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New Products
- Avacopan (Tavneos) is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a. The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability. Tavneos, in combination with a rituximab or cyclophosphamide-based regimen, is indicated for the treatment of adults with anti‑neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis). Tavneos capsules contain avacopan 10 mg and are available in packs of 180 capsules.
- Clascoterone (Winlevi) is an androgen receptor inhibitor. It is structurally similar to non-androgen corticosteroids and may exert its efficacy by means other than the androgen receptor. The main metabolite of clascoterone, cortexolone, is an intermediate in the synthesis of glucocorticoids and exhibits weak glucocorticoid properties. The exact mechanism of action of Winlevi for the topical treatment of acne vulgaris is unknown. It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Winlevi cream contains clascoterone 1% and is available in a 60 g tube.
- Teclistamab (Tecvayli) is a bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen, which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. In vitro, teclistamab activated T cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells. Tecvayli as monotherapy has provisional approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Tecvayli solution for injection contains teclistamab 30 mg/3 mL or 153 mg/1.7 mL and is available in packs of 1 vial.
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New Indications
- Bimekizumab (Bimzelx) is now also indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response to or who have been intolerant to previous disease modifying antirheumatic drug therapy; with active nonradiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein and/or magnetic resonance imaging who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs; and with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
- Somatropin (rmc) (Saizen) is now also indicated for growth disturbance (current height standard deviation score (H SDS) < -2.5 and parental adjusted H SDS < -1) in short children born small for gestational age with a birth weight and/or length below -2 standard deviations, who failed to show catch-up growth (height velocity SDS < 0 during the last year) by 4 years of age or later.
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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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