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Product Information safety updates - April 2022

Medicines Safety Update
Published

When the Therapeutic Goods Administration’s (TGA) ongoing safety monitoring identifies new safety information for medicines, we work closely with the sponsors of those medicines to update Product Information (PI) to ensure that health professionals and consumers have access to this information. Please see below details of some the medicines that have had safety related updates to their PI since December 2021.

New safety information can be identified in various ways. The TGA monitors the safety of medicines marketed in Australia using:

  • reports of adverse events
  • Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
  • reviews of literature
  • sharing of information with other regulatory agencies
  • sharing of information with Australian state and territory health authorities.

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 an 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 Medicines Safety Update (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

abatacept

Orencia

Bristol-Myers Squibb Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated 'non melanoma skin cancers' to 'malignancies including skin cancers'

4.8 - Adverse effects

  • Added 'melanoma skin cancer' as an adverse effect

8 December 2021

amisulpride

Solian

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on rhabdomyolysis

4.8 - Adverse effects

  • Added rhabdomyolysis and increased blood creatinine phosphokinase as new adverse effects

25 February 2022

carfilzomib

Kyprolis

Amgen Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on electrocardiographic changes
  • Inclusion of bradycardia as an infusion reaction

4.8 - Adverse effects

  • Inclusion of ventricular tachycardia as an adverse effect

8 February 2022

ChAdOx1-S

Vaxzevria

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warnings: 
  • venous thromboembolic events without thrombocytopenia
  • transverse myelitis
  • Expanded warning on immune thrombocytopenia

4.8 - Adverse effects

  • Added the following new adverse effects: cerebrovascular venous sinus thrombosis without venous thrombocytopenia, paraethesia, hypoaesthesia, transverse myelitis

15 March 2022

clozapine

Clozaril

Viatris Pty Ltd

Clopine

Pfizer Australia Pty Ltd

New boxed warning on clozapine-induced gastrointestinal hypomotility

4.4 -Special warnings and precautions for use

  • Expanded precautions on gastrointestinal hypomotility with severe complications
  • Expanded warning on anticholinergic effects

4.8 - Adverse effects

  • Included severe gastrointestinal effects (intestinal obstruction, severe constipation, gastrointestinal hypomotility) as new adverse effects

28 February 2022

donepezil

Aricept

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on cardiac conduction disorders

4.5 - Interactions with other medicines and other forms of interactions

  • New information on drug interaction with other medicines known to prolong QTc interval

4.8 - Adverse effects

  • Included electrocardiogram QT interval prolonged, polymorphic ventricular tachycardia including Torsade de Pointes as new adverse effects

Medicines Safety Update article

4 January 2022

esketamine

Spravato

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning to consider periodic monitoring of liver function due to the potential for hepatotoxicity

4.8 - Adverse effects

  • New information on potential for hepatotoxicity as reported with chronic ketamine use

10 February 2022

glecaprevir and pibrentasvir

Maviret

AbbVie Pty Ltd

4.2 - Dose and method of administration

and

4.3 Contraindications

  • New contraindication in patients with moderate hepatic impairment (Child-Pugh B)

4.4 Special warnings and precautions for use

  • New warning on hepatic decompensation and hepatic failure

23 March 2022

ibuprofen and codeine

Nurofen Plus

Reckitt Benckiser Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on drug reaction with eosinophilia with systemic symptoms (DRESS)

4.6 - Fertility, pregnancy and lactation

  • New warning on oligohydramnios and neonatal renal impairment

4.8 - Adverse effects

  • Added DRESS, oligohydramnios and neonatal renal impairment as new adverse effects

23 February 2022

lisdexamfetamine

Vyvanse

Takeda Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on QTc interval prolongation

4.8 - Adverse effects

  • Added electrocardiogram QT prolonged as a new adverse effect

28 March 2022

methoxy polyethylene glycol-epoetin beta

Mircera

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on serious allergic and anaphylactic reactions

4.8 - Adverse effects

  • Added anaphylactic reaction as a new adverse effect

21 January 2022

mycophenolic acid

Myfortic

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

New warning on potential increased severity of COVID-19 due to the medicine's cytostatic effect on B- and T-lymphocytes

16 March 2022

nintedanib

Ofev

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on ischaemic colitis and renal impairment/failure

4.8 - Adverse effects

  • Added colitis and renal failure as new adverse effects

14 December 2021

pentamidine

DBL Pentamidine Isethionate

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning that the medicine is not approved for inhaled use and bronchospasm has been reported to occur when inhaled.

