Product Information safety updates - September 2024

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.

Calquence 

Astrazeneca Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about hypertension.

Calquence

Astrazeneca Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about hypertension.

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.

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.

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.

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.

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).
  4. - Special warnings and precautions for use  

Dymista

Viatris Pty Ltd 

• Added information about benzalkonium chloride.

Panadeine Forte

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

• opioid induced hyperalgesia and allodynia 

Mersyndol Forte

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use 

• opioid induced hyperalgesia and allodynia 

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

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 

Caelyx

Baxter Healthcare Pty Ltd 

4.6 - Fertility, pregnancy and lactation  

• Clarified contraception advice. 

Cymbalta

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about stress cardiomyopathy (Takotsubo cardiomyopathy).

Xtandi

Astellas Pharma Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

• dysphagia related to product size
  8. - Adverse effects (undesirable effects)  
• dysphagia and decreased appetite 

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.

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.

DBL Gemcitabine

Pfizer Australia Pty Ltd

4.3 - Contraindications  

• pregnancy and breastfeeding 

Sunlenca

Gilead Sciences Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

• dexamethasone 

Priorix 

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about immune thrombocytopenia (ITP).

M-M-R II

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about immune thrombocytopenia (ITP).

Priorix-tetra

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about immune thrombocytopenia (ITP).

Proquad

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about immune thrombocytopenia (ITP).

Ofev

Boehringer Ingelheim Pty Ltd 

4.4 - Special warnings and precautions for use

&

4.8 - Adverse effects (undesirable effects)  

• posterior reversible encephalopathy syndrome (PRES) 

D-Penamine

Alphapharm Pty Ltd 

4.3 - Contraindications  

• Strengthened warning regarding use in breastfeeding.

Pariet

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about hyponatraemia.

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.

Shingrix

Glaxosmithkline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added information about vertigo.
• Added information about Guillain-Barré syndrome.

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 

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 

Brilinta

AstraZeneca Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

• rosuvastatin 

Tevimbra

Beigene Aus Pty Ltd 

4.4 - Special warnings and precautions for use  

• Updated information about immune-related endocrinopathies and diabetes mellitus.

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.

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.