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Product Information safety updates - May 2025

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.

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.

Active ingredients

Brand name

Sponsor

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

Epipen/  Epipen Jr

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added biphasic anaphylaxis
  • Updated high intraocular pressure

4.5 - Interactions with other medicines and other forms of interactions 

Updated:

  • Alpha-adrenergic blocking agents
  • Beta-adrenergic blocking agents
16 April 2025
American house dust mite extract / European house dust mite extract

Alustal House Dust Mites Extract

Stallergenes Australia Pty Ltd

4.2 - Dose and method of administration

Added:

  • Concomitant treatment with more than one allergen
  • Infection and atopic dermatitis

4.3 - Contraindications

Added:

  • Hypersensitivity to excipients
  • Auto-immune disorder
  • Asthma
  • Pregnancy
  • Renal insufficiency

4.4 - Special warnings and precautions for use

Added:

  • Previous systemic allergic reaction to allergen immunotherapy,
  • Cardiovascular diseases
  • Local allergic reactions

4.5 - Interactions with other medicines and other forms of interactions

  • Added vaccines

4.6 - Fertility, pregnancy and lactation

  • Added dose toxicity studies

4.8 - Adverse effects (undesirable effects)

Added:

  • Rhinitis
  • Conjunctivitis
  • Headache
  • Asthenia
8 April 2025
anthoxanthum odoratum, dactylis glomerata, lolium perenne, phleum pratense and poa pratensis

Alustal Pollen Extract of Five Grasses

Stallergenes Australia Pty Ltd

4.2 - Dose and method of administration

Added:

  • Concomitant treatment with more than one allergen
  • Infection and atopic dermatitis

4.3 - Contraindications

Added:

  • Hypersensitivity to excipients
  • Auto-immune disorder
  • Asthma
  • Pregnancy
  • Renal insufficiency

4.4 - Special warnings and precautions for use

Added:

  • Previous systemic allergic reaction to allergen immunotherapy,
  • Cardiovascular diseases
  • Local allergic reactions

4.5 - Interactions with other medicines and other forms of interactions

  • Added vaccines

4.6 - Fertility, pregnancy and lactation

  • Added dose toxicity studies

4.8 - Adverse effects (undesirable effects)

Added:

  • Rhinitis
  • Conjunctivitis
  • Headache
  • Asthenia
10 April 2025
asciminib hydrochloride

Scemblix

Novartis Pharmaceuticals Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Update to OATP1B substrates and strong CYP3A4 inducers
29 April 2025 
atomoxetine hydrochloride

APO-atomoxetine

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added serotonin syndrome
  • Added emotional lability
  • Updated aggressive behaviour to include homicidal ideation

4.5 - Interactions with other medicines and other forms of interactions

  • Added serotoninergic medications

4.8 - Adverse effects (undesirable effects)

  • Added bruxism

4.9 - Overdose

  • Added serotonin syndrome
2 April 2025
atomoxetine hydrochloride

Atomoxetine-WGR

GM Pharma International Pty Ltd

4.4 - Special warnings and precautions for use

  • Added serotonin syndrome
  • Added emotional lability
  • Updated aggressive behaviour to include homicidal ideation

4.5 - Interactions with other medicines and other forms of interactions

  • Added serotoninergic medications

4.8 - Adverse effects (undesirable effects)

  • Added bruxism

4.9 - Overdose

  • Added serotonin syndrome
3 April 2025
cemiplimab

Libtayo

Medison Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects)

  • Added new adverse effect, aplastic anaemia, under subheading ‘immune checkpoint inhibitor class effects’.
22 April 2025
cobimetinib

Cotellic

Roche Products Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added stomatitis with a frequency of very common.
7 April 2025
epoprostenol sodium

Veletri

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added urticaria
28 April 2025 
ipilimumab

Yervoy

Bristol-Myers Squibb Australia Pty Ltd

4.2 - Dose and Method of Administration

  • Added dosing modifications under subheading ‘recommended treatment modifications’. Added advice to permanently discontinue Yervoy as monotherapy with Grade 4 diabetes to Table 1 and advice to withhold dose of Yervoy as monotherapy with Grade 3 diabetes to Table 2.

