Product Information safety updates - November 2023

If you're a health professional, get the latest information about medicines with safety related updates to their product information.

Published

20 November 2023

When new safety information for medicines is identified, we work 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 our 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.

We monitor 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 our 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 we have 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 (sections updated and summary of key information)	Date of approval
abemaciclib	Verzenio Eli Lilly Australia Pty Ltd	4.4 — Special warnings and precautions for use  added information about arterial thromboembolic events	18 October 2023
amlodipine besilate / atorvastatin calcium trihydrate	Caduet Aspen Pharmacare Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Myasthenia Gravis/ Ocular Myasthenia’. In few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. 4.5 – Interactions with other medicines and other forms of interactions added ticagrelor. Co-administration of atorvastatin and ticagrelor increased the atorvastatin acid Cmax by 23% and AUC by 36%. These increases are not considered clinically significant. 4.8 — Adverse effects (undesirable effects) Subheading ‘Post-Marketing Experience’ added myasthenia gravis and ocular myasthenia	24 October 2023
apalutamide	Erlyand Janssen-Cilag Pty Ltd	4.8 — Adverse effects (undesirable effects)  restless leg syndrome	13 October 2023
apomorphine	Movapo Movapo Pfs Movapo Pen Stada Pharmaceuticals Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Neuroleptic malignant syndrome’. Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. It is recommended to taper treatment. added subheading ‘Dopamine agonist withdrawal syndrome’. Symptoms suggestive of dopamine agonist withdrawal syndrome have been reported with abrupt withdrawal of dopaminergic therapy. It is recommended to taper treatment. 4.8 — Adverse effects (undesirable effects) added dopamine agonist withdrawal syndrome added neuroleptic malignant syndrome	6 October 2023
atorvastatin calcium trihydrate	Lipitor Aspen Pharmacare Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Myasthenia Gravis/ Ocular Myasthenia’. In few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. 4.5 — Interactions with other medicines and other forms of interactions added ticagrelor. Co-administration of atorvastatin and ticagrelor increased the atorvastatin acid Cmax by 23% and AUC by 36%. These increases are not considered clinically significant. 4.8 — Adverse effects (undesirable effects) Subheading ‘Post-Marketing Experience’ added myasthenia gravis and ocular myasthenia	24 October 2023
avelumab	Bavencio Merck Healthcare Pty Ltd	4.4 — Special warnings and precautions for use added autoimmune haemolytic anaemia (AIHA) and systemic inflammatory response syndrome (SIRS) have been reported with avelumab or other PD-1/PD-L1 blocking antibodies	31 October 2023
azathioprine	Imuran Aspen Pharmacare Australia Pty Ltd	4.4 — Special warnings and precautions for use metabolism and nutrition disorders with purine analogues 4.6 — Fertility, pregnancy and lactation cholestasis of pregnancy	5 October 2023
captopril	Capoten Arrow Pharma Pty Ltd	4.5 — Interactions with other medicines and other forms of interactions  concomitant alpha blocking agents 4.8 — Adverse effects (undesirable effects)  pruritis, alopecia, stroke, cardiogenic shock, headache	23 October 2023
dasatinib	Sprycel Bristol-Myers Squibb Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Hepatotoxicity’. SPRYCEL may cause hepatotoxicity. Monitor transaminase at baseline and monthly or as clinically indicated during treatment. Reduce dose, withhold, or permanently discontinue SPRYCEL based on severity. 4.8 — Adverse effects (undesirable effects) Subheading ‘Post-Marketing Experience’ added hepatobiliary disorders: hepatotoxicity	26 October 2023
desvenlafaxine (as succinate)	Pristiq Pfizer Australia Pty Ltd	4.2 — Dose and method of administration  4.4 — Special warnings and precautions for use  updated guidance for discontinuing treatment 4.9 — Overdose  reports of fatal cases from post-marketing experience	30 October 2023
drospirenone and estetrol monohydrate	Nextstellis Mayne Pharma International Pty Ltd	4.4 — Special warnings and precautions for use  hepatitis C antiviral medications, hereditary and acquired angioedema	13 October 2023
duloxetine hydrochloride	Cymbalta Eli Lilly Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Postpartum haemorrhage’. SSRI/SNRIs may increase the risk of postpartum haemorrhage added subheading ‘Sexual dysfunction’. Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction with reports of long-lasting sexual dysfunction despite discontinuation of SSRI/SNRI. 4.6 — Fertility, pregnancy and lactation added observational data indicated increased risk of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth. 4.8 — Adverse effects (undesirable effects) added postpartum haemorrhage	25 October 2023
