GAVRETO®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
GAVRETO contains the active ingredient pralsetinib. GAVRETO is used to treat patients
who have certain types of cancer - known as rearranged during transfection (RET)-fusion
positive lung cancer or thyroid cancer.
For more information, see Section 1. Why am I using GAVRETO? in the full CMI.
For more information, see Section 1. Why am I using GAVRETO? in the full CMI.
Do not use if you have ever had an allergic reaction to GAVRETO or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. It is important to
tell you doctor if you have a history of lung and/or breathing problems, high blood
pressure, liver problems or bleeding problems.
For more information, see Section 2. What should I know before I use GAVRETO? in the full CMI.
Some medicines may interfere with GAVRETO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
The recommended dose is 400 mg (4 capsules) taken by mouth once daily. GAVRETO capsules
should be swallowed whole with a glass of water and must not be opened or chewed.
If you get side effects, your doctor may change your dose, temporarily stop, or permanently
stop treatment.
Take GAVRETO on an empty stomach. Do not eat for at least 2 hours before and at least
1 hour after taking GAVRETO.
More instructions can be found in Section 4. How do I use GAVRETO? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking GAVRETO.
Your doctor will perform regular checks of your blood pressure, and liver function
(via a blood test)
Tell your doctor straight away if you become pregnant
Tell your doctor straight away if you experience any new or worsening symptoms or
symptoms that concern you
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Driving or using machines
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GAVRETO may make some people feel fatigued. Be careful driving and/or operating heavy
machinery until you know how it affects you
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Looking after your medicine
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Store GAVRETO in a cool, dry place where children cannot access it. GAVRETO should
be stored at room temperature (below 30°C).
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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For more information, see Section 5. What should I know while using GAVRETO? in the full CMI.
GAVRETO can cause side effects that you need to tell your doctor about straight away.
Tell your doctor if you experience any side effects which concern you. Symptoms of
serious side effects include difficulty breathing, shortness of breath, fever, yellowing
of your skin or the whites of your eyes, pain on the right side of your stomach area,
dark urine, itchy skin, vomiting blood, bleeding or bruising more easily than normal.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
GAVRETO (GAV-RET-OH)
Active ingredient(s):
pralsetinib (prowl-set-ee-nib)
GAVRETO has provisional approval in Australia for the indications below:
Treatment of adult patients with locally advanced or metastatic rearranged during
transfection (RET) fusion-positive non-small cell lung cancer (NSCLC); and the treatment
of adult patients with advanced or metastatic RET-fusion positive thyroid cancer that
is refractory to (or unsuitable for) radioactive iodine and who have progressed on
or are unable to tolerate lenvatinib or sorafenib.
The decision to approve this medicine has been made on the basis of promising results
from preliminary studies. More evidence is needed to be submitted when available to
fully confirm the benefit and safety of the medicine for these uses.
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Consumer Medicine Information (CMI)
This leaflet provides important information about using GAVRETO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using GAVRETO.
Where to find information in this leaflet:
GAVRETO contains the active ingredient pralsetinib. GAVRETO is a cancer medicine. In patients whose cancer is due to an altered rearranged
during transfection (RET) gene, the change in the gene causes the body to make an
abnormal protein called a RET fusion protein, which can lead to uncontrolled cell
growth and cancer. GAVRETO blocks the action of RET fusion proteins and may help to
slow or stop your cancer from growing. It may also help to shrink your cancer.
GAVRETO is used to treat certain cancers caused by RET genes in:
- adults with non-small cell lung cancer (NSCLC) that is
advanced or spread to other parts of the body (metastatic)
- adults with thyroid cancer that is advanced or spread to other parts of the body
(metastatic) and who have received radioactive iodine (if suitable); and either lenvatinib
or sorafenib (if these are able to be tolerated) and they did not work or are no longer
working
Your healthcare provider will perform a test to make sure that GAVRETO is right for
you.
It is not known if GAVRETO is safe and effective in children younger than 18 years
of age.
Warnings
Do not use GAVRETO if:
you are allergic to pralsetinib, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions i.e. have lung or breathing problems; have high
blood pressure; have liver problems or have bleeding problems
plan to have surgery. You should not use GAVRETO for at least 5 days prior to your
surgery
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will perform a pregnancy test before you start treatment with GAVRETO.
Contraception in females:
You should avoid becoming pregnant while taking this medicine. If you are able to
have children, you must use highly effective contraception (for example, double-barrier
contraception such as condom and diaphragm) while on treatment and for at least 2
weeks after stopping treatment. GAVRETO may reduce the effectiveness of hormonal contraceptive
methods (for example, birth control pill); therefore, hormonal contraceptives may
not be considered highly effective. If hormonal contraception is unavoidable, it must
be used in combination with a condom.
