TGA Product Information Safety Updates 10 August

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.

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Active Ingredient	Brand name Sponsor	PI updates (sections updated and summary of key information)	Date of approval
adalimumab	Humira - external site AbbVie Pty Ltd	4.8 - Adverse Effects (undesirable effects) Added nephrolithiasis with a frequency of common.	2026-06-03
alanine, arginine, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine	Synthamin - external site Baxter Healthcare Pty Ltd	4.4 - Special warnings and precautions for use Added presence of sodium metabisulfite	2026-06-28
clobazam	Frisium - external site Atnahs Pharma Australia Pty Ltd	4.4 - Special warnings and precautions for use Updated warning under subheading 'Serious Skin Reactions'. Serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs, that are associated with serious skin reactions. SJS/TEN/DRESS could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN/DRESS, especially during the first 8 weeks of treatment. These commonly present as a combination of the following symptoms: extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy, and possible eosinophilia. Clobazam should be immediately discontinued when SJS/TEN/DRESS is suspected. If signs or symptoms suggest SJS/TEN/DRESS, use of this drug should not be resumed and alternative therapy should be considered 4.8 - Adverse effects (undesirable effects) Added drug reaction with eosinophilia and systemic symptoms syndrome	2026-06-09
combined diphtheria, tetanus, acellular pertussis (dtpa) and inactivated poliovirus vaccine	Infanrix-IPV - external site GlaxoSmithKline Australia Pty Ltd	4.8 - Adverse Effects (undesirable effects), post-marketing experience Added acute disseminated encephalomyelitis (causality not confirmed) with a frequency of very rare	2026-06-11
daratumumab	Darzalex - external site Janssen-Cilag Pty Ltd	4.8 - Adverse effects (undesirable effects) Added: weight decreased hypotension	2026-06-11
flucloxacillin	Staphylex - external site / Flopen Viatris - external site Alphapharm Pty Ltd	4.5 - Interactions with other medicines and other forms of interactions Added new interaction under subheading 'Tacrolimus'. Flucloxacillin (a CYP450 inducer) may decrease tacrolimus whole blood trough concentrations and increase the risk of rejection. Monitor tacrolimus whole blood trough concentrations and increase tacrolimus dose if needed. Monitor graft function closely.	2026-06-01
fludrocortisone acetate	Florinef - external site Aspen Pharmacare Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Added panniculitis	2026-06-23
gabapentin	Neurontin - external site Viatris Pty Ltd	4.4 - Special warnings and precautions for use Added new warning under subheading 'Myasthenia gravis'. Gabapentin should be used with caution in patients with myasthenia gravis as post-marketing cases of exacerbation of myasthenia gravis have been reported with gabapentin. 4.8 - Adverse effects (undesirable effects) Added exacerbation of myasthenia gravis	2026-06-09
galcanezumab	Emgality - external site Eli Lilly Australia Pty Ltd	4.4 - Special warnings and precautions for use Added new warning under subheading 'Hypertension'. Development of hypertension and worsening of pre-existing hypertension have been reported following the use of calcitonin gene-related peptide (CGRP) antagonists, including EMGALITY, in the post-marketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalisation. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with EMGALITY for new-onset hypertension or worsening of preexisting hypertension, and consider whether discontinuation of EMGALITY is warranted if evaluation fails to establish an alternative aetiology or blood pressure is inadequately controlled. 4.8 - Adverse effects (undesirable effects), post-marketing data Added hypertension with a frequency of unknown	2026-06-03
haemophilus type b conjugate vaccine (conjugated to tetanus protein)	Act-HIB - external site Sanofi-Aventis Australia Pty Ltd	4.2 - Dosage and Method of Administration Added new subsection 'Reconstitution before administration of Act-HIB vaccine'. Each single dose vial of Act-HIB contains freeze-dried powder which needs to be dissolved in 0.5 mL of the diluent for Act-HIB. Slowly inject the entire contents of the diluent pre-filled syringe into the centre of the stopper on the vial. Shake vigorously until the freeze-dried powder is completely dissolved and a colourless solution is visible. Withdraw the entire contents of the reconstituted vaccine into the syringe and administer the total volume (about 0.5 mL) via the intramuscular or subcutaneous route. Aseptic technique must be used for withdrawal of each dose.	2026-06-03

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