Product Information safety updates - November 2024

Eylea

Bayer Australia Ltd

4.4 Special warnings and precautions for use

• Added intravitreal injections, including EYLEA have been associated with retinal vasculitis and retinal occlusive vasculitis. Patients should be instructed to report any symptoms suggestive of retinal vasculitis and retinal occlusive vasculitis without delay.

4.8 Adverse effects (undesirable effects)

• Added retinal vasculitis and retinal occlusive vasculitis.

Lipitor

Aspen Pharmacare Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added depression.

Mektovi

Pierre Fabre Australia Pty Ltd

4.4 - Special warnings and precautions for use 

&

4.8 - Adverse effects (undesirable effects)

• Added tumour lysis syndrome

8 October 2024

Zyban SR

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use:

• Added unmasking of Brugada syndrome.

4.8 - Adverse effects (undesirable effects)

• Added alopecia.

cemiplimab

Libtayo

Medison Pharma Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added class effects (immune checkpoint inhibitors) coeliac disease and pancreatic exocrine insufficiency.

Aspen Ciprofloxacin

Aspen Pharmacare Australia Pty Ltd

Boxed warning

• Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 Special warnings and precautions for use

• Updated introductory paragraph regarding disabling and potentially irreversible serious adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Ciprofloxacin Sandoz

Sandoz Pty Ltd

Boxed warning

• Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 Special warnings and precautions for use

• Updated introductory paragraph regarding disabling and potentially persistent adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.

C-Flox

Alphapharm Pty Ltd

Boxed warning

• Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 Special warnings and precautions for use

• Updated introductory paragraph regarding disabling and potentially persistent adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Tafinlar

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added Vogt-Koyanagi-Harada-like syndrome.

4.8 - Adverse effects (undesirable effects)

• Added Guillain-Barre syndrome.

DBL Dexamethasone sodium phosphate injection

Pfizer Australia Pty Ltd

4.3 - Contraindications

• Update to specify local injection in patients.

Aricept

Pfizer Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added hypersexuality and pleurothotonus (Pisa syndrome).

Dupixent

Sanofi-Aventis Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added subheading ‘Arthralgia’ – Arthralgia has been reported with the use of Dupixent with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalisation. Advise patients to report new onset or worsening joint symptoms to their healthcare provider. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of Dupixent.

Novicrit

Sandoz Pty Ltd

4.4 Special warnings and precautions for use

• Added subheading ‘Abuse potential’ - Abuse of Novicrit may be seen in athletes for the effects on erythropoiesis. and may lead to life-threatening cardiovascular complications (e.g., stroke, myocardial infarction, or thromboembolism).

Ovestin

Aspen Pharmacare Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions 

• Added lamotrigine.

4.8 - Adverse effects (undesirable effects) 

• Added visual impairment.

Ezetrol

Zient

Organon Pharma Pty Ltd

4.4 Special warnings and precautions for use

• Added there is sufficient evidence to suggest a causal association between ezetimibe monotherapy and drug-induced liver injury.

Remicade

Janssen-Cilag Pty Ltd

4.2 - Dose and method of administration 

• Added precautionary statement to delay treatment in case of planned surgical procedure.

4.8 - Adverse effects (undesirable effects) 

• Added post-procedural complication.
• Added paradoxical drug-induced immune disorders

Cresemba

Pfizer Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added cyclophosphamide.

Arava

Sanofi-Aventis Australia Pty Ltd

2. - Special warnings and precautions for use 

• Added impaired wound healing after surgery.

Eligard

Mundipharma Pty Ltd

4.4 Special warnings and precautions for use

• Updated subheading to ‘Metabolic Changes’ – Metabolic changes associated with GnRH agonist may also include non-alcoholic fatty liver disease.

Bi Eligard Cp

Mundipharma Pty Ltd

4.4 Special warnings and precautions for use

• Updated subheading to ‘Metabolic Changes’ – Metabolic changes associated with GnRH agonist may also include non-alcoholic fatty liver disease.

Keppra

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

8. - Adverse effects (undesirable effects) 

• Added Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Quilonum SR

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added precaution for 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.

Proquad

Merck Sharp & Dohme Australia Pty Ltd

3. - Contraindications

• Strengthened warning regarding contraindication in pregnancy.

4.6 - Fertility, Pregnancy and Lactation

• Added congenital rubella syndrome information in pregnancy.

4.8 - Adverse effects (undesirable effects)

• Added injection site reactions in children.

Galafold

Amicus Therapeutics Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added angioedema.

Moxifloxacin Apo

Arrotex Pharmaceuticals Pty Ltd

Boxed warning

• Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 Special warnings and precautions for use

• Updated introductory paragraph regarding disabling and potentially persistent adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Avelox

Bayer Australia Ltd

Boxed warning

• Added fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects.

4.4 Special warnings and precautions for use

• Updated introductory paragraph regarding disabling and potentially irreversible adverse reactions to include patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Tysabri

Biogen Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation 

• Added update on neonatal anaemia.