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘immune-related endocrinopathy’, to include risk of type 1 diabetes mellitus and diabetic ketoacidosis with Yervoy. Also, for symptomatic diabetes, Yervoy should be withheld, and insulin replacement should be initiated as needed. Monitoring of blood sugar should continue to ensure appropriate insulin replacement is utilised. Yervoy must be permanently discontinued for life-threatening diabetes.
  • Added new warning under subheading ‘other immune-mediated adverse reactions’. Cases of haemolytic anaemia and aplastic anaemia have been observed during treatment with immune checkpoint inhibitors. Patients should be monitored for signs and symptoms indicative of these immune-mediated adverse reactions.
  • Added new warning under subheading ‘patients with autoimmune disease’. Data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased in patients with pre-existing autoimmune disease. In addition, flares of the underlying autoimmune disease were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects)

  • Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for monotherapy ipilimumab.
  • Added cytokine release syndrome to infusion related reactions. Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for combination ipilimumab therapy with nivolumab.
  • Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for combination ipilimumab therapy with nivolumab and platinum-doublet chemotherapy.
22 April 2025
midazolam

Midazolam Injection

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added local reactions and seizures with intraarterial injection (only intramuscularly or intravenously administration is recommended)
  • Expanded warning for use in children

4.6 - Fertility, pregnancy and lactation

  • Added advice to monitor neonates exposed to midazolam during pregnancy or labour

4.9 - Overdose

  • Added additional signs of overdose
17 April 2025
naltrexone hydrochloride, bupropion hydrochloride

Contrave 8/90

iNova Pharmaceuticals (Australia) Pty Ltd

4.3 - Contraindications

  • Added concomitant use of opioids contraindicated

4.4 - Special warnings and precautions for use

  • Added concomitant use of opioids contraindicated

4.5 - Interactions with other medicines and other forms of interactions

  • Added concomitant use of opioids contraindicated

4.8 - Adverse effects (undesirable effects)

  • Updated ADR serotonin syndrome to include opioid interaction
23 April 2025
nirsevimab

Beyfortus

Sanofi Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added additional warning under subheading ‘Hypersensitivity including anaphylaxis’. Serious hypersensitivity reactions included urticaria, dyspnoea, cyanosis, and/or hypotonia.
14 April 2025
nivolumab

Opdivo

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘other immune-related adverse reactions’. Cases of haemolytic anaemia and aplastic anaemia have been observed during treatment with immune checkpoint inhibitors. Patients should be monitored for signs and symptoms indicative of these immune-mediated adverse reactions.
  • Added new warning under subheading ‘patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects)

  • Added cytokine release syndrome to infusion related reactions. Added coeliac disease and pancreatic exocrine insufficiency with a frequency of rare for monotherapy nivolumab.
  • Added including cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of rare for combination nivolumab therapy with ipilimumab.
  • Added cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of not known for combination nivolumab therapy with ipilimumab and platinum-based chemotherapy.
  • Added coeliac disease with a frequency of not known for combination nivolumab therapy with cabozantinib.
  • Added cytokine release syndrome to infusion related reactions. Added coeliac disease with a frequency of not known for combination nivolumab therapy with chemotherapy.
  • Added new post marketing adverse effect enterocolitis.
22 April 2025
nivolumab and relatlimab

Opdualag

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning under subheading ‘patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.

4.8 - Adverse effects (undesirable effects)

  • Added new adverse effects under the ‘Postmarketing experience’ heading: infusion related reaction (including cytokine release syndrome), coeliac disease, pancreatic insufficiency and enterocolitis.
22 April 2025
oxycodone hydrochloride

Endone

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

  • Added hepatobiliary disorders

4.8 - Adverse effects (undesirable effects)

  • Added sphincter of Oddi dysfunction

4.9 - Overdose

  • Added hypoglycaemia
14 April 2025
risedronate sodium

Actonel once a month / Actonel EC once a week / Actonel

Theramex Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added orbital inflammation
31 March 2025
risperidone

Risperdal

Janssen-Cilag Pty Ltd

4.2 - Dose and Method of Administration

  • Added new dosing instructions and figures for the oral solution under subheading ‘Directions for Opening the Bottle and using the Pipette for the Oral Solution’.
15 April 2025
siponimod

Mayzent

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use 

  • Added risk of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients with PML

4.8 - Adverse effects (undesirable effects)

  • Added malignant melanoma
  • Updated infections
17 April 2025
teduglutide

Revestive

Takeda Pharmaceuticals Australia Pty Ltd.

4.8 - Adverse effects (undesirable effects)

Added:

  • Small intestinal polyps
  • Injection site reactions
1 April 2025
vemurafenib

Zelboraf

Roche Products Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added stomatitis with a frequency of common.
7 April 2025
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