Product Information safety updates - December 2024

aflibercept

Eylea

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

Botox

Abbvie Pty Ltd 

4.4 - Special warnings and precautions for use

&

4.8 - Adverse effects (undesirable effects)  

• Added cumulative dose and interval for paediatrics 

canakinumab

Ilaris

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.

Truqap

AstraZeneca Pty Ltd 

4. - 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) 

darbepoetin alpha (RCH)

Aranesp

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.

Imfinzi

AstraZeneca Pty Ltd 

All sections updated (including removal of black triangle)  

4.1 - Therapeutic indications

• Removed provisional indication for malignant pleural mesothelioma (MPM) 

epoetin alpha (RCH)

Eprex

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)

etanercept 

Nepexto
 
Maxx Pharma Pty Ltd 

4.8 - Adverse effects (undesirable effects)  

• Added glomerulonephritis 

fentanyl

Durogesic

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added dysphasia

fentanyl (as citrate)

Abstral

A Menarini Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added dysphasia

Zeffix

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 

Vitrakvi

Bayer Australia Ltd 

4.8 - Adverse effects (undesirable effects)  

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

Trexject

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 

migalastat hydrochloride

Galafold

Amicus Therapeutics Pty Ltd

4.8 - Adverse effects (undesirable effects)  

• Added angioedema

miqlustat

Zavesca

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.

Oxynorm 

Oxycontin

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

Zaldiar
 
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 

piroxicam

Mobilis & Moibilis D

 
Alphapharm Pty Ltd 

4. - 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 

rabeprazole

Pariet

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)

Nplate

Amgen Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

&

4.8 - Adverse effects (undesirable effects)  

• Added thrombotic/thromboembolic complications 

ropivacaine hydrochloride / fentanyl (as citrate)

Naropin With Fentanyl

Aspen Pharma Care Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added dysphasia

teriflunomide

Apo-Teriflunomide

Teriflunomide Dr.Reddy's

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

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

Lonsurf

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 

tobramycin (as sulfate)

DBL Tobramycin

Tobramycin PF

Tobramycin 

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.’