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New Products
- Elacestrant (dihydrochloride) (Orserdu) is an orally active estrogen receptor (ER)‑α antagonist and degrader. Elacestrant inhibits the estradiol-dependent and independent growth of ERα‑positive breast cancer cells, including models harbouring estrogen receptor 1 (ESR1) gene mutations in the ligand binding domain. Elacestrant displayed antitumour activity in patient derived xenograft models previously exposed to multiple endocrine therapies, harbouring wild type ESR1 or ESR1 gene mutations in the ligand binding domain. Orserdu, as monotherapy, is indicated for the treatment of postmenopausal women, and men, with ER-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor. Orserdu tablets contain elacestrant 86 mg or 345 mg and are available in packs of 28.
- Fruquintinib (Fruzaqla) is a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF) receptors -1, -2, and -3, with antitumor effects resulting from suppression of tumour angiogenesis. VEGF-mediated endothelial cell proliferation, and tubular formation were inhibited by fruquintinib in vitro. In vitro and in vivo studies showed fruquintinib inhibited VEGF‑induced VEGFR‑2 phosphorylation. Fruquintinib was shown to inhibit tumour growth in tumour xenograft mouse models. Fruzaqla is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and an anti-epidermal growth factor receptor agent if appropriate. Fruzaqla capsules contain fruquintinib 1 mg or 5 mg and are available in packs of 21.
- Lebrikizumab (Ebglyss) is an immunoglobulin G4 monoclonal antibody that binds with high affinity to interleukin (IL)‑13 and inhibits IL‑13 signalling through the IL‑4 receptor alpha (IL‑4Rα)/IL‑13 receptor alpha 1 (IL‑13Rα1) pathway, thereby blocking the downstream effects of IL-13 with high selectivity. Blockade of IL‑13 signalling is expected to be of benefit in diseases in which IL-13 is a key contributor to the disease pathogenesis. Ebglyss is indicated for the treatment of adult and adolescent patients (12 years of age and older) with moderate to severe atopic dermatitis who are candidates for systemic therapy. Ebglyss solution for injection contains lebrikizumab 250 mg per 2 mL and is available in packs of 1 prefilled pen.
- Tirbanibulin (Klisyri) disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells and is associated with disruption of Src tyrosine kinase signalling. Klisyri is indicated for the topical field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis of the face or scalp in adults. Klisyri is contraindicated during pregnancy or in women of childbearing potential not using contraception. Pregnancy should be excluded before treating women of childbearing potential with Klisyri. Klisyri ointment contains tirbanibulin 1% and is available in 250 mg sachets in packs of 5.
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New Presentations
- Calcipotriol (monohydrate) and betamethasone (dipropionate) (Actobet 50/500) is now available as a gel containing calcipotriol 0.005% and betamethasone 0.05% in a 60 g tube.
- Glycopyrronium bromide (Axhidrox) is now available as a cream. Axhidrox is indicated for the topical treatment of confirmed severe primary axillary hyperhidrosis in adults. It is contraindicated in medical conditions that can be exacerbated by the anticholinergic effect of Axhidrox (e.g. glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren syndrome autonomic neuropathy, and patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension or hyperthyroidism since an increase in heart rate may occur). Axhidrox cream contains glycopyrronium 1% and is available in a 50 g pump bottle.
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New Indications
- Acalabrutinib (maleate monohydrate) (Calquence) is now indicated as monotherapy for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy.
It is also indicated as monotherapy or in combination with obinutuzumab for the treatment of patients with previously untreated CLL/SLL.
It is also indicated in combination with venetoclax with or without obinutuzumab for the treatment of patients with previously untreated CLL/SLL.
- Atropine sulfate (Eikance) is now indicated as a treatment to slow the progression of myopia when initiated in children aged from 4 to 14 years. Atropine treatment may be initiated in children when myopia progresses ≥ 0.5 D or axial length increase of 0.2 mm per year.
- Finerenone (Kerendia) is now indicated in adults for the treatment of symptomatic heart failure with left ventricular ejection fraction of ≥ 40%.
- Glecaprevir and pibrentasvir (Maviret) is now also indicated for the treatment of adult and paediatric patients 3 years and older with acute hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV GT1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors.
- Onasemnogene abeparvovec (Zolgensma) is now indicated for the treatment of paediatric patients with 5q spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene with 3 or fewer copies of the SMN2 gene.
- Pembrolizumab (rch) (Keytruda) is now indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell cancer whose tumours express programmed cell death-ligand 1 with a Combined Positive Score ≥ 1, as determined by a validated test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent.
- Semaglutide (Wegovy FlexTouch) is now indicated (with provisional approval) for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
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New Contraindications
- Ephedrine hydrochloride (Ephedrine Hydrochloride Juno) is now contraindicated in patients with coronary thrombosis.
- Estradiol (hemihydrate) and dydrogesterone (Femoston 1/10 Tablets, Femoston 2/10 Tablets, Femoston-Conti) is now contraindicated in patients with meningioma or history of meningioma.
- Fluoxetine (Zactin) is now contraindicated in combination with metoprolol used in cardiac failure.
- Lopinavir/Ritonavir (Kaletra) and Ritonavir (Norvir) are now contraindicated for concomitant use with suzetrigine.
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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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