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Product Information safety updates - February 2026

Medicines Safety Update
Published

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:

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.

Active Ingredient 

Brand name

Sponsor

PI updates (sections updated and summary of key information) Date of approval 

  

acarbose

  

Glybosay

Arrotex Pharmaceuticals Pty Ltd

4.3 – Contraindications

Added:

  • severe hepatic impairment
  • colonic ulceration
  • chronic intestinal disease
  • diabetic ketoacidosis 

4.4 - Special warnings and precautions for use  

Added warnings about coadministration of antacids, fulminant hepatitis, severe hepatic impairment and renal impairment

4.5 - Interactions with other medicines and other forms of interactions  

  • Added interaction with colestyramine 

4.8 - Adverse effects (undesirable effects)  

  • Added acute generalised exanthematous pustulosis (post-marketing) 

4.9 - Overdose 

Updated overdose warning (no specific antidote known)

2026-01-11

  

American house dust mite extract, European house dust mite extract

  

Acarizax

Biocelect Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • Added rash
2026-01-04

  

bivalirudin

  

Bivalirudin ARX

Arrotex Pharmaceuticals Pty Ltd

4.3 – Contraindications

Added: 

  • acute gastric or duodenal ulcer
  • cerebral haemorrhage
  • severe cerebro-spinal trauma
  • diabetic or haemorrhagic retinopathy
  • proximal use of spinal/epidural anaesthesia  

4.4 - Special warnings and precautions for use

Updated: 

  • haemoglobin symptom
  • information on acute stent thrombosis
  • information on gamma brachytherapy

Added: 

  • cardiac surgery
  • warning for nursing women 

4.5 - Interactions with other medicines and other forms of interactions

Added: 

  • information on heparin
  • pregnancy interactions 

4.8 - Adverse effects (undesirable effects) 

  • Added additional information on HORIZON's Trial; platelets, bleeding and clotting.
2026-01-22

  

ceftaroline fosamil

  

Zinforo

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added statement to specify that severe cutaneous adverse reactions (SCAR) such as SJS, TEN, DRESS and AGEP have been reported in patients taking ceftaroline
2026-01-27

  

cobicistat, darunavir, emtricitabine, tenofovir alafenamide

  

Symtuza

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use 

  • Strengthened warning regarding possibility of HIV transmission 

4.6 - Fertility, pregnancy and lactation 

  • Updated lactation topic regarding the transmission of HIV
2026-01-12

  

doxorubicin hydrochloride

  

Caelyx

Baxter Healthcare Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • Added renal and urinary disorders for patients with high cumulative exposure to pegylated liposomal doxorubicin
2026-01-14

  

empagliflozin, metformin hydrochloride

  

Jardiamet

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added caution for patients with known or suspected mitochondrial diseases
2026-01-13

  

estradiol hemihydrate

  

Zumenon

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use 

Added: 

  • coronary artery disease (CAD)
  • combined estrogen-progestogen therapy
  • estrogen-only
  • ischaemic stroke
  • no safety data to support oral doses of estradiol > 2 mg 

Updated:

  • venous thromboembolism (VTE)
  • hypothyroidism
  • drug interaction information under the ALT elevations topic 

4.5 - Interactions with other medicines and other forms of interactions 

  • Information added on metabolism of progesterone and effect on uterine bleeding profile
  • Drug interaction information added to other interactions 

4.6 - Fertility, pregnancy and lactation 

  • Added information related to occurrence of pregnancy during treatment 

4.8 - Adverse effects (undesirable effects)

Added: 

  • haemolytic anaemia
  • hypertension, peripheral vascular disease, varicose vein, venous thromboembolism added to Vascular disorders
  • leg cramps
  • back pain
  • pelvic pain
  • change in cervical secretion and menorrhagia
  • asthenia
  • oedema/peripheral oedema frequency updated:  
  • headache
  • abdominal pain / nausea
  • breast pain
  • dysmenorrhoea
2026-01-07

  

itraconazole

  

Itracap / Itranox

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications 

  • Expanded contraindications with other medicines 

4.4 - Special warnings and precautions for use 

  • Updated use in CHF, hepatic and renal impairment and in immunocompromised patients

Added:

  • cardiac dysrhythmias
  • disorders of carbohydrate metabolism
  • interaction potential
  • monitoring and laboratory tests 

4.8 - Adverse effects (undesirable effects) 

  • Added hypersensitivity, oedema, leukopenia, serum sickness, angioneurotic oedema, anaphylactic reaction, hypertriglyceridaemia, tremor, paraesthesia, hypoaesthesia, dysgeusia, visual disturbance (including diplopia and blurred vision), transient or permanent hearing loss, tinnitus, congestive heart failure, tinnitus, dyspnoea, pancreatitis, serious hepatotoxicity (including some cases of fatal acute liver failure), hyperbilirubinaemia, toxic epidermal necrolysis, Stevens-Johnson Syndrome, acute generalised exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, blood creatine phosphokinase increased serum sickness, angioneurotic oedema, anaphylactic reaction, psuedoaldosteronism
2026-01-06

  

larotrectinib sulfate

  

