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Non small cell lung cancer locally advanced or metastatic entrectinib

This protocol is based on limited evidence; refer to the evidence section of this protocol for more information.

Check for clinical trials in this patient group. Link to Australian Clinical Trials opens in a new tab or window website

Link to Clinical practice guidelines for the treatment of lung cancer opens in a new tab or window

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Drug Dose Route
Entrectinib 600 mg ONCE a day PO

Continuous until disease progression or unacceptable toxicity.

Drug status:

Entrectinib is PBS authority opens in a new tab or window

Entrectinib is available as 100 mg (not PBS listed) and 200 mg capsules

Cost:
~ $6,720 per month "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Continuous treatment
Entrectinib 600 mg (PO) ONCE a day

Continuous until disease progression or unacceptable toxicity.

Drug Dose Route
Entrectinib 600 mg ONCE a day PO

Continuous until disease progression or unacceptable toxicity.

Drug status:

Entrectinib is PBS authority opens in a new tab or window

Entrectinib is available as 100 mg (not PBS listed) and 200 mg capsules

Cost:
~ $6,720 per month "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Continuous treatment
Entrectinib 600 mg (PO) ONCE a day

Continuous until disease progression or unacceptable toxicity.

Indications:

  • Treatment of locally advanced or metastatic c-ROS proto-oncogene 1 (ROS1) positive non small cell lung cancer (NSCLC), in patients not previously treated with, or who are intolerant to, ROS1 tyrosine kinase inhibitors.
    • ECOG 0 to 2.

Cautions/Exclusions:

  • Clinically significant uncontrolled cardiovascular disease e.g. congestive heart failure or bradyarrhythmias.
  • Congenital long-QT syndrome.
Caution with oral anti-cancer drugs

Select links for information on the safe prescribing, dispensing and administration of orally administered anti-cancer drugs. 

Read more about at COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy opens in a new tab or window and oral anti-cancer therapy opens in a new tab or window
Emetogenicity minimal or low

No routine prophylaxis required. If patients experience nausea and/or vomiting, consider using the low emetogenic risk regimen.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Cardiac toxicity

Tyrosine kinase inhibitors have been associated with cardiac complications of varying degrees and severity.

Patients, especially those with pre-existing cardiovascular disease, should have a baseline cardiac assessment including an electrocardiogram (ECG) and biochemistry and be closely monitored; consider an echocardiogram (ECHO) as clinically indicated.

Cardiac assessment should then be repeated as clinically indicated or when starting new medication which affects the QT interval.

Read more about cardiac toxicity associated with anti-cancer drugs
Prolongation of QT interval

This treatment may prolong the QT interval and increase the risk of cardiac arrhythmia. Use with caution in patients with a congenital long QT syndrome, patients treated with a high cumulative dose of anthracycline therapy, patients taking medications that may prolong the QT interval and those with electrolyte disturbances. Risk factors (e.g. electrolyte abnormalities) should be corrected, where possible, prior to commencement of treatment and the concurrent use of drugs that may prolong the QT interval should be avoided. Baseline and periodic monitoring of electrocardiogram (ECG) and electrolytes (potassium, magnesium, calcium) should be considered in patients at high risk of QT prolongation.

Read more about drugs that may prolong QTc interval at crediblemeds.org opens in a new tab or window (registration required).
Oedema

Patients may experience an increased incidence of oedema, including peripheral oedema, with this treatment. 
Central nervous system (CNS) effects

A broad spectrum of CNS effects can occur in patients receiving this treatment. Cognitive effects include memory impairment, cognitive disorder, amnesia and aphasia. Mood effects include irritability, anxiety, depression and mood lability. It is important to note if a patient has a history of a psychiatric disorder. Dizziness and sleep disturbance may also occur.
Diarrhoea and constipation

Both diarrhoea and constipation may occur with this treatment.

Patients may require either antidiarrhoeals or laxatives.

Read more about treatment induced diarrhoea
Hepatotoxicity

Severe hepatotoxicity (including drug-induced liver injury) has been observed with this treatment.

