February 2025

New Products

• RelabotulinumtoxinA (Relfydess) is a Clostridium botulinum type A neurotoxin product that blocks the release of acetylcholine from the presynaptic cholinergic neuronal synapse to produce muscle relaxation. The heavy chain of botulinum toxin type A mediates attachment to the presynaptic surface of cholinergic neurons and internalisation of the bound toxin occurs by endocytosis. The catalytic light chain is then translocated across the vesicular membrane into the cytosol. The light chain is an enzyme that cleaves the synaptosome-associated protein of 25 kDa in the nerve terminals to block binding of acetylcholine vesicles with the cell membrane and prevent the release of acetylcholine from vesicles into the synapse. When injected intramuscularly, the toxin induces partial paralysis of the affected muscle which temporarily reduces muscle activity, leading to the transient reduction of glabellar lines or lateral canthal lines. Muscle function will return gradually with regrowth of the nerve fibres with new nerve terminals (normally within 12 weeks) to innervate the muscles, reversing the denervation by toxin administration. Relfydess is indicated in adult patients for the temporary improvement in the appearance of moderate to severe glabellar lines at maximum frown and lateral canthal lines seen at maximum smile. Relfydess is contraindicated in patients with known hypersensitivity to any botulinum toxin and in the presence of infection at the proposed injection sites. Relfydess solution for injection contains relabotulinumtoxinA 150 units per 1.5 mL and is available in packs of 10 vials.
   
• Tislelizumab (Tevimbra) is a humanized IgG4 variant monoclonal antibody against programmed cell death protein 1 (PD-1), binding to the extracellular domain of human PD-1 with high specificity and affinity. 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 signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumours. Tislelizumab competitively blocks the binding of both PD‑L1 and PD‑L2, inhibiting PD‑1-mediated negative signaling and enhancing the functional activity in T-cells in in vitro cell-based assays. Tevimbra is indicated in combination with platinum-based chemotherapy for the first-line treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) with a PD-L1 expression ≥ 1% as determined by a validated test; as monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced, or metastatic OSCC after prior chemotherapy; in combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with PD-L1 expression ≥ 50% but no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour aberrations; in combination with carboplatin and either paclitaxel or nab‑paclitaxel for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC; and as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy. Tevimbra concentrate for infusion contains tislelizumab 100 mg per 10 mL and is available in packs of 1 vial.

New Indications

• Alectinib (Alecensa) is now indicated as an adjuvant treatment in adult patients following tumour resection of anaplastic lymphoma kinase-positive non-small cell lung cancer (tumours ≥ 4 cm or node positive).
   
• Daratumumab (rch) (Darzalex) is now indicated in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
   
• Daratumumab (rch) (Darzalex SC) is now indicated in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy and in combination with pomalidomide and dexamethasone after at least one prior therapy including lenalidomide and a proteasome inhibitor.
   
• Osimertinib (mesilate) (Tagrisso) is now indicated as monotherapy for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer whose tumours have activating epidermal growth factor receptor mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
   
• Semaglutide (Wegovy FlexTouch) is now also indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non‑fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a BMI ≥ 27 kg/m², and without established type 1 or type 2 diabetes.

New Contraindications

• Atazanavir and cobicistat (Evotaz) is now contraindicated for concomitant use with drugs that are strong inducers of CYP3A4; and apalutamide, encorafenib, ivosidenib, and ritonavir.
   
• Levothyroxine sodium (Eltroxin) is now contraindicated for concomitant use with antithyroid agents for the treatment of hyperthyroidism during pregnancy.
   
• Nirmatrelvir and ritonavir (Paxlovid) is now contraindicated for concomitant use with enzalutamide.

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.