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Product Information safety updates - December 2024

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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

aflibercept

Eylea - external site

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

  • Added intravitreal injections, including those with EYLEA have been associated with retinal vasculitis and retinal occlusive vasculitis. Patients should be instructed to report any symptoms suggestive of retinal vasculitis or retinal occlusive vasculitis without delay and should be managed appropriately. 

4.8 - Adverse effects (undesirable effects)

  • Added retinal vasculitis and retinal occlusive vasculitis, scleritis

1 November 2024
botulinim toxin type a 

Botox - external site

Abbvie Pty Ltd 

4.4 - Special warnings and precautions for use

&

4.8 - Adverse effects (undesirable effects)  

  • Added cumulative dose and interval for paediatrics 

25 November 2024 

canakinumab

Ilaris - external site

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘Drug reaction with eosinophilia and systemic symptoms (DRESS)’

  • Added DRESS has rarely been reported, predominantly in patients with systemic juvenile idiopathic arthritis (SJIA) and may require hospitalisation, as this condition may be fatal. If symptoms of DRESS are present and an alternative aetiology cannot be established, do not re-administer Ilaris, treat promptly and monitor until symptoms resolve.

15 November 2024
capivasertib 

Truqap - external site

AstraZeneca Pty Ltd 

  1. - Special warnings and precautions for use  

  • Updated special warnings and precautions for hyperglycaemia associated with diabetic ketoacidosis (DKA) 

  • Added schedule of monitoring of fasting glucose and HbA1c levels in patients treated with TRUQAP 

4.8 - Adverse effects (undesirable effects)  

  • Added diabetic ketoacidosis (DKA) 

6 November 2024 

darbepoetin alpha (RCH)

Aranesp - external site

Amgen Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added misuse or abuse of Aranesp by healthy persons, including athletes, may lead to an excessive increase in packed cell volume. This may be associated with life-threatening complications of the cardiovascular system.

19 November 2024
durvalumab 

Imfinzi - external site

AstraZeneca Pty Ltd 

All sections updated (including removal of black triangle)  

4.1 - Therapeutic indications

  • Removed provisional indication for malignant pleural mesothelioma (MPM) 

15 November 2024 

epoetin alpha (RCH)

Eprex - external site

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘Abuse potential’

  • Added abuse of EPREX may be seen in athletes for the effects on erythropoiesis and may lead to life-threatening cardiovascular complications (e.g., stroke, myocardial infarction, or thromboembolism)

19 November 2024

etanercept 

 

Nepexto - external site
 
Maxx Pharma Pty Ltd 

 

4.8 - Adverse effects (undesirable effects)  

  • Added glomerulonephritis 

 

1 November 2024 

fentanyl

Durogesic - external site

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added dysphagia

25 November 2024

fentanyl (as citrate)

Abstral - external site

A Menarini Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added dysphagia

5 November 2024
lamivudine 

Zeffix - external site

Arrotex Pharmaceuticals Pty Ltd 

4.4 - Special warnings and precautions for use  

  • Added hepatitis B rebound 

  • Expanded lactic acidosis warning 

  • Expanded HIV coinfection warning  

4.5 - Interactions with other medicines and other forms of interactions  

  • Added herbal remedies 

4.6 - Fertility, pregnancy and lactation  

  • Added breastfeeding warning 

4.8 - Adverse effects (undesirable effects) 

  • Multiple adverse effects added 

12 November 2024 
larotrectinib sulfate 

Vitrakvi - external site

Bayer Australia Ltd 

4.8 - Adverse effects (undesirable effects)  

  • Update to safety information (including patient numbers) from interim safety data from three clinical studies 

12 November 2024 
methotrexate 

Trexject - external site

Link Medical Products Pty Ltd T/A Link Pharmaceuticals 

4.4 - Special warnings and precautions for use: 

  • Added photosensitivity

4.5 - Interactions with other medicines and other forms of interactions 

  • Added use with metamizole

4.8 - Adverse effects (undesirable effects)  

  • Added photosensitivity reactions 

4 November 2024 

migalastat hydrochloride

Galafold - external site

 

Amicus Therapeutics Pty Ltd

4.8 - Adverse effects (undesirable effects)  

  • Added angioedema

31 October 2024

miqlustat

Zavesca - external site

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Added cases of Crohn’s disease have been reported post-marketing in Niemann-Pick type C disease patients treated with ZAVESCA. In patients with chronic diarrhoea and/or abdominal pain that do not respond to interventions or clinical worsening, the possibility of Crohn’s disease should be considered.

