Product Information safety updates - April 2026

Caduet

Aspen Pharmacare Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Skeletal Muscle'. The risk of myopathy and/or rhabdomyolysis may be increased by concomitant administration of HMG-CoA reductase inhibitors (e.g. atorvastatin) and daptomycin. Consideration should be given to temporarily suspend CADUET in patients taking daptomycin unless the benefits of concomitant administration outweigh the risk. If co- administration cannot be avoided, CK levels should be measured 2-3 times per week and patients should be closely monitored for any signs or symptoms that might represent myopathy.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Daptomycin'. Cases of myopathy and/or rhabdomyolysis have been reported with HMG-CoA reductase inhibitors (e.g. atorvastatin) co-administered with daptomycin. If co-administration cannot be avoided, appropriate clinical monitoring is recommended.

4.8 Adverse effects (undesirable effects)

• Added lichenoid drug reaction
• Added vasculitis

APO-Atomoxetine

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added pre-existing psychosis, phaeochromocytoma, priapism, peripheral vasculopathy (including Raynaud's Phenomenon)
• Amended Seizures, Cardiovascular events and anxiety

4.5 - Interactions with other medicines and other forms of interactions

• Added anti-hypertensive drugs, Pressor agents or drugs that increase blood pressure
• Added information for interaction with other QT prolonging medicine and seizure under Beta-Adrenergic Receptor Agonists

Lipitor

Aspen Pharmacare Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Skeletal Muscle'. The risk of myopathy and/or rhabdomyolysis may be increased by concomitant administration of HMG-CoA reductase inhibitors (e.g. atorvastatin) and daptomycin. Consideration should be given to temporarily suspend LIPITOR in patients taking daptomycin unless the benefits of concomitant administration outweigh the risk. If co- administration cannot be avoided, CK levels should be measured 2-3 times per week and patients should be closely monitored for any signs or symptoms that might represent myopathy.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Daptomycin'. Cases of myopathy and/or rhabdomyolysis have been reported with HMG-CoA reductase inhibitors (e.g. atorvastatin) co-administered with daptomycin. If co-administration cannot be avoided, appropriate clinical monitoring is recommended.

4.8 Adverse effects (undesirable effects)

• Added lichenoid drug reaction
• Added vasculitis

Vidaza

Bristol-Myers Squibb Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Cardiac and Pulmonary Disease'. Limited data from the pivotal clinical study in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with azacitidine. It is therefore advised to exercise caution when prescribing azacitidine to these patients.

4.8 Adverse effects (undesirable effects)

• Added pericardial effusion with frequency common
• Added pericarditis with frequency uncommon
• Added new adverse event under subheading 'Cardiac Events'. Data from a clinical study allowing enrolment of patients with known history of cardiovascular or pulmonary disease showed an increase in cardiac events in patients with newly diagnosed AML treated with azacitidine.

Duratocin

Ferring Pharmaceuticals Pty Ltd

4.3 - Contraindications

• Addition: Not to be used for the augmentation of labour

4.6 - Fertility, pregnancy and lactation

• Must not be used for the induction or augmentation of labour

4.8 - Adverse effects (undesirable effects)

• Added palpitations under post-marketing adverse reactions

Nextstellis

Mayne Pharma International Pty Ltd

4.4 - Special warnings and precautions for use

• Update to use in renal impairment - not recommended for use in moderate renal impairment. No dose adjustment required for mild renal impairment.

Epkinly

Abbvie Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning for hypogammaglobulinaemia under subheading ‘Serious infections'. Hypogammaglobulinaemia has also been reported in patients receiving epcoritamab. Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local guidelines, including infection precautions and antimicrobial prophylaxis.

4.8 Adverse effects (undesirable effects)

• Added hypogammaglobulinaemia

Staphylex / Flopen Viatris

Alphapharm Pty Ltd

4.5 Interactions with other medicines and other forms of interactions:

• Added new interaction under subheading 'Posaconazole'. Flucloxacillin (a CYP450 inducer) may decrease plasma posaconazole concentrations. Concomitant use of posaconazole and flucloxacillin should be avoided unless the benefit to the patient outweighs the risk.

Andembry

CSL Behring (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

• Updated hypersensitivity reactions

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity reactions

Varilrix

GlaxoSmithKline Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning, Encephalitis has been reported during post-marketing use of live attenuated varicella vaccines including VARILRIX. Fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees or parents should be instructed to seek prompt medical attention if they or their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache.