esomeprazole tablet, amoxicillin capsule, clarithromycin tablet composite pack	Nexium Hp7 AstraZeneca Pty Ltd	4.4 — Special warnings and precautions for use updated warnings about hypersensitivity reactions and use in renal impairment 4.5 — Interactions with other medicines and other forms of interactions  Amoxycillin interactions with methotrexate and probenecid 4.8 — Adverse effects (undesirable effects)  Linear IgA disease, Kounis syndrome, drug-induced enterocolitis syndrome, Renal and urinary tract disorders: including interstitial nephritis and crystalluria.	9 October 2023
estradiol (as hemihydrate)	Estrofem Vagifem Low Novo Nordisk Pharmaceuticals Pty Ltd	4.4 — Special warnings and precautions for use added exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema 4.8 — Adverse effects (undesirable effects) added angioedema	31 October 2023
ezetimibe	Ezetrol Zient Organon Pharma Pty Ltd	4.8 — Adverse effects (undesirable effects)  severe cutaneous adverse reactions (SCARs) and drug induced liver injury	13 October 2023
ezetimibe / atorvastatin calcium trihydrate	Atozet Organon Pharma Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions added ticagrelor. Co-administration of atorvastatin and ticagrelor increased the atorvastatin acid Cmax by 23% and AUC by 36%. These increases are not considered clinically significant.	6 October 2023
ezetimibe and rosuvastatin (as calcium) tablets composite pack	Rosuzet Ezalo Organon Pharma Pty Ltd	4.5 — Interactions with other medicines and other forms of interactions  potential interaction between ticagrelor and rosuvastatin 4.8 — Adverse effects (undesirable effects)  severe cutaneous adverse reactions (SCARs) and drug induced liver injury	18 October 2023
fluorouracil	Efudix iNova Pharmaceuticals (Australia) Pty Ltd	4.4 — Special warnings and precautions for use added warning regarding ingestion by pets	12 October 2023
fluoxetine hydrochloride	Prozac Eli Lilly Australia Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Sexual dysfunction’. Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction with reports of long-lasting sexual dysfunction despite discontinuation of SSRI/SNRI	9 September 2023
fluvoxamine	Luvox Movox Viatris Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Postpartum haemorrhage’. SSRI/SNRIs may increase the risk of postpartum haemorrhage added subheading ‘Sexual dysfunction’. Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction with reports of long-lasting sexual dysfunction despite discontinuation of SSRI/SNRI. 4.6 – Fertility, pregnancy and lactation added observational data indicated increased risk of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth. 4.8 — Adverse effects (undesirable effects) added postpartum haemorrhage	13 October 2023
fremanezumab	Ajovy Teva Pharma Australia Pty Ltd	4.4 — Special warnings and precautions for use  updated warnings about hypersensitivity and anaphylactic reactions 4.8 — Adverse effects (undesirable effects)  anaphylactic reaction (post-market)	11 October 2023
glucose	Glucose 5% & 10% Freeflex Fresenius Kabi Australia Pty Ltd	4.5 — Interactions with other medicines and other forms of interactions  drugs with increased vasopressin effect and drugs that may increase the risk of hyponatraemia 4.8 — Adverse effects (undesirable effects)  addition of multiple adverse reactions from post-marketing data	13 October 2023
ipilimumab	Yervoy Bristol-Myers Squibb Australia Pty Ltd	4.4 — Special warnings and precautions for use Subheading ‘Other immune related adverse reactions’ added cases of autoimmune haemolytic anaemia, some with fatal outcome, have been reported with YERVOY in combination with ipilimumab 4.8 — Adverse effects (undesirable effects) Subheading ‘Postmarketing Experience’ added nervous system disorders: myelitis (including transverse myelitis)	30 October 2023
itraconazole	Sporanox Janssen-Cilag Pty Ltd	4.8 — Adverse effects (undesirable effects)  pseudo aldosteronism	13 October 2023
labetalol hydrochloride	Labetalol SXP Southern XP IP Pty Ltd	4.4 — Special warnings and precautions for use  updated effect on skin and eyes, airway disease and heart block. 4.5 — Interactions with other medicines and other forms of interactions  NSAIDs, corticosteroids, oestrogens, progesterone, catecholamines and MIBG 4.6 — Fertility, pregnancy and lactation  Updated use in lactation 4.8 — Adverse effects (undesirable effects)  Nipple pain, Raynaud's phenomenon of the nipple	9 October 2023
larotrectinib sulfate	Vitrakvi Bayer Australia Ltd	4.2 — Dose and method of administration recommended dosage modifications and management for liver function test abnormalities co-administration with moderate CYP3A4 inducers 4.4 — Special warnings and precautions for use updated information about hepatotoxicity 4.5 — Interactions with other medicines and other forms of interactions  information about moderate CYP3A4 inhibitors and moderate CYP3A4 inducers 4.8 — Adverse effects (undesirable effects)  diarrhoea, liver injury, platelet count decreased (thrombocytopaenia)	12 October 2023
