CARBOPLATIN ACCORD

What it is

Carboplatin Eugia is a sterile solution of carboplatin in Water for Injections presented in vials containing 5, 15, or 45 mL of 10 milligrams/mL carboplatin. It is a solution for injection. Carboplatin is an antineoplastic agent which interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug.

Approved indications Carboplatin Eugia is indicated in the treatment of:

— Advanced stage ovarian cancer of epithelial origin — Small cell lung carcinoma — Carcinoma of the head and neck — Carcinoma of the testis — Paediatric cerebral tumours — Soft tissue sarcoma — Neuroblastoma

Dosing overview

The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 milligrams/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. It is recommended that according to clinical circumstances the initial dosage may require reduction by 20 to 25% in patients with risk factors such as increasing age, previous myelosuppressive therapy and poor performance status. In patients with impaired renal function, a suggested dosage schedule based on creatinine clearance is: for creatinine clearance greater than 40 mL/min, 400 milligrams/m²; for 20–39 mL/min, 250 milligrams/m²; and for 0–19 mL/min, 150 milligrams/m².

Key safety warnings

Bone marrow suppression (leucopenia, neutropenia and thrombocytopenia) is dose dependent and is the dose-limiting toxicity of carboplatin. Although at the recommended drug doses, the haematologic toxicity is usually moderate and reversible, severe myelosuppression (especially thrombocytopenia) may occur in patients with renal impairment and in patients who are concurrently receiving or have received other myelosuppressive drugs or radiation therapy. Hypersensitivity and anaphylactic reactions to carboplatin have been reported. These allergic reactions have been similar in nature and severity to those reported with other platinum containing compounds. Symptoms include rash, urticaria, erythema, pruritus, bronchospasm and hypotension. Neurotoxicity, such as paraesthesias and decreased deep tendon reflexes, and ototoxicity are more likely to be seen in patients who have received cisplatin previously. Routine neurologic examination is advisable during carboplatin therapy, particularly in patients previously treated with cisplatin and in patients over 65 years of age.

Contraindications

Carboplatin is contraindicated in patients with severe myelosuppression; pre-existing severe renal impairment (although dose adjustment may allow use in the presence of mild renal impairment); history of severe allergic reactions to carboplatin, other platinum-containing compounds or mannitol; severe bleeding; or pregnancy or lactation.

Regulatory history

Carboplatin Eugia received first approval on 21 February 2025.