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What's New in AusDI – December, 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 Octreotide (Systemic) monograph has been updated with information about atrioventricular (AV) block based on a recent TGA Medicines Safety Update. AV blocks, including complete AV block, have been reported in Europe in patients receiving high doses of octreotide continuous intravenous infusion (100 micrograms per hour) and in patients receiving bolus octreotide intravenously (50 micrograms bolus followed by 50 micrograms per hour continuous infusion). In Australia, the TGA-approved indications for octreotide do not involve intravenous administration. However, some off-label uses do involve intravenous administration.

New Consumer Medicine Information (CMI)




New Product Information (PI)

Product information with an update to safety includes Ajovy, Alkeran Injection, Alkeran Tablets, Anagrelide Apotex, Apo-Azathioprine, Apo-Moclobemide, Apo-Olmesartan/Amlodipine/HCTZ, Apo-Omeprazole Capsulesm Apo-Tramadol, Apo-Tramadol/Paracetamol, Atropine Injection BP (Pfizer), Azathioprine Sandoz, Brenzys, Brintellix, Brufen Plus, Brufen Tablets, Buprenorphine Sandoz, Carlevent, Ceftriaxone Alphapharm, Ceftriaxone-AFT, Chemists' Own Procalm, Cleocin, Clobemix, Co-Diovan, Comirnaty, Concerta, Crinone, Dalacin C Capsules, Dalacin C Injection, DBL Atracurium, DBL Dexamethasone Sodium Phosphate, DBL Phenytoin Injection BP, DBL Potassium Dihydrogen Phosphate Concentrated, Deralin, Dexmedetomidine Ever Pharma, Dizole One, Dopamine Juno, Dynastat, EllaOne, Enspryng, Feldene and Feldene-D, Fluconazole Sandoz Capsules, Fosrenol, GlucaGen HypoKit, Glyceryl Trinitrate Wockhardt, Glyxambi, Hydroxycarbamide Medsurge, Imfinzi, Janumet and Janumet XR, Januvia, Jardiamet, Kanuma, Mersynofen, MersynoNight Night Time Pain Relief, Methotrexate Ebewe, Minomycin, Mobic, Monofer, Myfortic, Myoview, Norlevo-1, Novicrit, Nurofen Plus, Odomzo, Opsumit, Painstop Day-Time Pain Reliever, Painstop Night-Time Pain Reliever, Panamax, PiperTaz Sandoz, Prezcobix, Prezista, Renitec Plus, Salpraz Heartburn Relief, Sandostatin, Symtuza, Thioprine, Tramadol Sandoz Injection, Tramadol Sandoz SR, Trelegy Ellipta, Trizivir, Ultomiris 10 mg/mL, Ultomiris 100 mg/mL, Uptravi, Urorec, Valprease, Vosevi, Xeljanz, Xtandi, Yervoy, Ziagen, Ziextenzo, Zydol, and Zydol SR.

Product information with an update to indications includes Cabometyx, Darzalex SC, Eraxis, Ezetimibe Sandoz, Influvac Tetra, Keytruda, Nplate, Opdivo, and Tivicay and Tivicay PD.

Past Content Updates

November 2021

The Ivermectin (Systemic) monograph has been updated to specify that it is not indicated for the prevention or treatment of coronavirus disease 2019 (COVID-19) based on a recent TGA media release & statement. Significant public health risks may occur due to individuals using ivermectin for the prevention of COVID-19 instead of getting vaccinated. Ivermectin doses suggested for use against COVID-19 have come from unreliable sources and are significantly higher than the approved doses for scabies or parasite treatment; these higher doses may be associated with serious side/adverse effects, including dizziness, neurological effects such as coma and seizures, severe nausea, and vomiting.

October 2021

The Metronidazole (Systemic) monograph has been updated with information about suicidal ideation based on updates to several metronidazole Product Information. Cases of suicidal ideation, with or without mental depression, have been reported during metronidazole treatment. It is recommended that patients be advised to discontinue metronidazole treatment and contact their healthcare professional immediately if psychiatric symptoms occur during treatment.

September 2021

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.

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