Product Information safety updates - August 2024

Kineret

Swedish Orphan Biovitrum Pty Ltd

4. - Special warnings and precautions for use 

• systemic AIL1RAP-type amyloidosis in NOMID/CINCA patients

Reyataz

Bristol-Myers Squibb Australia Pty Ltd 

4.3 - Contraindications  

• strong inducers of CYP3A4 
  4. - Special warnings and precautions for use  

Buvidal Weekly

Buvidal Monthly

Camurus Pty Ltd

• warning on subcutaneous use only  
• acute pain management  
• dose adjustment in hepatic impairment

6.6 – Special Precautions for disposal

• Updated administration instructions for health care professionals.
  4. - Special warnings and precautions for use  

Ceclor

Ceclor CD

Viatris Pty Ltd 

• history of bleeding disorders 
  4. - Interactions with other medicines and other forms of interactions  
• vitamin K synthesis inhibition and interaction with aluminium hydroxide-or magnesium-containing antacids 
  4. - Fertility, pregnancy and lactation 
• Update to ‘effects on fertility’.

Clopine

Pfizer Australia Pty Ltd 

4.2 - Dose and method of administration  

• updated neutropenia information and the requirement of Absolute Neutrophil Count (ANC) monitoring when starting and ending therapy 
• updated special population patients 

4.4 - Special warnings and precautions for use  

• intestinal perforation, ulceration or necrosis 
• agranulocytosis/ severe neutropenia and Orthostatic hypotension, bradycardia and syncope
• using clozapine with other drugs associated with neutropenia 

4.8 - Adverse effects (undesirable effects)  

• severe neutropenia
• appendicitis and perforated appendicitis

Colistin Link

Link Medical Products Pty Ltd T/A Link Pharmaceuticals 

4.3 - Contraindications  

4.4 - Special warnings and precautions for use  

• myasthenia gravis

4.5 - Interactions with other medicines and other forms of interactions  

• co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin 

Tafinlar

Novartis Pharmaceuticals Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects) 

• febrile neutrophilic dermatosis (Sweet’s syndrome) 

Trusopt

Mundipharma Pty Ltd 

4.3 - Contraindications  

• severe renal impairment  

4.4 - Special warnings and precautions for use    

• corneal oedemas and irreversible corneal decompensations 
• updated preservative benzalkonium chloride warning  
  8. - Adverse effects (undesirable effects)    
• tachycardia, rash, shortness of breath, bronchospasm, hypertension 

Soliris

Alexion Pharmaceuticals Australasia Pty Ltd

Boxed Warning 

• Added life-threatening meningococcal infections/sepsis have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognised and treated early. 

Stocrin

Merck Sharp & Dohme (Australia) Pty Ltd

4.5 – Interactions with other medicines and other forms of interactions

• Added subheading ‘Anthelmintic’ - Concomitant use of praziquantel with efavirenz is not recommended due to significant decrease in plasma concentrations of praziquantel. In case the combination is needed, an increased dose of praziquantel could be considered.
  4. - Interactions with other medicines and other forms of interactions  

estradiol 

Estradot

Sandoz Pty Ltd 

• interaction with lamotrigine 

Aromasin

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added subheading ‘Tendon disorders’ - The use of third generation aromatase inhibitors, including exemestane, were found to be associated with tendonitis and tenosynovitis in randomised controlled trials. Tendon rupture was found to be a potential risk. Monitor patients for signs and symptoms of tendon disorders during treatment with AROMASIN. 

4.8 - Adverse effects (undesirable effects)

• Added tendonitis, tenosynovitis and tendon rupture. 

Staphylex

Flopen Viatris

Alphapharm Pty Ltd

4.5 – Interactions with other medicines and other forms of interactions

• Added subheading ‘Voriconazole’ – Flucloxacillin has been reported to significantly decrease plasma voriconazole concentration. If concomitant administration can not be avoided, monitor patients for potential loss of voriconazole effectiveness. 

Prozac

Eli Lily Australia 

4.4 - Special warnings and precautions for use

• Added subheading ‘Bone fracture’ – Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. 

4.8 - Adverse effects (undesirable effects)

• Added bone fractures. 

