April 2026

New Products

• Fedratinib (as dihydrochloride monohydrate) (Inrebic) is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase (JAK) 2 and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor with higher inhibitory activity for JAK2 over family members JAK1, JAK3, and tyrosine kinase 2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythaemia vera. In cell models expressing mutationally active JAK2^V617F or FLT3^ITD, fedratinib reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. In mouse models of JAK2^V617F-driven myeloproliferative disease, fedratinib blocked phosphorylation of STAT3/5, and improved survival, white blood cell counts, haematocrit, splenomegaly, and fibrosis. Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are JAK inhibitor naïve or have been treated with ruxolitinib. Inrebic capsules contain fedratinib 100 mg and are available in packs of 120.
   
• Givosiran (sodium) (Givlaari) is a double-stranded small interfering ribonucleic acid that causes degradation of aminolevulinic acid synthase 1 (ALAS1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. ALAS1 is the first and rate-limiting enzyme of heme synthesis in the liver. Its expression is induced in acute hepatic porphyria (AHP) due to a loss-of-function gene mutation in a downstream heme synthesis enzyme. Givosiran acts to reduce elevated levels of liver ALAS1 mRNA. This leads to reduced circulating levels of neurotoxic heme intermediates aminolevulinic acid and porphobilinogen, the key causal factors of attacks and other disease manifestations of AHP. Givlaari is indicated for the treatment of AHP in adults and adolescents aged 12 years and older. Givlaari solution for injection contains givosiran 189 mg per 1 mL and is available in packs of 1 vial.
   
• Influenza virus vaccine, trivalent (live attenuated) (FluMist) is a trivalent vaccine that contains antigens for three influenza virus strains, an A/(H1N1) strain, an A/(H3N2) strain, and a B strain (Victoria lineage). The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e. they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e. they are restricted in replication at 37°C (Type B strain) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e. they do not produce classic influenza-like illness in the ferret model of human influenza infection). The cumulative effect of the antigenic properties and the ca, ts, and att phenotypes is that the attenuated vaccine viruses replicate in the nasopharynx and induce protective immunity. Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a role in prevention of infection and in recovery from infection. FluMist is indicated for the prevention of influenza in children and adolescents from 24 months to less than 18 years of age. FluMist is contraindicated in children and adolescents who have had a severe allergic reaction (e.g. anaphylaxis) to the active substances, any of the excipients (e.g. gelatin), gentamicin (a trace residue), eggs or egg proteins (e.g. ovalbumin); with clinical immunodeficiency due to conditions or immunosuppressive therapy such as acute and chronic leukaemias, lymphoma, symptomatic HIV infection, cellular immune deficiencies, and high-dose corticosteroids; and those receiving salicylate therapy because of the association of Reye’s syndrome with salicylates and wild-type influenza infection. FluMist nasal spray contains live attenuated trivalent influenza virus 30 million fluorescent focus units per 0.2 mL and is available in packs of 1 or 10.
  
  Mogamulizumab (Poteligeo) is a defucosylated, humanised immunoglobulin G1 kappa monoclonal antibody that selectively binds to CC chemokine receptor 4 (CCR4), a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin. CCR4 is expressed on the surface of some T cell malignancies, such as mycosis fungoides (MF) and Sézary syndrome (SS) as well as type 2 T helper T cells and regulatory T cells. Binding of mogamulizumab to CCR4 induces antibody-dependent cellular cytotoxicity, resulting in the depletion of target cells. Poteligeo is indicated for the treatment of adult patients (≥ 18 years of age) with MF or SS who have received at least one prior systemic therapy. Poteligeo concentrate for infusion contains mogamulizumab 20 mg per 5 mL and is available in packs of 1 vial.
   
• Repotrectinib (Augtyro) is a tyrosine kinase inhibitor (TKI) that inhibits the proto-oncogene tyrosine-protein kinase ROS1. Fusion proteins containing a ROS1 kinase domain can drive oncogenesis via constitutive activation of downstream signalling pathways and unconstrained cell proliferation. Point mutations within the ROS1 kinase domain, including those affecting the solvent front (e.g. G2032R) or gatekeeper residue (e.g. L2026M), can confer resistance to treatment with TKIs through steric hindrance of drug binding. Repotrectinib is a compact, macrocyclic TKI that binds entirely within the ATP-binding pocket of the kinase domain and lacks structural extensions into the solvent front region. Augtyro, as monotherapy, is indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer. Augtyro capsules contain repotrectinib 40 mg or 160 mg and are available in packs of 120 (40 mg) or 60 (160 mg).

New Indications

• Durvalumab (rch) (Imfinzi) in combination with FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) chemotherapy, as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is now indicated for the treatment of adults with resectable gastric or gastroesophageal junction adenocarcinoma.
   
• Selumetinib (sulfate) (Koselugo) is now also indicated for the treatment of adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

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.