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New Products
- Atropine sulfate monohydrate (Eikance) is a non-selective muscarinic receptor antagonist. It acts in the eye to block the action of acetylcholine, relaxing the cholinergically innervated sphincter muscle of the iris. The cholinergic stimulation of the accommodative ciliary muscle of the lens is also blocked. Eikance is indicated as a treatment to slow the progression of myopia in children aged from 4 to 14 years. Atropine treatment may be initiated in children when myopia progresses ≥-1.0 D per year. Eikance is contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. If used in glaucoma susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to the initiation of therapy. Eikance eye drops contain atropine sulfate monohydrate 100 mcg/mL (0.01%) and are available in a pack size of 30 single dose containers.
- Burosumab (Crysvita) is a recombinant human monoclonal IgG1 antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), present in excess in X-linked hypophosphataemia. Neutralisation of FGF23 by burosumab increases renal tubular reabsorption of phosphate and the serum concentration of 1, 25 dihydroxy-Vitamin D. Crysvita is indicated for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or older. It is contraindicated in concurrent administration with oral phosphate and / or active vitamin D analogues, serum phosphate level within or above the normal range for age at initiation of treatment, and severe renal impairment or end stage renal disease. Crysvita solution for injection contains burosumab 10 mg/mL, 20 mg/mL or 30 mg/mL and is available in pack sizes of 1 vial.
- Lurbinectedin (Zepzelca) is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Zepzelca has provisional approval for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy. Zepzelca powder for solution for infusion contains lurbinectedin 4 mg and is available in a pack size of 1 vial.
- Zanubrutinib (Brukinsa) is a small-molecule inhibitor of BTK. Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signalling molecule of the B‑cell antigen receptor (BCR) and cytokine receptor pathways. In B‑cells, BTK signalling results in activation of pathways necessary for B‑cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B‑cell proliferation and reduced tumour growth. Brukinsa is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. It also has provisional approval for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Brukinsa capsules contain zanubrutinib 80 mg and are available in a pack size of 120.
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New Indications
- Cabozantinib (S)-malate (Cabometyx), in combination with nivolumab, is now indicated for the first-line treatment of advanced renal cell carcinoma.
- Dapagliflozin propanediol monohydrate (Forxiga) is now indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2,3 or 4 and urine ACR ≥ 30 mg/g).
- Daratumumab (Darzalex SC), in combination with bortezomib, cyclophosphamide and dexamethasone, is now indicated for the treatment of patients with light chain AL amyloidosis.
- Ivacaftor (Kalydeco) is now indicated for the treatment of cystic fibrosis (CF) in patients aged 4 months and older who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
- Nivolumab (Opdivo), in combination with cabozantinib, is now indicated for the first-line treatment of patients with advanced renal cell carcinoma.
- Pembrolizumab (Keytruda) is now indicated for first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation, in combination with platinum and fluoropyrimidine based chemotherapy. Keytruda also now has provisional approval as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation and for treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB‑H) [≥ 10 mutations/megabase (mut/Mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
- Upadacitinib (Rinvoq) is now indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.
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New Contraindications
- Dolutegravir (Tivicay) is now contraindicated in combination with dofetilide.
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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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