Vitrakvi

Bayer Australia Ltd

4.4 - Special warnings and precautions for use 

  • Updated hepatotoxicity to remove reference to adult patients only 

4.8 - Adverse effects (undesirable effects) 

  • Updated summary of the safety profile. Adverse reactions for hepatoxicity, vomiting and diarrhoea and laboratory abnormalities increased for paediatric and elderly patients.
2026-02-02

  

leflunomide

  

Arava

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added warning statement section for musculoskeletal disorders
2026-01-14

  

linagliptin, metformin hydrochloride

  

Trajentamet

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added caution for patients with known or suspected mitochondrial diseases
2026-01-13

  

meropenem trihydrate

  

Meropenem GH

Lupin Australia Pty Limited

4.4 - Special warnings and precautions for use 

  • Added drug-induced liver injury (DILI) 

4.8 - Adverse effects (undesirable effects) 

  • Added metabolism and nutrition disorders - hypokalaemia  
  • Added hepatobiliary disorders - drug-induced liver injury
2026-01-06

  

metronidazole

  

Rozex

Galderma Australia Pty Ltd

4.3 - Contraindications 

  • Added Cockayne syndrome as a contraindication
2026-01-06

  

ofatumumab

  

Kesimpta

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added risk of liver injury 

4.6 - Fertility, pregnancy and lactation 

  • Update to the benefit-risk of ofatumumab use during pregnancy and lactation 

4.8 - Adverse effects (undesirable effects) 

  • Update to Table 2: Adverse drug reactions from spontaneous reports and literature (frequency not known) to include hepatobiliary disorders: liver injury
2026-01-08

  

paracetamol 1000 mg and ibuprofen (as sodium dihydrate) 300 mg

  

Maxigesic IV

AFT Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading ‘Cardiovascular and cerebrovascular effects'. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction. 

4.8 Adverse effects (Undesirable effects) 

  • Added Kounis syndrome with a frequency of unknown
2026-01-13

  

posaconazole

  

Noxafil

Merck Sharp & Dohme (Australia) Pty Ltd

4.3 Contraindications 

  • Added coadministration of posaconazole with rivaroxaban or apixaban is contraindicated as posaconazole may increase the plasma concentration of these medicines, which may increase the risk of bleeding 

4.5 Interactions with other medicines and other forms of interactions 

  • Added 'rivaroxaban' and 'apixaban' under the contraindicated column of table 2
  • Added interaction under subheading 'Effects of Posaconazole on other drugs'. Rivaroxaban and Apixaban: Posaconazole inhibits CYP3A4 and may have an inhibitory effect on P-gp, and therefore it may increase plasma concentrations of rivaroxaban and apixaban to a clinically relevant degree which may lead to an increased bleeding risk
2026-01-07

  

propantheline bromide

  

Pro-Banthine

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications 

  • Updated contraindication for glaucoma (may increase intra-ocular pressure) 

4.5 - Interactions with other medicines and other forms of interactions 

  • Added new interactions with medicines: antimuscarinics, anti-arrhythmics, antidepressants, antifungals, antihistamines, metoclopramide
2026-01-15

  

rituximab

  

Riximyo

Sandoz Pty Ltd

4.3 - Contraindications 

  • Added active, severe infections. immunocompromised patients, severe heart failure and severe, uncontrolled cardiac disease 

4.4 - Special warnings and precautions for use 

  • Updated progressive multifocal leukoencephalopathy (PML), infusions-related reactions, infections, and immunisation
2026-01-22

  

rosuvastatin calcium

  

Crestor

A Menarini Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions 

  • Updated AUC value for drug-drug interaction with ticagrelor and rosuvastatin
  • Added drug-drug interactions with belumosudil and momelotinib with rosuvastatin
  • Corrected AUC value for drug-drug interaction between enasidenib with rosuvastatin
2026-01-15

  

somatrogon

  

Ngenla

Pfizer Australia Pty Ltd

4.2 - Dose and method of administration 

  • Added reason for rotating injection site weekly 

4.4 - Special warnings and precautions for use 

  • Updated existing warning for 'epiphyseal disorders' 

4.5 - Interactions with other medicines and other forms of interactions 

  • Added content related to oral estrogen and dosing 

4.8 - Adverse effects (undesirable effects) 

  • Added lipoatrophy as ADR identified post-marketing with frequency not known
  • Added epiphysiolysis (including slipped capital femoral epiphysis) with frequency not known
2026-01-18

  

sotatercept

  

Winrevair

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects) 

  • Added pericardial effusion to the Post-marketing Experience section
2026-01-15

  

testosterone enantate

  

Primoteston Depot

Bayer Australia Ltd

4.5 Interactions with other medicines and other forms of interactions 

  • Added new interaction under subheading 'Other interactions'. Androgens may potentiate the effects of ciclosporin and increase risk of nephrotoxicity. The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema. 

