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Product Information safety updates - May 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 the 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

adalimumab

Humira

AbbVie Pty Ltd

4.8 - Adverse effects

  • Added thrombosis as an adverse effect

27 April 2022

alirocumab (rch)

Praluent

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.6 - Fertility, pregnancy and lactation

  • Updated warnings for pregnancy, lactation and immunogenicity

27 April 2022

aripiprazole

Abilify

Otsuka Australia Pharmaceutical Pty Ltd

4.8 - Adverse effects

  • Added information about decreases in blood prolactin under 'Investigations'

2 May 2022

azacitidine

Vidaza

Celgene Pty Ltd

4.2 - Dose and method of administration

  • Added warning that injectable and oral products are not interchangeable

4.6 - Fertility, pregnancy and lactation

  • Updated with advice about contraception for female and male patients

5 April 2022

calcium folinate

DBL Leucovorin Calcium

Pfizer Australia Pty Ltd

4.8 - Adverse effects

  • Added anaphylactic shock as an adverse effect under 'Immune system disorders', with a frequency of 'very rare'

21 April 2022

ciprofloxacin

Aspen Ciprofloxacin

Aspen Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added warning about aortic aneurysm and dissection

4.5 - Interactions with other medicines and other forms of interactions

  • Included interaction information about levothyroxine

4.8 - Adverse effects

  • Added risks of heart valve regurgitation

3 May 2022

citalopram

Citalopram Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

  • Added additional information about seizures

4.5 - Interactions with other medicines and other forms of interactions

  • Added information about drug-drug interaction with opioids

12 April 2022

desogestrel/ethinylestradiol

Marvelon

Organon Pharma Pty Ltd

4.4 – Special warnings and precautions for use

  • Added warning related to clinical trials with some hepatitis C virus (HCV) combination drug regimens
  • Added warning about exogenous estrogens
  • Updated text about (hereditary) angioedema

4.5 - Interactions with other medicines and other forms of interactions

  • Added information about HCV antiviral medicinal products, such as those containing glecaprevir/pibrentasvir

4.8 - Adverse effects

  • Added exacerbations of hereditary and acquired angioedema

11 April 2022

doxorubicin

Adriamycin

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added subsection on embryo-fetal toxicity pertaining to contraception advice, and cross-referencing to other sections

4.6 - Fertility, pregnancy and lactation

  • Added information to the 'Effects on fertility' section about advising patients to seek advice on fertility preservation before treatment
  • Added new subsection on 'Women of childbearing potential/contraception in males and females' including advice to avoid pregnancy and to use effective contraception during treatment and for at least 6 months and 10 days after last dose for women, and 3 months and 10 days after last dose for men
  • Updated information on 'Lactation' advising not to breastfeed for an additional 10 days after last dose

20 April 2022

epoetin alfa

Eprex

Janssen-Cilag Pty Ltd

4.2 - Dose and method of administration

  • Added advice that patients/caregivers should be provided administration instructions if the physician determines that they can effectively administer the drug subcutaneously
  • Added safety warning about the possibility of damaging the product when shaken vigorously for a prolonged period

20 April 2022

etanercept

Enbrel

Pfizer Australia Pty Ltd

4.2 - Dose and administration

  • Added statement about missed doses

4.4 - Special warnings and precautions for use

  • Added recommendation to record the brand and batch number in patient records

4.8 - Adverse effects

  • Added lichenoid reactions as a rare adverse effect
  • Changed frequency of demyelinating events from 'very rare' to 'rare'

30 March 2022

hydroxycarbamide (hydroxyurea)

Hydrea

Bristol-Myers Squibb Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

  • Added advice on use of effective contraception during therapy for female patients of reproductive potential

5 May 2022

influenza vaccine (quadrivalent)

Flucelvax Quad

Seqirus Pty Ltd

4.8 - Adverse effects

  • Added Guillain-Barré syndrome as a new adverse effect

22 April 2022

interferon beta 1-a

Avonex

Biogen Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects

  • Added injection site necrosis as a 'very rare' adverse effect

21 April 2022

lamotrigine

Lamictal

Aspen Pharmacare Australia

4.4 - Special warnings and precautions for use

  • Expanded warning on aseptic meningitis

4.8 - Adverse effects

  • Added photophobia as an adverse effect

13 April 2022

lenalidomide

Revlimid

Celgene Pty Ltd

4.4 - Special warnings and precautions for use

  • Wording updated about:
    • Counselling
    • Contraception
    • Tumour Lysis Syndrome (TLS) and Tumour Flare Reaction (TFR)
    • Multiple Myeloma (MM) and Myelodysplastic Syndrome (MDS)

