Mitoxantrone Baxter Warnings

Cardiotoxicity and Use in Patients with Cardiac Disease: Use with caution in patients with severe cardiovascular disease, as well as patients with prior treatment with anthracyclines and/or prior mediastinal radiotherapy (see Adverse Reactions).
In patients with cardiovascular risk factors or when mitoxantrone is used in combination with other cardiotoxic drugs, treatment should be carefully monitored and dose adjustment may be necessary (see Interactions).
Close monitoring of cardiac functions is advisable. More pronounced cardiotoxicity is observed after a total cumulative dose of 160 mg mitoxantrone/m² body surface area (BSA) (in at risk patients: 140 mg/m² BSA).
Secondary Acute Myelocytic Leukemia: Secondary acute myelocytic leukemia (therapy related AML or t-AML) has been reported in cancer patients treated with mitoxantrone. The risk is increased when topoisomerase II inhibitors are given in combination with other DNA-damaging antineoplastic agents and/or radiotherapy, if patients have been previously treated with high doses of cytotoxic drugs, or if doses of topoisomerase II inhibitors have been increased.
Genotoxicity and Effects on Fertility: Mitoxantrone may be genotoxic.
Women should not become pregnant during treatment with mitoxantrone and for up to 6 months after treatment (see Use in Pregnancy & Lactation).
Men who are treated with mitoxantrone should not father children during treatment and for up to 6 months after treatment with mitoxantrone.
Women and men should use effective methods of contraception during these periods of time.
Patients on mitoxantrone therapy should seek advice on the risk of irreversible infertility.