mitoxantrone
Regulatory sources consulted
Approved indications
- Metastatic breast cancer, non-Hodgkin lymphoma, acute myeloid leukemia, and castration-resistant prostate cancer, in authorized oncology regimens.
Contraindications
Absolute
- Hypersensitivity to mitoxantrone or sulfites; breastfeeding.
Clinical warnings
- Monitor blood counts before each cycle and through the nadir. Do not administer outside a specialist oncology protocol; myelosuppression may cause fatal infection or bleeding. — CIMA/AEMPS, ficha técnica 66166
- IV only: never intrathecal, IM, SC, or intra-arterial. Monitor extravasation. Assess LVEF at baseline and periodically; heart-failure risk increases with cumulative exposure, especially around 140 mg/m². — CIMA/AEMPS, ficha técnica 66166
- In leukemia, monitor uric acid and tumor lysis syndrome. It may cause secondary AML/MDS. — CIMA/AEMPS, ficha técnica 66166
Drug interactions
- HighCardiotoxic drugs, myelosuppressants, anticoagulants, and live vaccines
Mechanism: This may increase cardiac/marrow toxicity, alter INR, or cause vaccine infection.
Recommendation: Monitor LVEF, blood counts, and INR. Do not give live vaccines during treatment or for 3 months afterward.
CIMA/AEMPS, ficha técnica 66166
Pregnancy and lactation
It may cause fetal harm and amenorrhea. Use effective contraception during treatment; no post-treatment interval has been established. Breastfeeding is contraindicated. Consider gamete preservation.
Recent literature (PubMed)
Different therapeutic strategies are available for the treatment of people with relapsing-remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants and biological agents. Although each one of these therapies reduces relapse frequency and slows disability accumulation compared to no treatment, their relative benefit remains unclear. This is an update of a Cochrane review published in 2015. To compare the efficacy and safety, through network meta-analysis, of interferon beta-1b, interferon beta-1a, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, pegylated interferon beta-1a, daclizumab, laquinimod, azathioprine, immunoglobulins, cladribine, cyclophosphamide, diroximel fumarate, fludarabine, interferon beta 1-a and beta 1-b, leflunomide, methotrexate, minocycline, mycophenolate mofetil, ofatumumab, ozanimod, ponesimod, rituximab, siponimod and steroids for the treatment of people with RRMS. CENTRAL, MEDLINE, Embase, and two trials registers were searched on 21 September 2021 together with reference checking, citation searching and contact with study authors to identify additional studies. A top-up search was conducted on 8 August 2022. Randomised controlled trials (RCTs) that studied one or more of the available immunomodulators and immunosuppressants as monotherapy in comparison to placebo or to another active agent, in adults with RRMS. Two authors independently selected studies and extracted data. We considered both direct and indirect evidence and performed data synthesis by pairwise and network meta-analysis. Certainty of the evidence was assessed by the GRADE approach. We included 50 studies involving 36,541 participants (68.6% female and 31.4% male). Median treatment duration was 24 months, and 25 (50%) studies were placebo-controlled. Considering the risk of bias, the most frequent concern was related to the role of the sponsor in the authorship of the study report or in data ma