What’s New

September 2020

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.

A new abbreviated monograph for remdesivir has been included this month following the provisional approval of remdesivir for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older and weighing at least 40 kg) with pneumonia requiring supplemental oxygen. The use of remdesivir is restricted to healthcare facilities where patients can be closely monitored.

Remdesivir – Abbreviated (Systemic)

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

Product information with safety updates includes Abilify, Abstral, Adacel Polio, Alecensa, Apo-Bisoprolol, Apo-Indapamide SR, Apo-Mirtazapine, Apo-Olmesartan, Apo-Piroxicam, Aubagio, Bicard, Brufen Plus, Celecoxib Sandoz, Ciprofloxacin Sandoz Tablets, DBL Diazoxide, DBL Fentanyl, DBL Gemcitabine Solution for Injection, DBL Oxaliplatin, Efudix, Epilim, Epilim IV, Eraxis, Eviplera, Eylea, Ferinject, Imbruvica, Irinotecan Alphapharm, Kaletra, Linezolid Apo, Lonsurf, Maxydol, Melizide, Mersyndol, Methoblastin PFS, Mobilis and Mobilis D, Norvir, Omniscan, Oratane, Ordine, Paclitaxel Ebewe, Pregnyl Vial, Prezista, Prilace, Prograf and Advagraf XL, Replagal, Sevredol, Sodium Valproate Sandoz, Somac Heartburn Relief Tablets, Somac Injection, Somac Tablets and Granules, Somavert, Stribild, Symtuza, Tamate, Tasigna, Temizole, Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan, Topotecan Accord, Truvada, Typhim Vi, Valprease, Valproate Winthrop, Vfend, Xeljanz, and Zelitrex.

Product information with an update to indications includes DBL Morphine Sulfate, Dilaudid and Dilaudid-HP Injection, Dilaudid Tablets and Oral Liquid, Dysport, Fenofibrate Sandoz, Opdivo, Ordine, OxyContin, OxyNorm Capsules and Liquid, OxyNorm Injection, Toujeo, Trulicity, and Yervoy.


Past Content Updates
August 2020

The Zolpidem (Systemic) monograph has been updated based on an FDA Drug Safety Communication and recent updates to Australian Product Information documents regarding complex sleep-related behaviours. Complex sleep-related behaviours, including sleep walking, sleep driving, and engaging in other activities while not fully awake, have been reported with the use of zolpidem. It may result in serious injury or death. Complex sleep-related behaviours may occur following a single dose of zolpidem and at the recommended dose, with or without concurrent use of alcohol and other CNS depressants. The risk appears to increase with concurrent use of alcohol and other CNS depressants, or with the use of higher than recommended doses. It is recommended that zolpidem be discontinued immediately if complex sleep-related behaviours occur. Use of zolpidem is contraindicated in patients who have previously experienced complex sleep-related behaviours associated with zolpidem.

July 2020

The Ingenol mebutate (Topical) monograph has been updated based on an EMA review of ingenol mebutate gel. Following assessment of data from several studies, the EMA has concluded that ingenol mebutate gel may increase the risk of skin cancer and that the risks outweigh the benefits of treatment. Marketing authorisation for ingenol mebutate gel in the European Union has already been withdrawn.

June 2020

The Hydroxychloroquine (Systemic) monograph has been updated based on recent TGA and FDA safety communications regarding the use of hydroxychloroquine for COVID-19. At the time of publishing, the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 have not been established. The use of hydroxychloroquine for the treatment of COVID-19, other than in a clinical trial setting or in a controlled environment to treat severely ill patients in hospital, is not recommended because of the limited evidence for efficacy and the risk of significant side/adverse effects. FDA is investigating reports of serious heart rhythm problems (including QT interval prolongation, ventricular fibrillation, ventricular tachycardia, and death) in patients with COVID-19 treated with hydroxychloroquine or chloroquine, either alone or in combination with azithromycin and other medications that prolong the QT interval.

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