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New Products
- Calcifediol (monohydrate) (Vistella) is a precursor of the active form of vitamin D (1, 25‑dihydroxycholecalciferol or calcitriol) and its pharmacodynamic effects are expected to be compatible with known biological roles of vitamin D. Vitamin D has two main forms: D2 (ergocalciferol) and D3 (cholecalciferol). Vitamin D3 is synthesised in the skin by exposure to sunlight (ultraviolet radiation) and is obtained from the diet. Vitamin D3 must undergo a two-step metabolic process to be active; the first step occurs in the microsomal fraction of the liver where Vitamin D is hydroxylated at position 25 (25‑hydroxycholecalciferol or calcifediol); the second step takes place in the kidney where 1, 25‑dihydroxycholecalciferol or calcitriol is formed due to the activity of enzyme 25‑hydroxycholecalciferol 1-hydroxylase; conversion to 1, 25‑dihydroxycholecalciferol is regulated by its own concentration, by parathyroid hormone and by serum calcium and phosphate concentration. 1, 25-dihydroxycholecalciferol is transported from the kidney to target tissues (intestine, bone and possibly kidney and parathyroid gland) by binding to specific plasma proteins. Vistella is indicated for the treatment of vitamin D deficiency in adults, and maintenance treatment as required. Vistella is contraindicated in patients with hypercalcaemia (serum calcium > 2.620 mmol/L) or hypercalciuria, calcium lithiasis, and hypervitaminosis D. Vistella capsules contain calcifediol 255 mcg and are available in packs of 5.
- Eflornithine (hydrochloride) (Ifinwil) is an irreversible inhibitor of the enzyme ornithine decarboxylase, the first and rate-limiting enzyme in the biosynthesis of polyamines and a transcriptional target of MYCN. Polyamines are involved in differentiation and proliferation of mammalian cells and are important for neoplastic transformation. Inhibition of polyamine synthesis by eflornithine restored the balance of the LIN28/Let-7 metabolic pathway, which is involved in regulation of cancer stem cells and glycolytic metabolism, by decreasing expression of the oncogenic drivers MYCN and LIN28B in MYCN-amplified neuroblastoma. In vitro, eflornithine induced senescence and suppressed neurosphere formation in MYCN-amplified and MYCN non-amplified neuroblastoma cells, indicating a cytostatic effect. Ifinwil is indicated for the treatment of adults and paediatric patients with high-risk neuroblastoma who have responded to prior multiagent, multimodality therapy. Ifinwil tablets contain eflornithine 192 mg and are available in packs of 100.
- Foslevodopa and foscarbidopa (Vyalev) is a combination of prodrugs of levodopa and carbidopa (ratio 20:1) in a solution for 24 hour/day continuous subcutaneous infusion. Foslevodopa and foscarbidopa are converted in vivo to levodopa and carbidopa. Levodopa relieves symptoms of Parkinson’s disease following decarboxylation to dopamine in the brain. Carbidopa, which does not cross the blood-brain barrier, inhibits the extracerebral decarboxylation of levodopa to dopamine, which means that a larger amount of levodopa becomes available for transportation to the brain and transformation into dopamine. Vyalev is indicated for the treatment of advanced idiopathic Parkinson’s disease with severe motor fluctuations despite optimised alternative pharmacological treatment. Vyalev is contraindicated in patients with hypersensitivity to levodopa and/or carbidopa; narrow-angle glaucoma; severe heart failure; acute stroke; severe cardiac arrhythmia; for concomitant use with non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors; in conditions in which medication with adrenergic activity are contraindicated, e.g. pheochromocytoma, hyperthyroidism and Cushing’s syndrome; and in patients with suspicious undiagnosed skin lesions or a history of melanoma. Vyalev solution for subcutaneous infusion contains foslevodopa 2.4 g and foscarbidopa 120 mg per 10 mL and is available in packs of 7 vials.
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New Presentation
- Tacrolimus (monohydrate) (Azematop) is now available as an ointment. Tacrolimus binds to a specific cytoplasmic immunophilin (FKBP12) and inhibits calcium-dependent signal transduction pathways in T cells, thereby preventing the transcription and synthesis of IL-2, IL 3, IL-4, IL-5 and other cytokines such as GM-CSF, TNF-α and IFN-γ. In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells. Tacrolimus has also been shown to inhibit the release of inflammatory mediators from skin mast cells, basophils and eosinophils. In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells. Tacrolimus ointment does not affect collagen synthesis in humans. Azematop is indicated in adults and adolescents (16 years of age and above) as treatment for moderate to severe flares of atopic dermatitis in patients who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids, and for prevention of flares and prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations who have responded to tacrolimus treatment during flares. Azematop is contraindicated in patients with hypersensitivity to macrolides. Azematop ointment contains tacrolimus 0.1% and is available in a 30 g tube.
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New Indications
- Asciminib (hydrochloride) (Scemblix) is now also indicated for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase.
- Botulinum toxin type A (Botox) is now indicated for the temporary improvement in the appearance of platysma continuous bands in healthy adults.
Ipilimumab (rch) (Yervoy) and Nivolumab (rch) (Opdivo) in combination, are now indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
- Trastuzumab deruxtecan (Enhertu) is now indicated (with provisional approval) for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior systemic treatment and who have no satisfactory alternative treatment options.
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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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