Product Information safety updates - March 2025

Yonsa Mpred

Sun Pharma ANZ Pty Ltd

4.4 - Special warnings and precautions for use

• Added immunosuppression and increased risk of infection, concomitant use of potassium depleting agents, TPP for methylprednisolone

4.5 - Interactions with other medicines and other forms of interactions

• Revision of concomitant use of potassium depleting agents for methylprednisolone.

4.8 - Adverse effects (undesirable effects)

• Added flushing under Vascular Disorders, Bruises, Skin hypopigmentation or Hyperpigmentation

Diamox

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Non-cardiogenic pulmonary oedema’. Non-cardiogenic pulmonary oedema typically developes within minutes to hours after acetazolamide intake. Symptoms included dyspnoea, hypoxia, and respiratory insufficiency. If non-cardiogenic pulmonary oedema is suspected acetazolamide should be withdrawn, and supportive treatment should be given.

4.8 - Adverse effects (undesirable effects)

• Added non-cardiogenic pulmonary oedema

Glaumox

Phebra Pty Ltd

4.4 - Special warnings and precautions for use

• Added new precaution to include suicidal ideation and behaviour has been reported in patients treated with anti-epileptic agents in several indications. The mechanism of this risk is not known however, available data does not exclude the possibility of an increased risk. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
• Added new precaution to include cases of choroidal effusion/detachment have been reported after the use of acetazolamide. Symptoms include acute onset of decreased visual acuity or ocular pain and can occur within hours after initiation of acetazolamide treatment. If choroidal effusion/detachment is suspected acetazolamide should be discontinued as rapidly as possible.
• Added new precaution under subheading ‘Non-cardiogenic pulmonary oedema’. Non-cardiogenic pulmonary oedema typically developed within minutes to hours after acetazolamide intake. Symptoms include dyspnoea, hypoxia, and respiratory insufficiency. If non-cardiogenic pulmonary oedema is suspected acetazolamide should be withdrawn, and supportive treatment should be given.

4.8 - Adverse effects (undesirable effects)

• Added respiratory thoracic and mediastinal disorders reported include non-cardiogenic pulmonary oedema
• Added the following adverse events: bone marrow depression, pancytopenia, metabolic acidosis, hypokalaemia, loss of appetite, drowsiness, paraesthesia, involving numbness, tingling of extremities and face, reduced libido, convulsions, irritability, urticaria, photosensitivity, erythema multiforme, thrombocytic purpura and acute generalised exanthematous pustulosis (AGEP), myopia, choroidal effusion, choroidal detachment, increased risk of nephrolithiasis with long-term therapy, ureteral colic, renal lesions, calculus formations, abnormal liver function including fulminant hepatic necrosis, hepatitis or cholestatic jaundice and glycosuria.

Endep

Amitriptyline Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Severe Cutaneous Reactions’. Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported. Patients should be advised of symptoms and monitored closely for cutaneous reactions. If signs and symptoms suggestive of these reactions appear, Endep should be withdrawn immediately, treatment with Endep must not be restarted in this patient at any time and, an alternative treatment should be considered (as appropriate).

4.8 - Adverse effects (undesirable effects)

• Added severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS) with a frequency of not known.

Cephazolin Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

• Added Kounis syndrome

4.8 - Adverse effects (undesirable effects)

• Added Kounis syndrome

Premarin

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Expanded relative risk of breast cancer

5.1 - Pharmacodynamic properties

• Expanded relative risk of breast cancer

Darzalex

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Updated clinical trial ADRs (hypokalaemia, insomnia, dizziness, abdominal pain, rash, pruritus, musculoskeletal pain and arthralgia)

Belkyra

AbbVie Pty Ltd

4.8 - Adverse effects; Post marketing experience

• Added injection site mass

Jemperli

GlaxoSmithKline           Australia Pty Ltd

4.3 - Contraindications

• Added hypersensitivity

4.4 - Special warnings and precautions for use

Added:

• Guillain-Barre syndrome
• Aplastic anaemia
• Haemophagocitic lymphohistiocytosis (HLH)
• Patients with pre-existing autoimmune disease (AID)

