TGA Product Information safety updates 21 December

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:

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 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 Medicines Safety Update 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 (sections updated and summary of key information)	Date of approval
adefovir dipivoxil	APO-Adefovir Apotex Pty Ltd	4.4 - Special warnings and precautions for use Increased risk of renal impairment with long-term treatment Concurrent use with tenofovir alafenamide 4.6 - Fertility, pregnancy and lactation Recurrence of hepatitis on discontinuation 4.8 - Adverse effects (undesirable effects) Back pain, chest pain, anorexia, anaemia, thrombocytopenia, pharyngitis, rash, hyperkalaemia, liver function test abnormalities, jaundice, myalgia	25 October 2022
brinzolamide	Azopt Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Additional information on hypersensitivity reactions Stevens-Johnson syndrome and toxic epidermal necrolysis 4.5 - Interactions with other medicines and other forms of interactions NSAIDS	2 November 2022
brinzolamide/ brimonidine tartare	Simbrinza Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Additional information on hypersensitivity reactions Stevens-Johnson syndrome and toxic epidermal necrolysis	17 October 2022
brinzolamide/ timolol	Azarga Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Stevens-Johnson syndrome and toxic epidermal necrolysis	31 October 2022
candesartan, hydrochlorothiazide	Atacand Plus AstraZeneca Pty Ltd	4.4 - Special warnings and precautions for use Acute respiratory toxicity including acute respiratory distress syndrome (ARDS), and the withdrawal of hydrochlorothiazide if ARDS is suspected. 4.8 - Adverse effects (undesirable effects) ARDS	5 October 2022
captopril	Capoten Arrow Pharma Pty Ltd	4.3 - Contraindications Aliskiren-containing products in patients with diabetes mellitus or renal impairment and sacubitril/valsartan therapy 4.4 - Special warnings and precautions for use Anaemia, risk of oliguria and leukopenia 4.5 - Interactions with other medicines and other forms of interactions 4.8 - Adverse effects (undesirable effects)	25 November 2022
cisplatin	DBL Cisplatin Injection Pfizer Australia Pty Ltd	4.3 - Contraindications Generalised infections 4.4 - Special warnings and precautions for use 4.5 - Interactions with other medicines and other forms of interactions Concurrent or sequential use with ototoxic agents Concurrent use with anticonvulsant antigout agents 4.8 - Adverse effects (undesirable effects) Multiple new adverse effects added	27 October 2022
clofarabine	Evoltra Sanofi-Aventis Australia Pty Ltd	4.6 - Fertility, pregnancy and lactation Length of time for contraception and avoiding of breast feeding	28 November 2022
crizotinib	Xalkori Pfizer Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Increased blood creatine phosphokinase	7 November 2022
darolutamide	Nubeqa Bayer Australia Ltd	4.8 - Adverse effects (undesirable effects) Hepatic transaminase elevations reported in clinical trials	27 October 2022
darunavir	Prezista Janssen-Cilag Pty Ltd	4.8 - Adverse effects (undesirable effects) Crystal nephropathy	7 November 2022
darunavir/ cobicistat	Prezcobix Janssen-Cilag Pty Ltd	4.8 - Adverse effects (undesirable effects) Crystal nephropathy	7 November 2022
darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide	Symtuza Janssen-Cilag Pty Ltd	4.8 - Adverse effects (undesirable effects) Crystal nephropathy	11 November 2022
dolutegravir/ rilpivirine	Juluca ViiV Healthcare Pty Ltd	4.6 - Fertility, pregnancy and lactation Additional information about placental transfer and excretion into human breast milk	25 November 2022
elasomeran	Spikevax Moderna Australia Pty Ltd	4.4 - Special warnings and precautions for use Expanded warning on myocarditis and pericarditis to include reports in females, atypical presentations with non-specific symptoms, and the risk of severe outcomes including death 4.8 - Adverse effects (undesirable effects) Strengthened information on myocarditis and pericarditis to include reports in females and reports following booster doses	14 October 2022