Monitor for abnormal liver function tests (LFTs), jaundice and tiredness. Refer to blood tests and dose modification sections for specific recommendations.
Hyperuricaemia

Hyperuricaemia can occur with this treatment. Dose adjustment or initiation of urate-lowering agents may be required.
Visual disturbances

This treatment has been associated with visual disturbances, including blurred or impaired vision, diplopia, photophobia, floaters, flashes and cataracts.
Blood tests

FBC, EUC, eGFR, calcium, magnesium, phosphate, urate and LFTs at baseline then monthly throughout treatment and as clinically indicated. Repeat LFTs every 2 weeks for the first month.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is NOT usually recommended for patients receiving this treatment.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines should be used with caution in cancer patients. For cancer patients who are not receiving immunosuppressive therapy, there is currently no data as to the safety of giving live vaccines. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
Fertility, pregnancy and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. There is a risk of fetal harm in pregnant women. A pregnancy test should be considered prior to initiating treatment in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and adequate contraception timeframe should be discussed with all patients of reproductive potential. Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the impact of cancer treatment on fertility opens in a new tab or window
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) opens in a new tab or window unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Note: The dose modifications below are based on a combination of the clinical trial,r product information and reference committee consensus.

Entrectinib dose reduction schedule
Starting dose 600 mg once daily
First dose reduction 400 mg once daily
Second dose reduction 200 mg once daily

* Consider permanently discontinuing entrectinib if patient unable to tolerate 200 mg once a day
Haematological toxicity
ANC x 109/L (pre-treatment blood test)
1.0 to less than 1.5 Refer to local institutional guidelines; it is the view of the expert clinicians that treatment should continue if patient is clinically well
0.5 to less than 1.0 Delay treatment until recovery, then resume at the same dose or reduce to next lower dose level
less than 0.5 or febrile neutropenia Delay treatment until recovery, then resume at the same dose or reduce to next lower dose level
Kidney dosing recommendations 
No dose modification necessary
Hepatic impairment
At baseline
Mild No dose modification necessary
Moderate or severe No data available as has not been studied
Transaminases (ALT and AST) +/- bilirubin during treatment
Grade 1 or 2 No dose modification necessary
Grade 3

Delay treatment until recovery to less than or equal to grade 1 or baseline then treat as follows:
Resolution within 4 weeks: resume at the same dose for 1st recurrence, or reduce to next lower dose level for further recurrences
No resolution within 4 weeks: permanently discontinue entrectinib 
Grade 4 Delay treatment until recovery to less than or equal to grade 1 or baseline then treat as follows:
Resolution within 4 weeks: resume at the next lower dose level for 1st recurrence, or permanently discontinue entrectinib for further recurrences
No resolution within 4 weeks: permanently discontinue entrectinib
ALT or AST greater than 3 x ULN and bilirubin greater than 1.5 x ULN (in the absence of cholestasis or haemolysis) Permanently discontinue entrectinib
QTc prolongation
QTc 481 to 500 msec Delay treatment until recovery to baseline then resume at the same dose
QTc greater than 500 msec Delay treatment until recovery to baseline then resume as follows:
Factors that cause QT prolongation are identified and corrected: resume at the same dose 
Factors that cause QT prolongation are not identified: resume at the next lower dose level
QTc prolongation with signs/symptoms of serious arrhythmia Permanently discontinue entrectinib
Congestive heart failure
Grade 2 or 3 Delay treatment until recovery to less than or equal to grade 1 then resume at the next lower dose level
Grade 4 Permanently discontinue entrectinib
Central nervous system effects and cognitive disturbance
Intolerable grade 2

Delay treatment until recovery to less than or equal to grade 1 or to baseline then resume at the same dose or reduce to the next lower dose level, as clinically appropriate
Grade 3

Delay treatment until recovery to less than or equal to grade 1 or to baseline then resume at the next lower dose level
Grade 4

Permanently discontinue entrectinib
Hyperuricaemia
Symptomatic or grade 4 life-threatening consequences

Initiate urate-lowering medication
Delay treatment until improvement of signs or symptoms, then resume at the same dose or reduce to the next lower dose level
Vision disorders
Grade 2 or above Delay treatment until improvement or stabilisation, then resume at the same dose or reduce to the next lower dose level, as clinically appropriate
Other adverse reactions
Grade 3 or 4

Delay treatment until recovery to grade 1 or baseline then treat as follows:
Resolution within 4 weeks: resume at the same dose or at the next lower dose level
No resolution within 4 weeks or recurrent grade 4 reaction: permanently discontinue entrectinib

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources: 

For more information see References & Disclaimer.

