TGA Product Information safety updates 2 March

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

Date of approval

apalutamide

Eryland

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Severe Cutaneous Adverse Reactions (SCARs) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

5 January 2023

aspirin plus clopidogrel hydrogen sulfate

CoPlavix

Sanofi-aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) with Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)

17 January 2023

atazanivir/ cobicistat

Evotaz

Bristol-Myers Squibb Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Antiplatelet agents

9 January 2023

budesonide

Entocort

Chiesi Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Excipients (use with fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency)

4.8 - Adverse effects (undesirable effects)

  • Hypersensitivity reactions

3 January 2023

buprenorphine

Buvidal

Camurus Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Injection site-related reactions (abscess, ulceration and necrosis)

17 January 2023

caplacizumab

Cablivi

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

  • Concomitant use with thrombolytic and anti-platelet agents and low molecular weight heparin

19 January 2023

cisatracurium (as besilate)

Nimbex

Aspen Pharmacare Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

  • Added information for breastfeeding

4.8 - Adverse effects (undesirable effects)

  • Anaphylactic shock

23 January 2023

desferrioxamine mesilate

DBL Desferrioxamine Mesylate

Pfizer Australia Pty Ltd

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.7 - Effects on ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

4.9 - Overdose

  • Multiple updates to align with overseas product information

9 January 2023

desflurane

Suprane

Baxter Healthcare Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Delirium

23 January 2023

diclofenac

Voltaren and Voltaren Rapid

Novartis Pharmaceuticals Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

  • Expanded warning about oligohydraminios and neonatal renal impairment

3 January 2023

digoxin-specific antibody fragment F(ab) (Ovine)

DigiFab

Phebra Pty Ltd

4.4 - Special warnings and precautions for use

  • Alpha-gal allergan

24 January 2023

equine antithymocyte immunoglobulin

Atgam

Pfizer Australia Pty Ltd

4.2 - Dose and method of administration

  • Keep resuscitation equipment handy

4.4 - Special warnings and precautions for use

  • Monitoring of patients, symptoms of anaphylaxis, infusion-related reactions and serum sickness, opportunistic infections and concomitant use with vaccines

4.6 - Fertility, pregnancy and lactation

  • Fetal harm

4.8 - Adverse effects (undesirable effects)

  • Sepsis, Epstein-Barr virus, cytomegalovirus infection

19 January 2023

estradiol

Sandrena

Orion Pharma Aus Pty Limited

4.2 - Dose and method of administration

  • Additional information and warnings

4.3 - Contraindications

  • Expanded existing contraindications

4.4 - Special warnings and precautions for use

  • ALT elevations and potential transfer to children and other updates

4.5 - Interactions with other medicines and other forms of interactions

  • Pharmacodynamic interactions subsection

4.6 - Fertility, pregnancy and lactation

  • Pregnancy category changed from B1 to B3 (withdraw if pregnancy occurs)

16 December 2022

estradiol (as hemihydrate) and dydrogesterone

Femoston/ Femoston Conti

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

  • Change in breasts, hypothyroidism
  • Amended warning for angioedema and liver enzyme elevation with concomitant use of hepatitis C virus medication

4.8 - Adverse effects (undesirable effects)

  • Breast cancer, endometrial cancer, risk of venous thromboembolism and ischaemic stroke

4.9 - Overdose

  • Symptoms

16 January 2023

fludarabine phosphate

Fludara

Sanofi-aventis Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

  • Updated warning about genotoxic risk

3 January 2023

hydrochlorothiazide/ telmisartan

Micardis Plus

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use

  • Hyponatremia with hydrochlorothiazide
  • Acute respiratory toxicity including Acute Respiratory Distress Syndrome (ARDS) and the withdrawal of hydrochlorothiazide if ARDS is suspected
  • Photosensitivity reactions with the use of thiazide diuretics

4.5 - Interactions with other medicines and other forms of interactions

  • Interaction of diuretics with iodinated contrast products that may cause acute functional renal failure due to the dehydration caused by diuretics

4.8 - Adverse effects (undesirable effects)

  • Bone marrow failure, hypersensitivity and ARDS

12 January 2023

irinotecan (as sucrosofate)

Onivyde

Servier Laboratories Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Patients with a history of Whipple procedure
  • Updated warnings for vascular disorders and diarrhoea and cholinergic reactions

4.6 - Fertility, pregnancy and lactation

  • Increased recommended duration for contraception and added recommendation for preservation of gametes

4.8 - Adverse effects (undesirable effects)

  • Updated post-market frequencies for pruritis, rash and urticaria

20 January 2023

isoniazid

Isoniazid

Arrow Pharma Pty Ltd

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.6 - Fertility, pregnancy and lactation

4.8 - Adverse effects (undesirable effects)

  • Multiple updates to align with overseas product information

9 January 2023

lansoprazole

Zoton FasTabs

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Severe Cutaneous Adverse Reactions (SCARs)

4.8 - Adverse effects (undesirable effects)

  • Acute generalised exanthematous pustulosis

6 January 2023

laronidase (rch)

Aldurazyme

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Expanded information on infusion-related hypersensitivity reactions and anaphylaxis

4.8 - Adverse effects (undesirable effects)

  • Respiratory failure, drug specific antibody, neutralising antibodies, hypersensitivity, bradycardia

4.9 - Overdose

  • Expanded overdose information

12 January 2023

levothyroxine

Oroxine

Aspen Pharma Pty Ltd

4.4 - Special warnings and precautions for use

  • Circulatory collapse in neonates

15 December 2022

macitentan

Opsumit

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Flushing

5 January 2023

pembrolizumab

Keytruda

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Optic neuritis

27 January 2023

pemigatinib

Pemazyre

Specialised Therapeutics Alima Pty Ltd

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

  • Avoid grapefruit juice

17 January 2023

quinine bisulfate heptahydrate

Quinbisul

Arrow Pharma Pty Ltd

4.3 - Contraindications

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.6 - Fertility, pregnancy and lactation

4.7 - Effects on ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

  • Updated to align with overseas product information

9 January 2023

quinine bisulfate heptahydrate

Quinate

Arrow Pharma Pty Ltd

4.3 - Contraindications

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.6 - Fertility, pregnancy and lactation

4.7 - Effects on ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

Updated to align with overseas product information

10 January 2023

SARS-CoV-2 rS (NVX-CoV2373)

Nuvaxovid COVID-19 vaccine

Biocelect Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Tinnitus

25 January 2023

teicoplanin

Targocid

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Pancytopenia

23 January 2023

topiramate

Topamax

Janssen-Cilag Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Progestin only contraceptives

9 January 2023

trimethoprim

Triprim

Arrow Pharma Pty Ltd

4.3 - Contraindications

4.6 - Fertility, pregnancy and lactation

  • Precaution for administration in children and pregnant women

4.4 - Special warnings and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.8 - Adverse effects (undesirable effects)

  • Multiple updates to align with overseas product information

9 January 2023

umeclidinium (as bromide)/vilanterol (as trifenatate)

Anoro Ellipta

GlaxoSmithKline Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Eye pain

5 January 2023

vancomycin

DBL Vancomycin

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Kounis syndrome

25 January 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.