TGA Product Information safety updates 27 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

alectinib

Alecensa

Roche Products Pty Ltd

4.2 - Dose and method of administration

  • Dose modification advice for haemolytic anaemia

4.4 - Special warnings and precautions for use

  • Haemolytic anaemia

7 February 2023

allopurinol

Zyloprim

Allosig

Allopurinol APOTEX

Apotex Pty Ltd

4.4 - Special warning and precautions for use

4.5 - Interactions with other medicines and other forms of interactions

4.8 - Adverse effects (undesirable effects)

  • Updated to align with international Product Information

16 February 2023

aspirin, clopidogrel hydrogen sulfate

CoPlavix

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Drug reaction with eosinophilia systemic symptoms (DRESS)
  • Updated pregnancy precaution

4.6 - Fertility, pregnancy and lactation

  • Oligohydramnios and neonatal impairment

3 February 2023

atezolizumab

Tecentriq

Roche Products Pty Ltd

4.2 - Dose and method of administration

  • Instructions for patients that develop pericardial disorders

4.4 - Special warnings and precautions for use

  • Immune-mediated pericardial disorders

4.8 - Adverse effects (undesirable effects)

  • Pericardial disorders

23 February 2023

ChAdOx1-S

Vaxzevria

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated coagulation disorders/ thrombocytopenia text relating to ITP

6 February 2023

cilgavimab/ tixagevimab

Evusheld

AstraZeneca Pty Ltd

4.4 - Special warning and precautions for use

  • Updated hypersensitivity warning to include anaphylaxis

4.8 - Adverse effects (undesirable effects)

  • Hypersensitivity including anaphylaxis (post-market)

13 February 2023

colistimethate sodium

Tadim

Phebra Pty Ltd

4.4 - Special warning and precautions for use

  • Reports of choking sensation
  • Myasthenia gravis

4.5 - Interactions with other medicines and other forms of interactions

  • Co-treatment with macrolides and fluoroquinolones in patients with myasthenia gravis

2 February 2023

deoxycholic acid

Belkyra

Allergan Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Injection site infections

23 February 2023

enalapril/ lercanidipine

Zan-Extra

Viatris Pty Ltd

4.2 - Dose and method of administration

  • Grapefruit interactions

4.3 - Contraindications

  • Left ventricular outflow track obstruction, untreated congestive cardiac failure and unstable angina pectoris or recent MI

4.4 - Special warnings and precautions for use

  • Precautions for use with ACE inhibitors, symptomatic hypotension information, Dual Blockade of the Renin angiotensin aldosterone System (RAAS) and midazolam

4.6 - Fertility, pregnancy and lactation

  • Use in males and expanded pregnancy warnings

4.8 - Adverse effects (undesirable effects)

  • Additions and updated frequencies

4.9 - Overdose

20 February 2023

ethinylestradiol/ gestodene

Minulet

Pfizer Australia 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

  • Expanded to include HCV medicinal products

22 February 2023

ethinylestradiol/ levonorgestrel

Triphasil

Pfizer Australia 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

  • Expanded to include HCV medicinal products

22 February 2023

ethinylestradiol/ norethisterone

Brevinor 28 Day

Pfizer Australia 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

  • Expanded to include HCV medicinal products

22 February 2023

etoposide

Vepesid

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.4 - Special warnings and precautions for use

  • Secondary leukaemia and tumour lysis syndrome, parahydroxybenzoate as an allergic reaction
  • Expanded renal and hepatic, and Use in Elderly information

4.5 - Interactions with other medicines and other forms of interactions

  • Other myelosuppressive drugs

4.7 - Effects on ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

  • Severe myelosuppression

23 February 2023

etoposide phosphate

Etopophos

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.4 - Special warning and precautions for use

  • Secondary leukaemia and tumour lysis syndrome

4.5 - Interactions with other medicines and other forms of interactions

  • Drugs of similar myelosuppressive action

4.7 - Effects on ability to drive and use machines

4.8 - Adverse effects (undesirable effects)

  • Severe myelosuppression and infertility

6 February 2023

filgrastim

Neupogen

Amgen Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Extramedullary haematopoiesis

31 January 2023

fluvoxamine maleate

Luvox

Viatris Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

  • Ramelteon

3 February 2023

hydrochlorothiazide/ amiloride hydrochloride dihydrate

Moduretic

Aspen Pharmacare Australia

4.4 - Special warnings and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Acute respiratory distress syndrome

20 February 2023

influenza virus haemagglutinin

Flucelvax Quad

Seqirus Pty Ltd

4.8 - Adverse effects (Undesirable effects)

  • Febrile convulsions, syncope, presyncope

13 February 2023

iohexol

Omnipaque

GE Healthcare Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Beta-adrenergic blocking agents, encephalopathy and hypothyroidism in paediatric patients

4.8 - Adverse effects (undesirable effects)

  • Diplopia and blurred vision

1 February 2023

ioversol

Optiray

Guerbet Australia Pty Ltd

4.4 - Special warnings and precautions for use

  • Updated hypersensitivity reactions, extravasation, CNS disorders, Use in renal and hepatic impairment and hypothyroidism

4.5 - Interactions with other medicines and other forms of interactions

  • Interleukins and diuretics

4.6 - Fertility, pregnancy and lactation

  • Updated effects on fertility and use in pregnancy

4.8 - Adverse effects (undesirable effects)

  • Updated adverse effects based on clinical trial and post marketing experience

1 February 2023

isatuximab

Sarclisa

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warning and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Herpes zoster

6 February 2023

lamivudine

Zeffix

Arrow Pharma Pty Ltd

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)

  • Updated to align with overseas Product Information

4.6 - Fertility, pregnancy and lactation

  • Hepatitis B virus and mitochondrial dysfunction

30 January 2023

lisdexamfetamine dimesilate

Vyvanse

Takeda Pharmaceuticals Australia Pty Ltd

4.2 - Dose and method of administration

  • Psychiatric status

4.8 - Adverse effects (undesirable effects)

  • Epistaxis and intestinal ischemia

22 February 2023

midostaurin

Rydapt

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Acute febrile neutrophilic dermatosis

14 February 2023

osilodrostat phosphate

Isturisa

Recordati Rare Diseases Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

  • Myalgia and arthralgia

17 February 2023

somatrogon

Ngenla

Pfizer Australia Pty Ltd

4.4 - Special warning and precautions for use

  • Closed epiphyses, scoliosis, neoplasm, Prader-Willi syndrome and myositis
  • Updated hypoadrenalism, thyroid function and benign intracranial hypertension statements

4.8 - Adverse effects (undesirable effects)

  • Updated summary of safety text and added additional adverse reactions

10 February 2023

sulfamethoxazole/ trimethoprim

Septrin

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

4.8 - Adverse effects (undesirable effects)

  • Updated to align with overseas Product Information

21 February 2023

trametinib (as dimethyl sulfoxide)

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warning and precautions for use

4.8 - Adverse effects (undesirable effects)

  • Haemphagocytic lymphohistiocytosis (HLH)

3 February 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

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