TGA Product Information safety updates 23 June

TGA

When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through the TGA's ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. Please see below details of some medicines that have recently had safety related updates to their PI.

The TGA monitors the safety of medicines marketed in Australia using:

reports of adverse events
Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
reviews of literature
sharing of information with other regulatory agencies
sharing of information with Australian state and territory health authorities.

Changes to the PI that result from TGA safety monitoring activities may:

narrow indications
add or modify specific sections, such as:
- contraindications
- warnings or precautions
- use in fertility, pregnancy and lactation
- use in special populations
- adverse effects.

It is important for prescribers and other health professionals to be aware of safety-related PI changes, as they may require you to take actions or do things differently, such as:

counsel patients on identified risks
undertake special monitoring or precautions
in some instances select alternate medications.

Significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine's sponsor and sent directly to health professionals.

We will publish a Medicines Safety Update (MSU) article detailing recent safety-related PI updates each month, although this may not include all safety-related updates. We will continue to publish MSU articles for critical safety issues or topics of special interest.

The below medicines are generally innovator brands (generic brands may be included in some circumstances). Generic brands containing the same active ingredients as the medicines below are required to align with the safety information in the innovator's PI and will be updated accordingly.

To view the full PI for each listing, click on the name of the product in the 'Brand/trade name' column. A 'Summary table of changes' appears at the end of the PI. If the TGA has published any further risk communication, such as a safety alert or stand-alone MSU article, it will be linked to in the 'Safety issue' column.