elasomeran, imelasomeran	Spikevax Bivalent Original/ Omicron Moderna Australia Pty Ltd	4.4 - Special warnings and precautions for use Expanded warning on myocarditis and pericarditis to include reports in females, atypical presentations with non-specific symptoms, and the risk of severe outcomes including death 4.8 - Adverse effects (undesirable effects) Strengthened information on myocarditis and pericarditis to include reports in females and reports following booster doses	14 October 2022
emicizumab	Hemlibra Roche Products Pty Ltd	4.8 - Adverse effects (undesirable effects) Angioedema, urticaria, rash	31 October 2022
epoetin alfa	Eprex Janssen-Cilag Pty Ltd	4.2 - Dose and method of administration Providing information to patients/ caregivers for subcutaneous administration Safe handling and disposal	17 November 2022
estradiol hemihydrate	Zumenon Viatris Pty Ltd	4.4 - Special warnings and precautions for use ALT elevation (with concurrent Hepatitis C treatment) and angioedema 4.5 - Interactions with other medicines and other forms of interactions Liver enzyme elevation with concurrent Hepatitis C treatment	14 November 2022
gabapentin	Neurontin Viatris Pty Ltd	4.4 - Special warnings and precautions for use Abuse and dependence in patients with a history of psychiatric disorders	19 October 2022
gadoteric acid	Dotarem Guerbet Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Update based on new safety analysis	9 November 2022
human menopausal gonadotrophin	Menopur Ferring Pharmaceuticals Pty Ltd	4.8 - Adverse effects (undesirable effects) Pelvis discomfort during treatment	4 November 2022
hydrochlorothiazide, valsartan	Co-Diovan Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use Acute respiratory toxicity including acute respiratory distress syndrome (ARDS), and the withdrawal of hydrochlorothiazide if ARDS is suspected. 4.8 - Adverse effects (undesirable effects) ARDS	27 October 2022
hydrochlorothiazide, valsartan, amlodipine	Amlodipine/ Valstartan/ HCT Novartis Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use Acute respiratory toxicity including acute respiratory distress syndrome (ARDS), and the withdrawal of hydrochlorothiazide if ARDS is suspected. 4.8 - Adverse effects (undesirable effects) ARDS	27 October 2022
hydrochlorothiazide, valsartan, amlodipine	Exforge HCT Novartis Pharmaceuticals Australia Pty Ltd	4.4 - Special warnings and precautions for use Acute respiratory toxicity including acute respiratory distress syndrome (ARDS), and the withdrawal of hydrochlorothiazide if ARDS is suspected. 4.8 - Adverse effects (undesirable effects) ARDS	27 October 2022
hydroxychloroquine sulfate	Plaquenil Sanofi-Aventis Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.5 - Interactions with other medicines and other forms of interactions Interaction with macrolides	26 October 2022
ibuprofen/ codeine	Nurofen Plus Reckitt Benckiser Pty Ltd	4.4 - Special warnings and precautions for use Severe skin reactions and risk of sleep-related breathing disorder warnings 4.5 - Interactions with other medicines and other forms of interactions Serotonergic drugs	28 October 2022
influenza virus HA	Vaxigrip Tetra Sanofi-Aventis Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Febrile convulsions	14 November 2022
levetiracetam	Keppra UCB Australia Pty Ltd (T/A UCB Pharma Division of UCB Australia)	4.4 - Special warnings and precautions for use Lack of efficacy in patients with SCN8A mutations 4.8 - Adverse effects (undesirable effects) Rare cases of obsessive-compulsive disorders (OCD) in patients with underlying history of OCD or psychiatric disorders	24 November 2022
mefenamic acid	Ponstan Pfizer Australia Pty Ltd	4.2 - Dose and method of administration 4.3 - Contraindications Patients in third trimester of pregnancy or are breastfeeding 4.6 - Fertility, pregnancy and lactation Strengthened information about use in pregnancy, including contraindication during the third trimester Updated information about oligohydramnios and neonatal renal impairment - Use of NSAIDs in second or third trimester may cause fetal renal dysfunction Breastfeeding	28 October 2022
nirmatrelvir/ ritonavir	Paxlovid Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Anaphylaxis and hypersensitivity reactions	4 November 2022
