July 2023

New Products

• Finerenone (Kerendia) is a nonsteroidal antagonist of the mineralocorticoid receptor (MR) that potently attenuates inflammation and fibrosis mediated by MR overactivation. The MR is expressed in the kidneys, heart and blood vessels where finerenone also counteracts sodium retention and hypertrophic processes. Finerenone has high selectivity for the MR due to its nonsteroidal structure and bulky binding mode. Its binding to the MR leads to a specific receptor ligand complex that blocks recruitment of transcriptional coactivators implicated in the expression of pro-inflammatory and pro-fibrotic mediators. Kerendia is indicated to delay progressive decline of kidney function in adults with chronic kidney disease associated with Type 2 diabetes (with albuminuria), in addition to standard of care. Kerendia is contraindicated in patients taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone) and patients with adrenal insufficiency. Kerendia tablets contain finerenone 10 or 20 mg and are available in packs of 28.
   
• Inclisiran (Leqvio) is a cholesterol-lowering double-stranded small interfering ribonucleic acid, conjugated on the sense strand with triantennary N-acetylgalactosamine to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilises the RNA interference mechanism and directs catalytic breakdown of mRNA for proprotein convertase subtilisin/kexin type 9. This increases low-density lipoprotein cholesterol (LDL-C) receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation. Leqvio is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event: in combination with a statin or statin with other lipid‐lowering therapies in patients unable to reach LDL‐C goals with the maximum tolerated dose of a statin; or alone or in combination with other lipid‐lowering therapies in patients who are statin‐intolerant. Leqvio solution for injection contains inclisiran 284 mg per 1.5 mL in a pre-filled syringe and is available in a pack of 1.

New Presentation

• Acalabrutinib (as maleate monohydrate) (Calquence) is now available as a tablet. Calquence is indicated for the treatment of patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma. It also has provisional approval for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Calquence tablets contain acalabrutinib 100 mg and are available in packs of 56.
   
• Midazolam (as maleate) (Zyamis) is now available as an oromucosal solution. Zyamis, as buccal midazolam, is indicated for the treatment of Generalised Convulsive Status Epilepticus, in those over 6 months old. Zyamis is contraindicated in patients with myasthenia gravis, with hypersensitivity to benzodiazepines, in shock or coma, in acute alcoholic intoxication with depression of vital signs, and with acute narrow angle glaucoma. It may be used in patients with open angle glaucoma only if they are receiving appropriate therapy. Zyamis is available in a pre-filled oral syringe containing midazolam 5 mg/0.5 mL or 10 mg/1 mL in packs of 1.
   
• Misoprostol (Angusta) is now available as a 25 mcg tablet. Angusta is indicated for induction of labour. Angusta is contraindicated when labour has started; when there is suspicion or evidence of foetal compromise prior to induction (e.g., failed non-stress or stress test, meconium staining or diagnosis or history of non-reassuring foetal status); when oxytocic drugs and/or other labour induction agents are being given; when there is suspicion or evidence of uterine scar resulting from previous uterine or cervical surgery, e.g. caesarean delivery; when there is uterine abnormality (e.g. bicornuate uterus) preventing vaginal delivery; when there is placenta praevia or unexplained vaginal bleeding after 24 weeks gestation with this pregnancy; when there is foetal malpresentation, contraindicating vaginal delivery; and in patients with kidney failure (GFR < 15 ml/min/1.73 m²). Angusta tablets contain misoprostol 25 mcg and are available in packs of 8.

New Indications

• Baricitinib (Olumiant) is now indicated for the treatment of severe alopecia areata in adult patients in whom other treatments have failed or are not appropriate and no spontaneous improvement is observed.
   
• Cemiplimab (Libtayo) is now indicated in combination with platinum‐based chemotherapy for the first‐line treatment of patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and are locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
   
• Lumacaftor and ivacaftor (Orkambi) is now indicated for patients 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
   
• Ravulizumab (Ultomiris) is now indicated as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.

New Contraindications

• Desogestrel and ethinylestradiol (Marvelon 28) is now contraindicated for concomitant use with glecaprevir and pibrentasvir.
   
• Ethinylestradiol and etonogestrel (NuvaRing) is now contraindicated for concomitant use with glecaprevir and pibrentasvir.
   
• Grass pollen allergen extracts (Oralair) is now contraindicated in patients with severe uncontrolled or unstable asthma (FEV1 < 70% of predicted value) or severe exacerbation of asthma within the previous 3 months; active or poorly controlled autoimmune disease, immune defects, immunodeficiencies or immunosuppression or malignant neoplastic diseases with current disease relevance; severe oral inflammation (such as oral lichen planus, oral ulcerations or oral mycosis). Initiation of allergen immunotherapy treatment during pregnancy is contraindicated.
   
• Iodised oil (Lipiodol Ultra Fluid) is now contraindicated for use in hysterosalpingography in patients with known or suspected reproductive tract neoplasia.

Safety Related Changes

• Risdiplam (Evrysdi) may now be used in infants less than 2 months of age. No data are available in infants below 16 days of age (based on corrected age for preterm infants).

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.