TGA Product Information Safety Updates 20 July

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
acalabrutinib (as maleate)	Calquence – external site AstraZeneca Pty Ltd	4.4 – Special warnings and precautions Updated warning under subheading ‘Cardiac arrhythmias including atrial fibrillation and flutter’. Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. In the combined safety database of 1478 patients with haematological malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 7.4% of patients and Grade 3 or higher occurred in 2.3% of patients. Monitor for symptoms of cardiac arrhythmia, including atrial fibrillation and atrial flutter, (e.g., palpitations, dizziness, syncope, chest pain, dyspnoea) and obtain an ECG as appropriate. Added new warning under subheading ‘Hepatotoxicity, including drug-induced liver injury’. Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE. Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE. 4.8 – Adverse effects (Undesirable effects) Added: cardiac arrhythmias. hepatotoxicity. drug-induced liver injury	2026-05-14
alprazolam	Kalma – external site Alphapharm Pty Ltd	4.9 – Overdose Updated management information	2026-05-26
amoxicillin trihydrate/potassium clavulanate	Augmentin Duo – external site / Augmentin Duo Forte – external site Aspen Pharmacare Australia Pty Ltd	4.4 – Special warnings and precautions for use Added haemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) 4.6 – Fertility, pregnancy and lactation Added excretion in breastmilk 4.8 – Adverse effects (undesirable effects) Added to haematopoietic and lymphatic systems: haemolytic anaemia haemophagocytic lymphohistiocytosis/macrophage activation syndrome anaphylaxis angioneurotic oedema serum sickness-like syndrome hypersensitivity vasculitis	2026-05-14
aspirin/clopidogrel hydrogen sulfate	APX-Clopidogrel/Aspirin – external site / Clopidogrel Winthrop Plus Aspirin – external site / Duoplidogrel – external site / Duocover – external site Sanofi-Aventis Australia Pty Ltd	4.4 – Special warnings and precautions for use Added Kounis syndrome related to aspirin use	2026-05-24
atenolol	Tenormin atenolol tablet – external site Atnahs Pharma Australia Pty Ltd	4.4 – Special warnings and precautions for use Updated concomitant use of beta-blockers with sulfonylureas 4.5 – Interactions with other medicines and other forms of interactions Updated concomitant use of beta-blockers with sulfonylureas	2026-05-24
bevacizumab	Vegzelma – external site Celltrion Healthcare Australia Pty Ltd	4.8 – Adverse effects (undesirable effects) Added hyaline occlusive glomerular microangiopathy	2026-05-14
bretovameran	Comirnaty JN.1 – external site Pfizer Australia Pty Ltd	4.4 – Special warnings and precautions for use Updated warning under subheading ‘Myocarditis and pericarditis’. Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. Cases have occurred following first and second vaccinations and following booster doses. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males (adolescents and young adults). There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through to 12 years are lower than in ages 12 to 17 years.	2026-05-03
cabotegravir	Apretude – external site ViiV Healthcare Pty Ltd	4.8 – Adverse Effects (Undesirable Effects) Added new description of selected adverse reaction ‘Injection site reaction (pain* and discomfort, site nodule, induration) in table 6: Adverse Reactions. *May rarely result in temporary gait disturbance.	2026-04-30
ceftriaxone	Cftriax – external site Steriscience Pty Ltd	4.4 – Special warnings and precautions Updated warning under subheading ‘Hypersensitivity to cephalosporins, penicillins or other drugs’. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). 4.8 – Adverse effects (undesirable effects) Added Kounis syndrome with a frequency of not known	2026-05-19
cladribine	Mavenclad – external site / Cladritab – external site Merck Healthcare Pty Ltd	4.6 – Fertility, Pregnancy and Lactation Updated information under subheading ‘Use in Lactation’. Limited data from case reports have shown that cladribine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, breast-feeding is contraindicated during treatment with MAVENCLAD and for 1 week after the last dose.	2026-04-30

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