linezolid	Zyvox Pfizer Australia Pty Ltd	4.4 — Special warnings and precautions for use  4.8 — Adverse effects (undesirable effects)  rhabdomyolysis	19 October 2023
lipegfilgrastim	Lonquex Teva Pharma Australia Pty Ltd	4.4 — Special warnings and precautions for use  myelodysplastic syndrome and acute myeloid leukaemia in breast and lung cancer patients	11 October 2023
mefenamic acid	Ponstan Pfizer Australia Pty Ltd	4.4 Special warnings and precautions for use 4.8 Adverse effects (undesirable effects) generalised bullous fixed drug eruption	27 October 2023
mercaptamine (cysteamine) bitartrate	Cystagon Alphapharm Pty Ltd	4.4 — Special warnings and precautions for use  aspiration in paediatric use 4.6 — Fertility, pregnancy and lactation  Updated risk during breastfeeding 4.8 — Adverse effects (undesirable effects)  Lethargy and pyrexia	9 October 2023
metformin hydrochloride dapagliflozin propanediol monohydrate	Xigduo XR AstraZeneca Pty Ltd	4.4 — Special warnings and precautions for use 4.8 — Adverse effects (undesirable effects) Update to warning and frequency – vitamin B₁₂ deficiency	28 September 2023
metformin hydrochloride/vildagliptin	Galvumet Novartis Pharmaceuticals Australia Pty Ltd	4.8 — Adverse effects (undesirable effects) cholecystitis	31 October 2023
midazolam (as hydrochloride)	B.Bruan Midazolam B Braun Australia Pty Ltd	4.8 — Adverse effects (undesirable effects) Kounis syndrome	29 September 2023
midodrine	Vasodrine Southern XP IP Pty Ltd	4.3 — Contraindications acute nephritis, hypertrophy of the prostate gland with residual urine volume increased, Vasovagal hypotension 4.4 — Special warnings and precautions for use  monitoring of patients with a history of CVA. caution in patients with diabetes mellitus with high blood pressure levels renal function and blood pressure monitoring in patients with long-term treatment. 4.5 — Interactions with other medicines and other forms of interactions  updated list of vasoconstrictive substances updated glycosides or psychopharmaceutical drugs 4.8 — Adverse effects (undesirable effects) light headedness, increased tear production, arrhythmias, chest pain, cerebrovascular accident	11 October 2023
molnupiravir	Lagevrio Merck Sharp & Dohme (Australia) Pty Ltd	4.8 — Adverse effects (undesirable effects) vomiting pruritus	18 October 2023
morphine sulfate pentahydrate	Anamorph Arrotex Pharmaceuticals Pty Ltd	4.4 — Special warnings and precautions for use  respiratory depression, endocrine effects, abdominal conditions, cordotomy, biliary tract disorders, acute ulcerative colitis, ACS and SCAR 4.5 — Interactions with other medicines and other forms of interactions  acidifying or alkalinizing agents, amphetamines, anticholinergics, anticoagulants and CNS depressants 4.6 — Fertility, pregnancy and lactation  updated information about fertility added information about and use in labour 4.8 — Adverse effects (undesirable effects)  updated information about sedation, nausea and vomiting and constipation added multiple adverse events	12 October 2023
nirmatrelvir and ritonavir	Paxlovid Pfizer Australia Pty Ltd	4.2 — Dose and method of administration clarification of baseline symptom severity 4.4 — Special warnings and precautions for use added warning about reports of drug interactions leading to severe, life-threatening, and fatal outcomes updated hypersensitivity reactions warning 4.5 — Interactions with other medicines and other forms of interactions  added information about inhibition of CYP2D6, P-pg, and OATP1B1 4.8 — Adverse effects (undesirable effects)  Stevens-Johnson syndrome and toxic epidermal necrolysis	16 October 2023
nivolumab	Opdivo Bristol-Myers Squibb Australia Pty Ltd	4.4 — Special warnings and precautions for use Subheading ‘Other immune related adverse reactions’ added cases of autoimmune haemolytic anaemia, some with fatal outcome, have been reported with OPDIVO or OPDIVO in combination with ipilimumab 4.8 — Adverse effects (undesirable effects) Subheading ‘Postmarketing Experience’ added systemic inflammatory response syndrome added nervous system disorders: myelitis (including transverse myelitis) added hepatobiliary: cholangitis.	30 October 2023
Nivolumab / relatlimab	Opdualag Bristol-Myers Squibb Australia Pty Ltd	4.8 — Adverse effects (undesirable effects) added cholangitis.	30 October 2023
ofatumumab	Kesimpta Novartis Pharmaceuticals Australia Pty Ltd	4.4 — Special warnings and precautions for use  4.8 — Adverse effects (undesirable effects)  systemic injection-related reactions and hypersensitivity	30 October 2023
parecoxib (as sodium)	Dynastat Pfizer Australia Pty Ltd	4.4 — Special warnings and precautions for use  added warning about the possibility of generalised bullous fixed drug eruption	30 October 2023
