mitoxantrone
Sources réglementaires consultées
Indications approuvées
- Cancer du sein métastatique, lymphome non hodgkinien, leucémie aiguë myéloïde et cancer de la prostate résistant à la castration, dans les protocoles oncologiques autorisés.
Contre-indications
Absolues
- Hypersensibilité à la mitoxantrone ou aux sulfites ; allaitement.
Mises en garde cliniques
- Surveiller la numération avant chaque cycle et pendant le nadir. Ne pas administrer hors protocole oncologique spécialisé ; la myélosuppression peut provoquer une infection ou une hémorragie mortelle. — CIMA/AEMPS, ficha técnica 66166
- Voie IV uniquement : jamais intrathécale, IM, SC ou intra-artérielle. Surveiller l’extravasation. Évaluer la FEVG au départ et périodiquement ; le risque d’insuffisance cardiaque augmente avec l’exposition cumulée, notamment autour de 140 mg/m². — CIMA/AEMPS, ficha técnica 66166
- Dans la leucémie, surveiller acide urique et syndrome de lyse tumorale. Peut provoquer LAM/SMD secondaires. — CIMA/AEMPS, ficha técnica 66166
Interactions médicamenteuses
- SévèreCardiotoxiques, myélosuppresseurs, anticoagulants et vaccins vivants
Mécanisme: Peut augmenter toxicité cardiaque/médullaire, modifier l’INR ou provoquer une infection vaccinale.
Recommandation: Surveiller FEVG, numération et INR. Ne pas administrer de vaccins vivants pendant le traitement ni pendant 3 mois après.
CIMA/AEMPS, ficha técnica 66166
Grossesse et allaitement
Peut provoquer atteinte fœtale et aménorrhée. Utiliser une contraception efficace pendant le traitement ; aucun délai après traitement n’est établi. L’allaitement est contre-indiqué. Envisager la préservation des gamètes.
Bibliographie récente (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