June 2022

New Products

• Anifrolumab (Saphnelo) is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biological activity of type I IFNs. Anifrolumab also induces the internalisation of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signalling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T‑cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in multiple autoimmune disorders. Saphnelo is indicated as add‑on treatment in adults with moderate to severe, active systemic lupus erythematosus (SLE), despite standard therapy. Saphnelo concentrate for infusion contains anifrolumab 300 mg/2 mL and is available in a pack size of 1 vial.
   
• Bimekizumab (Bimzelx) is a humanised IgG1/κ monoclonal antibody. It has two identical antigen binding regions that bind and neutralise IL‑17A, IL‑17F and IL‑17AF cytokines. Levels of IL‑17A and IL‑17F are elevated in several immune mediated inflammatory diseases and drive chronic inflammation and damage across multiple tissues. In human in vitro disease models, dual neutralisation of both IL‑17A and IL‑17F with bimekizumab suppresses the expression of inflammation related genes and proteins to a greater extent than inhibition of IL‑17A alone. Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Live vaccines are contraindicated in patients treated with Bimzelx. Bimzelx solution for injection contains bimekizumab 160 mg/mL and is available in a pack size of two 1 mL pre‑filled pens.

New Indications

• Lenvatinib (Lenvima), in combination with pembrolizumab, is now indicated for the first‑line treatment of advanced renal cell carcinoma in adults.
   
• Remdesivir (Veklury) now has provisional approval for the treatment of coronavirus disease 2019 (COVID‑19) in paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS‑CoV‑2 and who require supplemental oxygen; and adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID‑19.
   
• Risankizumab (Skyrizi) is now indicated for the treatment of active psoriatic arthritis in adults who have responded inadequately to or are intolerant to one or more disease‑modifying anti‑rheumatic drugs (DMARDs). Skyrizi may be used with or without conventional synthetic disease‑modifying anti‑rheumatic drugs (csDMARDs).
   
• Testosterone (AndroForte 2) is now indicated for the treatment of hypoactive sexual desire dysfunction in postmenopausal women.

New Contraindications

• Clarithromycin (Klacid) is now contraindicated in patients with hypomagnesaemia; and with concomitant lomitapide.
   
• Methotrexate (DBL Methotrexate Injection) is now contraindicated with live vaccines.
   
• Testosterone (AndroForte 2) is now contraindicated in patients with a history of thromboembolism and in women with normal reproductive function.

Safety Related Changes

• Ertugliflozin (Steglatro) is no longer contraindicated in patients with eGFR persistently < 45 mL/min (CKD stage 3B).
   
• Ertugliflozin/metformin hydrochloride (Segluromet) is no longer contraindicated in patients with eGFR persistently < 45 mL/min (CKD stage 3B).

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.