What’s New

April 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 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.

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

Product information with an update to safety includes Ajovy, Allosig, Amoxil, Anastrozole Sandoz, Anoro Ellipta, Apidra, Apo-Amisulpride, Apo-Amoxycillin Capsules, Apo-Amoxycillin Suspension, Apo-Atorvastatin, Apo-Azathioprine, Apohealth Pantoprazole Heartburn Relief, Apo-Sertraline, Aubagio, Axit, Azathioprine Sandoz, Besponsa, Bretaris Genuair, Bridion, Caelyx Injection, Cefalexin Sandoz Capsules and Powder for Suspension, Celapram, CellCept, Cyprone 100, Cyprone 50, DBL Acetylcysteine, DBL Amikacin, DBL Docetaxel, DBL Potassium Acetate Concentrated Injection, Diane-35 ED, Duodopa, Escitalopram Sandoz, Fampyra, Fentanyl (AstraZeneca), Fluconazole Sandoz Capsules, Fluconazole Sandoz Injection, Fluorescite, Gardasil 9, Gazyva, Gilenya, Gold Cross Codeine Linctus, Grisovin, Humira, Iclusig, Infanrix, Influvac Tetra, Irbesartan Sandoz, Kanjinti, Kapanol, Keytruda, Kineret, Kyleena, Lipex, Lukair, Lynparza Capsules, Mezavant, Mirena, Neulasta, Neupogen, Nexavar, Puri-Nethol, Renitec, Renitec Plus, Rhinocort Hayfever & Allergy Extra Strength, Rhinocort Hayfever & Allergy Original, Rifadin, Rinvoq, Ristempa, Sensipar, Simponi, Sinemet CR, Singulair, Sodium Bicarbonate Injection (Pfizer), Stivarga, Strensiq, Tezmota, Thioprine, Tomudex, Toujeo, Valpam, Zavedos, Zocor, and Zyloprim.

Product information with an update to indications includes Alunbrig, Bavencio, Fycompa, Morphine Juno, Olumiant, Opdivo, Solu-Cortef, Solu-Medrol, Tramadol Mylan SR, and Tramedo.

 

Past Content Updates
March 2021

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.

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.

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