Product Information safety updates - July 2026

Humira

AbbVie Pty Ltd

4.8 - Adverse Effects (undesirable effects)

• Added nephrolithiasis with a frequency of common.

Synthamin

Baxter Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Added presence of sodium metabisulfite

Frisium

Atnahs Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Serious Skin Reactions'. Serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs, that are associated with serious skin reactions. SJS/TEN/DRESS could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN/DRESS, especially during the first 8 weeks of treatment. These commonly present as a combination of the following symptoms: extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy, and possible eosinophilia. Clobazam should be immediately discontinued when SJS/TEN/DRESS is suspected. If signs or symptoms suggest SJS/TEN/DRESS, use of this drug should not be resumed and alternative therapy should be considered

4.8 - Adverse effects (undesirable effects)

• Added drug reaction with eosinophilia and systemic symptoms syndrome

Infanrix-IPV

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse Effects (undesirable effects), post-marketing experience

• Added acute disseminated encephalomyelitis (causality not confirmed) with a frequency of very rare

Darzalex

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• weight decreased
• hypotension

Staphylex / Flopen Viatris

Alphapharm Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Tacrolimus'. Flucloxacillin (a CYP450 inducer) may decrease tacrolimus whole blood trough concentrations and increase the risk of rejection. Monitor tacrolimus whole blood trough concentrations and increase tacrolimus dose if needed. Monitor graft function closely.

Florinef

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added panniculitis

Neurontin

Viatris Pty Ltd

4.4 - Special warnings and precautions for use 

• Added new warning under subheading 'Myasthenia gravis'. Gabapentin should be used with caution in patients with myasthenia gravis as post-marketing cases of exacerbation of myasthenia gravis have been reported with gabapentin.

4.8 - Adverse effects (undesirable effects)

• Added exacerbation of myasthenia gravis

Emgality

Eli Lilly Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypertension'. Development of hypertension and worsening of pre-existing hypertension have been reported following the use of calcitonin gene-related peptide (CGRP) antagonists, including EMGALITY, in the post-marketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalisation. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with EMGALITY for new-onset hypertension or worsening of preexisting hypertension, and consider whether discontinuation of EMGALITY is warranted if evaluation fails to establish an alternative aetiology or blood pressure is inadequately controlled.

4.8 - Adverse effects (undesirable effects), post-marketing data

• Added hypertension with a frequency of unknown

Act-HIB

Sanofi-Aventis Australia Pty Ltd

4.2 - Dosage and Method of Administration

• Added new subsection 'Reconstitution before administration of Act-HIB vaccine'. Each single dose vial of Act-HIB contains freeze-dried powder which needs to be dissolved in 0.5 mL of the diluent for Act-HIB. Slowly inject the entire contents of the diluent pre-filled syringe into the centre of the stopper on the vial. Shake vigorously until the freeze-dried powder is completely dissolved and a colourless solution is visible. Withdraw the entire contents of the reconstituted vaccine into the syringe and administer the total volume (about 0.5 mL) via the intramuscular or subcutaneous route. Aseptic technique must be used for withdrawal of each dose.

Rotarix

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning. Appropriate medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine

4.8 - Adverse effects (undesirable effects), post-marketing data

• Added anaphylactic reaction with a frequency of not known

Aldara

iNova Pharmaceuticals (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added mouth ulceration

Priorix

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects), post-marketing data

• Added skin granuloma associated with vaccine derived rubella virus with a frequency of unknown

Priorix Tetra

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects), post-marketing data

• Added skin granuloma associated with vaccine derived rubella virus with a frequency of unknown

Increlex

Asteri Pharma Pty Ltd

4.2 - Dose and method of administration

• Added instructions on how to inject Increlex

Beyfortus

Sanofi-Aventis Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Added new safety information under subheading 'Use in pregnancy (Category B2)'. BEYFORTUS is not indicated for use in females of reproductive potential

ARX-Nitrofurantoin

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications

• Added renal disfunction, G6PD deficiency, acute porphyria

4.4 - Special warnings and precautions for use

• Updated peripheral neuropathy, renal impairment, pulmonary reactions
• Added hepatotoxicity
• Added clostridium difficile-associated diarrhoea
• Added galactose intolerance, total lactase deficiency or glucose-galactose malabsorption warning
• Added information for patients
• Updated use in elderly

4.5 - Interactions with other medicines and other forms of interactions

• Updated antacids
• Added carbonic anhydrase inhibitors, urine alkalinising agents, quinolone antimicrobials, oral typhoid vaccines

4.6 - Fertility, pregnancy and lactation

• Updated pregnancy
• Updated breastfeeding information

4.8 - Adverse effects (undesirable effects)

Added:

• aplastic anaemia
• nervous system disorders
• asthma
• pseudomembranous colitis, dyspepsia, constipation, flatulence
• angioedema
• malaise, myalgia
• increased AST (SGOT), increased ALT (SGPT), decreased haemoglobin, increased serum phosphorus

Alepam

Alphapharm Pty Ltd

4.3 - Contraindications

Added:

