Product Information safety updates - April 2025

Humira

Abbvie Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added autoimmune hepatitis
• Updated liver enzyme reactions

Zyloprim

Arrotex Pharmaceutical Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added lichenoid drug reaction

Tecentriq  / Tecentriq SC

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use   

• Added pre-existing autoimmune disease (AID)

4.8 - Adverse effects (undesirable effects) 

Added:

• Peripheral neuropathy 
• Pancreatic exocrine insufficiency
• Coeliac disease

Oluminant

Eli Lilly Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Hypoglycaemia in patients treated for diabetes’. Hypoglycaemia has been reported following initiation of JAK inhibitors, in patients receiving treatment for diabetes. Dose adjustment of anti-diabetic medicinal products may be necessary in the event that hypoglycaemia occurs.

Temgesic

Echo Therapeutics Pty Ltd

4.2 – Dose and method of administration

Added:

• Treatment goals and discontinuation
• Duration of treatment

4.4 – Special warnings and precautions for use

• Added tolerance and opioid use disorder

4.5 – Interactions with other medicines and other forms of interactions

Added:

• Central nervous system
• Gabapentinoids 
• Antihistamines
• Anti-Parkinson drugs

4.8 – Adverse effects (undesirable effects)

Added:

• Dental caries
• Drug dependency

4.4 - Special warnings and precautions for use

• Added Kounis syndrome

4.8 - Adverse effects (undesirable effects) 

• Added Kounis syndrome

Celebrex

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• Fixed drug eruption (FDE) 
• Generalised bullous fixed drug eruption (GBFDE)

4.8 - Adverse effects (undesirable effects)

Added:

• Fixed drug eruption (FDE) 
•  Generalised bullous fixed drug eruption (GBFDE)

Ikervis

Seqirus Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added Urinary Tract Infection. 

4.4 - Special warnings and precautions for use

• Added advice to avoid using other products containing denosumab

4.4 - Special warnings and precautions for use

• Added rhabdomyolysis

4.8 - Adverse effects (undesirable effects)

• Added rhabdomyolysis

Trikafta

Vertex Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• Advanced liver disease
• Revised monitoring
• Hepatic injury 

4.8 - Adverse effects (undesirable effects)

• Added pre-existing advanced liver disease

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity

4.4 - Special warnings and precautions for use

Added:

• Haemophagocytic lymphohistiocytosis (HLH)
• Progressive multifocal leukoencephalopathy (PML) 

4.8 - Adverse effects (undesirable effects) 

• Added haemophagocytic lymphohistiocytosis (HLH)

Halaven

Eisai Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Added contraception timeframes in males and females

Ovestin

 

Aspen Pharmacare Pty Ltd

4.4 - Special warnings and precautions for use

• Added pancreatitis

Gilenya 

Novartis Pharmaceuticals Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Progressive multifocal leukoencephalopathy’. Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients treated with S1P receptor modulators, including Gilenya who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.
• Added additional warning under subheading ‘Return of disease activity (rebound) after Gilenya discontinuation’. After stopping Gilenya in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS). 

4.8 - Adverse effects (undesirable effects) 

• Added diarrhoea

Tolak 4% once daily

Aspen Pharmacare Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Added contraception timeframes in males and females

Emgality

Eli Lilly Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added fatigue.

hydrocortisone sodium succinate

4.4 - Special warnings and precautions for use

• Added rhabdomyolysis

4.8 - Adverse effects (undesirable effects)

• Added rhabdomyolysis

4.8 - Adverse effects (undesirable effects) 

• Added fixed eruption 

Avonex

Biogen Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Pulmonary Arterial Hypertension’. Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products, including Avonex. PAH has occurred in patients in the absence of other contributory factors. Many of the reported cases required hospitalisation, including one case of lung transplant. PAH has developed at various time points after initiating therapy and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnoea, new or increasing fatigue) should be assessed for PAH. If alternative aetiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.

4.8 Adverse effects (undesirable effects)

• Added Pulmonary Arterial Hypertension.

4.2 - Dose and method of administration    

• Updated administration guidance 

4.4 - Special warnings and precautions for use

• Added injection site reaction

Cozaar

Organon Pharma Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added intestinal angioedema

methylprednisolone acetate

4.4 - Special warnings and precautions for use

• Added rhabdomyolysis

4.8 - Adverse effects (undesirable effects)

• Added rhabdomyolysis

Solu-Medrol  
Solu-Medrol Act-O-Vial

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added rhabdomyolysis

4.8 - Adverse effects (undesirable effects)

• Added rhabdomyolysis

Avelox

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

• Added Kounis syndrome

4.8 - Adverse effects (undesirable effects)

• Added Kounis syndrome

Lynparza

Astrazeneca Pty Ltd

4.4 Special warnings and precautions for use 

• Added new warning under subheading ‘Drug-Induced Liver injury’. Cases of drug-induced liver injury (DILI) have been reported in patients treated with Lynparza in the post-marketing setting. If DILI is suspected, treatment should be interrupted. If DILI is confirmed, treatment should be discontinued.

