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Product Information safety updates - September 2024

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. 

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
abatacept (rch)

Orencia

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘Progressive multifocal leukoencephalopathy (PML)’ - Cases have been reported in patients receiving abatacept mostly in combination with other immunosuppressive medication. PML can be fatal and should be considered in the differential diagnosis in immunosuppressed patients with new onset or worsening neurological, psychiatric and cognitive symptoms. If symptoms are suggestive of PML, treatment with ORENCIA should be discontinued and appropriate diagnostic measures initiated.
27 August 2024
acalabrutinib

Calquence 

Astrazeneca Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about hypertension.
23 August 2024
acalabrutinib (as maleate)

Calquence

Astrazeneca Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about hypertension.
23 August 2024
amlodipine (as besilate)

Norvasc

Aspen Pharmacare Australia Pty Ltd

4.9 - Overdose

  • Added non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
26 August 2024
amlodipine (as besilate) / atorvastatin (as calcium trihydrate)

Caduet

Aspen Pharmacare Australia Pty Ltd

4.9 - Overdose

  • Added non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
29 August 2024
amlodipine (as besilate) / valsartan

Exforge

Amlodipine / Valsartan Novartis

Novartis Pharmaceuticals Australia Pty Ltd

4.9 - Overdose

  • Added non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
30 August 2024
avacopan 

Tavneos

Seqirus Pty Ltd 

4.4 - Special warnings and precautions for use

&

4.8 - Adverse effects (undesirable effects)

  • Added information about Vanishing Bile Duct Syndrome.
13 August 2024 
avanafil

Spedra

A. Menarini Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated information under subheading ‘Visual problems’ – visual defects including central serous chorioretinopathy (CSCR) have been reported. Most cases resolve after stopping the PDE5 inhibitor. Stop use of PDE5 inhibitors, including SPEDRA, in the event of sudden visual defect, visual acuity impairment and/or visual distortion. 

4.8 - Adverse effects (undesirable effects)

  • Added information about central serous chorioretinopathy (CSCR).
    1. - Special warnings and precautions for use  
12 August 2024
azelastine / fluticasone nasal spray 

Dymista

Viatris Pty Ltd 

  • Added information about benzalkonium chloride.
5 August 2024 
codeine phosphate hemihydrate and paracetamol 

Panadeine Forte

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

  • opioid induced hyperalgesia and allodynia 
26 August 2024 
codeine phosphate hemihydrate, doxylamine succinate and paracetamol 

Mersyndol Forte

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

  • opioid induced hyperalgesia and allodynia 
26 August 2024 
diltiazem 

Cardizem

Cardizem CD

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

  • interaction with direct oral anticoagulants. 

4.5 - Interactions with other medicines and other forms of interactions  

  • colchicine, direct oral anticoagulants and drug interactions leading to QT prolongation
8 August 2024 
Dorzolamide / timolol 

Cosopt

Mundipharma Pty Ltd 

4.3 - Contraindications  

  • sick sinus syndrome, severe renal impairment, hyperchloraemic acidosis 

4.4 - Special warnings and precautions for use  

  • beta-blockers  
  • urolithiasis 
  • Updated warning about corneal oedema. 

4.5 - Interactions with other medicines and other forms of interactions  

  • digitalis glycosises 
  • guanehtidine 
  • narcotics 
  • monoamine oxidase inhibitors 
  • antidiabetic drugs 

 

4.8 - Adverse effects (undesirable effects)  

  • potential for atrioventricular block, cardiac failure, tachycardia, hypertension, dysgeusia 
22 August 2024 
doxorubicin 

Caelyx

Baxter Healthcare Pty Ltd 

4.6 - Fertility, pregnancy and lactation  

  • Clarified contraception advice. 
28 August 2024 
duloxetine (as hydrochloride)

Cymbalta

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about stress cardiomyopathy (Takotsubo cardiomyopathy).
12 August 2024
enzalutamide 

Xtandi

Astellas Pharma Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

  • dysphagia related to product size
    1. - Adverse effects (undesirable effects)  
  • dysphagia and decreased appetite 
5 August 2024 
gadoteric acid

Dotarem

Guerbet Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added that gadoteric acid must not be used intrathecally and should be strictly administered via intravenous injection. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use.

