PACLITAXEL INJECTION USP 6 MG

What is PACLITAXEL INJECTION USP?

PACLITAXEL INJECTION USP 6 MG contains PACLITAXEL : 6 MG. It is listed in the Health Canada Drug Product Database under DIN 02320150, held by SANDOZ CANADA INCORPORATED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 31-Mar-2015. 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 PACLITAXEL INJECTION USP used for?

Paclitaxel Injection USP is indicated, alone or in combination, for the treatment of carcinoma of the ovary, breast and lung. Ovarian Carcinoma - First-line treatment in combination with other chemotherapeutic agents. - Second-line treatment of metastatic carcinoma of the ovary after failure of standard therapy. Breast Carcinoma - Adjuvant treatment of node-positive breast cancer administered sequentially to standard combination therapy. In the clinical trial, there was an overall favourable effect on disease free and overall survival in the total population of patients with receptor-positive and receptor-negative tumours, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumours. (See PHARMACOLOGY, Clinical Trials). - Second-line treatment of metastatic carcinoma of the breast after failure of standard therapy. Lung Carcinoma - First-line treatment of advanced non-small cell lung cancer.

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

Product details and regulatory record

How is it administered?

Paclitaxel Injection USP should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients receiving Paclitaxel Injection USP should be pretreated with corticosteroids, antihistamines, and H2 antagonists (such as dexamethasone, diphenhydramine and cimetidine or ranitidine) to minimize hypersensitivity reactions. Paclitaxel Injection USP should be administered as a diluted infusion through an in-line filter with a microporous membrane not greater than 0.22 microns. Metastatic Carcinoma of the Ovary: - Primary treatment: 175 mg/m² over 3 hours in combination with cisplatin 75 mg/m² every 3 weeks. Paclitaxel should be given before cisplatin. - Previously treated: 175 mg/m² administered intravenously over 3 hours every 3 weeks. Carcinoma of the Breast: - Adjuvant treatment: 175 mg/m² intravenously over 3 hours every 3 weeks for four courses administered sequentially to standard combination therapy. - After failure of initial chemotherapy or relapse: 175 mg/m² administered intravenously over 3 hours every 3 weeks. Non-Small Cell Lung Carcinoma: - Recommended regimen: 175 mg/m² administered intravenously over 3 hours followed by cisplatin, every 3 weeks. Dosage Adjustment: - For severe neutropenia (<500 cells/mm³) or severe peripheral neuropathy, the dosage should be reduced by 20% for subsequent courses. - Single courses should not be repeated until neutrophil count is at least 1500 cells/mm³ and platelet count is at least 100,000 cells/mm³.

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

How is it stored and handled?

Paclitaxel Injection USP should be stored between 15 and 30 °C. Retain in the original package and protect from light. Once punctured, the 5 and 16.7 mL vials of Paclitaxel Injection USP are stable for 28 days at room temperature. The 50 mL Pharmacy Bulk Vial should be used within 24 hours after initial entry. Solutions for infusion prepared as recommended may be stored at room temperature (only if necessary). However, the infusion should be initiated within 24 hours of reconstitution. If unopened vials are refrigerated, a precipitate may form which redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.

How is it supplied?

Paclitaxel Injection USP is available in multidose vials of 5 mL, 16.7 mL and Pharmacy Bulk Vial of 50 mL containing respectively 30 mg, 100 mg and 300 mg paclitaxel at a concentration of 6 mg/mL.

Contraindications

Paclitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor¹ EL (polyethoxylated castor oil). Paclitaxel should not be used in patients with severe baseline neutropenia (<1500 cells/mm³).

Warnings and precautions

Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients receiving Paclitaxel Injection USP should be pretreated with corticosteroids, antihistamines, and H2 antagonists to minimize hypersensitivity reactions. Severe hypersensitivity reactions, including anaphylaxis, dyspnea, hypotension, angioedema, and generalized urticaria, have occurred. Rare fatal reactions have occurred despite pretreatment. Patients who experience severe hypersensitivity reactions should not be rechallenged. Paclitaxel should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm³. Bone marrow suppression (primarily neutropenia) is dose and schedule dependent and is the dose-limiting toxicity. Frequent monitoring of blood counts is recommended. Patients should not be retreated until neutrophils recover to >1500 cells/mm³ and platelets to >100,000 cells/mm³. Severe cardiac conduction abnormalities have been reported in <1% of patients. If significant conduction abnormalities develop, appropriate therapy and continuous electrocardiographic monitoring should be performed. Paclitaxel may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should avoid becoming pregnant during therapy. Paclitaxel Injection USP contains dehydrated ethanol (401 mg/mL); consideration should be given to possible CNS and other effects of ethanol. Children may be more sensitive to the effects of ethanol.

What can be used instead?

Other Canadian products sharing ATC code L01CD01 PACLITAXEL. 5 of 19 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies PACLITAXEL worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. PACLITAXEL appears in 289 registered pack listings across 11 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.