drug.
Frequently Asked Questions
What is Pemetrexed used for?▼
1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: 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.
What are the side effects of Pemetrexed?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Renal failure [see Warnings and Precautions ( 5.2 )] Bullous and exfoliative skin toxicity [see Warnings 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, when administered as a single agent are fatigue, nausea, and anorexia. ( 6.1 ) The most common adverse reactions (incidence ≥ 20%) of pemetrexed when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.
Can I take Pemetrexed during pregnancy?▼
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 Pharmacology ( 12.1 )] . There are no available data on pemetrexed 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 ).
What are the important warnings for Pemetrexed?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression : Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer PEMFEXY when the absolute neutrophil count is less than 1500 cells/mm 3 and platelets are less than 100,000 cells/mm 3 . Initiate supplementation with oral folic acid and intramuscular vitamin B 12 to reduce the severity of hematologic and gastrointestinal toxicity of PEMFEXY. ( 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. 4 CONTRAINDICATIONS PEMFEXY 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.