Multihance

Bracco Pty Ltd 

4.4 - Special warnings and precautions for use

• Added gadobenate dimeglumine must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions have been reported with intrathecal use. Gadobenate dimeglumine should be strictly administered via intravenous injection.

Gadovist 1.0

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

• Added subheading ‘Risks associated with intrathecal use’ – Gadobutrol must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions, have been reported with intrathecal use. Gadobutrol should be strictly administered via intravenous injection.

Omniscan

Ge Healthcare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added gadodiamide must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions, have been reported with intrathecal use. Gadodiamide should be strictly administered via intravenous injection.

Dotagraf

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

• Added gadoteric acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions have been reported with intrathecal use. Gadoteric acid should be strictly administered via intravenous injection.

Clariscan

GE Healthcare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added gadoteric acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions, have been reported with intrathecal use. Gadoteric acid should be strictly administered via intravenous injection.

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. It is unknown whether exposure to gadolinium is associated with adverse effects in the foetus.

Gliclazide MR Viatris 

Alphapharm Pty Ltd 

4.4 - Special warnings and precautions for use 

• debilitated patients as a factor that may increase risk of hypoglycaemia. 
• oral hypoglycaemic agents 
• patients with porphyria

4.8 - Adverse effects (undesirable effects)  

• pancreatitis acute

4.9 - Overdose    

• relapse for elderly or malnourished patients 
  4. - Special warnings and precautions for use  

Plaquenil

Sanofi-Aventis Australia Pty Ltd 

• Updated ‘Reactivation of infections’ and included herpes zoster and tuberculosis.
  8. - Adverse effects (undesirable effects)  

Sporanox

Janssen-Cilag Pty Ltd 

• pseudoaldosteronism bradycardia  
  4. - Fertility, pregnancy and lactation  

M-M-R II

Merck Sharp & Dohme (Australia) Pty Ltd 

• update to ‘use in pregnancy’  
• Congenital Rubella Syndrome 
  4. - Adverse effects (undesirable effects)  
• injection site reaction 

Nimenrix

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added febrile convulsion. 
• Added hypersensitivity including anaphylaxis. 

MenQuadfi

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added subheading ‘Intercurrent illness’ – Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection should not result in the deferral of vaccination.

4.8 - Adverse effects (undesirable effects)

• Added convulsions with or without fever. 
  8. - Adverse effects (undesirable effects) 

Concerta

Janssen-Cilag Pty Ltd 

• obsessive-compulsive disorders and symptoms 

morphine sulfate pentahydrate 

MS Contin

MS Mono

Sevredol

Mundipharma Pty Ltd 

4.2 - Dose and method of administration  

• treatment goals and duration of treatment 

4.4 - Special warnings and precautions for use  

• sleep-related breathing disorders 
• acute generalized exanthematous pustulosis (AGEP) 
• opioid use disorder (abuse and dependence) 
  8. - Adverse effects (undesirable effects)  
• spasm of sphincter of Oddi 
• central sleep apnoea syndrome 
• acute generalised exanthematous pustulosis (AGEP) 
• drug dependence 
  8. - Overdose    
• toxic leukoencephalopathy 

norethisterone acetate / estradiol 

Estalis Sequi

Estalis Continuous

Sandoz Pty Ltd 

4.5 - Interactions with other medicines and other forms of interactions  

• interaction with lamotrigine 
  8. - Adverse effects (undesirable effects)  

Pravachol

Arrotex Pharmaceuticals Pty Ltd 

• muscle rupture 

Crestor

A. Menarini Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added paraesthesia. 
  4. - Special warnings and precaution for use  

Cosentyx

Novartis Pharmaceuticals Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects)  

• eczematous eruptions and hypersensitivity reactions, angioedema 

Epilim

Sanofi-Aventis Australia Pty Ltd 

4.4 - Special warnings and precautions for use  

• severe Cutaneous Adverse Drugs Reactions (SCARs) and angioedema 
  8. - Adverse effects (undesirable effects)  
• hyperpigmentation 

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd 

4.8 - Adverse effects (undesirable effects) 

• febrile neutrophilic dermatosis (Sweet’s syndrome) 
  4. - Special warnings and precautions for use  

Imovane

Sanofi-Aventis Australia Pty Ltd 

• chemical submission (drug facilitated illicit use for criminal intent)