Entrectinib
  Interaction Clinical management
Drugs that may prolong the QTc interval (e.g. azole antifungals, tricyclic antidepressants, antiarrhythmics etc.) Additive effect with entrectinib; may lead to torsades de pointes and cardiac arrest Avoid combination or minimise additional risk factors (e.g. correct electrolyte imbalances) and monitor ECG for signs of cardiac arrhythmia
CYP3A4 inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of entrectinib possible due to reduced clearance Avoid combination or monitor for entrectinib toxicity. If concomitant use of strong CYP3A4 inhibitors cannot be avoided, reduce entrectinib starting dose to 100 mg once a day. If concomitant use of moderate CYP3A4 inhibitors cannot be avoided, reduce entrectinib starting dose to 200 mg once a day. After discontinuation of a strong or moderate CYP3A4 inhibitor, entrectinib should be resumed at the dose that was tolerated prior to the initiation of the CYP3A4 inhibitor and after a washout period of 3 to 5 half lives of the CYP3A4 inhibitor. 
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of entrectinib due to increased clearance Avoid combination with strong or moderate CYP3A4 inducers or monitor for decreased effect of entrectinib
H2 blockers (e.g. famotidine, ranitidine etc.) and proton pump inhibitors (e.g. omeprazole, pantoprazole, rabeprazole etc.) Reduced efficacy of entrectinib possible due to decreased absorption when gastric acid secretion suppressed (entrectinib requires acidic environment for absorption) Avoid combination
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines. Live vaccines should be used with caution in cancer patients. For cancer patients who are not receiving immunosuppressive therapy, there is currently no data as to the safety of giving live vaccines.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook opens in a new tab or window

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter or address chemical compatibilities related to IV drug preparation and administration. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Administration

This is a continuous oral treatment

Pre treatment assessment

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Anti-cancer drug patient assessment tool prior to each day of treatment.

Entrectinib

Administer entrectinib:
  • orally ONCE a day
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • may be taken with or without food.

Note: If a dose is missed it should be taken as soon as possible unless it is less than 12 hours before the next dose. If a dose is vomited, normal dosing should be resumed at the next scheduled dose.

Post administration

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Discharge information

Discharge medications

Entrectinib capsules - with written instructions on how to take them.

Patient information

Ensure patient receives protocol patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Diarrhoea

Read more about treatment induced diarrhoea
Constipation
Fatigue

Read more about fatigue
Peripheral neuropathy

Typically symmetrical sensory neuropathy, affecting the fingers and toes, sometimes progressing to the hands and feet.  It is associated with several classes of anti-cancer drugs. These include taxanes, platinum-based compounds, vinca alkaloids and some drugs used to treat multiple myeloma.

Read more about peripheral neuropathy
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Ocular changes

Symptoms may include blurred vision, diplopia, visual impairment, photophobia, cataracts and vitreous floaters.
QT prolongation

This treatment can cause QTc interval prolongation. QTc prolongation can lead to ventricular arrhythmias that may be fatal.
Dizziness

Feeling faint or lightheaded, weak or unsteady. Advise patients to stand up slowly from sitting down or lying down positions and increase fluid intake if dehydrated.
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Hepatotoxicity

Anti-cancer drugs administered either alone or in combination with other drugs and/or radiation therapy may cause direct or indirect hepatotoxicity. Hepatic dysfunction can alter the metabolism of some drugs resulting in systemic toxicity.
Hyperuricaemia

Elevated serum urate/uric acid may occur. Initiate urate-lowering medications as clinically indicated.
CNS effects

Mood effects include irritability, anxiety, depression and mood lability. Cognitive effects include memory impairment, cognitive disorder, amnesia and aphasia. Sleep disturbance can also occur.

