New Products
- Capivasertib (Truqap) is an inhibitor of the kinase activity of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3). AKT is a pivotal node in the phosphatidylinositol 3-kinase (PI3K) signalling cascade regulating multiple cellular processes including cellular survival, proliferation, cell cycle, metabolism, gene transcription and cell migration. AKT activation in tumours is a result of upstream activation from other signalling pathways, mutations of AKT, loss of Phosphatase and Tensin Homolog (PTEN) function and mutations in the catalytic subunit of PI3K (PIK3CA). Capivasertib inhibits the phosphorylation of AKT substrates such as glycogen synthase kinase 3-β and proline-rich AKT substrate of 40 kilodaltons. Capivasertib reduces growth of a range of cell lines derived from solid tumours and haematological disease. Multiple breast cancer cell lines were sensitive to capivasertib monotherapy. Within cell lines showing greater sensitivity to capivasertib there was an enrichment of PIK3CA or AKT1 mutations, or loss of PTEN. Some cell lines lacking such mutations were also sensitive to capivasertib. Combined treatment with capivasertib and fulvestrant demonstrated a greater anti-tumour response in a range of human breast cancer PDX models representative of different breast cancer subsets. Truqap is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen. Truqap tablets contain capivasertib 160 mg or 200 mg and are available in packs of 64.
- Toripalimab (Zytorvi) is a humanised immunoglobulin G4 monoclonal antibody that binds to the programmed cell death protein-1 (PD-1) receptor and blocks its interaction with programmed cell death-ligand 1 (PD-L1) and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumour immune response. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumours and signalling through this pathway can contribute to inhibition of active T cell immune surveillance of tumours. In syngeneic mouse tumour models, blocking PD-1 activity resulted in decreased tumour growth. Zytorvi is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC); and as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Zytorvi concentrate for infusion contains toripalimab 240 mg per 6 mL and is available in packs of 1 vial.
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New Indications
- Daratumumab (rch) (Darzalex SC) is now indicated in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- Macitentan (Opsumit) is now indicated as monotherapy or in combination, in paediatric patients (2 years to less than 18 years of age) for the treatment of pulmonary arterial hypertension (idiopathic, heritable, associated with connective tissue disease, associated with congenital heart disease with repaired shunts or with co-incidental congenital heart disease) with WHO functional class I, II, III or IV symptoms. Currently, 2.5 mg dispersible tablets are not available, so only children ≥ 40 kg can be dosed with 10 mg tablets.
- Semaglutide (rys) (Ozempic) is now indicated as an adjunct to standard of care therapy to reduce the risk of sustained decline of kidney function and to reduce the risk of cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
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New Contraindications
- Colchicine (Colgout) is now contraindicated in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Fulvestrant (Fulvestrant Sandoz) is now contraindicated in severe hepatic impairment and lactation.
- Isosorbide dinitrate (Isordil) is now contraindicated in hypertrophic obstructive cardiomyopathy.
- Procarbazine (hydrochloride) (Natulan) is now contraindicated in breastfeeding.
- Rifampicin (Rifadin) is now contraindicated for concomitant use with cabotegravir, fostemsavir and lenacapavir.
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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.
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