pembrolizumab	Keytruda Merck Sharp & Dohme (Australia) Pty Ltd	4.4 — Special warnings and precautions for use gastritis	17 October 2023
pemigatinib	Pemazyre Specialised Therapeutics Alim Pty Ltd	4.8 — Adverse effects (undesirable effects)  cutaneous calcification	19 October 2023
pravastatin sodium	Pravachol Arrow Pharma Pty Ltd	4.4 — Special warnings and precautions for use  updated warning about skeletal muscle and immune mediated necrotizing myopathy 4.5 — Interactions with other medicines and other forms of interactions  coadministration with Colchicine, Nicotinic acid, Rifampicin and Coumarin Anticoagulants 4.8 — Adverse effects (undesirable effects)  hepatobiliary disorders	17 October 2023
pravastatin sodium	Pravachol Arrow Pharma Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Myasthenia Gravis/ Ocular Myasthenia’. In few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. 4.8 — Adverse effects (undesirable effects) subheading ‘Post marketing’ – added myasthenia gravis and ocular myasthenia under.	6 September 2023
pregabalin	Lyrica Viatris Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Severe cutaneous adverse reactions (SCARs)’. SCARs including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be fatal, have been reported rarely in association with pregabalin treatment. 4.8 — Adverse effects (undesirable effects) Subheading ‘Post-Marketing Experience’ added toxic epidermal necrolysis.	23 October 2023
quinine bisulfate heptahydrate	Quinbisul Arrow Pharma Pty Ltd	4.4 — Special warnings and precautions for use  updated warnings about cinchonism and hypersensitivity added warning about cardiac disorders 4.5 — Interactions with other medicines and other forms of interactions  ciclosporin	18 October 2023
quinine sulfate dihydrate	Quinate Arrow Pharma Pty Ltd	4.4 — Special warnings and precautions for use  added warning about galactose intolerance, total lactose deficiency or glucose-galactose malabsorption 4.6 — Fertility, pregnancy and lactation  updated warning about not using during pregnancy 4.8 — Adverse effects (undesirable effects)  oliguria atroventricular conduction disturbances 4.9 — Overdose  added deafness and visual disturbances	19 October 2023
rosuvastatin calcium	Crestor A Menarini Australia Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions added ticagrelor. Concomitant use of ticagrelor and rosuvastatin led to renal function decrease, increased CK level and rhabdomyolysis.	3 October 2023
saxagliptin metformin	Kombiglyze XR AstraZeneca Pty Ltd	4.4 — Special warnings and precautions for use 4.8 — Adverse effects (undesirable effects) Update to warning and frequency – vitamin B₁₂ deficiency	28 September 2023
sertraline	Zoloft Viatris Pty Ltd	4.4 — Special warnings and precautions for use added subheading ‘Postpartum haemorrhage’. SSRI/SNRIs may increase the risk of postpartum haemorrhage 4.8 — Adverse effects (undesirable effects) added postpartum haemorrhage	3 October 2023
ticagrelor	Brilinta Astrazeneca Pty Ltd	4.5 – Interactions with other medicines and other forms of interactions added rosuvastatin. Concomitant use of ticagrelor and rosuvastatin led to renal function decrease, increased CK level and rhabdomyolysis.	3 October 2023
trimethoprim	Triprim Arrotex Pharmaceuticals Pty Ltd	4.3 — Contraindications severe hepatic insufficiency 4.4 — Special warnings and precautions for use updated warning about electrolyte abnormalities 4.5 — Interactions with other medicines and other forms of interactions  updated information about warfarin and other coumarins updated information about phenytoin, digoxin, procainamide antibacterials updated information about ACE Inhibitors 4.8 — Adverse effects (undesirable effects)  skin rashes, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, pruritus, raised serum creatinine and blood urea nitrogen levels, hepatic necrosis
valaciclovir	Valtrex Zelitrex APX-Valaciclovir Arrow Pharma Pty Ltd	4.4 — Special warnings and precautions for use  updated precaution about use in genital herpes 4.8 — Adverse effects (undesirable effects)  headache, aggressive behaviour, delirium (post-market)	12 October 2023

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

We encourage 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.

To report a suspected side effect or for more information about reporting, go to our ‘Report problem or side effect’ webpage or contact our Pharmacovigilance Branch ADR.Reports@health.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.

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.

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 Branch at ADR.Reports@health.gov.au.

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Product Information safety updates - November 2023

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

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