20 November 2024
oxycodone 

Oxynorm - external site 

Oxycontin - external site

Mundipharma 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 - Overdosage 

  • Added hypoglycemia

6 November 2024 
paracetamol 
tramadol hydrochloride 

Zaldiar - external site
 
Aspen Pharmacare Australia Pty Ltd 

 

4.2 - Dose and method of administration 

  • Added withdrawal syndrome after abrupt discontinuation of the treatment 

4.4 - Special warnings and precautions for use   

  • Replaced section ‘Tolerance, dependence and withdrawal’ with section ‘Tolerance and Opioid Use Disorder (abuse and dependence)’ 

4.5 - Interactions with other medicines and other forms of interactions   

  • Added interaction with CNS depressants (including addition of gabapentinoids) and potential risk of respiratory depression, coma, and death

  • Added interaction with anticholinergics 

4.9 - Overdose  

  • Added  death 

27 November 2024 

piroxicam

Mobilis & Moibilis D - external site

 
Alphapharm Pty Ltd 

  1. - Special warnings and precautions for use   

  • Updated galactose intolerance  

4.5 - Interactions with other medicines and other forms of interactions   

  • Updated increased haematological toxicity with methotrexate 

  • Updated nephrotoxicity with ciclosporin or tacrolimus 

4. 8 - Adverse effects (undesirable effects)  

  • jaundice 

27 November 2024 

rabeprazole

Pariet - external site

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated acute tubulointerstitial nephritis warning and added acute tubulointerstitial nephritis can progress to renal failure

4.8 - Adverse effects (undesirable effects)

  • Added tubulointerstitial nephritis (with possible progression to renal failure)

8 November 2024
romiplostim 

Nplate - external site

Amgen Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

&

4.8 - Adverse effects (undesirable effects)  

  • Added thrombotic/thromboembolic complications 

21 November 2024 

ropivacaine hydrochloride / fentanyl (as citrate)

Naropin With Fentanyl - external site

Aspen Pharma Care Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added dysphasia

27 November 2024

teriflunomide

Apo-Teriflunomide - external site

Teriflunomide Dr.Reddy's - external site

Dr Reddys Laboratories Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, have been reported and may occur at any time during treatment

4.8 - Adverse effects (undesirable effects)

  • Added herpes infection

5 November 2024

teriflunomide

Pharmacor Teriflunomide

Pharmacor Pty Ltd

4.4 - Special warnings and precautions for use

  • Added cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, have been reported and may occur at any time during treatment

4.8 - Adverse effects (undesirable effects)

  • Added herpes infection

19 November 2024
tipiracil hydrochloride and trifluridine 

Lonsurf - external site

Servier Laboratories (Aust) Pty Ltd 

4.4 - Special warnings and precautions for use  

  • Added use of G-CSF when taking trifluridine/tipiracil 

4.6 - Fertility, pregnancy and lactation  

  • Added advice about pregnancy after treatment 

4.8 - Adverse effects (undesirable effects)  

  • Added multiple adverse effects from the SUNLIGHT trial 

5 November 2024 

tobramycin (as sulfate)

DBL Tobramycin - external site

Tobramycin PF - external site

Tobramycin - external site 

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘Severe cutaneous adverse reactions’

  • Added: ‘Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens Johnson Syndrome have been reported rarely in patients on tobramycin therapy with fatalities reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.’

18 November 2024
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