Pegunigalsidase alfa (Elfabrio)is a pegylated recombinant form of human alpha‑galactosidase‑A. The amino acid sequence of the recombinant form is similar to the naturally occurring human enzyme. Pegunigalsidase alfa supplements or replaces alpha‑galactosidase‑A, the enzyme that catalyses the hydrolysis of the terminal α-galactosyl moieties of oligosaccharides and polysaccharides in the lysosome, where it is thought to exert enzymatic activity and reduce accumulated globotriaosylceramide (Gb3). Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease. Elfabrio concentrate for infusion contains pegunigalsidase alfa 20 mg per 10 mL and is available in packs of 1 vial.
Tafasitamab (Minjuvi)is an Fc-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes, and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Upon binding to CD19, tafasitamab mediates B-cell lysis through engagement of immune effector cells like natural killer cells, γδ T cells and phagocytes and direct induction of cell death (apoptosis). The Fc modification results in enhanced antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Minjuvi in combination with lenalidomide followed by Minjuvi monotherapy is indicated (with provisional approval) for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). It is also indicated in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a). It is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. See lenalidomide and rituximab product information for the contraindications to combination therapy. Minjuvi powder for infusion contains tafasitamab 200 mg and is available in packs of 1 vial. Each vial contains 40 mg/mL of tafasitamab after reconstitution.
New Indications
Belzutifan (Welireg) is now indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component following a programmed cell death 1/ligand 1 (PD‑1/L1) and a vascular endothelial growth factor (VEGF)-targeted therapy.
Lutetium (177Lu) vipivotide tetraxetan (Pluvicto)is now indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.
Odevixibat (sesquihydrate) (Bylvay)is now also indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older.
New Contraindications
Cyproheptadine hydrochloride (sesquihydrate) (Periactin) is now also contraindicated in children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and CNS (central nervous system) events.
This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.
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