September 2025

New Products

• Albutrepenonacog alfa (Idelvion) is a recombinant fusion protein linking recombinant coagulation factor IX (FIX) with recombinant albumin that effectively replaces the missing coagulation FIX needed for haemostasis and provides for longer dose regimens. The prolongation of the half-life of FIX and the enhanced systemic exposure are achieved by fusion with recombinant albumin. Albumin is a natural, inert carrier protein in plasma with a long half-life of approximately 20 days that is not involved in immune defence or immune response. Genetic fusion of recombinant coagulation FIX with albumin extends the half-life of FIX. Idelvion remains intact in the circulation until FIX is activated, whereupon albumin is cleaved, releasing activated FIX when it is needed for coagulation. FIX is activated by factor VII/tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway. Activated FIX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. FIX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required. Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of FIX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy, the plasma levels of FIX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. Idelvion is indicated in all patients with haemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes, and for control and prevention of bleeding episodes including in the perioperative setting. Idelvion is contraindicated in patients who have a known hypersensitivity to hamster protein. Idelvion powder for injection contains albutrepenonacog alfa 250 IU, 500 IU, 1000 IU, 2000 IU or 3500 IU and is available in packs of 1 vial of powder plus 1 vial of diluent.
   
• Garadacimab (Andembry) is a specific inhibitor of activated factor XII (FXIIa). Garadacimab is a fully human IgG4/lambda recombinant monoclonal antibody which binds to the catalytic domain of activated factor XII (FXIIa and βFXIIa) and potently inhibits its catalytic activity. FXII is the first factor activated in the contact activation pathway and initiates the inflammatory bradykinin-producing kallikrein-kinin system. The inhibition of FXIIa prevents the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in hereditary angioedema (HAE) attacks, thus blocking the cascade of events leading to an HAE attack. Andembry is indicated for routine prevention of recurrent HAE attacks in patients aged 12 years and older with C1-esterase inhibitor deficiency or dysfunction HAE. Andembry solution for injection contains garadacimab 200 mg per 1.2 mL and is available in packs of 1 prefilled pen.
   
• Palovarotene (Sohonos) is a retinoic acid receptor gamma (RARγ) selective agonist. Fibrodysplasia ossificans progressiva (FOP) (formerly referred as myositis ossificans progressiva) is a genetic condition caused by a gain-of-function mutation in the gene encoding activin A receptor type 1 (also known as activin receptor-like kinase 2), a bone morphogenetic protein (BMP) expressed by chondrocytes and osteoblasts. The mutant protein aberrantly activates the Smad1/5/8 signalling pathway, diverting mesenchymal progenitor cells from a soft tissue fate (allowing for normal tissue repair) to an osseous fate (promoting chondrogenesis and heterotopic bone formation). RARγ is expressed in chondrogenic cells and chondrocytes, where it operates as an unliganded transcriptional repressor. Activation of RARγ downregulates BMP signalling by reducing phosphorylation of downstream effectors Smad1/5/8. In this way, palovarotene prevents chondrogenesis and heterotopic ossification in FOP, and enables normal muscle tissue repair or regeneration to take place, reducing damage to muscle tissue. Sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with FOP. Sohonos is contraindicated in patients with a history of allergy or hypersensitivity to other retinoids; in females of childbearing potential unless all of the conditions of pregnancy prevention are met, or they are not at risk for pregnancy; in women who are pregnant; and in women who are breastfeeding (women should also not breastfeed for at least 1 month following cessation of Sohonos). Sohonos capsules contain palovarotene 1 mg, 1.5 mg, 2.5 mg or 5 mg and are available in packs of 28.
   
• Talquetamab (Talvey) is a humanised immunoglobulin G4 proline, alanine, alanine bispecific antibody directed against G protein-coupled receptor family C group 5 member D (GPRC5D) on multiple myeloma cells and the cluster of differentiation 3 (CD3) receptor on T cells. Talquetamab promotes enhanced T cell-mediated cytotoxicity through recruitment of CD3-expressing T cells to GPRC5D-expressing cells. This leads to the activation of T cells and induces subsequent lysis of GPRC5D-expressing cells mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. Based on the expression of GPRC5D on plasma cells with minimal to no expression detected on B cells and B cell precursors, talquetamab targets multiple myeloma cells particularly, reducing potential off-target effects toward other cell lineages. In addition to non-malignant plasma cells, GPRC5D is expressed on healthy tissues such as epithelial cells in keratinised tissues of the skin and tongue. Talvey as monotherapy has provisional approval for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talvey solution for injection contains talquetamab 3 mg per 1.5 mL or 40 mg per 1 mL and is available in packs of 1 vial.

New Indications

• Cabozantinib ((S)-malate) (Cabometyx) is now indicated for the treatment of adult patients with locally advanced/unresectable or metastatic, well-differentiated extra-pancreatic or pancreatic neuroendocrine tumours who have progressed on at least one prior systemic therapy other than a somatostatin analogue.
   
• Guselkumab (Tremfya) is now indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biological treatment, or a Janus kinase inhibitor; and moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological treatment.
   
• Pembrolizumab (rch) (Keytruda) is now indicated in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, and as monotherapy for the treatment of adult and adolescent (12 years and older) patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

New Contraindications

• Ocrelizumab (Ocrevus) is now contraindicated in patients with current active infection; in a severely immunocompromised state; and with known active malignancies.

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.