TGA Product Information safety updates 23 June

TGA

When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through the TGA's ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. Please see below details of some medicines that have recently had safety related updates to their PI.

The TGA monitors the safety of medicines marketed in Australia using:

Changes to the PI that result from TGA safety monitoring activities may:

  • narrow indications
  • add or modify specific sections, such as:
    • contraindications
    • warnings or precautions
    • use in fertility, pregnancy and lactation
    • use in special populations
    • adverse effects.

It is important for prescribers and other health professionals to be aware of safety-related PI changes, as they may require you to take actions or do things differently, such as:

  • counsel patients on identified risks
  • undertake special monitoring or precautions
  • in some instances select alternate medications.

Significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine's sponsor and sent directly to health professionals.

We will publish a Medicines Safety Update (MSU) article detailing recent safety-related PI updates each month, although this may not include all safety-related updates. We will continue to publish MSU articles for critical safety issues or topics of special interest.

The below medicines are generally innovator brands (generic brands may be included in some circumstances). Generic brands containing the same active ingredients as the medicines below are required to align with the safety information in the innovator's PI and will be updated accordingly.

To view the full PI for each listing, click on the name of the product in the 'Brand/trade name' column. A 'Summary table of changes' appears at the end of the PI. If the TGA has published any further risk communication, such as a safety alert or stand-alone MSU article, it will be linked to in the 'Safety issue' column.

Table: Details of safety-related PI updates

Active ingredients

Brand name

Sponsor

PI updates (sections updated and summary of key information)

Date of approval

alfentanil hydrochloride

Rapifen

Piramal Critical Care Pty Ltd

4.4 - Special warnings and precautions for use

  • Tolerance and opioid use disorder

4.5 - Interactions with other medicines and other forms of interactions

  • Gabapentinoids

24 May 2023

apixaban

Eliquis

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Anticoagulant-related nephropathy (ARN)

4.8 - Adverse effects (undesirable effects)

  • Renal and urinary disorders

15 May 2023

asciminib hydrochloride

Scemblix

Novartis Pharmaceuticals Australia Pty Limited

4.8 - Adverse effects (undesirable effects)

  • Hypersensitivity

5 May 2023

atorvastatin and ezetimibe

Atozet

Organon Pharma Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Myasthenia gravis, ocular myasthenia

12 May 2023

bevacizumab

Abevmy

Alphapharm Pty Ltd trading as Viatris

4.4 - Special warnings and precautions for use

4.8 - Adverse Effects (UNDEISRABLE EFFECTS)

  • Anaphylactic shock
  • Updated frequencies of hypersensitivity and infusion reactions

15 May 2023

cabozantinib

Cabometyx

Ipsen Pty Ltd

4.4 - Special warnings and precautions for use

  • Vanishing bile duct syndrome

4.8 - Adverse effects (undesirable effects)

  • Embolism arterial
  • Vanishing bile duct syndrome

24 May 2023

carboplatin

DBL Carboplatin Injection

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Kounis syndrome

30 May 2023

cefuroxime (as axetil)

Zinnat

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Seizure

24 May 2023

dabigatran

Pradaxa

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use

  • Anticoagulant-related nephropathy (ARN)

4.8 - Adverse effects (undesirable effects)

  • Renal and urinary disorders

5 May 2023

desogestrel/ ethinylestradiol

Marvelon

Organon Pharma Pty Ltd

4.3 - Contraindications

  • Expanded to include certain hepatitis C virus (HCV) medicinal products, such as glecaprevir and pibrentasvir.

