Product Information safety updates

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
dd 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 Medicines Safety Update 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
amikacin	DBL Amikacin Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Ototoxicity for patients with mitochondrial DNA mutations	10 October 2022
anagrelide hydrochloride	Agrylin Takeda Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use Monitoring CV effects Concomitant aspirin use Expanded thrombotic risk warning 4.5 - Interactions with other medicines and other forms of interactions Products that inhibit platelet aggregation 4.6 - Fertility, pregnancy and lactation Studies in animals have shown reproductive toxicity 4.8 - Adverse effects (undesirable effects) Cerebral infarction	19 September 2022
atezolizumab	Tecentriq Roche Products Pty Ltd	4.8 - Adverse effects (undesirable effects) Sarcoidosis	7 September 2022
avalglucosidase alfa	Nexviazyme Sanofi-Aventis Australia Pty Ltd	4.7 - Effects on ability to drive and use machines Updated infusion associated reactions warning 4.8 - Adverse effects (undesirable effects) Updated frequency of pain in extremity and asthenia to 'common' 6.4 - Special precautions for storage Updated	14 October 2022
bendamustine hydrochloride	Ribomustin Janssen-Cilag Pty Ltd	4.8 - Adverse effects (undesirable effects) Nephrogenic diabetes insipidus	27 September 2022
ChAdOx1-S	Vaxzevria AstraZeneca Pty Ltd	4.4 - Special warnings and precautions for use Acute disseminated encephalomyelitis (ADEM) 4.8 - Adverse effects (undesirable effects) Cutaneous vasculitis	9 September 2022
dapagliflozin (as propanediol monohydrate)/ metformin hydrochloride	Xigduo XR AstraZeneca Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions New potential interaction between dapagliflozin and lithium; concomitant use may lead to a reduction in serum lithium levels	19 September 2022
daratumumab	Darzalex SC Janssen-Cilag Pty Ltd	4.4 - Special warnings and precautions for use Update to patient numbers, frequencies and range in time of onset in infusion-related reactions 4.8 - Adverse effects (undesirable effects) Hypertension, headache, oedema peripheral	21 September 2022
empagliflozin	Jardiance Boehringer Ingelheim Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions May increase renal lithium excretion and decrease blood lithium levels, so serum concentration of lithium should be monitored frequently	9 September 2022
empagliflozin plus metformin	Jardiamet Boehringer Ingelheim Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions May increase renal lithium excretion and decrease blood lithium levels, so serum concentration of lithium should be monitored frequently	9 September 2022
empagliflozin plus linagliptin	Glyxambi Boehringer Ingelheim Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions May increase renal lithium excretion and decrease blood lithium levels, so serum concentration of lithium should be monitored frequently	9 September 2022
encorafenib	Braftovi Pierre Fabre Australia Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions Updated regarding coadministration of encorafenib with OATP1B1, OATP1B3 or BCRP substrates	13 September 2022
esketamine (as hydrochloride)	Spravato Janssen-Cilag Pty Ltd	4.2 - Dose and method of administration Dosing information for patients of Chinese ancestry 4.8 - Adverse effects (undesirable effects) Respiratory depression	16 September 2022
exenatide	Byetta AstraZeneca Pty Ltd	4.8 - Adverse effects (undesirable effects) Intestinal obstruction, including ileus Cholelithiasis and cholecystitis	12 September 2022
gentamicin	DBL Gentamicin/ Gentamicin Injection Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Ototoxicity for patients with mitochondrial DNA mutations	26 September 2022
gilteritinib fumarate	Xospata Astellas Pharma Australia Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions P-gp inhibition and coadministration with P-gp substrates Clarified that gliterinib is a substrate of BCRP in-vitro	14 September 2022
heparin sodium	Heparinised Saline Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.5 - Interactions with other medicines and other forms of interactions 4.8 - Adverse effects (undesirable effects) 6.2 - Incompatibilities Additional information added to above sections to align with the Italian SmPC	12 September 2022
hydrochlorothiazide	Dithiazide Phebra Pty Ltd	4.4 - Special warnings and precautions for use Acute respiratory toxicity including acute respiratory distress syndrome (ARDS) and withdrawal of hydrochlorothiazide if ARDS is suspected 4.8 - Adverse effects (undesirable effects) ARDS	26 September 2022
irinotecan hydrochloride trihydrate	DBL Irinotecan Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Recommendation to use reduced starting dose in patients with UGT1A16 and 28 alleles expression Added information about administration and use in elderly 4.5 - Interactions with other medicines and other forms of interactions Bevacizumab 4.8 - Adverse effects (undesirable effects) Urinary tract infection, breast pain Renal and cardiovascular disorders added under post-marketing experience	27 September 2022
isavuconazole (as isavuconazonium sulfate)	Cresemba Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Anaphylactic reactions	28 September 2022
levetiracetam	Hospira Levetiracetam Pfizer Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Neuroleptic malignant syndrome, with a significantly higher prevalence in Japanese patients	29 September 2022
metronidazole	Metronidazole Pfizer Australia Pty Ltd	4.3 - Contraindications 4.8 - Adverse effects (undesirable effects) Cockayne syndrome	16 September 2022
nivolumab	Opdivo Bristol-Myers Squibb Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Strengthened warning relating to immune-related pneumonitis adverse effect to include fatal cases in combination with chemotherapy (nivolumab in combination with Folfox or Xelox chemotherapy in gastric, gastrooesophageal junction or oesophageal adenocarcinoma)	13 October 2022
phenytoin	Phenytoin Juno Juno Pharmaceuticals Pty Ltd	4.4 - Special warnings and precautions for use Use in women of childbearing potential 4.6 - Fertility, pregnancy and lactation Strengthened safety information about use in pregnancy/ women of childbearing potential and emphasised the importance of contraception and pre-conception care	20 September 2022
saxagliptin/ dapagliflozin	QTERN 5/10 AstraZeneca Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions May increase renal lithium excretion and decrease blood lithium levels, lithium dose may need to be adjusted	6 September 2022
sertraline	Zoloft Viatris Pty Ltd	4.8 - Adverse effects (undesirable effects) Eosinophilic pneumonia	11 October 2022
siponimod	Mayzent Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Squamous cell carcinoma	27 September 2022
tobramycin	Tobramycin Injection/ Tobramycin PF/ DBL Tobramycin Injection Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Ototoxicity for patients with mitochondrial DNA mutations	26 September 2022
valaciclovir hydrochloride	Valtrex Arrow Pharma Pty Ltd	4.4 - Special warnings and precautions for use Central nervous system effects and use in renal impairment Use in ocular HSV infections and CMV infections 4.5 - Interactions with other medicines and other forms of interactions Mycophenolate mofetil 4.8 - Adverse effects (undesirable effects)	10 October 2022

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.

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to [email protected].

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at [email protected].

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