4.8 Adverse effects (Undesirable effects)

• Added new description of selected adverse reaction, Encephalitis has been observed following vaccination with live attenuated varicella vaccines. Fatal outcome was reported in a few cases, especially in immunocompromised people.

Caldolor

Phebra Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Cardiovascular and cerebrovascular effects'. Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
• Added new warning under subheading 'Renal'. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients treated with ibuprofen over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

4.8 Adverse effects (undesirable effects)

• Added Kounis syndrome with frequency not known
• Added hypokalaemia with frequency not known
• Added renal tubular acidosis with frequency not known. Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of ibuprofen at higher than recommended doses.

4.9 Overdose

• Added prolonged use at higher than recommended doses or overdose may result in renal tubular acidosis and hypokalaemia. Symptoms may include reduced level of consciousness and generalised weakness.

Sarclisa

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updating information relating to anaphylaxis with infusion as fatalities have been reported. Additon of advice to permanently discontinue SARCLISA and institute appropriate management in the case of anaphylactic or life-threatening infusion reaction.

4.7 - Effects on ability to drive and use machines

• Post-market experience of anaphylactic reactions including fatal cases

4.8 - Adverse effects (undesirable effects)

• Post-market experience of anaphylactic reactions including fatal cases

Isoniazid

Arrotex Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Cerebellar Syndrome'. Cerebellar syndrome which may include abnormal motor coordination presenting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, has been reported in post-marketing case reports with the use of isoniazid. Most cases of cerebellar syndrome involved patients with chronic kidney disease (CKD), however, cerebellar syndrome was also reported in patients without CKD. Discontinue isoniazid if symptoms or signs of cerebellar syndrome occur.

4.8 Adverse effects (undesirable effects)

• Added new adverse event under subheading 'Nervous system'. Cerebellar syndrome, which may include abnormal motor coordination manifesting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, have been reported in post marketing case reports.

Priorix-Tetra

GlaxoSmithKline Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning, Encephalitis has been reported during post-marketing use of live attenuated measles, mumps, rubella and varicella vaccines including PRIORIX-TETRA. Fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees or parents should be instructed to seek prompt medical attention if they or their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache.

4.8 Adverse effects (Undesirable effects)

• Added new description of selected adverse reaction, encephalitis has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines. Fatal outcome was reported in a few cases, especially in immunocompromised people.

APO-Metformin XR / Metex XR

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Hypothyroidism - Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism
• Mitochondrial diseases - Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome
• Maternal inherited diabetes and deafness (MIDD)

4.5 - Interactions with other medicines and other forms of interactions

• Levothyroxine can reduce the hypoglycaemic effect of metformin

4.6 - Fertility, pregnancy and lactation

• Updated warning about use in pregnancy

4.8 - Adverse effects (undesirable effects)

Added:

• May increase the risk of lactic acidosis and adversely affect renal function
• Adverse effects in patients with hypothyroidism

Palynziq

BioMarin Pharmaceutical Australia Pty Ltd

4.2 - Dose and method of administration

• Added injection site infections

4.4 - Special warnings and precautions for use

• Added injection site infections.

4.8 - Adverse effects (undesirable effects)

• Added: Injection site infection, cellulitis, necrosis, and abscess

Keytruda

Merck Sharp & Dohme (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

• Under immune mediated reactions additional information has been added relating to myocarditis-myositis-myasthenia gravis overlap syndrome.

DBL Promethazine Hydrochloride

Pfizer Australia Pty Ltd

4.3 Contraindications

• Updated contraindication for use in paediatric patients less than two years of age because of potential for psychiatric and CNS (central nervous system) events

4.4 Special warnings and precautions for use

• Updated warning under subheading 'Paediatric use' with potential for psychiatric and CNS events in patients two years of age and older

4.8 Adverse effects (Undesirable effects)

• Added new adverse event under subheading 'CNS'. Children less than 6 years of age also experienced aggression, hallucination and psychomotor hyperactivity.

4.9 Overdose

• Added new overdose symptoms under subheading 'symptoms'. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, reversible intellectual disability and cognition deficit in children less than 6 years of age, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence.

Efexor-XR

Viatris Pty Ltd

4.9 Overdose

• Added 'hypoglycaemia' as a new symptom of overdose

Voranigo

Servier Laboratories (Aust) Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Addition of Post-marketing experience information - hepatobiliary disorders