What’s New

July 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 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.

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

Product information with an update to safety includes Adcetris, Aimovig, Akamin, Alecensa, Apo-Enalapril, Apo-Escitalopram, Apo-Lansoprazole, Apo-Nicorandil, Apo-Sotalol, Aridol, Arimidex, Asacol, Atacand Plus, Avaxim, Bactrim DS, Bisolvon Chesty, Brenda-35 ED, Byetta, Comirnaty, Covid-19 Vaccine AstraZeneca, DBL Fluorouracil, Duloxetine Sandoz, Duodopa, DuoResp Spiromax, Esbriet Capsules, Esbriet Tablets, Fareston, Flagyl S Suspension, Fluconazole-Baxter, Galvumet, Glyxambi, Granocyte, Grazax, Harvoni, Hydrea, Hyrimoz, Idacio, Jardiamet, Jardiance, Keytruda, Lisinopril generichealth, Lorviqua, Mersynofen, Methoblastin PFS, Minims Cyclopentolate, NovoRapid and NovoMix, Ocrevus, Ofev, Ogivri, Oncaspar Powder for Injection, Ovidrel Pen, Pharmorubicin, Plaquenil, Polivy, Solavert, Somac Injection, Somac Tablets and Granules, Sotacor, Sublimaze, Symdeko, Tysabri, Velphoro, Zopral and Zopral ODT, Zykadia, and Zyvox.

Product information with an update to indications includes Braftovi, Ferinject, Opdivo, Rimycin, Rinvoq, Trelegy Ellipta, Xofluza, and Zavicefta.

Past Content Updates

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.

May 2021

The Gabapentin (Systemic) monograph has been updated to strengthen the precautions regarding the risks of abuse and dependence, which can lead to overdose and death, especially when used concurrently with opioids or other CNS depression-producing medications. It is recommended that the risk of abuse or dependence be assessed prior to initiating gabapentin treatment and patients be regularly monitored during treatment, especially in those with current or history of abuse or dependence of opioids and/or benzodiazepines.

April 2021

The Pregabalin (Systemic) monograph has been updated based on a recent MHRA Drug Safety Update regarding reports of severe respiratory depression associated with pregabalin, including cases without the concurrent use of opioid medications. Cases of respiratory depression have been temporally associated with the initiation of pregabalin or dose increases. Other cases have been reported in patients with risk factors or underlying medical history. It is recommended that adjustments in dose or dosing regimen be considered in patients at increased risk of respiratory depression, including patients with compromised respiratory function, neurological or respiratory disease, renal function impairment, patients taking concurrent CNS depression-producing medications, and patients over 65 years of age.

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