What’s New

March 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 Influenza Virus Vaccine (Systemic) monograph has been updated with information for the Australian 2020 influenza season. Fluarix TetraFluQuadri, 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.

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

Product information with safety updates includes Abstral, Acarbose Mylan, Adefin XL, Afeme Duo, Amipride, Apo-Finasteride 1, Apo-Finasteride 5, Apo-Ibuprofen, Apo-Levetiracetam Oral Solution, Apo-Lorazepam, Apo-Metoprolol, Apo-Modafinil, Apo-Venlafaxine XR, Atgam, Azithromycin Alphapharm, Belkyra, Benadryl Original Oral Liquid, Brilinta, Cefazolin-AFT, C-Flox, Ciprofloxacin Alphapharm, Clopine, Contrave, Dapa-Tabs, Descovy, Diprivan, Epiramax, Fluarix Tetra, Fludara, Frisium, Ibilex, Implanon NXT, Jardiance, Kapanol, Keflor, Kevtam, Klyx, Kyprolis, Lamivudine Alphapharm, Lemtrada, Levetiracetam Sandoz, Levetiracetam SZ, Lucrin Depot Paediatric, MabCampath, Neupro, Nexium 24HR Once Daily Dosing, Nicorette Inhalator, Nuromol, Obizur, Olmetec, Omnitrope, Palexia IR, Palexia SR, Pharmacor Finasteride 5, Picato gel, Placil, Prograf and Advagraf XL, Remicade, Sertraline generichealth, Sevikar, Sevikar HCT, Spinraza, Teriflunomide Sandoz, Tranalpha, Uptravi, Valprease, Xeljanz, Xigduo XR, Xolair, Zan-Extra, and Zircol.

Product information with an update to indications includes Apo-Fentanyl, Azithromycin Mylan, Denpax, Durogesic, Fentanyl Sandoz, and Hydrea.


Past Content Updates
February 2020

The Ondansetron (Systemic) monograph has updated information on use in pregnancy. Based on epidemiological data, it is suspected that ondansetron administration during the first trimester may cause orofacial malformations. One cohort study (which included 1.8 million pregnancies) found that ondansetron use during the first trimester was associated with an increased risk of developing oral clefts (three additional cases per 10,000 treated women). Available epidemiological data regarding ondansetron use and cardiac malformations are conflicting. Use of ondansetron during the first trimester of pregnancy is not recommended. It is recommended that use of effective contraception be considered in women of childbearing potential.

January 2020

The Ingenol mebutate (Topical) monograph has been updated in light of a recent MHRA drug safety update. The MHRA has advised that an increased incidence of benign and malignant skin tumours has been observed following use of ingenol mebutate gel in several clinical studies. It is recommended that patients be advised to monitor for any new skin lesions (e.g., elevated or wart-like growths, new red scaly patches, or open sores) within the treatment area and seek immediate medical advice if they occur. Caution is recommended with use of ingenol mebutate gel in patients with a history of skin cancer.

December 2019

The Desvenlafaxine (Systemic) monograph has been updated with more information relating to adverse effects. Cases of long-lasting sexual dysfunction have been reported with serotonin and noradrenaline reuptake inhibitor (SNRI) use, where symptoms have persisted despite SNRI discontinuation.

This monograph has also been updated with further details regarding discontinuation effects and their management. To minimise the risk of discontinuation symptoms when withdrawing desvenlafaxine therapy, it is recommended that the dose be reduced gradually and that the patient be monitored. If dosage reduction or withdrawal of therapy is followed by intolerable symptoms, resumption of the previous dose may be considered, followed by subsequent dosage reduction at a more gradual rate. Discontinuation over a period of months (or even longer) may be required in some cases.

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