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Updates

What's New in AusDI – December 2024

Browse the latest AusDI drug updates and medicines information – created and curated by trusted Australian editorial pharmacists, monthly.

Drug Monographs

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 Gabapentin (Systemic) monograph has been updated with information on pregnancy based on changes to product information. The Australian pregnancy category for gabapentin has been updated to category D (previously category B3). The use of gabapentin during the first trimester of pregnancy may cause major birth defects. It is recommended that gabapentin not be used during pregnancy unless the anticipated benefits clearly outweigh the potential risks. It is recommended that women of child-bearing potential use effective contraception during gabapentin treatment.

Past Content Updates

November 2024

The Abatacept (Systemic) monograph has been updated to include information on progressive multifocal leucoencephalopathy (PML) based on changes to product information. There have been cases of PML reported in patients receiving abatacept, mostly during concurrent use with other immunosuppressive medicines. It is recommended that PML be considered in the differential diagnosis in immunosuppressed patients who develop new or worsening cognitive, neurological, and psychiatric symptoms. It is recommended that abatacept be discontinued and appropriate diagnostic measures initiated if symptoms suggestive of PML occur.

October 2024

The Levonorgestrel (Intrauterine-Systemic) monograph has been updated with changes to the duration of use based on changes to product information. The Mirena brand of levonorgestrel intrauterine device has been shown to be effective for up to eight years when used for contraception. It can now be inserted and left in the uterine cavity for up to eight years for contraception (previously five years), then removed or replaced after eight years.

September 2024

The Anastrozole (Systemic) and Exemestane (Systemic) monographs have been updated to include information about tendon disorders based on changes to product information. The use of third generation aromatase inhibitors, including anastrozole, exemestane and letrozole, have been associated with tendinitis and tenosynovitis. Tendon rupture may also be a potential risk. It is recommended that patients be monitored for signs and symptoms of tendon disorders during treatment with these medications.

New Product Summary

Abiraterone-Teva

Adsine

Agomelatine-WGR

Atovacue

Clonazepam USP [Advagen Pharma]

Dasatinib Sandoz

Dostamine

Dutasteride/Tamsulosin Lupin

Ezetimibe USP [Camber]

Fruzaqla

Misty-Duo Allergy

Rivaroxaban Sandoz

Rivoxa

Sohonos

Souvenaid

Varenicline Sandoz

Varenicline Sandoz - Initiation Pack

WGR-Ibuprofen

New Product Information

Comirnaty JN.1

Dutatam

Fruzaqla

Sohonos

Xylonor

Product information with an update to safety includes Alkeran Injection, Alkeran Tablets, Apo-Exemestane, Apo-Zopiclone, Arava, Aricept, Aspen Ciprofloxacin, Avelox, Bi Eligard CP, Buvidal Weekly and Monthly, Camzyos, C-Flox, Cialis, Ciprofloxacin Sandoz Tablets, Cresemba, Dolapril, Dupixent, Eligard, Exemestane Sandoz, Fluoxetine Sandoz, Galafold, Keppra Tablets and Solution, Lemtrada, Libtayo, Lipitor, Lipostat, Lorazepam Viatris, Mekinist, Mektovi, Mersynofen, Methylphenidate-Teva XR, MS-2 Step, Nordip, Novicrit, Nupentin, Omeprazole Sandoz IV, Ovestin Tablets, Pariet 10, Phenergan, Pravachol, Prilace, Privigen, Privigen AU, ProQuad, Revatio, Rilast Rapihaler, Rilast Turbuhaler, Rinvoq, Sevikar, Sevikar HCT, Signifor, Stelara, Symbicort Rapihaler, Symbicort Turbuhaler, Tacidine, Tafinlar, Tazopip, Teriflunomide Sandoz, Tranalpha, Trexject, Tysabri, Valaciclovir Sandoz, Velsipity, Viagra, Vincristine (Pfizer), Zabep, Zolgensma, and Zyban SR.

Product information with an update to indications includes Humira, Illuccix, and Opdivo.

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