Late (onset weeks to months)
Weight gain
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia

eviQ is currently updating the way information is presented in the evidence section to improve usability, consistency and facilitate easier update and maintenance. An updated evidence template is being implemented in a staged approach, first across new protocols, then existing protocols as they are reviewed. Find out more

A search of the literature did not find strong evidence to support the use of entrectinib in the treatment of locally advanced or metastatic non small cell lung cancer. The expert reference panel supported publication of the protocol on the basis of the information summarised below. The committee was most strongly influenced by the pooled results of three phase I and II trials (ALKA 372-001, STARTRK-1, STARTRK-2).rr

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments

Phase I/II trials

Integrated analysis of ALKA 372-001, STARTRK-1, STARTRK-2 2020/2021rr

Yes

Yes

-

Guidelines

Date published/revised

Supports Use

Is the dose and regimen consistent with the protocol?

Comments

NCCN

March 2021

Yes

N/A

No doses stated
ESMO September 2020 Yes N/A

No doses stated

Supports use in metastatic NSCLC

CCO

N/A

N/A

-

-
BCCA N/A N/A - -

Efficacy

A total of 161 patients with ROS-1 fusion positive locally advanced or metastatic NSCLC were enrolled in three ongoing phase I/II trials of entrectinib (ALKA 372-001, STARTRK-1 and STARTRK-2).rr

Median treatment duration was 10.7 months (IQR 6.4-17.7) with an objective response rate (ORR) in 108 patients (67.1%; 95% CI 59.3-74.3) with a complete response achieved in 8.7%, partial response in 58.4%, and stable disease in 8.7%.r The median progression free survival (PFS) was 15.7 months (95% CI 11.0-21.1) and 12 month overall survival (OS) rate was 81% (95% CI 74-87). Median OS and median time to CNS progression was not estimable. 38 (23.6%) patients died during follow-up.

In 24 patients with measurable baseline CNS metastases, the intracranial ORR was 79.2% (95% CI, 57.9-92.9). The median intracranial PFS was 12 months (95% CI 6.2-19.3) and the median intracranial duration of response was 12.9 months (95% CI 6.8-22.1).

Kaplan-Meier curves of (A) duration of response, (B) progression free survival, (C) time to CNS progression and (D) overall survivalr

© J Clin Oncol 2021

Toxicity

A summary of the toxicities associated with this protocol are included in the table below. The most common toxicities for this treatment were dysgeusia and dizziness.r

Adverse eventsr

Toxicity Grade 1-2 (%) Grade 3-4 (%)
Dysgeusia 42.9 0.5
Dizziness 34.3 0.5
Constipation 31.4 0
Fatigue 29.5 0.5
Diarrhoea 23.8 2.9
Weight increased 20.5 8.1
Paraesthesia 18.6 0
Blood creatinine increased 18.1 0.5
Nausea 17.6 1.0
Peripheral oedema 17.6 0.5
Myalgia 15.7 1.0
Vomiting 13.3 1.0
Anaemia 11.0 0.5
AST increased 9.5 2.4
Arthralgia 8.6 0.5
ALT increased 7.6 3.3
Hyperuricaemia 6.7 1.0
Peripheral sensory neuropathy 5.7 1.0
Cognitive disorder 5.7 1.0
Muscular weakness 5.2 0.5
Neutropenia 2.4 1.9
QTc prolongation 0.5 1.0
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Version 2

Date Summary of changes
08/02/2024

Protocol updated with ADDIKD guideline recommendations.

PDF of previous protocol.

Version number changed to V.2.
27/09/2024 Protocol reviewed electronically by respiratory reference committee, no changes. Next review in 4 years.

Version 1

Date Summary of changes
30/04/2021 Protocol discussed at Medical Oncology reference committee meeting.
21/05/2021 Protocol approved and published on eviQ.
21/12/2021 Changed antiemetic clinical information block to minimal or low, to align with new categories. See ID 7 Prevention of anti-cancer therapy induced nausea and vomiting (AINV) v5.
20/05/2022 Protocol reviewed electronically by Medical Oncology Reference Committee. EGFR TKI cardiac toxicity clinical information updated. Next review in 2 years.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/3958

15 Jun 2025