July 2024

New Products

• Etrasimod (as arginine) (Velsipity) is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1, 4 and 5 (S1P1, 4, 5). Etrasimod has no activity on S1P2 or S1P3. Etrasimod partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs, reducing the number of lymphocytes in peripheral blood thereby lowering the number of activated lymphocytes in the tissue. The mechanism by which etrasimod exerts therapeutic effects in ulcerative colitis (UC) is unknown but may involve the reduction of lymphocyte migration into the intestines. Velsipity is indicated for the treatment of adults with moderately to severely active UC who have had inadequate response, loss of response or intolerance to conventional, biologic or Janus kinase inhibitor therapies. Velsipity is contraindicated in patients who in the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalisation, or New York Heart Association class III/IV heart failure; in patients with a history or presence of Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker; during pregnancy and in women of childbearing potential not using effective contraception; in breastfeeding women; and in active malignancies. Velsipity tablets contain etrasimod 2 mg and are available in packs of 28.
   
• Spesolimab (rch) (Spevigo) is a humanised antagonistic monoclonal immunoglobulin G1 antibody blocking human interleukin-36 receptor (IL36R) signalling. Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. IL36R signalling is differentiated from TNF-α, integrin and IL-23 inhibitory pathways by directly and simultaneously blocking both inflammatory and pro-fibrotic pathways. Genetic human studies have established a strong link between IL36R signalling and skin inflammation. Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis. Spevigo concentrated solution for infusion contains spesolimab 450 mg/7.5 mL and is available in packs of 2 vials.

New Presentation

• Semaglutide (Wegovy FlexTouch) is now available as a product specifically indicated for weight management. It is indicated as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m² (obesity), or ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity; and for weight management in adolescents ages 12 years and above with initial obesity [(BMI ≥ 95^th percentile) as defined on sex and age-specific BMI growth charts (CDC.gov)] and body weight above 60 kg. Wegovy FlexTouch is available in packs of single pre-filled disposable pens containing 4 doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg semaglutide per dose.

New Indication

• Tozinameran and famtozinameran (Comirnaty Original/Omicron BA.4-5) is now indicated (with provisional approval) for active immunisation to prevent COVID‑19 in individuals 6 months of age and older in accordance with official recommendations.

New Contraindications

• Bupropion hydrochloride (Zyban SR) is now contraindicated in children.
   
• Rifampicin (Rifadin) is now contraindicated for concomitant administration with lurasidone.

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.