Table: Details of safety-related PI updates

Active ingredients	Brand name Sponsor	PI updates (sections updated and summary of key information)	Date of approval
alfentanil hydrochloride	Rapifen Piramal Critical Care Pty Ltd	4.4 - Special warnings and precautions for use Tolerance and opioid use disorder 4.5 - Interactions with other medicines and other forms of interactions Gabapentinoids	24 May 2023
apixaban	Eliquis Bristol-Myers Squibb Australia Pty Ltd	4.4 - Special warnings and precautions for use Anticoagulant-related nephropathy (ARN) 4.8 - Adverse effects (undesirable effects) Renal and urinary disorders	15 May 2023
asciminib hydrochloride	Scemblix Novartis Pharmaceuticals Australia Pty Limited	4.8 - Adverse effects (undesirable effects) Hypersensitivity	5 May 2023
atorvastatin and ezetimibe	Atozet Organon Pharma Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Myasthenia gravis, ocular myasthenia	12 May 2023
bevacizumab	Abevmy Alphapharm Pty Ltd trading as Viatris	4.4 - Special warnings and precautions for use 4.8 - Adverse Effects (UNDEISRABLE EFFECTS) Anaphylactic shock Updated frequencies of hypersensitivity and infusion reactions	15 May 2023
cabozantinib	Cabometyx Ipsen Pty Ltd	4.4 - Special warnings and precautions for use Vanishing bile duct syndrome 4.8 - Adverse effects (undesirable effects) Embolism arterial Vanishing bile duct syndrome	24 May 2023
carboplatin	DBL Carboplatin Injection Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Kounis syndrome	30 May 2023
cefuroxime (as axetil)	Zinnat Aspen Pharmacare Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Seizure	24 May 2023
dabigatran	Pradaxa Boehringer Ingelheim Pty Ltd	4.4 - Special warnings and precautions for use Anticoagulant-related nephropathy (ARN) 4.8 - Adverse effects (undesirable effects) Renal and urinary disorders	5 May 2023
desogestrel/ ethinylestradiol	Marvelon Organon Pharma Pty Ltd	4.3 - Contraindications Expanded to include certain hepatitis C virus (HCV) medicinal products, such as glecaprevir and pibrentasvir. 4.4 - Special warnings and precautions for use Expanded hepatitis C warning to include ALT elevation observed with HCV medicinal products 4.5 - Interactions with other medicines and other forms of interactions Consult the relevant anti-viral medicine product safety information and the use of an alternative method of contraception prior to starting HCV therapy	3 May 2023
dinutuximab beta	Qarziba Recordati Rare Diseases Australia Pty Ltd	4.2 - Dose and Method of Administration Treatment modification and discontinuation information - central neurotoxicity, posterior reversible encephalopathy syndrome and transverse myelitis 4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Central neurotoxicity	26 April 2023
dulaglutide	Trulicity Eli Lilly Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Cholecystitis, constipation, flatulence, abdominal distention, gastroesophageal reflux disease and eructation	8 May 2023
enfortumab vedotin	Padcev Astellas Pharma Australia Pty Ltd	4.2 - Dose and method of administration Updated dose modification for pneumonitis with interstitial lung disease 4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Pneumonitis, interstitial lung disease	18 May 2023
estradiol hemihydrate	Vagifem Low Novo Nordisk Pharmaceuticals Pty Ltd	4.8 - Adverse effects (undesirable effects) Updated post-market adverse drug reactions	18 May 2023
etonogestrel/ ethinylestradiol	Nuvaring Organon Pharma Pty Ltd	4.3 - Contraindications Expanded to include certain hepatitis C virus (HCV) medicinal products, such as glecaprevir and pibrentasvir 4.4 - Special warnings and precautions for use Expanded hepatitis C warning to include ALT elevation observed with HCV medicinal products 4.5 - Interactions with other medicines and other forms of interactions Consult the relevant anti-viral medicine product safety information and the use of an alternative method of contraception prior to starting HCV therapy	12 May 2023
etoricoxib	Arcoxia Organon Pharma Pty Ltd	4.8 - Adverse effects (undesirable effects) Intracranial haemorrhage, pulmonary embolism and deep vein thrombosis	11 May 2023
etravirine	Intelence Janssen-Cilag Pty Ltd	4.4 - Special warnings and precautions for use Precautions about preventing transmission of HIV	1 May 2023
ezetimibe and rosuvastatin	Rosuzet Composite Pack Organon Pharma Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Myasthenia gravis, ocular myasthenia	12 May 2023
ezetimibe and simvastatin	Vytorin Organon Pharma Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Myasthenia gravis, ocular myasthenia	12 May 2023
hydrocortisone sodium succinate	Solu-Cortef Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Tumour lysis syndrome 4.8 - Adverse effects (undesirable effects) Updated preferred term hypothalamic pituitary-adrenal axis suppression	5 May 2023
iodised oil	Lipiodol Ultra Fluid Guerbet Australia Pty Ltd	4.3 - Contraindications Known or suspected reproductive tract neoplasia	18 May 2023
liraglutide	Victoza Novo Nordisk Pharmaceuticals Pty Ltd	4.8 - Adverse effects (undesirable effects) Dysgeusia	18 May 2023
mesalazine	Mezavant Takeda Pharmaceuticals Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Chromaturia	18 May 2023
