Published: 5 June 2025

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Recent data sheet updates: important new safety information

Published: 5 June 2025
Prescriber Update 46(2): 34–35
June 2025

Table 1 below provides a list of data sheets recently updated with important new safety information. Note that this is not a comprehensive list of all recently updated data sheets, nor does it describe all changes to a particular data sheet.

To find out if sponsors have made any changes to their data sheets, refer to:

Table 1: Recently updated data sheets (by active ingredient): important new safety information

Click on the specific medicine to open the data sheet.

Active ingredient(s): Medicine(s) Data sheet updates
Sectiona Summary of new safety information
Adalimumab
Humira
4.8 Autoimmune hepatitis
Dorzolamide + Timolol
Dortimopt
4.8 Atrioventricular block; Cardiac failure; Tachycardia; Hypertension; Dysgeusia
Dulaglutideb
Trulicity
4.4 Severe gastrointestinal disease: advise patients of the risk of dehydration and take precautions to avoid fluid depletion
Flucloxacillin
Staphlex
4.5 Interaction with voriconazole
Liraglutideb
Saxenda
Victoza
4.4 Risk of pulmonary aspiration in association with general anaesthesia or deep sedation due to delayed gastric emptying
Losartan
Losartan Actavis
4.4, 4.8 Intestinal angioedema
Macrogol + electrolytes
Plenvu
4.4, 4.8 Seizures; Oesophageal rupture (Boerhaave syndrome)
Metronidazole
Flagyl
4.3 Cockayne syndrome
4.4 Posterior reversible encephalopathy syndrome (PRES); Inflammatory bowel disease (IBD)
4.8 PRES; Severe irreversible hepatoxicity/acute liver failure in patients with Cockayne syndrome
Neisseria meningitidis Group A, C, W135, Y polysaccharide
MenQuadfi
4.2 May be given as a single booster dose to individuals who have previously been primed with meningococcal vaccine at least 3 years prior (changed from 4 years)
4.5 May be given concomitantly with meningococcal B (MenB) vaccine
4.8 Increased rate and intensity of systemic adverse reactions with concomitant MenB (clinical study in those aged 13–26 years)
Normal immunoglobulin
Privigen
Privigen NZ
4.4 Aseptic meningitis syndrome (AMS): new information about AMS symptoms and examination; monitor patients with recurrent AMS for the emergence or worsening of symptoms that may indicate progression to brain/cerebral oedema.
Oxaliplatin
Oxaliplatin Accord
Oxaliplatin (Alchemy)
4.6 Use effective contraception before starting and during treatment, and for at least 9 months after the last dose for female patients of childbearing potential and for at least 6 months after the last dose for male patients with female partners of childbearing potential; Potential adverse effects on male fertility; Breastfeeding is contraindicated during treatment and for 3 months after the last dose.
Oxycodone
Oxycodone Sandoz
4.4 Hepatobiliary disorders (pancreatitis and diseases of the biliary tract)
4.5 Interactions with selective serotonin re-uptake inhibitors (SSRI) or serotonin norepinephrine re-uptake inhibitors (SNRI)
Risedronate
Risedronate Sandoz
4.4 Bisphosphates may cause hypocalcaemia and/or hypophosphatemia due to effects on bone. Monitoring of calcium and phosphate may be needed throughout treatment, especially in individuals with risk factors.
Rivaroxaban
Xarelto
4.8 Splenic rupture (secondary to severe bleeding)
Tamoxifen
Tamoxifen Sandoz
4.4 QTc interval prolongation in patients with underlying risks and cardiac morbidities
Tigecycline
Tygacil
4.8 Fixed drug eruption
Zoledronic acidc
Aclasta
4.4 Bisphosphates may cause hypocalcaemia and/or hypophosphatemia due to effects on bone. Consider calcium and phosphate post each infusion and monitor for symptoms of hypocalcaemia and hypophosphatemia.
  1. Data sheet sections listed in the table are: 4.2: Dose and method of administration; 4.3: Contraindications; 4.4: Special warnings and precautions for use; 4.5: Interaction with other medicines and other forms of interaction; 4.6: Fertility, pregnancy and lactation; 4.8: Undesirable effects.
  2. See also the article on GLP-1 receptor agonists and renal adverse events on page 24.
  3. See also the Gathering Knowledge article on page 31 for a case of hypophosphataemia following a zoledronic acid infusion.
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