Loading…
CARBOPLATIN is a brand name for Carboplatin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Carboplatin Injection BP is indicated for the treatment of ovarian cancer of epithelial origin in first line therapy, and in second line therapy after other treatments have failed. 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
). • History of severe allergic reactions to carboplatin, other platinum-containing compounds, or to any ingredients in the formulation, including any non-medicinal ingredients, or component of the container (see
) • Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations • Carboplatin Injection BP should only be administered to patients under the supervision of a qualified physician who is experienced in the use of chemotherapeutic agents. • Dosage reduction or discontinuation may be necessary in the case of severe alteration of renal function tests.
• Patients presenting with impaired renal function requires adequate dosage adjustments and frequent monitoring of both hematological nadirs and renal function. • Peripheral blood counts and renal function should be monitored closely.
• Audiograms should be performed prior to initiating therapy and during treatment or when auditory symptoms occur. 2 Recommended Dose and Dosage Adjustment Adult Dosage The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 mg/m2 given as a single intravenous infusion over 15 to 60 minutes.
Therapy should not be repeated until four weeks after the previous carboplatin course. Initial dosage should be reduced 20 to 25% in patients with risk factors such as previous myelosuppressive therapy and poor performance status. Initial and subsequent dose reduction may be required in elderly patients, depending upon their physical status.
Determination of hematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin. Dosage in Patients with Impaired Renal Function Hematological nadir and renal function should be closely monitored.
A suggested dosage schedule based on creatinine clearance is:
) • Hypersensitivity reactions, sometimes fatal, have been reported and may occur within minutes of Carboplatin Injection BP administration (see
• Severe myelosuppression. • Pre-existing severe renal impairment. Dosage adjustment may allow use in the presence of mild renal impairment (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
CREATININE CLEARANCE DOSE OF CARBOPLATIN > 40 mL/min. 400 mg/m2 20 - 39 mL/min. 250 mg/m2 0 - 19 mL/min. 150 mg/m2 Pediatric dosage Specific dosage recommendations cannot be made due to insufficient use in pediatrics (<18 years of age); therefore, Health Canada has not authorized an indication for pediatric use.
0 mg/mL carboplatin. Carboplatin Injection BP – Product Monograph Page 6 of 25 Diluted solutions of Carboplatin Injection BP are stable for 24 hours in glass or plastic containers, in light and dark storage conditions. Discard unused portion after 24 hours.
9% sodium chloride injection are stable for 48 hours under refrigeration from the time of initial dilution, after which time the unused portion should be discarded. 4 Administration • Carboplatin Injection BP should be prepared for administration by professionals who have been trained in the safe use of cytotoxic drugs.
• The personnel carrying out these procedures should be adequately protected with clothing, gloves, masks and eye protection. 5 Missed Dose For a missed dose of Carboplatin Injection BP, the physician will decide when the patient should receive the next one.
5 OVERDOSAGE No cases of overdosage of carboplatin are known. Should it occur, the patient may need to be sustained through complications relating to myelosuppression, renal and hepatic impairment. Death may follow. Signs and symptoms of overdosage should be managed with supportive measures including hemodialysis.
From reports in which doses up to 1600 mg/m2 were used, patients were said to feel extremely unwell and developed diarrhea and alopecia. Use of higher than recommended doses of carboplatin has been associated with loss of vision, especially in patients with impaired renal function (see 8 ADVERSE REACTIONS).
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Carboplatin Injection BP, 10 mg / mL is supplied as a sterile aqueous solution for intravenous use, available in clear glass vials of 5 mL, 15 mL, 45 mL and 60 mL, each wrapped in a clear plastic ONCO-TAIN® Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous Infusion Solution 10 mg/mL carboplatin Sterile water for injection.
Contains no preservatives. Carboplatin Injection BP – Product Monograph Page 7 of 25 sleeve. Each single-use vial is individually packaged in a carton. Carboplatin Injection BP is preservative- free and latex-free. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Carboplatin Injection BP should only be administered to patients under the supervision of a qualified physician who is experienced in the use of chemotherapeutic agents. Diagnostic and treatment facilities should be readily available for appropriate management of therapy and possible complications.
Blood counts as well as renal and hepatic function tests must be done regularly. Discontinue the drug if abnormal depression of bone marrow or abnormal renal or hepatic function is seen. Carcinogenesis and Mutagenesis Acute promyelocytic leukaemia (APL) and myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments.
Carboplatin is mutagenic in in vitro tests (see 16 NON-CLINICAL TOXICOLOGY). Cardiovascular There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (defined as acute allergic mediated coronary […]