4.8 Adverse effects (undesirable effects)

• Added Drug-induced liver injury with frequency of rare.

Trileptal

Novartis Pharmaceuticals Australia Pty Ltd

4.6  - Fertility, pregnancy and lactation 

• Added risk of infants being born small (SGA)

Zeposia

Bristol-Myers Squibb Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added additional warning under subheading ‘Return of MS disease activity (rebound) after Zeposia discontinuation’. After stopping Zeposia in the setting of progressive multifocal leukoencephalopathy (PML), monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS).
• Added new warning under subheading ‘Progressive multifocal leukoencephalopathy (PML)’. Immune reconstitution inflammatory syndrome (IRIS) has been reported in MS patients treated with S1P receptor modulators who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.

Panadeine forte

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added opioids and gabapentinoids

4.5 – Interactions with other medicines and other forms of interactions

• Added opioids and gabapentinoids

Mersyndol

Mersyndol Forte

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added opioids and gabapentinoids

4.5 – Interactions with other medicines and other forms of interactions

• Added opioids and gabapentinoids

Plegridy 

Biogen Australia Pty Ltd 

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Pulmonary Arterial Hypertension’. Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products, including Plegridy. PAH has occurred in the absence of other contributory factors. Many of the reported cases required hospitalisation, including one case of a lung transplant. PAH has developed at various time points after initiating therapy and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnoea, new or increasing fatigue) should be assessed for PAH. If alternative aetiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.

4.8 Adverse effects (undesirable effects)

• Added Pulmonary Arterial Hypertension.

Abrysvo

Pfizer Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Guillain-Barré syndrome’. Guillain-Barré syndrome has been reported rarely following vaccination with Abrysvo in individuals ≥60 years of age. Healthcare professionals should be alert to signs and symptoms of Guillain-Barré syndrome to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes.

4.8 Adverse effects (undesirable effects)

• Added new ‘post-marketing experience’ table to include Guillain-Barré syndrome with frequency of very rare.

4.8 - Adverse effects (undesirable effects) 

• Added dizziness

sacituzumab govitecan

Trodelvy

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

• Update to G-CSF primary prophylaxis mitigation

4.8 - Adverse effects (undesirable effects)

• Update to G-CSF primary prophylaxis mitigation

Cosentyx

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use  

Added:

• Pre-treatment evaluation for tuberculosis
• Hepatitis B reactivation

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity vasculitis

Ozempic 

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Aspiration in association with general anaesthesia or deep sedation’. Pulmonary aspiration has been reported in patients receiving GLP-1 RAs undergoing general anaesthesia (GA) or deep sedation despite reported adherence to preoperative fasting recommendations. Therefore, the increased risk of residual gastric content should be considered prior to performing procedures with GA or deep sedation.
• Added new warning under ‘Populations not studied’ subheading, there is limited experience in patients with a history of severe gastroparesis. Use with caution in these patients.

4.8 Adverse effects (undesirable effects)

• Added new adverse reaction headache with frequency of common.
• Added new post-marketing adverse effect urolithiasis and hiccups.
• Added expansion of intestinal obstruction* to include Intestinal obstruction, Ileus and small intestinal obstructions. 

4.8 - Adverse effects (undesirable effects) 

Added:

• Hypersensitivity
• Update injection site reactions 
• Update upper respiratory tract infection 

4.4 - Special warnings and precautions for use

• Updated cytokine release syndrome warning 

Tecvayli

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added progressive multifocal leukoencephalopathy (PML) 

Primoteston depot

Bayer Australia Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Updated hypoglycaemic agents section to include oral antidiabetic drugs

4.8 - Adverse effects (undesirable effects)

Added:

• Depression
• Insomnia 
• Restlessness 
• Headache 
• Hot flush 
• Hypertension 
• Dysphonia 
• Diarrhoea 
• Nausea 
• Arthralgia 
• Pain in extremity 
• Myalgia 
• Fatigue 
• Asthenia 

Blood testosterone increased

Mounjaro

Eli Lilly Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Benzyl Alcohol’. Mounjaro KwikPen contains 5.4 mg benzyl alcohol in each 0.6 mL dose. Benzyl alcohol may cause allergic reactions. Patients with hepatic or renal impairment should be informed of the potential risk of metabolic acidosis due to accumulation of benzyl alcohol over time.

4.8 Adverse effects (undesirable effects)

• Added acute gallbladder disease including cholelithiasis, cholecystitis, biliary colic and cholecystectomy with a frequency of uncommon.

vandetanib 

Caprelsa

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use  

• Added osteonecrosis

4.8 - Adverse effects (undesirable effects) 

• Added osteonecrosis