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PEMETREXED DISODIUM FOR is a brand name for Pemetrexed, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Hypersensitivity to pemetrexed or to any other ingredient used in the formulation. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING Section. Concomitant yellow fever vaccine (see DRUG INTERACTIONS). WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Pemetrexed Disodium For Injection USP (pemetrexed disodium) should only be administered by, or under the supervision of, a physician who is experienced in cancer chemotherapy and in the management of related toxicities.
Hepatotoxicity: See WARNINGS AND PRECAUTIONS - Hepatic/Biliary. Carcinogenesis and Mutagenesis No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was clastogenic in the in vivo micronucleus assay in mouse bone marrow but was not mutagenic in multiple in vitro tests (Ames assay, CHO cell assay).
v. 1 mg/kg/day or greater to male mice (about 1/1666 the recommended human dose on a mg/m2 basis) resulted in reduced fertility, hypospermia, and testicular atrophy. Because Pemetrexed Disodium For Injection USP may cause irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
See Part II:
TOXICOLOGY Section. Cardiovascular No thorough clinical QT/QTc study was performed to rule out the effect of pemetrexed on QT prolongation. Routine ECG assessments during clinical trials did not identify any concerns regarding QT prolongation.
Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischemic attack have been uncommonly reported in clinical trials with pemetrexed, usually when given in combination with another cytotoxic agent.
Most of the patients in whom these events have been observed had preexisting cardiovascular risk factors. Gastrointestinal Stomatitis, nausea, vomiting, and diarrhea are common in patients receiving pemetrexed disodium with or without cisplatin.
In rare cases gastrointestinal toxicity may lead to severe dehydration. Gastrointestinal toxicity should be vigorously managed (see ADVERSE REACTIONS - Clinical Trial Adverse Drug Reactions and DOSAGE AND ADMINISTRATION-Nonhematologic Toxicities).
Hepatic/Biliary Serious hepatobiliary toxicity and rare cases of fatal hepatic failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents in clinical trials. Underlying risk factors for the development of hepatic toxicity including hepatic metastases and/or underlying hepatic disease have been present in some cases.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A causal relationship Page 5 of 61 between pemetrexed and these events has not been established. Hematologic Pemetrexed can suppress bone marrow function, as manifested by neutropenia, thrombocytopenia, and anemia (or pancytopenia) (see ADVERSE REACTIONS Section); myelosuppression is usually the dose-limiting toxicity (see Laboratory Monitoring and Dose Reduction Recommendations under DOSAGE AND ADMINISTRATION Section).
In clinical trials, sepsis which in some cases was fatal occurred in approximately 1% of patients. Dose reductions for subsequent cycles are based on nadir Absolute Neutrophil Count (ANC), platelet count, and maximum nonhematologic toxicity seen in the previous cycle (see Dose Reduction Recommendations under DOSAGE AND ADMINISTRATION Section).
In the Phase 3 mesothelioma clinical trial, less overall toxicity and reductions in Grade 3/4 hematologic and nonhematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Prior to treatment with Pemetrexed Disodium For Injection USP patients must receive supplementation with folic acid and intramuscular vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see DOSAGE AND ADMINISTRATION Section).
The intramuscular vitamin B12 should not be substituted with an oral formulation. Immune Cases of hypersensitivity, including anaphylaxis, have been reported in patients treated with pemetrexed. Renal Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Most, but not all, of the patients in whom these serious renal events occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes. A causal relationship between pemetrexed and these events has not been established.
Respiratory Interstitial pneumonitis with respiratory insufficiency, sometimes fatal, has been reported in clinical trials. In patients with progressive dyspnea and cough, Pemetrexed Disodium For Injection USP should be interrupted and prompt investigation initiated.
Cases of radiation pneumonitis have been reported in patients with radiation either prior to, during, or subsequent to their pemetrexed therapy. Skin Rare cases of bullous epidermolysis have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Treatment-related adverse events of pemetrexed seen in clinical trials have been reversible. Skin rash has been reported in patients not pretreated with a corticosteroid in clinical trials. Pretreatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reaction (see DOSAGE AND ADMINISTRATION Section).
Page 6 of 61 Radiation recall dermatitis has been reported in patients on pemetrexed who have previously received radiotherapy. Severity of symptoms can vary from mild dermatitis to necrosis (see REFERENCES Barlesi et al, Hureaux et al).
Third Space Fluid The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed disodium is not fully defined. A phase 2 study of pemetrexed in 31 solid tumor patients with stable third space fluid suggested no difference in pemetrexed dose-normalized plasma concentrations or […]