4.8 Adverse effects (Undesirable effects) 

·  Added the following adverse events with a frequency of unknown. Increased appetite, hypercholesterolaemia, blood triglycerides increased, blood cholesterol increased, emotional disorder, migraine, tremor, bronchitis, sinusitis, snoring, urine flow decreased, urinary retention, urinary tract disorder, nocturia, dysuria, dry skin, muscle disorder (muscle spasm, muscle strain), musculoskeletal stiffness, aspartate aminotransferase increased, glycosylated haemoglobin increased, estradiol increased, blood creatine phosphokinase increased, prostate examination abnormal, benign prostatic hyperplasia, prostatic dysplasia, prostate induration, prostatitis, prostatic disorder, breast induration and breast pain.

2026-01-12

  

tocilizumab

  

Actemra

Roche Products Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading ‘Hypersensitivity Reactions, including Anaphylaxis'. In addition, serious cutaneous reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients with autoinflammatory conditions treated with Actemra. 

4.8 Adverse effects (undesirable effects) 

  • Added Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
2026-01-11

  

tofacitinib (as citrate)

  

Xeljanz / Xeljanz XR

Pfizer Australia Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading ‘Viral Reactivation'. At least one confirmed case of progressive multifocal leukoencephalopathy (PML) has been reported in RA patients receiving tofacitinib in the post marketing setting. PML can be fatal and should be considered in the differential diagnosis in immunosuppressed patients with new onset or worsening neurological symptoms.
2026-01-11

  

trastuzumab

  

Herceptin SC

Roche Products Pty Ltd

4.2 Dose and method of administration 

  • Updated wording under subheading ‘General'. Do not substitute Herceptin SC for or with trastuzumab emtansine or trastuzumab deruxtecan. In order to prevent medication errors, it is important to check the vial labels to ensure the medicine being prepared and administered is Herceptin SC (trastuzumab) and not trastuzumab emtansine or trastuzumab deruxtecan.
2026-01-12

  

trastuzumab

  

Herzuma

Celltrion Healthcare Australia Pty Ltd

4.2 Dose and method of administration 

  • Updated wording under subheading ‘General'. Do not substitute HERZUMA for or with trastuzumab emtansine or trastuzumab deruxtecan. In order to prevent medication errors it is important to check the vial labels to ensure the medicine being prepared and administered is HERZUMA (trastuzumab) and not trastuzumab emtansine or trastuzumab deruxtecan.
2026-01-11

  

trastuzumab

  

Kanjinti

Amgen Australia Pty Ltd

4.2 Dose and method of administration 

  • Updated wording to prevent medication errors, do not substitute KANJINTI for or with trastuzumab emtansine or trastuzumab deruxtecan. In order to prevent medication errors, it is important to check the vial labels to ensure the medicine being prepared and administered is KANJINTI (trastuzumab) and not trastuzumab emtansine or trastuzumab deruxtecan.
2026-01-21

  

trastuzumab

  

Ogivri

Maxx Pharma Pty Ltd

4.2 Dose and method of administration 

  • Updated wording under subheading ‘General'. Do not substitute OGIVRI for or with trastuzumab emtansine or trastuzumab deruxtecan. In order to prevent medication errors, it is important to check the vial labels to ensure the medicine being prepared and administered is trastuzumab (OGIVRI) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).
2026-01-12

  

trastuzumab

  

Trazimera

Pfizer Australia Pty Ltd

4.2 Dose and method of administration 

  • Updated wording to prevent medication errors; do not substitute TRAZIMERA for or with trastuzumab emtansine or trastuzumab deruxtecan. In order to prevent medication errors, it is important to check the vial labels to ensure the medicine being prepared and administered is TRAZIMERA (trastuzumab) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).
2026-01-11

  

trastuzumab emtansine

  

Kadcyla

Roche Products Pty Ltd

Boxed warning 

  • Updated warning to be clearer and prevent medication errors. 

4.2 Dose and method of administration 

  • Updated wording to prevent medication errors; do not substitute Kadcyla for or with trastuzumab or trastuzumab deruxtecan. In order to prevent medication errors, it is important to check the vial labels to ensure the medicine being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab or trastuzumab deruxtecan.
2026-01-12

  

upadacitinib

  

Rinvoq

Abbvie Pty Ltd

4.4 Special warnings and precautions for use 

  • Added new warning under subheading ‘Retinal vein occlusion'. Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion. 

4.8 Adverse effects (undesirable effects) 

  • Added new adverse event, semen discolouration, under subheading 'Post Marketing Experience'. Reports of semen discolouration (blue or green) have occurred in patients taking RINVOQ. Most reports occurred with RINVOQ 45 mg. Discolouration intensity decreased or resolved after dose reduction or discontinuation. There were no clinically meaningful adverse events reported with the semen discolouration.
2026-01-14

  

valaciclovir hydrochloride

  

APX-Valaciclovir / Valtrex / Zelitrex

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use 

  • Updated frequency of viral shedding
  • Updated risk of transmission in the use of genital herpes 

4.5 - Interactions with other medicines and other forms of interactions 

  • Added tenofovir, cimetidine, probenecid and mycophenolate mofetil 

4.6 - Fertility, pregnancy and lactation 

  • Added malformative or foetal / neonatal toxicity Reproductive toxicity 

4.8 - Adverse effects (undesirable effects) 

  • Updated hepato-biliary disorders to include bilirubin and liver enzymes
2026-01-05
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