What’s New

March 2021

New Product Summaries
Content Updates to Monographs
As part of our rigorous editorial updating process, the AusDI editorial team monitors safety information issued by the Australian Therapeutic Goods Administration (TGA), the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). FDA-approved indications and dosing information in adults and children are also reviewed by our editorial team and included in selected monographs.

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2021 influenza season. The composition of the 2021 vaccine differs from last year’s southern hemisphere vaccine with the inclusion of two new strains for the A (H1N1)-like and A (H3N2)-like viruses. In addition to egg-based influenza virus vaccines, there will also be a cell-based influenza virus vaccine available this year which is propagated in Madin Darby Canine Kidney (MDCK) cells instead of hens’ eggs.

New Consumer Medicine Information (CMI)
New Product Information (PI)

Product information with an update to safety includes Afluria Quad; Allmercap; Apo-Exemestane; Apo-Fluconazole One; Apo-Fluvoxamine; Apo-Mirtazapine; Apo-Zolpidem; Apo-Zopiclone; Avapro HCT; Bicillin L-A; Budamax; Bupredermal; Citalopram Sandoz; Clomid; Copaxone; Diflucan One; Dizole; Esmeron; Faverin; Flixotide CFC-Free Inhaler, Junior CFC-Free Inhaler, Accuhaler and Junior Accuhaler; Humulin; Hydrea; Ibudeine; Iressa; Jakavi; Karvezide; Mavenclad; Mekinist; Minims Phenylephrine; Norflex; Norspan; Onkotrone; Optisulin; OxyContin; OxyNorm Capsules and Liquid; OxyNorm Injection; Phospho-Soda; Primoteston Depot; Rhinocort Aqueous; Salofalk Enemas; Salofalk Foam; Salofalk Granules; Salofalk Suppositories; Salofalk Tablets; Scheriproct; Signifor; Somidem; Sulprix; Tafinlar; Tecfidera; Vaxigrip Tetra; Verzenio; Ziextenzo; Zinforo; and Zolpidem Sandoz.

Product information with an update to indications includes Apo-Tramadol; Berinert SC; Depo-Medrol; Depo-Nisolone; Ofev; and Tremfya.

 

Past Content Updates
February 2021

The Hydroxychloroquine (Systemic) monograph has been updated based on the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) findings that confirmed a link between the use of chloroquine and hydroxychloroquine and the risk of psychiatric disorders and suicidal behaviour. Psychiatric disorders, sometimes serious, have occurred in patients with or without previous mental health problems. For hydroxychloroquine, the side effects may occur in the first month following the start of treatment. It is recommended that patients contact a doctor immediately if mental health problems (e.g., anxiety, feeling confused or depressed [including thoughts of self-harm or suicide], hallucinations, or irrational thoughts) occur.

January 2021

The Bupropion (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding the risk of serotonin syndrome. Cases of serotonin syndrome have been associated with the use of bupropion, especially in overdose or when it is used concurrently with other medications with serotonergic activity (e.g., selective serotonin reuptake inhibitors [SSRIs] and serotonin and noradrenaline reuptake inhibitors [SNRIs]). If concurrent use of bupropion with other serotonergic medications is clinically necessary, the recommended dose of bupropion should not be exceeded, and patients should monitor for symptoms of serotonin syndrome. If serotonin syndrome is suspected, a reduction in dose or discontinuation of bupropion should be considered, depending on the severity of symptoms.

December 2020

The Insulin and Insulin Analogues (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding the risk of cutaneous amyloidosis at the injection site with all types of insulins. Injection of insulin can lead to cutaneous amyloidosis at the injection site, especially if the site is used regularly. Cutaneous amyloidosis interferes with insulin absorption and may affect glycaemic control if insulin is administered at the site. Patients should be advised to rotate injection sites within the same body region to reduce or prevent the risk of cutaneous amyloidosis and other skin reactions. Patients who are currently injecting insulin into an area with cutaneous amyloidosis should contact their doctor before changing injection sites because a sudden change may result in hypoglycaemia.

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