mesalazine	Pentasa Ferring Pharmaceuticals Pty Ltd	4.4 - Special warnings and precautions for use Severe cutaneous adverse reactions (SCARs), drug reaction with eosinophilia and systemic symptoms (DRESS), urine discolouration	30 May 2023
methotrexate	Methotrexate Ebewe Sandoz Pty Ltd	4.8 - Adverse effects (undesirable effects) Injection site reactions, injection site necrosis	25 May 2023
methylprednisolone acetate	Depo-Medrol Depo-Nisolone Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Tumour lysis syndrome 4.8 - Adverse effects (undesirable effects) Updated preferred term hypothalamic pituitary-adrenal axis suppression	5 May 2023
methylprednisolone sodium succinate	Solu-Medrol Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Tumour lysis syndrome 4.8 - Adverse effects (undesirable effects) Updated preferred term hypothalamic pituitary-adrenal axis suppression	4 May 2023
metronidazole	Metronidazole Intravenous Infusion Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Hypersensitivity reactions 4.8 - Adverse effects (undesirable effects) Dermatitis bullous Drug reaction with eosinophilia and systemic symptoms (DRESS) Scute generalised exanthematous pustulosis (AGEP)	4 May 2023
Morphine sulfate pentahydrate	MS Contin MS Mono Sevredol Mundipharma Pty Ltd	4.4 - Special warnings and precautions for use Updated warning about use with biliary tract disorders 4.8 - Adverse effects (undesirable effects) Sphincter of Oddi dysfunction, allodynia, sleep apnoea disorder	8 May 2023
osimertinib	Tagrisso AstraZeneca Pty Ltd	4.4 - Special warnings and precautions for use Updated interstitial lung disease section 4.8 - Adverse effects (undesirable effects) Updated interstitial lung disease section Blood creatinine phosphokinase increased	8 May 2023
pegaspargase	Oncaspar Servier Laboratories (Aust) Pty Ltd	4.2 - Dose and method of administration 4.4 - Special warnings and precautions for use Pre-medication for management of hypersensitivity reactions	18 May 2023
rivaroxaban	Xarelto Bayer Australia Ltd	4.4 - Special warnings and precautions for use Anticoagulant-related nephropathy (ARN) 4.8 - Adverse effects (undesirable effects) Renal and urinary disorders	5 May 2023
rosuvastatin calcium	Crestor A. Menarini Australia Pty Ltd	4.4 - Special warnings and precautions for use New onset and aggravation of myasthenia gravis and ocular myasthenia 4.5 - Interactions with other medicines and other forms of interactions Roxadustat, enasidenib and tafamidis 4.6 - Fertility, pregnancy and lactation Lactation data for human milk Updated pregnancy and lactation warnings 4.8 - Adverse effects (undesirable effects) Myasthenia gravis, ocular myasthenia and lichenoid drug eruption	11 May 2023
secukinumab	Cosentyx Novartis Pharmaceuticals Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Pyoderma gangrenosum	4 May 2023
simvastatin	Zocor Organon Pharma Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Myasthenia gravis, ocular myasthenia	11 May 2023
siponimod hemifumarate	Mayzent Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use Meningitis, meningoencephalitis caused by VZV and cases of cryptococcal meningitis Live and non-live attenuated vaccines Updated information on progressive multifocal leukoencephalopathy 4.5 - Interactions with other medicines and other forms of interactions Live and non-live attenuated vaccines 4.8 - Adverse effects (undesirable effects) Meningitis, meningoencephalitis caused by VZV and cases of cryptococcal meningitis	5 May 2023
terlipressin	Glypressin Solution Ferring Pharmaceuticals Pty Ltd	4.2 - Dose and method of administration Average duration of treatment 4.4 - Special warnings and precautions for use monitoring during treatment and sepsis/septic shock information injection site reaction, skin necrosis and respiratory effects Updated use in renal impairment and use in hepatic impairment 4.8 - Adverse effects (undesirable effects) Sepsis/septic shock and effects related to Type 1 hepatorenal syndrome and bleeding oesophageal varices	8 May 2023
topiramate	Topamax Topamax Sprinkle Janssen-Cilag Pty Ltd	4.3 - Contraindications Migraine prophylaxis in pregnancy and women of childbearing potential 4.4 - Special warnings and precautions for use Updated text about women of childbearing potential 4.6 - Fertility, pregnancy and lactation Fetal neurodevelopment disorder Updated information about risks in women of childbearing potential	3 May 2023
tramadol hydrochloride	Tramal Seqirus Pty Ltd	4.8 - Adverse effects (undesirable effects) Hypoglycaemia	19 May 2023
ustekinumab	Stelara Janssen-Cilag Pty Ltd	4.4 - Special warnings and precautions for use Six-month waiting period for administration of live vaccines after in utero infant exposure 4.5 - Interactions with other medicines and other forms of interactions In utero infant exposure 4.6 - Fertility, pregnancy and lactation Systemic exposure in breastfed infants	3 May 2023
zopiclone	Imoclone IPCA Pharma (Australia) Pty Ltd	4.1 - Therapeutic indications 4.4 - Special warnings and precautions for use Updated treatment period from '2 to 4 weeks' to '7 - 14 days' 4.2 - Dose and method of administration 4.6 - Fertility, pregnancy and lactation Restricted treatment period 6.5 - Nature and contents of container 14-tablet pack size	20 April 2023

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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