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Updates

What's New in AusDI – September, 2021

Browse the latest AusDI drug updates and medicines information – created and curated by trusted Australian editorial pharmacists, monthly.

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 Varicella-Zoster Vaccine Live (Systemic) monograph has been updated to strengthen the precautions regarding the risk of disseminated varicella-zoster virus infection associated with live-attenuated zoster vaccine ( Zostavax brand) following a recent TGA safety alert and black box warning in the Zostavax Product Information. Disseminated varicella-zoster virus infection with vaccine (Oka) strain has occurred in rare cases following administration of live-attenuated zoster vaccine. Fatal cases have been reported, including in patients receiving low-dose immunosuppressive medication. The risk increases with the level of immunosuppression. Live-attenuated zoster vaccine is contraindicated in patients with current or recent severe immunocompromising conditions due to a primary or acquired medical condition or medical treatment.

New Consumer Medicine Information (CMI)

New Product Information (PI)

Product information with an update to safety includes Adenuric, Adrenaline Jr Mylan, Adrenaline Mylan, Agrylin, Amira, Anastrol, Anastrozole Sandoz, Ancotil, Apo-Candesartan HCTZ, Apo-Citalopram, Apo-Duloxetine, Apo-Hydroxychloroquine, Apo-Levetiracetam Tablets, Apo-Levodopa/Carbidopa, Apo-Nifedipine XR, Apo-Pantoprazole, Apo-Perindopril Arginine, Aripiprazole Sandoz, Aurorix, Azithromycin Mylan, Bexsero, Candesartan/HCT Sandoz, Contrave, Covid-19 Vaccine AstraZeneca, Daptomycin Juno, DBL Pentamidine Isethionate, DBL Tobramycin, DBL Vincristine, Diflucan, Dotarem, Enalapril/HCT Sandoz, Engerix-B, EpiPen, EpiPen Jr, Eprex, Erlyand, Esipram, Estelle-35 ED, Flagyl, Flagyl S, Gadovist, Galafold, Gliolan, Gold Cross Codeine Linctus, Imigran Tablets Injection and Nasal Spray, Imuran Tablets and Injection, Inderal, Lorstat, Maxor, Metronidazole Intravenous Infusion (Pfizer), Metronide, Mycobutin, Mycophenolate Sandoz, NutropinAq, Omeprazole Sandoz Tablets, Ontruzant, Optiray, Pantoprazole Sandoz Tablets, Privigen, Rikodeine, Salpraz, Salpraz Heartburn Relief, Saxenda, Slenyto, Somavert, Sotalol Sandoz, Spiriva, Stromectol, Tamosin, Tarka, Telfast Decongestant, Tenofovir Disoproxil Emtricitabine Mylan, Urocarb, Velphoro, Zyban SR, and Zyvox.

Product information with an update to indications includes Comirnaty, Keytruda, Kiovig, Taltz, and Tramedo SR.

Past Content Updates

August

The Bupropion (Systemic) monograph has been updated to strengthen the precautions regarding the risk of serotonin syndrome following a recent TGA Medicines Safety Update on bupropion and serotonin syndrome. Serotonin syndrome has been reported when bupropion is used concurrently with other medications known to be associated with serotonin syndrome, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). If concurrent use of bupropion with other serotonergic medications is clinically necessary, careful monitoring of the patient is recommended, especially during treatment initiation and dose increases.

July

The Diphtheria, Tetanus and Acellular Pertussis Vaccine (Systemic) monograph has been updated based on changes to the Adacel PI and Boostrix PI. The adult formulations of diphtheria, tetanus and acellular pertussis vaccine (dTpa) are now indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy, which is consistent with recommendations in The Australian Immunisation Handbook. The Australian Pregnancy Category of Adacel and Boostrix have been updated from category B2 and B1, respectively, to category A.

June

The Influenza Virus Vaccine (Systemic) monograph has been updated with information regarding co-administration with coronavirus disease 2019 (COVID-19) vaccine based on recommendations in The Australian Immunisation Handbook and a recent TGA safety alert. Concurrent administration of influenza virus vaccine and COVID-19 vaccine on the same day is not recommended. A minimum interval of 14 days between administration of the vaccines is preferred. However, if an influenza virus vaccine has been inadvertently administered concurrently or within 14 days of a COVID-19 vaccine, revaccination with either vaccine is not considered necessary.

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