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PMS-TOPOTECAN is a brand name for Topotecan, 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 ......................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions pms-TOPOTECAN should be prescribed by a qualified health care professional who is experienced in the use of antineoplastic therapy agents. The following is a clinically significant adverse event: Bone marrow suppression, primarily neutropenia (see WARNINGS AND PRECAUTIONS, Hematologic); Potentially fatal neutropenic colitis (see WARNINGS AND PRECAUTIONS, Gastrointestinal); Potentially fatal interstitial lung disease (see WARNINGS AND PRECAUTIONS, Respiratory).
General pms-TOPOTECAN should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Bone marrow suppression, primarily neutropenia, is the dose limiting toxicity. 5x109/L or less.
In order to monitor the occurrence of bone marrow suppression, frequent peripheral blood cell counts should be performed on all patients receiving pms-TOPOTECAN (see DOSAGE AND ADMINISTRATION). Inadvertent extravasation with topotecan hydrochloride has been associated only with mild local reactions such as erythema (and bruising).
Caution should be observed when driving or operating machinery if fatigue or asthenia persist. 3% for patients with refractory disease. As the risk for toxicity is similar, the overall benefit/risk is reduced. The benefit to patients versus the risk of toxicity must be carefully weighed.
Carcinogenesis and Mutagenesis The carcinogenic potential of topotecan hydrochloride has not been studied. ) Topotecan hydrochloride has been shown to be genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro, and mouse bone marrow cells in vivo, but is not mutagenic in bacterial cells (Salmonella typhimurium and Escherichia coli).
pms-TOPOTECAN Product Monograph Page 5 of 29 Gastrointestinal Topotecan-induced neutropenia can cause neutropenic colitis (caecitis or typhlitis). Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered. Hematologic Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity of topotecan.
Neutropenia is not cumulative over time. Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan [2% fatalities across all SCLC studies (n = 426 subjects), which includes 3% fatalities in one Phase III SCLC study (n = 107 subjects, Table 4)] (see ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5x109/L. To monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving topotecan hydrochloride. Patients should not be retreated with subsequent courses of topotecan hydrochloride until neutrophils recover to a level > 1x109/L, platelets recover to a level > 100x109/L and hemoglobin recovers to 90 g/L, using transfusion if necessary.
5x109/L) occurred in 78% of patients and in 39% of all courses, with a median duration of 7 days. The nadir neutrophil count occurred at a median of 12 days. 3%. Topotecan-induced neutropenia can cause neutropenic colitis (see WARNINGS AND PRECAUTIONS, Gastrointestinal).
25 mg/m2 for subsequent courses of therapy is recommended (see DOSAGE AND ADMINISTRATION). Thrombocytopenia Grade 4 thrombocytopenia (< 25x109/L) occurred in 27% of patients and in 9% of courses, with a median duration of 5 days and platelet nadir at a median of 15 days.
Platelet transfusions were given to 15% of patients in 4% of courses. Anemia Severe anemia (Grade 3/4, < 80 g/L) occurred in 37% of patients and in 14% of courses. Median nadir was at day 15. Transfusions were needed in 52% of patients in 22% of courses.
5x109/L and platelet count at pms-TOPOTECAN Product Monograph Page 6 of 29 least 100x109/L. Frequent monitoring of blood counts should be instituted during treatment with topotecan hydrochloride (see DOSAGE AND ADMINISTRATION). Respiratory Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see ADVERSE REACTIONS).
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/or colony stimulating factors. g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Special Populations Pregnant Women:
Topotecan hydrochloride may cause fetal harm when administered to a pregnant woman. 5 mg/m2). 59 mg/m2), topotecan caused malformations, primarily of the eye, brain, skull, and vertebrae. This drug is […]