Keeping up to date

A review of the recent changes to prescription medicine listings and new product listings

Our monthly review of medicine listing changes, from MIMS Australia

New Products

  • Budesonide (Jorveza) is a non-halogenated glucocorticosteroid, which acts primarily as an anti-inflammatory by binding to the glucocorticoid receptor. In the treatment of eosinophilic oesophagitis (EoE), budesonide may inhibit antigen-stimulated secretion of many pro-inflammatory signal molecules, which may result in a significant reduction of the oesophageal eosinophilic inflammatory infiltrate. Jorveza is indicated for the treatment of EoE in adults. It is contraindicated in patients with uncontrolled infections or active tuberculosis. Jorveza orally disintegrating tablets contain budesonide 1 mg and are available in a pack size of 90.
  • COVID-19 (ChAdOx1-S) Vaccine (COVID-19 Vaccine AstraZeneca) is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S-glycoprotein of SARS-CoV-2. Following administration, the S‑glycoprotein of SARS-CoV-2 is expressed, locally stimulating neutralising antibody and cellular immune responses. COVID‑19 Vaccine AstraZeneca has provisional approval for the active immunisation of individuals ≥ 18 years to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. COVID-19 Vaccine AstraZeneca solution for injection contains ChAdOx1-S 5 x 1010 viral particles/0.5 mL dose and is available in multidose vials containing 10 doses/vial.
  • COVID-19 mRNA (BNT162b2) Vaccine (Comirnaty, Pfizer) contains nucleoside-modified messenger RNA (mRNA) formulated in lipid nanoparticles, which enable the 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. Comirnaty elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute towards protection against COVID‑19. Comirnaty has provisional approval for the active immunisation of individuals ≥ 16 years to prevent COVID-19 caused by SARS-CoV-2. Comirnaty concentrated suspension for injection contains BNT162b2 [mRNA] (embedded in lipid nanoparticles) 30 mcg/0.3 mL dose and is available in multidose vials containing 6 doses/vial.
  • Indacaterol (acetate)/mometasone furoate (Atectura Breezhaler) combines indacaterol, a long-acting β2-agonist (LABA), which acts locally on airways to produce bronchodilation, and mometasone furoate, an inhaled corticosteroid (ICS), which reduces pulmonary inflammation. Atectura Breezhaler is indicated as once-daily maintenance treatment of asthma in adults and adolescents ≥ 12 years where use of a combination of LABA and ICS is appropriate: patients not adequately controlled with ICS and “as needed” inhaled short-acting β2-agonists (SABAs); or patients not adequately controlled with LABA and low dose ICS and “as needed” inhaled SABA. Atectura Breezhaler powder for inhalation is available in 3 strengths: 125/62.5 mcg, 125/127.5 mcg, 125/260 mcg, in a pack size of 30 capsules and 1 Breezhaler inhaler.
  • Ozanimod (Zeposia) is a sphingosine 1-phosphate (S-1-P) receptor modulator, which binds with a high affinity to S-1-P receptor subtypes 1 and 5. Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system. Zeposia is indicated for the treatment of adults with relapsing forms of MS. Zeposia should not be initiated in patients who, in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischaemic attack, decompensated heart failure requiring hospitalisation or Class III/IV heart failure; in patients who have a history or presence of second-degree atrioventricular (AV) block type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker; and in patients with severe untreated sleep apnoea. Zeposia capsules are available as an initiation pack (containing 4 capsules of 230 mcg ozanimod and 3 capsules of 460 mcg ozanimod), and as a maintenance pack (containing 28 capsules of 920 mcg ozanimod).
  • Trientine dihydrochloride (Trientine Waymade) has a structure similar to polyamines and chelates copper by forming a stable complex with the four constituent nitrogens in a planar ring. Its pharmacodynamic action is dependent on its property of chelating copper and elimination of the trientine-copper complex in the urine. Trientine may also chelate copper in the intestinal tract and, in the process, inhibit copper absorption. Trientine Waymade is indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. Trientine Waymade capsules contain trientine dihydrochloride 250 mg and are available in a pack size of 100.

New Indications

  • Emtricitabine/tenofovir alafenamide (Descovy), in combination with other antiretroviral agents, is now indicated for the treatment of HIV-1 infection in adults and children weighing at least 25 kg; and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk in adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex. Do not use Descovy for PrEP in individuals with unknown or positive HIV-1 status.
  • Guselkumab (rch) (Tremfya) is now indicated for the treatment of adults with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to, prior disease modifying anti-rheumatic drug (DMARD) therapy.
  • Human C1 esterase inhibitor (Berinert SC) is now indicated for the prevention of recurrent hereditary angioedema attacks in patients ≥ 8 years with C1 esterase inhibitor deficiency.
  • Nintedanib (esilate) (Ofev) is now indicated for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype.

New Contraindications

  • Cyproterone acetate/ethinylestradiol (Diane-35) is now contraindicated in patients with meningioma or a history of meningioma.
  • Fluticasone propionate (Axotide, Flixotide Accuhaler) is now contraindicated in patients with severe milk-protein allergy.
  • Mercaptopurine monohydrate (Allmercap) is now contraindicated with concomitant yellow fever vaccine.
  • Selegiline hydrochloride (Eldepryl) should not be used in combination with serotonin noradrenaline reuptake inhibitors (e.g. venlafaxine), tricyclic antidepressants, sympathomimetics, monoamine oxidase inhibitors; nor in patients with active duodenal or gastric ulcer.

Safety Related Changes

  • Hydrocortisone (sodium succinate) (Solu-Cortef) is no longer indicated for seasonal or perennial allergic rhinitis.
  • Methylprednisolone acetate (Depo-Medrol, Depo-Nisolone) is no longer indicated for seasonal or perennial allergic rhinitis, nor acute exacerbations of multiple sclerosis.

This list is a summary of only some of the changes that have occurred over the last month.

Provided by MIMS Australia

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