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New Products
- Faricimab (Vabysmo) is a humanised bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of two distinct pathways by neutralisation of both Ang-2 and vascular endothelial growth factor A (VEGF-A). Ang-2 causes vascular instability by promoting endothelial destabilisation, pericyte loss, and pathological angiogenesis, thus potentiating vascular leakage and inflammation. It also sensitises blood vessels to the activity of VEGF-A resulting in further vascular destabilisation. Ang-2 and VEGF-A synergistically increase vascular permeability and stimulate neovascularisation. By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability. Vabysmo is indicated for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema. Vabysmo is contraindicated in patients with ocular or periocular infections and active intraocular inflammation. Vabysmo solution for intravitreal injection contains faricimab 6 mg/0.05 mL and is available in packs of 1 vial.
- Maribavir (Livtencity) is a benzimidazole riboside antiviral, the activity of which is mediated by competitive inhibition of the protein kinase activity of hCMV enzyme UL97, which results in inhibition of the phosphorylation of proteins; an effect achieved at low concentrations of maribavir. Livtencity is indicated for the treatment of adults with post-transplant cytomegalovirus infection and disease resistant, refractory or intolerant to one or more prior therapies. Livtencity is contraindicated with coadministration of ganciclovir or valganciclovir. Livtencity tablets contain maribavir 200 mg and are available in packs of 28 or 56.
- Osilodrostat (phosphate) (Isturisa) is a cortisol synthesis inhibitor. It inhibits 11β-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. CYP11B1 inhibition is associated with the accumulation of precursors such as 11‑deoxycortisol and acceleration of adrenal biosynthesis including androgens. In Cushing’s disease, the fall in plasma cortisol concentration also stimulates ACTH secretion, via the feedback mechanism which accelerates steroid biosynthesis. Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults. Isturisa tablets contain osilodrostat 1 mg, 5 mg or 10 mg and are available in packs of 60.
- Pegcetacoplan (Empaveli) is a PEGylated peptide that binds to complement protein C3 and its activation fragment C3b with high affinity, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In paroxysmal nocturnal haemoglobinuria (PNH), extravascular haemolysis (EVH) is facilitated by C3b opsonization while intravascular haemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). Pegcetacoplan exerts broad regulation of the complement cascade by acting proximal to both C3b and MAC formation, thereby controlling the mechanisms that lead to EVH and IVH. These functions of pegcetacoplan underlie the observed sustained reduction in complement-mediated haemolytic activity in patients with PNH. Empaveli is indicated in the treatment of adult patients with PNH who have an inadequate response to, or are intolerant of, a C5 inhibitor. Empaveli is contraindicated in patients with unresolved infection caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae. Empaveli solution for injection contains pegcetacoplan 1.08 g/20 mL and is available in packs of 1 vial.
- Tozinameran and Riltozinameran (Comirnaty Original/Omicron BA.1) is a nucleoside-modified messenger RNA vaccine. It is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 spike (S) antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against coronavirus disease 2019 (COVID-19). Comirnaty Original/Omicron BA.1 has provisional approval as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Comirnaty Original/Omicron BA.1 ready to use suspension for injection contains tozinameran 15 mcg and riltozinameran 15 mcg per 0.3 mL dose and is available in packs of 10 or 195 six dose vials with a grey cap.
- Vericiguat (Verquvo) is a stimulator of soluble guanylate cyclase (sGC). Heart failure is associated with impaired synthesis of nitric oxide (NO) and decreased activity of its receptor, sGC. Soluble guanylate cyclase catalyses synthesis of intracellular cyclic guanosine monophosphate (cGMP), an important signalling molecule that regulates critical physiological processes such as cardiac contractility, vascular tone, and cardiac remodelling. Deficiency in sGC-derived cGMP contributes to myocardial and vascular dysfunction. Vericiguat restores the relative deficiency in this signalling pathway by directly stimulating sGC, independently of and synergistically with NO, to augment the levels of intracellular cGMP, which may improve both myocardial and vascular function. The complementary cardiovascular benefits of vericiguat in heart failure patients are therefore attributed to the active restoration of the deficient NO-sGC-cGMP pathway driving heart failure progression. Verquvo is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy. Verquvo is contraindicated with concomitant use of other sGC stimulators, such as riociguat. Verquvo tablets contain vericiguat 2.5 mg, 5 mg or 10 mg and are available in packs of 28.
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New Presentation
- Lorazepam (Lorazepam SXP) is now available as a solution for injection. It is indicated as pre‑operative medication, premedication for prolonged investigations; for treatment of acute anxiety states, acute agitation; and control of status epilepticus in adults, adolescents and children. It is contraindicated in pulmonary insufficiency, sleep apnoea syndrome, myasthenia gravis and severe hepatic insufficiency. Lorazepam SXP solution for injection contains lorazepam 4 mg/mL and is available in packs of 5 one mL ampoules.
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New Indications
- Brolucizumab (Beovu) is now indicated for the treatment of diabetic macular oedema.
- Pembrolizumab (Keytruda) is now indicated, as monotherapy, for the adjuvant treatment of patients with renal cell carcinoma with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
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New Contraindications
- Cisplatin (DBL Cisplatin Injection) is now contraindicated in patients with generalised infections.
- Mefenamic acid (Ponstan) is now contraindicated in patients in the third trimester of pregnancy or who are breastfeeding.
- Prochlorperazine maleate (Stemetil) is now contraindicated in children weighing less than 10 kg, due to a possible association between use of phenothiazine containing products and Sudden Infant Death Syndrome (SIDS).
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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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