Privigen

Privigen AU

CSl Behring Australia Pty Ltd

4.4 Special warnings and precautions for use

• Updated warning regarding aseptic meningitis syndrome to include patients exhibiting symptoms of severe headache, nuchal rigidity, drowsiness, fever, photophobia, nausea, and vomiting should receive a thorough neurological examination, including cerebrospinal fluid studies, to rule out other causes of meningitis.

4.8 Adverse effects (undesirable effects)

• Added brain oedema (cerebral oedema). 

Gazyva

Roche Products Pty Ltd

 4.8 Adverse effects (undesirable effects)

• Added hypogammaglobulinaemia.

Ocrevus

Roche Products Pty Ltd

4.4 Special warnings and precautions for use

• Added serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies.

Kesimpta

Novartis Pharmaceuticals Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies.

Sevikar

Olmesartan / Amlodipine -Myl

Organon Pharma Pty Ltd

4.9 Overdose

• Added non-cardiogenic pulmonary oedema has rarely been reported with amlodipine overdose that may manifest with delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures may be a precipitating factor.

Sevikar Hct

Organon Pharma Pty Ltd

4.9 Overdose

• Added non-cardiogenic pulmonary oedema has rarely been reported with amlodipine overdose that may manifest with delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures may be a precipitating factor.

Zolgensma

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added Safety data in patients weighing 8.5 to 21 kg.

Trileptal

Novartis Pharmaceuticals Australia Pty Ltd

3. - Dose and method of administration 

• Maximum dosage reduced due to EG/DEG content of oral suspension.

pasireotide diaspartate

pasireotide embonate

Signifor

Signifor LAR

Recordati Rare Diseases Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• steatorrhea
  &
• discoloured stools

Pravachol

Arrotex Pharmaceuticals Pty Ltd

4. - Special warnings and precautions for use 

Added:

• hypercholesterolaemia due to elevated HDL-cholesterol
• combination of pravastatin with fibrates
• an update to myopathy and contributing factors to risk of muscular toxicity
• clarithromycin and other macrolides
• colchicine
• children before puberty.

4.5 - Interactions with other medicines and other forms of interactions 

• Updated macrolides.
• Added lenalidomide.

4.6 - Fertility, pregnancy and lactation 

• Strengthened caution in pregnancy.

4.8 - Adverse effects (undesirable effects)

• Dizziness, headache, sleep disturbance, myasthenia gravis; dyspepsia/heartburn, abdominal pain, constipation, diarrhoea, flatulence; rash, urticaria, calp/hair abnormality; abnormal urination; vision disturbance, ocular myasthenia
• Events of special clinical interest – skeletal muscle effects and liver effects
• Post-marketing – added skin and subcutaneous tissue disorders.

Viagra

Viatris Pty Ltd

4.4 Special warnings and precautions for use

• Added visual defects including central serous chorioretinopathy have been reported in connection with the intake of tadalafil and other PDE5 inhibitors, with most cases resolving spontaneously after stopping.

4.8 Adverse effects (undesirable effects)

• Added central serous chorioretinopathy.

Revatio

Viatris Pty Ltd

4.4 Special warnings and precautions for use

• Added visual defects including central serous chorioretinopathy have been reported in connection with the intake of tadalafil and other PDE5 inhibitors, with most cases resolving spontaneously after stopping.

4.8 Adverse effects (undesirable effects)

• Added central serous chorioretinopathy.

Cialis

Eli Lilly Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added visual defects including central serous chorioretinopathy have been reported in connection with the intake of tadalafil and other PDE5 inhibitors, with most cases resolving spontaneously after stopping.

4.8 Adverse effects (undesirable effects)

• Added central serous chorioretinopathy.

Terimide

Alphapharm Pty Ltd

4.4 Special warnings and precautions for use

• Added cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, have been reported and may occur at any time during treatment.

4.8 Adverse effects (undesirable effects)

• Added herpes infection.

Teriflunomide Gh

Generic Health Pty Ltd

4.4 Special warnings and precautions for use

• Added cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, have been reported and may occur at any time during treatment.

4.8 Adverse effects (undesirable effects)

• Added herpes infection.

Teriflunomide Sandoz

Sandoz Pty Ltd

4.4 Special warnings and precautions for use

• Added cases of herpes virus infections, including oral herpes, herpes zoster, herpetic meningoencephalitis and herpes dissemination, have been reported and may occur at any time during treatment.

4.8 Adverse effects (undesirable effects)

• Added herpes infection.

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added Guillain-Barre syndrome.

DBL Vincristine sulfate

Pfizer Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions 

• Added granulocyte-colony stimulating factors (G-CSFs).

Vfend

Pfizer Australia Pty Ltd

4. - Contraindications

&

4.5 - Interactions with other medicines and other forms of interactions 

• Added finerenone contraindication.