Product Information safety updates - October 2024

Diamox

Arrotex Pharmaceuticals Pty Ltd 

4.4 - Special warnings and precautions for use 

• Added choroidal effusion/detachment and suicidal ideation.

4.8 - Adverse effects (undesirable effects) 

• Added choroidal effusion/detachment and reduced libido.

4.4 - Special warnings and precautions for use   

• Added lidocaine induced hypersensitivity reactions leading to Kounis syndrome.

23 September 2024 

Lemtrada

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions of use 

• Added subheading ‘Immune-Mediated Colitis’ - Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, has been reported in patients receiving Lemtrada in the post-marketing setting. The time from treatment initiation to onset of symptoms ranged from a few months to years. Monitor patients for immune-mediated colitis during and after Lemtrada treatment. 

4.8 - Adverse effects (undesirable effects)

• Added immune-mediated colitis.

Exforge HCT

Amlodipine / Valsartan / HCT 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.

4.5 - Interactions with other medicines and other forms of interactions

• Added hydroxychloroquine.

4.8 - Adverse effects (undesirable effects) 

• Added symmetrical drug-related intertriginous and flexural exanthema” (SDRIFE) (baboon syndrome).

Spikevax XBB.1.5

Moderna Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added breast swelling and mastitis.

Scemblix

Novartis Pharmaceuticals Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects)  

• Added hypothyroidism.

Rezurock

Sanofi-Aventis Australia Pty Ltd 

4.2- Dose and method of administration 

• Updated precautions for moderate or severe hepatic impairment.

4.5 - Interactions with other medicines and other forms of interactions

• Updated interaction with UGT1A1, P-gp and OATP1B1/BCRP substrates.

Symbicort Turbuhaler

Symbicort Rapihaler

Rilast Turbuhaler

Rilast Rapihaler

Astrazeneca Pty Ltd

4.4 - Special warnings and precautions of use 

• Added Cushing’s Syndrome and Cushingoid features. These effects are much less likely to occur with inhaled corticosteroid treatments than with oral corticosteroids.

Pulmicort

Astrazeneca Pty Ltd

4.4 - Special warnings and precautions of use 

• Added Cushing’s Syndrome and Cushingoid features. These effects are much less likely to occur with inhaled corticosteroid treatments than with oral corticosteroids.

4.4 - Special warnings and precautions for use  

• Added toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS).

4.8 - Adverse effects (undesirable effects) 

• Added severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Tegretol

Novartis Pharmaceuticals Australia Pty Ltd 

4.2 - Dose and method of administration  

• Added a maximum dose of the oral liquid.

4.4 - Special warnings and precautions for use  

&

4.8 - Adverse effects (undesirable effects)  

• Added corneal injury.

4.8 - Adverse effects (undesirable effects)  

• Added hepatoxicity following intravenous use.

DBL Docetaxel concentrated injection 

Pfizer Australia Pty Ltd 

4.6 - Fertility, pregnancy and lactation 

• Revised duration of contraception in both males and females.

5.2 - Pharmacokinetic properties

• Added mean terminal elimination half-life (affects contraception).

4.4 - Special warnings and precautions for use  

&
4.8 - Adverse effects (undesirable effects)  

• Added tumour lysis syndrome.
    

Ausfam

Arrotex Pharmaceuticals Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

• Added posaconazole and tyrosine kinase inhibitors.

4.8 - Adverse effects (undesirable effects)

Added:

• arrhythmias 
• QT prolongation.

Actiq

Fentora

Teva Pharma Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects) 

• Added dysphagia.

4.9 – Overdose 

• Added leukoencephalopathy.

Sublimaze

Piramal Critical Care Pty Ltd 

4.8 - Adverse effects (Undesirable effects) 

• Added dysphagia.

Diflucan

Pfizer Australia Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions

• Added abrocitinib.

Neurontin

Viatris Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Pregnancy Category updated – Pregnancy Category D

Xospata

Astellas Pharma Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

• Updated use in renal impairment.
• Added warning for use in severe renal impairment.

 5.2 - Pharmacokinetic properties

• Updated Renal impairment.

Columvi

Roche Products Pty Ltd 

Black box warning 

• Added neurological toxicity including Immune effector cell-associated neurotoxicity syndrome (ICANS).

4.2 - Dose and method of administration   

• Added guidance for the management of ICANS (table 4).

4.4 - Special warnings and precautions for use  

• Added ICANS.