omeprazole	Losec Pharmaco Australia Ltd	4.4 - Special warnings and precautions of use 4.8 - Adverse effects (undesirable effects) Hypomagnesaemia and potential to cause hypocalcaemia and/or hypokalaemia.	21 November 2022
osimertinib mesilate	Tagrisso AstraZeneca Pty Ltd	4.4 - Special warnings and precautions for use 4.8 - Adverse effects (undesirable effects) Aplastic anaemia	5 November 2022
phenobarbital (phenobarbitone)	Phenobarb Arrow Pharma Pty Ltd	4.3 - Contraindications Severe respiratory depression or pulmonary insufficiency, alcoholism and sleep apnoea and elderly patient 4.4 - Special warnings and precautions for use Steven-Johnson syndrome and toxic epidermal necrolysis Update to Paediatric Neurotoxicity section 4.5 - Interactions with other medicines and other forms of interactions 4.6 - Fertility, pregnancy and lactation 4.8 - Adverse effects (undesirable effects) General disorders and administration site conditions, Dupuytren's contracture, frozen shoulder, arthralgia, Peyronie's disease and behavioural disturbances in children	16 November 2022
phenytoin	DBL Phenytoin Injection BP Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Use of phenytoin in 'Women of childbearing potential' 4.6 - Fertility, pregnancy and lactation Strengthened information about use in pregnancy, women of childbearing potential and emphasised the importance of adequate contraception and pre-conception care	5 October 2022
prochlorperazine maleate/ prochlorperazine mesilate	Stemetil Sanofi-aventis Australia Pty Ltd	4.3 - Contraindications Possible association between phenothiazine-containing products and SIDS 4.4 - Special warnings and precautions for use Gradual withdrawal, signs of infection, use in depression, stroke, alcohol use, and use in elderly patients 4.5 - Interactions with other medicines and other forms of interactions 4.8 - Adverse effects (undesirable effects) Various, including some related to nervous system	4 November 2022
rabeprazole sodium	Pariet Janssen-Cilag Pty Ltd	4.4 - Special warnings and precautions of use 4.8 - Adverse effects (undesirable effects) Hypomagnesaemia and potential to cause hypocalcaemia and/or hypokalaemia.	24 November 2022
reboxetine mesilate	Edronax Pfizer Australia 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) Serotonin syndrome	8 November 2022
roxithromycin	Rulide and Rulide D Biaxsig Sanofi-Aventis Australia Pty Ltd	4.4 - Special warnings and precautions for use 4.5 - Interactions with other medicines and other forms of interactions Concurrent use with hydroxychloroquine or chloroquine	21 October 2022
SARS-CoV-2 rS [NVX-CoV2373]	Nuvaxovid Biocelect Pty Ltd	4.4 - Special warnings and precautions for use Myocarditis and pericarditis 4.8 - Adverse effects (undesirable effects) Myocarditis	29 November 2022
sorafenib	Nexavar Bayer Australia Ltd	4.4 - Special warnings and precautions for use Tumour lysis syndrome, which may be fatal, and the need to closely monitor patients with risk factors 4.8 - Adverse effects (Undesirable effects) Tumour lysis syndrome	12 October 2022
tacrolimus	Prograf and Advagraf XL Astellas Pharma Australia Pty Ltd	4.4 - Special warnings and precautions for use Updated information about nephrotoxicity Thrombotic microangiopathy 4.8 - Adverse effects (undesirable effects) Updated frequency of thrombotic microangiopathy	10 November 2022
tozinameran	Comirnaty Comirnaty [tris/sucrose presentation] Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Expanded warning on myocarditis and pericarditis to include reports in females, atypical presentations with non-specific symptoms, and the risk of severe outcomes including death 4.8 - Adverse effects (undesirable effects) Non-sexually acquired genital ulceration	6 October 2022
tozinameran	Comirnaty Pfizer Australia Pty Ltd	4.8 - Adverse effects (undesirable effects) Dizziness	14 November 2022
tozinameran/ riltozinameran	Comirnaty Bivalent BA.1 Pfizer Australia Pty Ltd	4.4 - Special warnings and precautions for use Myocarditis and pericarditis 4.8 - Adverse effects (undesirable effects) Dizziness, non-sexually acquired genital ulceration	14 November 2022

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.

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