4.8 - Adverse effects

  • Addition of local reactions ranging in severity from cough, breathlessness, wheezing, bronchospasms (with inhaled use) as new adverse effects

7 January 2022

phenobarbital

Phenobarb tablets

Arrow Pharma Pty Ltd

Phenobarbitone injection

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

and

4.6 - Fertility, pregnancy and lactation

  • Expanded details on the risks of phenobarbital use in pregnancy and emphasised the importance of adequate contraception and pre-conception care.

5.3 - Preclinical safety data

  • New information on the teratogenic effects of phenobarbital in rodents

1 March 2022

phenytoin

Dilantin

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

and

4.6 - Fertility, pregnancy and lactation

  • Expanded details on the risks of phenytoin use in pregnancy and emphasised the importance of adequate contraception and pre-conception care.

8 February 2022

primidone

Mysoline

Link Medical Products Pty Ltd

4.4 - Special warnings and precautions for use

and

4.6 - Fertility, pregnancy and lactation

  • Expanded details on the risks of primidone use in pregnancy and emphasised the importance of adequate contraception and pre-conception care.

5.3 - Preclinical safety data

  • New information on the teratogenic effects of primidone in rodents

3 February 2022

ribociclib

Kisqali

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on increased blood creatinine

7 March 2022

ruxolitinib

Jakavi

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on haemorrhage

4.8 - Adverse effects

  • Added bleeding including bruising, gastrointestinal and intracranial bleeding, epistaxis, post-procedural haemorrhage and haematuria as new adverse effects

17 March 2022

sodium valproate

Epilim

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

and

4.5 - Interactions with other medicines and other forms of interactions

  • New warning on risk of liver injury and transaminase enzyme elevations when given concomitantly with cannabidiol

16 December 2021

sofosbuvir

Sovaldi

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on the potential for dysglycaemia in diabetic patients

4.8 - Adverse effects

  • Added Stevens-Johnson syndrome as a new adverse effect

16 February 2022

sofosbuvir and ledipasvir

Harvoni

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on the potential for dysglycaemia in diabetic patients

4.8 - Adverse effects

  • Added Stevens-Johnson syndrome as a new adverse effect

10 February 2022

sofosbuvir and velpatasvir

Epclusa

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on the potential for dysglycaemia in diabetic patients

4.8 - Adverse effects

  • Added Stevens-Johnson syndrome as a new adverse effect

10 February 2022

Sofosbuvir, velpatasvir and voxilaprevir

Vosevi

Gilead Sciences Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on the potential for dysglycaemia in diabetic patients

4.8 - Adverse effects

  • Added Stevens-Johnson syndrome as a new adverse effect

10 February 2022

tacrolimus

Prograf, Prograf XL and Advagraf XL  

Astellas Pharma Australia Pty Ltd

4.8 - Adverse effects

  • Added thrombotic microangiopathy as a new adverse effect

31 March 2022

tapentadol

Palexia IR and Palexia SR

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on the potential to increase seizure risk when given concomitantly with medicines that lower the seizure threshold.

4.8 Adverse effects

  • Added hallucinations as an adverse effect

1 March 2022

teriflunomide

Aubagio

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • New warning on pulmonary hypertension

4.8 Adverse effects

  • Added pulmonary hypertension as a new adverse effect

2 February 2022

tenofovir, darunavir, cobicistat and emtricitabine

Symtuza

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

and

4.8 - Adverse effects

  • New warning and adverse effects on renal impairment (including acute renal failure, proximal renal tubulopathy and Fanconi syndrome) with tenofovir

Medicines Safety Update article

5 January 2022

zonisamide

Zonegran

Amdipharm Mercury Australia Pty Ltd

4.4 - Special warnings and precautions for use

and

4.6 - Fertility, pregnancy and lactation

Expanded details on the risks of zonisamide use in pregnancy and emphasised the importance of adequate contraception and pre-conception care.

28 February 2022

zopiclone

Imovane

Sanofi-Aventis Pty Ltd

4.1 - Therapeutic indications

4.2 - Dose and method of administration

4.4 - Special warnings and precautions for use

and

4.6 Fertility, pregnancy and lactation

  • Changes to duration of use from '2 to 4 weeks' to '7 to 14 days'

1 February 2022

What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

  • all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
  • all suspected medicines interactions
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.

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 2022

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 .

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at .

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