4.6 - Fertility, pregnancy and lactation

  • Added data on the use of gadolinium-based contrast agents, including gadoteric acid, in pregnant women is limited. Gadolinium can cross the placenta. Gadoteric acid should not be used during pregnancy unless the clinical condition of the woman requires the use of gadoteric acid.
20 August 2024
gadoteridol

Prohance

Bracco Pty Ltd

4.4 - Special warnings and precautions for use

  • Added that gadoteridol must not be used intrathecally and should be strictly administered via intravenous injection. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use.
20 August 2024
gemcitabine  

DBL Gemcitabine

Pfizer Australia Pty Ltd

4.3 - Contraindications  

  • pregnancy and breastfeeding 
15 August 2024 
lenacapavir

Sunlenca

Gilead Sciences Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

  • dexamethasone 
22 August 2024 
measles, mumps, rubella vaccine

Priorix 

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about immune thrombocytopenia (ITP).
12 August 2024
measles, mumps, rubella vaccine

M-M-R II

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about immune thrombocytopenia (ITP).
15 August 2024
measles, mumps, rubella, varicella vaccine

Priorix-tetra

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about immune thrombocytopenia (ITP).
9 August 2024
measles, mumps, rubella, varicella vaccine

Proquad

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about immune thrombocytopenia (ITP).
16 August 2024
nintedanib

Ofev

Boehringer Ingelheim Pty Ltd 

4.4 - Special warnings and precautions for use

&

4.8 - Adverse effects (undesirable effects)  

  • posterior reversible encephalopathy syndrome (PRES) 
28 June 2024 
penicillamine 

D-Penamine

Alphapharm Pty Ltd 

4.3 - Contraindications  

  • Strengthened warning regarding use in breastfeeding.
1 August 2024 
rabeprazole sodium

Pariet

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about hyponatraemia.
12 August 2024
ranibizumab (rbe)

Lucentis

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subheading ‘Withholding Lucentis treatment in adults’ – Treatment should be withheld if decrease in best corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity, retinal break, subretinal haemorrhage involving the centre of the fovea, or if the size of the haemorrhage is ≥50% of the total lesion area and/or performed or planned intraocular surgery within the previous or following 28 days.
  • Added subheading ‘Retinal vasculitis and/or retinal occlusive vasculitis’ – Cases have been reported with the use of Lucentis. Discontinue treatment in patients who develop these events. Patients should report any change in vision without delay.
19 August 2024
recombinant Varicella zoster virus glycoprotein E antigen vaccine

Shingrix

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Added information about vertigo.
  • Added information about Guillain-Barré syndrome.
13 August 2024
remifentanil (as hydrochloride) 

Remifentanil Viatris

Alphapharm Pty Ltd 

 

4.4 - Special warnings and precautions for use 

  • hypotension – risk of concomitant use of benzodiazepines/other CNS depressants 
  • risk of use with biliary tract disease 

4.5 - Interactions with other medicines and other forms of interactions  

  • drugs affecting serotonergic neurotransmitter system 
  • monoamine oxidase inhibitors 

4.9 - Overdose  

  • symptoms of overdose 
13 August 2024 
salbutamol 

Asmol 

Zempreon

Alphapharm Pty Ltd 

4.4 - Special warnings and precautions for use  

  • overuse of short-acting beta 2-agonists (SABAs) 

4.8 - Adverse effects (undesirable effects)    

  • thrombocytopenia  

30 August 2024 

 

ticagrelor 

Brilinta

AstraZeneca Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

  • rosuvastatin 
8 August 2024 
tislelizumab 

Tevimbra

Beigene Aus Pty Ltd 

4.4 - Special warnings and precautions for use  

  • Updated information about immune-related endocrinopathies and diabetes mellitus.
29 August 2024 
triptorelin 

Decapeptyl

Ferring Pharmaceuticals Pty Ltd 

4.4 - Special warnings and precautions for use  

  • treatment duration without add-back therapy to prevent bone loss 
  • depression and mood changes

4.8 - Adverse effects (undesirable effects)  

  • Updated frequency of multiple adverse events and added multiple adverse events.

5.3 - Preclinical safety data  

  • Updated information about carcinogenicity.
6 August 2024 
vinblastine 

DBL Vinblastine

Pfizer Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation  

  • Update to duration of contraception after last dose.
  • Update to information about breastfeeding, added washout period.
  • Update to information about fertility and fertility preservation.
19 August 2024 
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