TGA Product Information safety updates 13 September

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	Date of approval
arsenic trioxide	Phenasen Phebra Pty Ltd	4.3 - Contraindications Added pregnancy and possibility of pregnancy 4.6 - Fertility, pregnancy and lactation Updated information about pregnancy and contraception in male and female patients Added information about period of abstinence for breastfeeding	23 August 2023
citalopram hydrobromide	Cipramil Lundbeck Australia Pty Ltd	4.4 - Special warnings and precautions for use Added subsection 'Sexual dysfunction' Addition of warning relating to persistent sexual dysfunction	23 August 2023
darolutamide	Nubeqa Bayer Australia Ltd	4.4 - Special warnings and precautions for use Added information about hepatotoxicity 4.8 - Adverse effects (undesirable effects) Updated Laboratory Test Abnormalities - liver function tests	23 August 2023
denosumab	Prolia Amgen Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Updated information about risk of severe hypocalcaemia	30 August 2023
durvalumab	Imfinzi Aspen Pharmacare Australia Pty Ltd	- Dose and method of administration Added 'Myelitis transverse' to the table 'Treatment modifications and management recommendations for IMFINZI or IMFINZI in combination with tremelimumab'. With the development of myelitis transverse at any grade, IMFINZI should be permanently discontinued Added immune-mediated arthritis and uveitis to 'Other immune-mediated adverse reactions' in the table 'Treatment modifications and management recommendations for IMFINZI or IMFINZI in combination with tremelimumab' 4.4 - Special warnings and precautions for use Added myelitis transverse and immune-mediated arthritis - Adverse effects (undesirable effects) Added psoriasis and immune-mediated arthritis Added subheading 'Eye disorders' to include uveitis Added subsection 'Post-marketing experience' to include autoimmune haemolytic anaemia, myelitis transverse and systemic inflammatory response syndrome	1 August 2023
escitalopram oxalate	Lexapro Lundbeck Australia Pty Ltd	4.4 - Special warnings and precautions for use Added subsection 'Sexual dysfunction'. Addition of warning relating to persistent sexual dysfunction	23 August 2023
estradiol hemihydrate	Estraderm MX Juno Pharmaceuticals Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions Updated information about interaction between HRT and lamotrigine	30 August 2023
estriol	Ovestin cream Ovestin tablets Ovestin ovula Aspen Pharmacare Australia Pty Ltd	4.4 - Special warnings and precautions for use Added hereditary and acquired angioedema Added hepatitis C warning to include ALT elevation observed with HCV combination regimen ombitasvir/paritaprevir/ritonavir and glecaprevir/pibrentasvir in women using ethinylestradiol-containing medicinal products. Caution is warranted for co-administration with the combination drug regimen 4.5 Interactions with other medicines and other forms of interactions Added subsection 'other interactions' to include the warning of ALT elevation observed with HCV combination regimen ombitasvir/paritaprevir/ritonavir and glecaprevir/pibrentasvir in women using ethinylestradiol-containing medicinal products. Caution is warranted for co-administration with the combination drug regimen 4.8 - Adverse effects (undesirable effects) Added angioedema	3 August 2023
fentanyl	Sublimaze Piramal Critical Care Pty Ltd	4.4 - Special warnings and precautions for use Added information about opioid use disorder 4.5 - Interactions with other medicines and other forms of interactions Gabapentin and pregabalin 4.9 - Overdosage Toxic leukoencephalopathy observed with fentanyl overdose	18 August 2023
fluorouracil	DBL Fluorouracil Pfizer Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Hepatocellular injury	5 July 2023
hydroxychloroquine sulfate	Plaquenil Sanofi-Aventis Australia Pty Ltd	4.4 - Special warnings and precautions for use Added Hepatitis B reactivation, hepatotoxicity and drug induced phospholipidosis 4.6 - Fertility, pregnancy and lactation Added information about congenital malformations 4.8 - Adverse effects (undesirable effects) Renal phospholipids Hepatitis B reactivation	9 August 2023
lamotrigine	Lamictal Aspen Pharmacare Australia Pty Ltd	4.4 - Special warnings and precautions for use Added subsection 'Cardiac Rhythm and Conduction Abnormalities'. Avoid the use of Lamictal in people who have cardiac conduction disorders, ventricular arrhythmias, or cardiac disease or abnormality. Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia 5.3 Preclinical safety data Added subsection 'Effect of Lamictal on Cardiac Rhythm and Conduction'	17 August 2023
methotrexate	DBL Methotrexate Pfizer Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Added pulmonary oedema, brain oedema, oedema, and oedema peripheral	7 August 2023
methoxyflurane	Penthrox Medica Developments International Limited	4.4 - Special warnings and precautions for use Respiratory depression Updated warning about occupational exposure 4.8 - Adverse effects (undesirable effects) Respiratory depression 4.9 - Overdosage Updated warning	2 August 2023
pembrolizumab	Keytruda Merch Sharpe & Dohme (Australia) Pty Ltd	4.8 - Adverse effects (undesirable effects) Added systemic inflammatory response syndrome	25 August 2023
pirfenidone	Esbriet Roche Products Pty Ltd	4.4 - Special warnings and precautions for use Added subsection 'Severe Cutaneous Adverse Reactions' (SCAR). If signs of SCAR occur interrupt Esbriet treatment until the aetiology of the reaction has been determined. If a SCAR is confirmed, permanently discontinue Esbriet 4.8 - Adverse effects (undesirable effects) Added skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS); toxic epidermal necrolysis (TEN); and drug reaction with eosinophilia and systemic symptoms (DRESS)	31 August 2023
plerixafor	Mozobil Sanofi-Aventis Pty Ltd	4.6 Fertility, pregnancy and lactation Updated information about use in pregnancy and contraception use during treatment	1 August 2023
pneumococcal purified capsular polysaccharides	Pneumovax 23 Merch Sharpe & Dohme (Australia) Pty Ltd	4.8 - Adverse effects (undesirable effects) Added systemic extensive swelling of the vaccinated limb with short onset time from vaccine administration.	28 August 2023
tamsulosin hydrochloride	Flomaxtra Astellas Pharma Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Chest discomfort	26 July 2023
tioguanine	Lanvis Aspen Pharmacare Australia Pty Ltd	4.4 - Special warnings and precautions for use Susceptibility to viral, fungal, and bacterial infections	14 August 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.

/Public Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).View in full here.

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