TOPOTECAN

What it is

Topotecan Accord is a concentrated injection containing topotecan hydrochloride equivalent to 1 mg topotecan per mL. It is a clear, yellow concentrated injection. Topotecan Accord must be diluted before use.

Approved indications —

Small cell lung carcinoma after failure of first line chemotherapy. — Metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. — Histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix (in combination with cisplatin), which is not amenable to curative treatment with surgery and/or radiation therapy.

Dosing overview

Prior to administration of the first course, patients must have a baseline neutrophil count of ≥ 1.5 x 10⁹/L, a platelet count of ≥ 100 x 10⁹/L and a haemoglobin level of ≥ 9 g/dL (after transfusion if necessary).

Key safety warnings

Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly. Severe neutropenia has been seen in some clinical study patients, with fever and infection occurring concurrently with severe neutropenia. Patients who experience prolonged severe neutropenia, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, should either be given a reduced topotecan dose or prophylactic G-CSF in subsequent courses. Topotecan-induced neutropenia can cause neutropenic colitis, and fatalities due to neutropenic colitis have been reported in clinical trials with topotecan. Moderate and severe thrombocytopenia have been seen in some clinical study patients, with infrequent reports of significant sequelae including fatalities due to tumour bleeds. Moderate to severe anaemia and severe myelosuppression have been observed, with myelosuppression leading to sepsis and fatalities due to sepsis reported in patients treated with topotecan. Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal. Patients should be monitored for pulmonary symptoms indicative of ILD (such as cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.

Contraindications

Topotecan Accord is contraindicated in patients with a history of severe hypersensitivity reactions to topotecan or any of its excipients. It is contraindicated in women who are pregnant or breastfeeding. It is contraindicated in persons who already have severe bone marrow depression prior to starting the first course, as evidenced by baseline neutrophil count of < 1.5 x 10⁹/L and/or a platelet count of less than 100 x 10⁹/L.

Regulatory history

Topotecan Accord was first listed on the ARTG on 4 December 2019.