November 2025

New Products

• Elafibranor (Iqirvo) and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-α, PPAR-γ, and PPAR-δ in vitro. In vitro, both elafibranor and GFT1007 demonstrated 3 to 8 fold higher activity for PPAR-α compared to PPAR-γ and PPAR-δ. Although the in vitro pharmacology studies detected PPAR-γ activation by elafibranor and its metabolite GFT1007, toxicology studies in rats and monkeys (species with plasma metabolite profiles comparable to human) showed none of the adverse effects that are associated with PPAR-γ activation. PPAR-α/δ are thought to be key regulators of bile acid (BA) homeostasis, inflammation and fibrosis. Activation of PPAR-α decreases BA synthesis, increases BA detoxification, and modulates BA output, resulting in decreased bile toxicity, and less injury to cholangiocytes and hepatocytes. Activation of PPAR-δ also regulates transporters that absorb and secrete bile components, contributing this way to decreased bile toxicity and improving cholestasis. Activation of PPAR-α and PPAR-δ also has anti-inflammatory effects by acting on different pathways of inflammation, nuclear factor kappa B and B‑cell lymphoma 6 pathways, respectively. Iqirvo is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Iqirvo tablets contain elafibranor 80 mg and are available in packs of 30.
   
• Elranatamab (cho) (Elrexfio) is a bispecific antibody that binds B‑cell maturation antigen (BCMA) expressed on plasma cells, plasmablasts, and multiple myeloma cells and cluster of differentiation 3 (CD3) expressed on T‑cells. Simultaneous binding of BCMA and CD3 by elranatamab leads to T‑cell activation and proliferation and the release of pro-inflammatory cytokines, resulting in the lysis of BCMA-expressing tumour and normal cells. Elrexfio has provisional approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody and have demonstrated disease progression on the last therapy. Elrexfio solution for injection contains elranatamab 44 mg per 1.1 mL or 76 mg per 1.9 mL and is available in packs of 1 vial.
   
• Lumasiran (sodium) (Oxlumo) is a double-stranded small interfering ribonucleic acid (siRNA) that reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 gene messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. This results in reduction of urinary and plasma oxalate levels, the underlying cause of disease manifestations in patients with primary hyperoxaluria type 1 (PH1). As the GO enzyme is upstream of the deficient alanine: glyoxylate aminotransferase (AGT) enzyme that causes PH1, the mechanism of action of lumasiran is independent of the underlying AGXT gene mutation. Oxlumo is indicated for the treatment of PH1 in all age groups. Oxlumo solution for injection contains lumasiran 94.5 mg/0.5 mL and is available in packs of 1 vial.
  
  
• Tremelimumab (Imjudo) is a selective, fully human immunoglobulin G2 antibody that blocks cytotoxic T‑lymphocyte antigen 4 (CTLA-4) interaction with CD80 and CD86, thus enhancing T‑cell activation and proliferation, resulting in increased T‑cell diversity and enhanced antitumour immune activity. CTLA‑4 is primarily expressed on the surface of T‑lymphocytes. Interaction of CTLA‑4 with its ligands, CD80 and CD86, limits effector T‑cell activation, through a number of potential mechanisms, but primarily by limiting co-stimulatory signalling through CD28. In syngeneic mouse tumour models, blocking CTLA‑4 activity resulted in decreased tumour growth and increased proliferation of T-cells in tumours. The combination of durvalumab, a programmed cell death ligand‑1 (PD‑L1) inhibitor, and tremelimumab functions to enhance anti-tumour T‑cell activation and functions at multiple stages of the immune response, maximising anti-tumour immunity. Imjudo in combination with durvalumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma who have not received prior treatment with a PD‑1/PD‑L1 inhibitor. Imjudo concentrated injection contains tremelimumab 300 mg per 15 mL and is available in packs of 1 vial.
   
• Vorasidenib (Voranigo) is a small molecule dual inhibitor that targets the mutant isocitrate dehydrogenase (IDH) 1 and IDH2 enzymes. In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations lead to overproduction of the oncogenic metabolite 2‑hydroxyglutarate (2‑HG), resulting in impaired cellular differentiation and increased cellular proliferation contributing to oncogenesis. Direct inhibition of the gain-of-function activity of the IDH1‑ and IDH2‑mutated proteins by vorasidenib inhibits the abnormal production of 2‑HG through the differentiation of the malignant cells and reduction of cellular proliferation. Voranigo is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 mutation or IDH2 mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention. Voranigo tablets contain vorasidenib 10 mg or 40 mg and are available in packs of 30.

New Presentations

• SARS-CoV-2 spike protein (mRNA) LP.8.1 vaccine (Comirnaty LP.8.1) is now available. Comirnaty LP.8.1 is indicated for active immunisation to prevent COVID-19 in individuals 6 months of age and older in accordance with official recommendations. Comirnaty LP.8.1 suspension for injection contains SARS-CoV-2 spike protein (mRNA) LP.8.1 10 mcg per 0.3 mL (single dose vial with light blue cap or 6-dose vial with dark blue cap) or 30 mcg per 0.3 mL (single dose glass prefilled syringe or 6-dose vial with dark grey cap) and is available in packs of 10. Comirnaty LP.8.1 concentrate for suspension for injection contains SARS-CoV-2 spike protein (mRNA) LP.8.1 3 mcg per 0.3 mL (3-dose vial with yellow cap) and is available in packs of 10.

New Indications

• Acalabrutinib (maleate monohydrate) (Calquence Tablets) is now also indicated in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous haematopoietic stem cell transplantation.
   
• Inactivated quadrivalent influenza vaccine (surface antigen) (Fluad Quad) is now also indicated for active immunisation against influenza in persons 50 years of age and older.

New Contraindications

• Duloxetine (hydrochloride) (Duloxetine Sandoz) is now contraindicated in severe renal impairment (creatinine clearance < 30 mL/min). The initiation of treatment with duloxetine is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.
   
• Methenamine hippurate (Hiprex) is now contraindicated in hypersensitivity or allergy to formaldehyde; severe renal failure (eGFR < 10 mL/min/1.73m²), kidney infection, severe dehydration, or gout; severe hepatic impairment; and metabolic acidosis.

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.