July 2025

New Products

• Canakinumab (rmc) (Ilaris) is a human monoclonal anti-human interleukin (IL)-1beta antibody of the IgG1/kappa isotype. Excess production of IL-1beta in inflammatory diseases leads to local or systemic inflammation, increased production of the inflammatory markers C-reactive protein or serum amyloid A, and fever. Canakinumab binds with high affinity to human IL-1beta and neutralises its biological activity by blocking its interaction with IL-1 receptors, thereby preventing IL-1beta-induced gene activation and the production of inflammatory mediators such as IL-6 or cyclooxygenase-2. Canakinumab is therefore suited to treat diseases and pathologies characterised by local or systemic overproduction of IL-1beta. Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: cryopyrin-associated periodic syndromes including familial cold autoinflammatory syndrome/ familial cold urticaria, Muckle-Wells syndrome, neonatal-onset multisystem inflammatory disease/ chronic infantile neurological, cutaneous, articular syndrome; tumour necrosis factor receptor associated periodic syndrome; hyperimmunoglobulin D syndrome/ mevalonate kinase deficiency; and familial mediterranean fever in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years or older. Ilaris solution for injection contains canakinumab 150 mg per 1 mL and is available in packs of 1 vial.
   
• Crisantaspase (recombinant asparaginase Erwinia chrysanthemi) (Enrylaze) catalyses the conversion of the amino acid L-asparagine into L-aspartic acid and ammonia. The pharmacological effect of Enrylaze is based on the killing of leukaemic cells due to depletion of plasma asparagine. Leukaemic cells with low expression of asparagine synthetase have a reduced ability to synthesise asparagine and therefore are dependent on an exogenous source of asparagine for survival. Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Enrylaze is contraindicated in patients with severe pancreatitis and history of severe pancreatitis, thrombosis and haemorrhagic events during previous asparaginase therapy. Enrylaze solution for injection contains crisantaspase 10 mg per 0.5 mL and is available in packs of 3 vials.
   
• Donanemab (cho) (Kisunla) is an IgG1 monoclonal antibody directed against an insoluble, pyroglutamate N-terminal truncated form of amyloid beta (N3pE Aβ) present only in brain amyloid plaques. Donanemab binds to N3pE Aβ and aids plaque removal through microglial-mediated phagocytosis. Kisunla is indicated for the treatment of patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia (early symptomatic Alzheimer’s disease) that are apolipoprotein E ε4 heterozygotes or non-carriers. Kisunla is contraindicated in patients with baseline MRI findings of prior intracerebral haemorrhage greater than 1 cm, more than 2 microhaemorrhages, superficial siderosis or vasogenic oedema, which are suggestive of cerebral amyloid angiopathy; in patients with severe white matter disease; and in patients with any finding that could prevent a satisfactory MRI evaluation for safety monitoring. Kisunla concentrate for infusion contains donanemab 350 mg per 20 mL and is available in packs of 1 vial.
   
• Leniolisib (phosphate) (Joenja) selectively inhibits phosphoinositide 3-kinase delta (PI3Kδ) by blocking the active binding site of PI3Kδ. In cell-free isolated enzyme assays, leniolisib was selective for PI3Kδ over PI3K alpha (28-fold), PI3K-beta (43-fold), and PI3K-gamma (257-fold), as well as the broader kinome. In cell-based assays, leniolisib reduced phosphorylated protein kinase B (pAkt) pathway activity and inhibited proliferation and activation of B and T cell subsets. Gain-of-function variants in the gene encoding p110δ catalytic subunit (resulting in activated phosphoinositide 3-kinase delta syndrome (APDS) 1) or loss-of-function variants in the p85α regulatory subunit (resulting in APDS2) both lead to hyperactive PI3Kδ signalling leading to increased production of phosphatidylinositol 3,4,5 trisphosphate (PIP3) and downstream pAkt. Through inhibiting PI3Kδ thus decreasing production of PIP3, leniolisib reduces hyperactivity of the downstream Akt/mammalian target of rapamycin pathway, subsequently modifying dysregulation of B and T cell populations and disease progression. Joenja is indicated for the treatment of APDS in adults and adolescents 12 years of age and older. Joenja tablets contain leniolisib 70 mg and are available in packs of 60.

New Indications

• Belzutifan (Welireg) is now indicated for the treatment of adult patients with advanced renal cell carcinoma following a programmed cell death 1/ligand 1 and a vascular endothelial growth factor-targeted therapy.
   
• Elexacaftor + tezacaftor + ivacaftor and ivacaftor (Trikafta) is now indicated for the treatment of those who meet the diagnostic criteria of cystic fibrosis in patients aged 2 years and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive based on clinical or in vitro evidence.
   
• Incobotulinumtoxin A (Xeomin) is now indicated in adults for the treatment of unilateral spasticity of the lower limb affecting the ankle joint.
   
• Ipilimumab (rch) (Yervoy) and Nivolumab (rch) (Opdivo) are now indicated in combination for the treatment of adult patients with unresectable or metastatic colorectal cancer that is microsatellite instability high or mismatch repair deficient as determined by a validated test.
   
• Tirzepatide (Mounjaro) is now indicated for the treatment of moderate to severe obstructive sleep apnoea in adults with obesity.
   
• Tislelizumab (Tevimbra) is now indicated in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma.
   
• Venetoclax (Venclexta) is now indicated in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma, regardless of suitability for chemo-immunotherapy.

New Contraindications

• Mefloquine (hydrochloride) (Lariam) is now also contraindicated in patients with a history of blackwater fever; for prophylactic use in patients with a recent history of suicide attempts, suicidal ideations and self-endangering behaviour; and for concomitant use with halofantrine during mefloquine chemoprophylaxis or treatment of malaria or within 15 weeks after the last dose of mefloquine.

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.