4.4 - Special warnings and precautions for use

  • Expanded hepatitis C warning to include ALT elevation observed with HCV medicinal products

4.5 - Interactions with other medicines and other forms of interactions

  • Consult the relevant anti-viral medicine product safety information and the use of an alternative method of contraception prior to starting HCV therapy

3 May 2023

dinutuximab beta

Qarziba

Recordati Rare Diseases Australia Pty Ltd

4.2 - Dose and Method of Administration

  • Treatment modification and discontinuation information - central neurotoxicity, posterior reversible encephalopathy syndrome and transverse myelitis

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Central neurotoxicity

26 April 2023

dulaglutide

Trulicity

Eli Lilly Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Cholecystitis, constipation, flatulence, abdominal distention, gastroesophageal reflux disease and eructation

8 May 2023

enfortumab vedotin

Padcev

Astellas Pharma Australia Pty Ltd

4.2 - Dose and method of administration

  • Updated dose modification for pneumonitis with interstitial lung disease

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Pneumonitis, interstitial lung disease

18 May 2023

estradiol hemihydrate

Vagifem Low

Novo Nordisk Pharmaceuticals Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Updated post-market adverse drug reactions

18 May 2023

etonogestrel/ ethinylestradiol

Nuvaring

Organon Pharma Pty Ltd

4.3 - Contraindications

  • Expanded to include certain hepatitis C virus (HCV) medicinal products, such as glecaprevir and pibrentasvir

4.4 - Special warnings and precautions for use

  • Expanded hepatitis C warning to include ALT elevation observed with HCV medicinal products

4.5 - Interactions with other medicines and other forms of interactions

  • Consult the relevant anti-viral medicine product safety information and the use of an alternative method of contraception prior to starting HCV therapy

12 May 2023

etoricoxib

Arcoxia

Organon Pharma Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Intracranial haemorrhage, pulmonary embolism and deep vein thrombosis

11 May 2023

etravirine

Intelence

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Precautions about preventing transmission of HIV

1 May 2023

ezetimibe and rosuvastatin

Rosuzet Composite Pack

Organon Pharma Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Myasthenia gravis, ocular myasthenia

12 May 2023

ezetimibe and simvastatin

Vytorin

Organon Pharma Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Myasthenia gravis, ocular myasthenia

12 May 2023

hydrocortisone sodium succinate

Solu-Cortef

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Tumour lysis syndrome

4.8 - Adverse effects (undesirable effects)

  • Updated preferred term hypothalamic pituitary-adrenal axis suppression

5 May 2023

iodised oil

Lipiodol Ultra Fluid

Guerbet Australia Pty Ltd

4.3 - Contraindications

  • Known or suspected reproductive tract neoplasia

18 May 2023

liraglutide

Victoza

Novo Nordisk Pharmaceuticals Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Dysgeusia

18 May 2023

mesalazine

Mezavant

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Chromaturia

18 May 2023

mesalazine

Pentasa

Ferring Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Severe cutaneous adverse reactions (SCARs), drug reaction with eosinophilia and systemic symptoms (DRESS), urine discolouration

30 May 2023

methotrexate

Methotrexate Ebewe

Sandoz Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Injection site reactions, injection site necrosis

25 May 2023

methylprednisolone acetate

Depo-Medrol

Depo-Nisolone

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Tumour lysis syndrome

4.8 - Adverse effects (undesirable effects)

  • Updated preferred term hypothalamic pituitary-adrenal axis suppression

5 May 2023

methylprednisolone sodium succinate

Solu-Medrol

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Tumour lysis syndrome

4.8 - Adverse effects (undesirable effects)

  • Updated preferred term hypothalamic pituitary-adrenal axis suppression

4 May 2023

metronidazole

Metronidazole Intravenous Infusion

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Hypersensitivity reactions

4.8 - Adverse effects (undesirable effects)

  • Dermatitis bullous
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Scute generalised exanthematous pustulosis (AGEP)

4 May 2023

Morphine sulfate pentahydrate

MS Contin

MS Mono

Sevredol

Mundipharma Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated warning about use with biliary tract disorders

4.8 - Adverse effects (undesirable effects)

  • Sphincter of Oddi dysfunction, allodynia, sleep apnoea disorder

8 May 2023

osimertinib

Tagrisso

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated interstitial lung disease section