• severe pulmonary insufficiency
• myasthenia gravis
• spinal or cerebellar ataxia

4.4 - Special warnings and precautions for use

• Updated withdrawal
• Updated amnesia
• Updated psychiatric and paradoxical reactions
• Added thyroid disease may affect the levels of oxazepam
• Added worsening hepatic encephalopathy

4.5 - Interactions with other medicines and other forms of interactions

• Added oxazepam with opioids increases the risk of sedation, respiratory depression, coma, death

4.6 - Fertility, pregnancy and lactation

• Updated use in pregnancy
• Added sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines

4.8 - Adverse effects (undesirable effects)

Added:

• coma
• extrapyramidal disorder
• convulsion
• amnesia
• tremor
• vertigo
• dysarthria
• hypothermia
• paradoxical drug reaction (anxiety)
• ataxia
• confusional state
• dizziness

4.9 - Overdose

• Added flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines

Stivarga

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Thrombotic microangiopathy (TMA)'. TMA, including thrombotic thrombocytopaenic purpura (TTP), have been associated with the use of regorafenib. The diagnosis of TMA should be considered in patients presenting with haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurological manifestation, renal impairment, and fever. Regorafenib therapy should be discontinued in patients who develop TMA and prompt treatment is required. Reversal of the effects of TMA has been observed after treatment discontinuation.

4.8 - Adverse effects (undesirable effects), post-marketing experience

• Added cases of thrombotic microangiopathy have been reported (frequency rare).

Kisqali

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning 'Thromboembolic events'. Thromboembolic events, including pulmonary embolism, were reported in patients treated with CDK4/6 inhibitors in combination with endocrine therapy. Patients at risk of thromboembolic events should be closely monitored while receiving KISQALI.

4.8 - Adverse effects (undesirable effects)

• Added thrombosis

Rifadin

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• restricted therapeutic indications for rifampicin oral syrup
• contraception for males and females
• genotoxicity statement for rifampicin oral syrup

4.6 - Fertility, pregnancy and lactation

• contraception for males and females
• genotoxic potential in animals

Rocuronium Baxter

Baxter Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Added hypertensive crisis in patients with phaeochromocytoma

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity observed for rocuronium and for rocuronium-sugammadex complex

Wegovy / Ozempic

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use 

• Updated gastrointestinal effects and dehydration
• Added patients with gastroparesis may experience more serious or severe gastrointestinal effects
• Added non-arteritic anterior ischaemic optic neuropathy (NAION)

4.8 - Adverse effects (undesirable effects)

Added:

• more serious or severe gastrointestinal effects for patients with gastroparesis
• non-arteritic anterior ischaemic optic neuropathy (NAION)
• alopecia
• cholecystitis

Zoloft

Viatris Pty Ltd

4.8 - Adverse effects (undesirable effects), post-marketing experience

• Added multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorder with a frequency of unknown

Epilim / Epilim IV / Sodium Valproate Sandoz / Valproate Winthrop / Valpro

Sanofi-Aventis Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Updated warning under subheading 'Clozapine'. Concomitant treatment of valproate and clozapine may increase the risk of clozapine-induced myocarditis. If concomitant use of valproate with clozapine is necessary, careful monitoring for this event is required.

Tamosin

Orion Pharma (AUS) Pty Limited

4.4 - Special warnings and precautions for use

• Updated QTc interval prolongation warning
• Added decrease in bone mineral density in premenopausal women warning

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction with other medicines known to cause QT prolongation

4.8 - Adverse effects (undesirable effects)

Added:

• decreased bone mineral density 
• QT prolongation

Mounjaro

Eli Lilly Australia Pty Ltd

4.8 - Adverse Effects (undesirable effects)

• Added new adverse event under subheading 'Eye Disorders'. Events of non-arteritic anterior ischaemic optic neuropathy (NAION), a rare condition associated with the potential for decreased vision including permanent loss of vision, have been reported in patients treated with products with GLP-1 receptor agonist activity. A sudden loss of vision should lead to ophthalmological examination.

Pytest

Tri-Med Distributors Pty Ltd

4.2 - Dose and method of administration

• Added instructions for patients to discontinue H2 antagonists 24 hours prior to test

4.4 - Special warnings and precautions for use

• Added instructions for patients to discontinue H2 antagonists 24 hours prior to test

4.5 - Interactions with other medicines and other forms of interactions

• Added histamine H2-receptor antagonists (such as cimetidine, famotidine, nizatidine, and ranitidine) are known to supress H. Pylori and ingestion within 24 hours of testing may give false negative result

APX-Valaciclovir / Valtrex / Zelitrex

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Expanded drug reaction with eosinophilia and systemic symptoms (DRESS) precaution to include additional severe cutaneous adverse reactions (SCARs)

4.8 - Adverse effects (undesirable effects)

Added:

• acute generalised exanthematous pustulosis (AGEP)
• toxic epidermal necrolysis (TEN)
• Stevens-Johnson Syndrome (SJS)