4.8 - Adverse effects (undesirable effects) 

• Added updated information from Study NP30179.
• Multiple adverse events updated.

Biostate 

CSL Behring Australia Pty Ltd 

4.4 - Special warnings and precautions for use

• Updated information relating to formation of neutralising antibodies (inhibitors) to FVIII.

Holoxan

Baxter Healthcare Pty Ltd 

4.4 - Special warnings and precautions for use  

• Added encephalopathies.

4.6 - Fertility, pregnancy and lactation  

• Added contraceptive timeframes.

4.8 - Adverse effects (undesirable effects) 

• Updated CNS toxicity.

Xeomin

Merz Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects) 

Added:

• hyperhidrosis and rash 
• updated dry mouth and thickened saliva.

Indocid

Aspen Pharmacare Australia Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions 

• Added gold preparations.

4.7 - Effects on ability to drive and use machines

• Updated effects on driving.

Lithicarb

Aspen Pharmacare Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

• Added bariatric surgery.

4.5 - Interactions with other medicines and other forms of interactions  

• Added topiramate.

4.8 - Adverse effects (undesirable effects)  

• Added parathyroid adenoma, parathyroid hyperplasia.

4.4 - Special warnings and precautions for use 

• Added severe cutaneous adverse reactions (SCARs).

4.8 - Adverse effects (undesirable effects)  

• Added hypersensitivity reactions (including anaphylaxis).

nizatidine 

Nizac
 
Arrotex Pharmaceuticals Pty Ltd 

4.8 Adverse effects (undesirable effects) 

• Added leucopenia, agranulocytosis, anaemia.

16 September 2024 

Omacor

Viatris Pty Ltd 

4.4 - Special warnings and precautions for use  

&

4.8 - Adverse effects (undesirable effects)  

• Added atrial fibrillation.

Empaveli

Swedish Orphan Biovitrum Pty Ltd 

4.8 - Adverse effects (undesirable effects)

Added:

• urticaria
• anaphylactic reaction
• anaphylactic shock.

4.4 - Special warnings and precautions for use

Added:

• galactose malabsorption 
• chronic pain 
• young patients 
• existing liver problems 
• patients with a history of drug abuse or alcoholism.

4.8 - Adverse effects (undesirable effects)

Added:

• paradoxical reaction (unusual excitement) 
• hallucinations 
• restlessness 
• confusion in the elderly 
• lethargy.

Propofol-lipuro

B Braun Australia Pty Ltd 

4.1 - Therapeutic indications 

• Added indication amended for conscious sedation – to be used in adults only. 

4.2 - Dose and method of administration  

• Added dose adjustments in hypoproteinaemia and cardiorespiratory depression. 

4.3 - Contraindications  

• Added ‘patients 16 years of age or younger for sedation’.

4.4 - Special warnings and precautions for use  

• Added ‘pregnancy, young children, hypoproteinaemia, occurrence of PRIS.

4.5 - Interactions with other medicines and other forms of interactions  

• Added rifampicin, valproate, midazolam and opiate analgesics. 

4.8 - Adverse effects (undesirable effects)  

• Multiple adverse events added.

Xarelto

Ixarola

Bayer Australia Ltd

4.8 - Adverse effects (undesirable effects)

• Added splenic rupture.

Appese

Repreve
 
Arrotex Pharmaceuticals Pty Ltd 

4.4 - Special Warnings and Precautions for Use

• Added regular monitoring of impulse control disorders.

Naropin with Fentanyl

Aspen Pharmacare Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

• Added Horner’s syndrome following epidural administration especially in pregnant women.

4.6 - Fertility, pregnancy and lactation  

• Added foetal bradycardia.

4.8 - Adverse effects (undesirable effects) 

• Added anaphylactic shock.

tamoxifen

4.4 - Special warnings and precautions for use  

• Added QTc interval prolongation.

4.8 - Adverse effects (undesirable effects)  

• Added oral fungal infection.

4.4 - Special warnings and precautions for use  

• Added ‘not to be given to premature infants or infants in first few weeks of life’.

4.5 - Interactions with other medicines and other forms of interactions 

• Added antifolate effect when given with pyrimethamine.

4.8 - Adverse effects (undesirable effects)

Added:

• haematopoiesis
• gastrointestinal disturbance.

zolpidem tartrate 

Zolpimist
 
Arovella Therapeutics Ltd

4.4 - Special warnings and precautions for use  

• Added warning relating to chemical submission.