4.8 - Adverse effects (undesirable effects)

  • Updated interstitial lung disease section
  • Blood creatinine phosphokinase increased

8 May 2023

pegaspargase

Oncaspar

Servier Laboratories (Aust) Pty Ltd

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

  • Pre-medication for management of hypersensitivity reactions

18 May 2023

rivaroxaban

Xarelto

Bayer Australia Ltd

4.4 - Special warnings and precautions for use

  • Anticoagulant-related nephropathy (ARN)

4.8 - Adverse effects (undesirable effects)

  • Renal and urinary disorders

5 May 2023

rosuvastatin calcium

Crestor

A. Menarini Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New onset and aggravation of myasthenia gravis and ocular myasthenia

4.5 - Interactions with other medicines and other forms of interactions

  • Roxadustat, enasidenib and tafamidis

4.6 - Fertility, pregnancy and lactation

  • Lactation data for human milk
  • Updated pregnancy and lactation warnings

4.8 - Adverse effects (undesirable effects)

  • Myasthenia gravis, ocular myasthenia and lichenoid drug eruption

11 May 2023

secukinumab

Cosentyx

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Pyoderma gangrenosum

4 May 2023

simvastatin

Zocor

Organon Pharma Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Myasthenia gravis, ocular myasthenia

11 May 2023

siponimod hemifumarate

Mayzent

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Meningitis, meningoencephalitis caused by VZV and cases of cryptococcal meningitis
  • Live and non-live attenuated vaccines
  • Updated information on progressive multifocal leukoencephalopathy

4.5 - Interactions with other medicines and other forms of interactions

  • Live and non-live attenuated vaccines

4.8 - Adverse effects (undesirable effects)

  • Meningitis, meningoencephalitis caused by VZV and cases of cryptococcal meningitis

5 May 2023

terlipressin

Glypressin Solution

Ferring Pharmaceuticals Pty Ltd

4.2 - Dose and method of administration

  • Average duration of treatment

4.4 - Special warnings and precautions for use

  • monitoring during treatment and sepsis/septic shock information
  • injection site reaction, skin necrosis and respiratory effects
  • Updated use in renal impairment and use in hepatic impairment

4.8 - Adverse effects (undesirable effects)

  • Sepsis/septic shock and effects related to Type 1 hepatorenal syndrome and bleeding oesophageal varices

8 May 2023

topiramate

Topamax

Topamax Sprinkle

Janssen-Cilag Pty Ltd

4.3 - Contraindications

  • Migraine prophylaxis in pregnancy and women of childbearing potential

4.4 - Special warnings and precautions for use

  • Updated text about women of childbearing potential

4.6 - Fertility, pregnancy and lactation

  • Fetal neurodevelopment disorder
  • Updated information about risks in women of childbearing potential

3 May 2023

tramadol hydrochloride

Tramal

Seqirus Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Hypoglycaemia

19 May 2023

ustekinumab

Stelara

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Six-month waiting period for administration of live vaccines after in utero infant exposure

4.5 - Interactions with other medicines and other forms of interactions

  • In utero infant exposure

4.6 - Fertility, pregnancy and lactation

  • Systemic exposure in breastfed infants

3 May 2023

zopiclone

Imoclone

IPCA Pharma (Australia) Pty Ltd

4.1 - Therapeutic indications

4.4 - Special warnings and precautions for use

  • Updated treatment period from '2 to 4 weeks' to '7 - 14 days'

4.2 - Dose and method of administration

4.6 - Fertility, pregnancy and lactation

  • Restricted treatment period

6.5 - Nature and contents of container

  • 14-tablet pack size

20 April 2023

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

© Commonwealth of Australia 2023

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to [email protected].

For the latest safety information from the TGA, subscribe to the TGA Safety Information email list via the TGA website.

For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance Branch at [email protected].

/Public Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).View in full here.