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Product Information safety updates - August 2022

Medicines safety update
Published

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

Erlyand

Janssen-Cilag Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Changed frequency of interstitial lung disease as adverse effect from Unknown to Uncommon
 21 June 2022
aripiprazole

Abilify Maintena

Lundbeck Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added post-market reports of decreased blood prolactin
 23 June 2022
ciprofloxacin

Aspen Ciprofloxacin

Aspen Pharmacare Australia Pty Ltd

4.3 – Contraindications

  • New contraindication on concurrent administration of ciprofloxacin and tizanidine

4.4 – Special warnings and precautions for use

  • Strengthened information on QT prolongation including increased sensitivity of women to QT prolongation
  • Added a warning to discontinue ciprofloxacin in patients experiencing symptoms of neuropathy to prevent development of an irreversible condition
  • Added new warnings on:
    • increased risk of psychiatric adverse reactions which may occur after the first dose
    • triggering seizures or lowering seizure threshold
    • vision disorders
    • dysglycaemia

4.5 – Interactions with other medicines and other forms of interactions

  • Strengthened information on drugs known to prolong the QT interval
  • Added text on xanthine derivates, oral antidiabetic agents, phenytoin, tizanidine, cytochrome P450, omeprazole, duloxetine, ropinirole, lidocaine, clozapine, sildenafil, agomelatine and zolpidem

4.8 – Adverse effects (undesirable effects)

  • Subheading 'skin/hypersensitivity' – Added drug reaction with eosinophilia and systemic symptoms (DRESS)
 23 June 2022
hydroxocobalamin chloride

Neo-B12

Pfizer Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Monitoring platelet count in first weeks of treatment of megaloblastic anaemia
  • Increased risk of aluminium toxicity in patients in renal impairment and in pre-term infants with long-term parenteral administration
  • Warning regarding pink, red/reddish colour to blood urine, body fluids and discoloured faeces.
  • Information on various laboratory parameters

4.5 – Interactions with other medicines and other forms of interactions

  • Information regarding hydroxocobalamin may antagonise the toxic effects of cyanide poisoning
  • Advice that consideration need to be taken in measuring plasma vitamin B12 concentration in interactions with oral contraceptives

4.8 – Adverse effects (undesirable effects)

  • Added transitory hypertension; hypokalaemia; loss of pigmentation of the skin and mucosa; reddish colour faeces; urine may turn a pink or reddish tinge allergic reactions; generalised itching; redding of the skin; bronchospasm; dysnoea; angioedema; orpharyngeal oedema; cardiocirculatory collapse; anaphylactic shock

6.2 - Incompatibilities

  • Added precautionary statement relating to lack of compatibility with diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, propofol and thiopental
 29 June 2022
isosorbide dinitrate

Isordil

Arrow Pharma Pty Ltd

4.3 – Contraindications

  • Added acute circulatory failure (shock, vascular collapse), aortic/mitral valve stenosis and disease associated with raised intra-cranial pressure

4.4 – Special warnings and precautions for use

  • Added warning to use in caution in patients with hypothyroidism, hypothermia, malnutrition, angle closure glaucoma

4.5 – Interactions with other medicines and other forms of interactions

  • Nitrates can act as physiological antagonists to noradrenaline, acetylcholine and histamine

4.8 – Adverse effects (undesirable effects)

  • Added adverse reactions: headache, dizziness, fatigue, palpitations, orthostatic hypotension, and flushing may occur at the beginning of treatment
  • Added to less common adverse reactions: hypoxaemia, Stevens-Johnson syndrome, pallor, excessive perspiration
  • Added information for severe hypotension adverse effect (may lead to enhanced angina symptoms)
 22 June 2022
leflunomide

Arava

Sanofi-aventis Australia Pty Ltd

4.4 – Special warnings and precautions for use

  • Added precaution about skin ulcers
 6 July 2022
meropenem

Merrem

Pfizer Australia Pty Ltd

4.8 – Adverse effects (undesirable effects)

  • Added renal impairment as a new adverse event
 28 June 2022
nivolumab

Opdivo

Bristol-Myers Squibb Australia Pty Ltd

5.1 – Pharmacodynamic properties

  • Subheading 'Clinical trials: Non-small cell lung cancer (NSCLC)' – Updated information about early deaths followed by overall survival benefit observed in Clinical Trial CA209057 and its associated factors
 21 June 2022
SARS-CoV-2 rS (NVX-CoV2373)

Nuvaxovid COVID-19 Vaccine

Biocelect Pty Ltd

4.4 – Special warnings and precautions for use

  • New warning that events of anaphylaxis have been reported

4.8 – Adverse effects (undesirable effects)

  • Added anaphylaxis, pericarditis, hypoaesthesia and paraesthesia as new adverse reactions
 22 June 2022
sodium valproate

Epilim / Epilim IV / Sodium Valproate Sandoz / Valpro EC / Valproate Winthrop

Sanofi-aventis Australia Pty Ltd

5.3 – Preclinical safety data

  • Updated testicular function information
 30 June 2022
tobramycin

Tobra-Day

Phebra Pty Ltd

4.4 – Special warnings and precautions for use

  • Added a new warning on increased risk of ototoxicity in patients with mitochondrial DNA mutations and to consider alternative treatments in those with a family history of aminoglycoside-induced deafness or known mitochondrial DNA mutations in the 12S rRNA gene.
 30 June 2022
upadacitinib

Rinvoq

Abbvie Pty Ltd

4.4 – Special warnings and precautions for use

  • Inclusion of additional information on venous thromboembolism, major adverse cardiovascular events and malignancy precautions in relation to JAK inhibitors.
  • Added warning regarding serious hypersensitivity reactions

4.5 – Interactions with other medicines and other forms of interactions

  • Added warning regarding interaction with grapefruit

4.8 – Adverse effects (undesirable effects)

  • Added non-melanoma skin cancer and hypersensitivity.
 29 June 2022
zopiclone

Imrest

Alphapharm Pty Ltd

4.1 – Therapeutic indications

4.2 – Dose and method of administration

4.4 – Special warnings and precautions for use

4.6 – Fertility, pregnancy and lactation

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

4.8 – Adverse effects (undesirable effects)

  • Added adverse effect 'delirium'

6.5 – Nature and contents of container

  • Added 14-tablet pack size
 2 June 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 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 Branch at .

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