6 April 2022

losartan

Cozaar

Organon Pharma Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Added warning about reduced therapeutic effect due to a food interaction with grapefruit juice

14 April 2022

meningococcal (Groups A, C, W-135, Y) polysaccharide tetanus toxoid conjugate

Nimenrix

Pfizer Australia Pty Ltd

4.8 - Adverse effects

  • Added urticaria in the table of adverse reactions

22 April 2022

methylphenidate hydrochloride

Ritalin 10/Ritalin LA Artige

Novartis Pharmaceuticals Australia Pty Limited

4.5 - Interactions with other medicines and other forms of interactions

  • Strengthened precaution about use with dopaminergic drugs

6 April 2022

molnupiravir

Lagevrio

Merck Sharp & Dohme (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects

  • Added information about hypersensitivity

22 April 2022

nirmatrelvir/ritonavir

Paxlovid

Pfizer Australia Pty Ltd

4.5 – Interactions with other medicines and other forms of interactions

  • Added dabigatran as a drug interaction

4.8 - Adverse effects

  • Added hypersensitivity as an adverse effect

27 April 2022

oxaliplatin

DBL Oxaliplatin

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Expanded existing allergic reactions to include cross reactions with all platinum compounds
  • Added warning about possible persistent symptoms of peripheral sensory neuropathy
  • Added warning about reversible posterior leukoencephalopathy syndrome (RPLS)

4.6 – Fertility, pregnancy and lactation

  • Added advice that it is not recommended in women of childbearing potential who are not using contraceptive measures

4.8 - Adverse effects

  • Expand on neurological adverse effects.
  • Expand on supportive measures for acute pharyngolaryngeal dysaesthesia syndrome
  • Add new adverse reactions: depression, insomnia, haemorrhage, flushing, leucopenia, lymphopenia, rectal haemorrhage, gastro-oesophageal reflux disease, melena, hypernatremia, bone pain, haematuria, dysuria, abnormal micturition frequency, rash erythematous, skin exfoliation, hand and foot syndrome, hyperhidrosis, nail disorder, pain, injection site reaction, hepatic enzyme increase, blood bilirubin increase, blood lactate dehydrogenase increase, weight increase (adjuvant setting), blood creatinine increase and weight decrease (metastatic setting).

4 April 2022

pegaspargase

Oncaspar

Servier Laboratories Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects

  • Added information about osteonecrosis (avascular necrosis) as a possible complication of hypercoagulability observed in children and adolescents when pegaspargase and glucocorticoids are used simultaneously (specific mention to dexamethasone), with a higher incidence seen in girls.

19 April 2022

semaglutide

Ozempic

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

  • Added new warning on acute kidney injury and worsening of chronic renal failure

4.8 - Adverse effects

  • Added acute kidney injury as an adverse effect
  • Added photophobia as an adverse effect

25 March 2022

Sulfamethoxazole/trimethoprim

DBL Sulfamethoxazole and Trimethoprim concentrate injection

Pfizer Australia 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.

4.4 - Special warnings and precautions for use

  • Added and updated information about life-threatening adverse reactions
  • Added and updated information about Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia with systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)

4.8 - dverse effects

  • Added new adverse reactions:
    • overgrowth fungal infection
    • haemolysis in certain susceptible G-6-PD deficient patients
    • severe hypersensitivity reactions associated with Pneumocystis jirovecii pneumonia
    • hepatic enzyme increased
    • decreased appetite
    • metabolic acidosis
    • psychotic disorder
    • dizziness
    • uveitis
    • dyspnoea
    • lung infiltration
    • tubulointerstitial nephritis and uveitis syndrome
    • renal tubular acidosis
  • Updated information on severe subcutaneous adverse reactions (SCARs)

8 April 2022

triamcinolone

Kenacomb Otic and Otocomb Otic

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Added a new warning on higher risk for ototoxicity in individuals with mitochondrial DNA mutations

28 April 2022

vedolizumab

Entyvio

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects

  • Added acute pancreatitis as an adverse effect

17 March 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 tga.copyright@tga.gov.au(link sends e-mail).

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 and Special Access Branch at ADR.Reports@tga.gov.au(link sends e-mail).

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