4.8 - Adverse effects (undesirable effects)

• Added immune checkpoint inhibitor class effects

Trulicity

Eli Lilly Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added severe gastrointestinal disease

Vyepti

Lundbeck Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added fatigue with a frequency of ‘common’

Sandrena

Orion Pharma (AUS) Pty Limited

4.4 - Special warnings and precautions for use

• Added ALT elevations

4.5 - Interactions with other medicines and other forms of interactions

• Added antivirals

Alkindi

Chiesi Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added risk of adrenal crisis when transferring from other oral hydrocortisone formulations

Yervoy

Bristol-Myers Squibb Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Expanded post marketing experience - tumour lysis syndrome (nivolumab in combination with ipilimumab)

Lucrin depot

Abbvie Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added necrosis

Provera

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Expanded relative risk of breast cancer

5.1 - Pharmacodynamic properties

• Expanded relative risk of breast cancer

Puri-Nethol

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added metabolism and nutrition disorders

4.5 - Interactions with other medicines and other forms of interactions

• Added concomitant infliximab therapy

Mesasal

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

• Added idiopathic intracranial hypertension

4.8 - Adverse effects (undesirable effects)

• Added idiopathic intracranial hypertension

Methoblastin

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated information about exposure to intense sunlight or UV rays

4.5 - Interactions with other medicines and other forms of interactions

• Added haematotoxic agents

Flagyl

Flagyl S

Sanofi-Aventis Australia Pty Ltd

4.3 - Contraindications

• Added contraindication in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome.

4.8 - Adverse effects (undesirable effects)

• Added addition information under subheading ‘Liver’. Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days).

Flagyl

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

• Added information on PRES and IBD

Paxlovid

Pfizer Australia Pty Ltd

4.3 - Contraindications

• Added concomitant administration of cariprazine is contraindicated

4.5 - Interactions with other medicines and other forms of interactions

• Updated cariprazine clinical comments - coadministration is contraindicated due to increased plasma exposure of cariprazine and its active metabolites

Phoxilium

Vantive Pty Ltd

4.2 - Dose and method of administration

• Added injection port is a swabbable port

Polivy

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Infusion Related Reactions (IRRs)’. IRRs can occur as late as 24 hours after receiving Polivy. Patients should be administered premedication with an antihistamine and anti-pyretic prior to administration of Polivy. Symptoms include fever, chills, flushing, dyspnoea, hypotension, or urticaria. If an IRR occurs, the infusion should be interrupted, and appropriate medical management should be instituted.

Skyrizi

Abbvie Pty Ltd

4.4 - Special warnings and precautions for use

• Added serious hypersensitivity reactions including anaphylaxis

4.8 - Adverse effects (undesirable effects)

• Added immune system disorders – anaphylactic reaction

Spikevax JN.1

Moderna Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added chronic urticaria with a frequency of not known

Sutent

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Hyperammonaemic encephalopathy’. In patients who develop unexplained lethargy or changes in mental status, ammonia level should be measured, and appropriate clinical management should be initiated.

4.8 - Adverse effects (undesirable effects)

• Added hyperammonaemic encephalopathy

Genox

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

• Added contraception in males and females warning

4.6 - Fertility, pregnancy and lactation

• Added contraceptive warnings for men

Palexia IR

Palexia SR

Seqirus Pty Ltd

4.9 - Overdose

• Added death following respiratory arrest

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction with concomitant anticholinergics

Tygacil

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added Fixed Drug Eruptions

Xeljanx

Xeljanx XR

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

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

Tramal

Tramal injection

Tramal SR

Tramal oral drops

Seqirus Pty Ltd

4.9 - Overdose

• Added death following respiratory arrest

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction with concomitant anticholinergics

Rinvoq

Abbvie Pty Ltd

4.4 - Special warnings and precautions for use

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

4.7 - Effects on ability to drive and use machines

• Updated to Rinvoq may have a minor influence on the ability to drive and use machines because vertigo may occur during treatment.

4.8 Adverse effects (undesirable effects)

• Added vertigo.