What’s New

December 2019

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 Desvenlafaxine (Systemic) monograph has been updated with more information relating to adverse effects. Cases of long-lasting sexual dysfunction have been reported with 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.

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

Product information with safety updates includes Adenuric, Apo-Sertraline, Apo-Telmisartan, Apo-Terbinafine, Aratac, Avandamet, Azith, Betaloc, Bisolvon Chesty, Bridion, Brineura, Cernevit, Ciproxin, Ciproxin IV, Clopidogrel Winthrop, Clopidogrel Winthrop Plus Aspirin, CoPlavix, DBL Diazepam, DBL Metronidazole Intravenous Infusion, Dexmedetomidine Sandoz, Duloxetine Sandoz, DuoCover, Durogesic, Efexor-XR, Enlafax XR, Entyvio, Epilim, Erlyand, Evotaz, Ganfort, Glivec, Glyxambi, Inflectr, Iscover, Keflex, Keppra Tablets and Solution, Keytruda, Kyprolis, Lyrica, Mersyndol, Mezavant, Moxifloxacin Apotex, NuvaRing, Olimel and PeriOlimel, Orfadin, Panalgesic, Plavix, Precedex, Prolia, Propofol-Lipuro, Saizen, Sandoz Venlafaxine XR, Seroquel, Seroquel XR, Sodium Chloride 0.9% Freeflex, Solian, Sutent, Tivicay, Topamax, Toprol-XL, Trajenta, Trajentamet, Voltaren, Zaldiar, and Zoloft

Product information with an update to indications includes Botox, Dupixent, FluQuadri, Janumet and Janumet XR, Januvia, Praluent, SalplusF, Solu-Cortef, Tecentriq, and Vallergan.

Past Content Updates
November 2019

The Denosumab (Systemic) monograph has been updated with more information relating to adverse effects. Atypical femoral fractures have been reported with denosumab use, including during treatment and up to nine months after treatment discontinuation; the risk of atypical femoral fractures is increased with longer denosumab treatment durations. Hypophosphataemia has been reported as a common adverse effect of Xgeva brand denosumab. New postmarketing adverse effects associated with denosumab include alopecia and lichenoid drug eruptions (including lichen planus-like reactions).

October 2019

The Modafinil (Systemic) monograph has been updated with strengthened pregnancy precautions following a recent Health Canada safety alert. A pregnancy registry report has revealed cases of spontaneous abortion and major congenital anomalies associated with use of modafinil during pregnancy; there have also been postmarketing reports of major congenital anomalies. Examples of reported major congenital anomalies include cardiac congenital anomalies and microcephaly. Low fetal growth and cases of failure to thrive have also been reported in postmarketing evaluation. In light of these findings, it is recommended that effective contraception be used by female patients of child-bearing potential during, and for two months after, modafinil treatment. As modafinil may reduce the concentration and efficacy of hormonal contraceptives, alternative or additional nonhormonal contraception should be used during, and two months after, modafinil treatment. Use of modafinil during pregnancy is not recommended. Females of child-bearing potential should have a negative pregnancy test within a week before initiating modafinil.

September 2019

The Salbutamol (Inhalation-Local) monograph has been reviewed and updated. Some recommendations from the latest Australian Asthma Handbook update (Version 2.0) have been included in the monograph, particularly in relation to salbutamol use in infants. It is recommended that advice from a paediatric respiratory physician or paediatrician be sought prior to administering short-acting beta2-adrenergic receptor agonists to infants less than 12 months of age. Wheezing in this population is usually due to acute viral bronchiolitis or small and/or flopping airways, rather than asthma; use of bronchodilators is not recommended in this age group.

The Exenatide (Systemic) and Liraglutide (Systemic) monographs have been updated in light of a recent MHRA drug safety update regarding glucagon-like peptide-1 (GLP-1) receptor agonists. Cases of serious and life-threatening diabetic ketoacidosis have been reported in association with GLP-1 receptor agonists (including exenatide and liraglutide), particularly following rapid reduction or discontinuation of concurrent insulin (leading to poor glycaemic control). Many of the reported cases occurred within two weeks of GLP-1 receptor agonist initiation. It is recommended that any reductions in concurrent insulin dose be done in a stepwise manner with careful self-monitoring of blood glucose concentrations. Although nausea and vomiting may occur as adverse effects of GLP-1 receptor agonists, they are also potential symptoms of diabetic ketoacidosis and so should be taken seriously when commencing GLP-1 receptor agonist treatment and adjusting insulin doses.

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