What’s New

October 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 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 treatment.

Past Content Updates
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.

August 2019

The Deferiprone (Systemic) monograph has updated safety information regarding use in children. Neurological disorders have previously been reported in children treated for several years with three times the maximum recommended deferiprone dose. However, more recently, hypotonia, instability, inability to walk, and hypertonia with inability of limb movement have been reported in children using recommended doses of deferiprone during postmarketing evaluation.

July 2019

The TGA has recently advised of a potential interaction between Vitex agnus-castus (also known as Chaste tree, Chasteberry, and Monk’s Pepper) and oral contraceptives, which may result in decreased contraceptive effectiveness. One report of unintended pregnancy with concurrent use of Vitex agnus-castus and norethisterone (progestogen-only oral contraceptive) has been received by the TGA, with one other similar case reported internationally.

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

Product information with safety updates includes Actrapid, Mixtard, Protaphane; Ampicyn; Apo-Alendronate Plus D3; Apo-Frusemide; Apo-Lansoprazole ODT; Apo-Metoclopramide; Apo-Olanzapine; Apo-Olanzapine ODT; Apo-Prazosin; Apo-Topiramate; Apo-Ziprasidone; Apo-Zonisamide; APOC-5FU; Austrapen; Baxter Glucose; Baxter Potassium Chloride and Sodium Chloride 10mmol/100mL, 20mmol/1000mL, 30mmol/1000mL, 40mmol/1000mL; Baxter Potassium Chloride in Glucose Intravenous Infusion; Benlysta; Bisolvon Dry; Caduet; Cilicaine Syringe; Clozaril; DBL Fluorouracil; DBL Phenytoin Injection BP; Diamicron MR; Efexor-XR; Eliquis; Enalapril/HCT Sandoz; Faverin; Glyade; Hemlibra; Imatinib-Teva; Imfinzi; Latuda; MabThera; MersynoNight Night Time Pain Relief; Methotrexate Ebewe; Methylpred; Mezavant; Minims Oxybuprocaine; Mircera; MS Mono; Natrilix; Natrilix SR; Neotigason; Odomzo; Optive Fusion; Optive Fusion Preservative-Free; Orencia; Paclitaxel Ebewe; Pantoprazole Sandoz Tablets; Pharmacor Finasteride 5; Pharmorubicin; Piax; PiperTaz Sandoz; Pomalyst; Pradaxa; Precedex; Prevymis; Priligy; Probitor; Resotrans; Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid; Sabril; Sevredol; Spiriva Respimat; Stocrin; Tagrisso; Tamsulosin Sandoz SR; Targin; Tazopip; Xarelto; Yervoy; Zabep; Zeldox; Zostavax; Zoton; and Zytiga.

Product information with an update to indications includes Imbruvica; Keytruda; Kisqali; Largactil; and Revlimid.


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