What’s New

June 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.

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.

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

Product information with safety updates includes Aclasta, Act-HIB, Adacel, Albumex 20, Albumex 4, Apo-Lansoprazole ODT, Apo-Pramipexole ER, Apo-Ramipril Capsules, Apo-Ramipril Tablets, Apo-Teriflunomide, Apo-Ziprasidone, Avanza SolTab, Avanza Tablets, Bicor, Bispro, Boostrix-IPV, Camptosar, Celapram, Celebrex, Clonac, Creon Capsules, Cubicin, DBL Ciprofloxacin, DBL Cisplatin, DBL Irinotecan, DBL Sulfamethoxazole and Trimethoprim Concentrate, Depo-Provera, Depo-Ralovera, Dilart HCT, Elonva, Epilim, Epilim IV, Erivedge, Esbriet, Etoposide Ebewe, Feldene and Feldene-D, Fluconazole Sandoz Capsules, Fluconazole Sandoz Injection, Fragmin, Fucidin, Gazyva, Genvoya, Imrest, Intragam 10, Jardiamet, Latanoprost Sandoz, Luvox, MabThera SC, Mersyndol DayStrength, MonoFIX-VF, Movox, Nivestim, Odefsey, Opdivo, Osteovan, Panadeine Forte, Panamax Co, Plaquenil, Prodeine, Prodeine Forte, Prodeinextra, Proladone, Provera, Quilonum SR, Ralovera, Revestive, Rifadin, Sinemet, Sintetica Baclofen Intrathecal, Sodium Valproate Sandoz, Somavert, Tenofovir Disoproxil Emtricitabine Mylan, Tenofovir Disoproxil Mylan, Thrombotrol-VF, Topiramate Sandoz, Tripacel, Tysabri, Valpro EC, Valproate Winthrop, Xigduo XR, and Zolpidem Sandoz.

Product information with an update to indications includes Actemra, Endone, Fenpatch, Forxiga, Jurnista, Lucentis, Ofev, Xigduo XR, and Zerbaxa.

 

Past Content Updates
May 2020

The Iron Supplements (Systemic) monograph has been updated based on a recent TGA Medicines Safety Update about the risk of symptomatic hypophosphataemia associated with ferric carboxymaltose. The risk of developing clinically significant hypophosphataemia following parenteral iron is increased in patients on long-term iron replacement, and in those with gastrointestinal disorders, lower baseline ferritin concentrations, malnutrition, or other causes of phosphate deficiency. Symptoms of hypophosphataemia may include asthenia, breathlessness, fatigue, headaches, muscular weakness and tachycardia, which may be misdiagnosed as failure to respond to treatment of iron deficiency anaemia; it is recommended that hypophosphataemia be considered as a potential cause for the continuation of these symptoms after using ferric carboxymaltose.

April 2020

The Clozapine (Systemic) monograph has been updated in light of a recent FDA drug safety communication. The FDA has strengthened an existing warning that constipation caused by clozapine can uncommonly progress to serious bowel problems, such as intestinal ischaemia, intestinal necrosis, necrotising colitis, and volvulus; fatal outcomes have been reported. The risk is increased at higher doses of clozapine or when used with other medications that cause constipation, such as anticholinergics and opioids.

March 2020

The Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2020 influenza season. Fluarix Tetra, FluQuadri, and Vaxigrip Tetra brand quadrivalent vaccines are indicated for use in adults and children six months of age and over, Influvac Tetra brand quadrivalent vaccine is indicated for use in adults and children three years of age and over, and Afluria Quad brand quadrivalent vaccine is indicated for use in adults and children five years of age and over.

Fluad Quad is an adjuvanted quadrivalent influenza vaccine specifically indicated for use in adults aged 65 years and over; it produces an increased antibody response compared to unadjuvanted influenza vaccines. The second B-strain contained in the quadrivalent Fluad Quad brand provides additional benefit over the 2019 influenza season trivalent Fluad brand of adjuvanted vaccine.

At the time of publishing, there are no trivalent vaccines marketed for the Australian 2020 influenza season.

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