What’s New

January 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 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.

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

Product information with safety updates includes Acetec; Actemra; Adriamycin; Afluria Quad; Aimovig; Apo-Diclofenac; Apo-Duloxetine; Apo-Enalapril; Apo-Fluconazole One; Apo-Galantamine MR; Apohealth Thrush Treatment Duo; Apo-Norfloxacin; Apo-Omeprazole Capsules; Asasantin SR; Biological Therapies IV B-Dose; Captopril Sandoz; Carboplatin (Pfizer); Cefepime-AFT; Certican; Codral Original Day & Night Tablets; DBL Carboplatin; Dilart HCT; Duratocin; Dymista; Enlafax XR; Epilim IV; Eviplera; Faslodex; Fluad; Flucil Powder for Injection; Flucil Powder for Oral Liquid; Fluorouracil Ebewe; Hydrene; Ibrance; Influvac Tetra; Inlyta; Irbesartan/HCT Sandoz; Jinarc; Jurnista; Keytruda; Lidocaine (Pfizer); Lincomycin SXP; Lioresal Tablets; Monace; Monofer; Moviprep Orange; Muphoran; Nicorette Lozenge; Nicorette QuickMist; Nidem; Opdivo; Oralair; Prevymis; Pritor/Amlodipine; Prolia; Qpril; Ramipril Sandoz Tablets; Rexulti; Saizen Powder for Injection; Sandoz Venlafaxine XR; Sudafed Sinus + Allergy & Pain Relief Tablets; Sudafed Sinus + Pain Relief Day & Night; Sudafed Sinus + Pain Relief Tablets; Sudafed Sinus and Nasal Decongestant; Syntocinon; Tarka; Teveten; Teveten Plus; Tramedo; Truvada; Tryzan Caps and Tryzan Tabs; Twynsta; Uvadex; Valproate Winthrop; Vincristine (Pfizer); Viread; Voltaren Rapid 50; Zedace; Zinnat Suspension; Zinnat Tablets; Zinopril; Zofran Tablets, Syrup and Zofran Zydis Wafers; Zyprexa IM; Zyprexa Relprevv; and Zyprexa Tablets and Zyprexa Zydis.

Product information with an update to indications includes Cimzia; Oripro; Tivicay; Utrogestan; and Zeklen.

Past Content Updates
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.

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.

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