TOPOTECAN INJECTION 1 MG — DIN 02390981

What is TOPOTECAN INJECTION?

TOPOTECAN INJECTION 1 MG contains TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02390981, held by SANDOZ CANADA INCORPORATED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 05-Feb-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TOPOTECAN INJECTION used for?

Topotecan Injection (topotecan hydrochloride) is indicated for the treatment of: • metastatic carcinoma of the ovary after failure of initial or subsequent therapy. • sensitive small cell lung cancer after failure of first-line chemotherapy (defined as recurrence at least 60 days after first-line chemotherapy).

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Initial Dose: Prior to administration of the first course of Topotecan Injection (topotecan hydrochloride), patients must have: • a baseline absolute neutrophil count of ≥ 1.5 x 109/L • a platelet count of ≥ 100 x 109/L • a hemoglobin level of ≥ 90 g/L Recommended dose and dosage adjustment Initial Dose The recommended dose of Topotecan Injection is 1.5 mg/m² by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. Because median time to response in three ovarian cancer clinical trials was 9 to 12 weeks and median time to response in four small cell lung cancer trials was 5 to 7 weeks, a minimum of 4 courses of Topotecan Injection is recommended. Subsequent Doses Topotecan should not be re-administered unless the absolute neutrophil count is more than or equal to 1 x 109/L, the platelet count is more than or equal to 100 x 109/L and the hemoglobin level is more than or equal to 90 g/L (after transfusion if necessary). Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e.g. G-CSF) or to dose reduce to maintain neutrophil counts. If dose reduction is chosen for patients who experience severe neutropenia (absolute neutrophil count less than 0.5 x 109/L) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m²/day to 1.25 mg/m²/day (or subsequently down to 1.0 mg/m²/day if necessary). Doses should be similarly reduced if the platelet count falls below 25 x 109/L. Routine pre-medication for the prevention of non-hematological adverse events is not required with Topotecan Injection. Administration Topotecan Injection is a cytotoxic anticancer drug. As with other potentially toxic compounds, Topotecan Injection solution should be prepared under a vertical laminar flow hood while wearing gloves and protective clothing. If Topotecan Injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If Topotecan Injection contacts mucous membranes, flush thoroughly with water. Preparation for Intravenous Administration: An appropriate volume of the solution is diluted to an infusion concentration of 20-500 mcg/mL in 50 to 100 mL of either 0.9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Topotecan Injection is contraindicated: • in patients who have a history of hypersensitivity reactions (anaphylactoid reactions) to topotecan or to any of its excipients; • in patients who are pregnant or breast-feeding; • in patients who already have severe bone marrow depression prior to starting first course, as evidenced by baseline absolute neutrophils < 1.5 x 109/L and/or a platelet count of < 100 x 109/L; • in patients with severe renal impairment (creatinine clearance of < 20 mL/min or < 0.33 mL/sec).

Warnings and precautions

Serious Warnings and Precautions Topotecan Injection 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 Topotecan Injection 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. Therapy with Topotecan Injection should not be given to patients with baseline absolute neutrophil counts of 1.5x109/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 Topotecan Injection (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. Selection of Patients in Small Cell Lung Cancer Clinical studies were conducted in patients with sensitive and refractory small cell lung cancer; a reduced chance for benefit in the refractory patients was noted with response rates ranging from 11 to 31% for patients with sensitive disease and 2.1 to 7.3% 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 (see Special Populations, Pregnant Women). 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).