Contraception in males:
Males with female partners of childbearing potential should use effective contraception
during treatment and for 1 week after completion of treatment.
Talk to your doctor about the right methods of contraception for you and your partner.
Pregnancy:
This medicine is not recommended for use during pregnancy unless absolutely necessary.
Avoid becoming pregnant while being treated with this medicine as it may harm your
unborn baby. Your doctor will discuss with you the potential risks of taking GAVRETO
during pregnancy.
Breastfeeding:
It is not known if GAVRETO passes into your breast milk. Do not breastfeed during
treatment and for one week after your final dose of GAVRETO.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with GAVRETO and affect how it works.
Medicines that may
increase
the effect of GAVRETO include:
Medicines used to treat AIDS/HIV (e.g. ritonavir)
Medicines used to treat infections. These include medicines that treat fungal infections
(antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines
that treat certain types of bacterial infection (e.g. certain types of antibiotics)
Medicines that may
reduce
the effect of GAVRETO include:
Medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine
or phenobarbital)
Medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
St. John's Wort, a herbal medicine used to treat depression
GAVRETO may affect the way some other medicines work, including:
ciclosporin
paclitaxel
warfarin
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect GAVRETO.
How much to take
Follow the instructions provided and use GAVRETO until your doctor tells you to stop.
The recommended dose is 400 mg (4 capsules) taken by mouth, once daily.
When to take GAVRETO
GAVRETO is usually taken once a day.
Take GAVRETO on an empty stomach. Do not eat for at least 2 hours before and at least
1 hour after taking GAVRETO.
GAVRETO capsules should be swallowed whole with a glass of water and must not be opened
or chewed.
Do not change your dose or stop taking GAVRETO unless your healthcare provider tells
you to. Your healthcare provider may change your dose, temporarily stop, or permanently
stop treatment with GAVRETO.
If you forget to take GAVRETO
GAVRETO should be taken regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as possible on the same day. Then take your next
dose of GAVRETO at your regular time the next day. If you vomit after taking a dose
of GAVRETO, do not take an extra dose. Take your next dose of GAVRETO at your regular
time the next day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much GAVRETO
If you think that you have used too much GAVRETO, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Call your doctor straight away if you:
if you have any new or worsening symptoms including difficulty in breathing, shortness
of breath, or cough with or without mucous, or fever. GAVRETO may cause severe, life-threatening
or fatal swelling (inflammation) of the lungs during treatment.
if you have any yellowing of your skin or the whites of your eyes, pain on the right
side of your stomach area, dark urine, itchy skin, feeling less hungry than usual,
nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
are vomiting blood or vomit that looks like coffee-grounds, coughing up blood or blood
clots, have pink or brown urine, red or black (looks like tar) stools, unusual bleeding
or bruising of your skin, menstrual bleeding that is heavier than normal, unusual
vaginal bleeding, nose bleeds that happen often, drowsiness or difficulty being awakened.
Remind any doctor, dentist or pharmacist you visit that you are using GAVRETO.
While you are taking GAVRETO
Your doctor will take blood tests before you start treatment, then every 2 weeks for
the first 3 months of your treatment and then as needed. This is to check you do not
have any liver problems while taking GAVRETO.
GAVRETO can increase the chance of high blood pressure. Your doctor will monitor your
blood pressure before you start treatment, then after 1 week of your treatment and
then as needed.
You should avoid drinking grapefruit juice and eating grapefruit while on treatment
with GAVRETO.
Tell your doctor straight away if you become pregnant or think you might be pregnant
during treatment with GAVRETO.
Wounds may not heal properly during treatment with GAVRETO. You should not take GAVRETO
for at least 5 days before surgery. Your doctor should tell you when you may start
taking GAVRETO again after surgery.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how GAVRETO
affects you.
GAVRETO may cause fatigue in some people.
Looking after your medicine
Store GAVRETO at room temperature (below 30°C).
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date which is stated on the bottle label
and outer carton after "EXP". The expiry date refers to the last day of that month.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gastrointestinal system:
Constipation
Diarrhoea
Dry Mouth
Nausea
Vomiting
General:
Tiredness
Muscle and joint pain
Headache
Change in the way things taste
Infections:
Symptoms of urinary (bladder) infection including strong and frequent urge to urinate.
cloudy, bloody, or strong-smelling urine, pain or a burning sensation when urinating
Skin:
Rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Lung problems:
Severe or life-threatening inflammation of the lungs. Symptoms include shortness of
breath, cough, fever
Bleeding problems:
Vomiting blood or if your vomit looks like coffee grounds
Pink or brown urine
Red or black (looks like tar) stools
Coughing up blood or blood clots
Unusual bleeding or bruising of your skin
Menstrual bleeding that is heavier than normal
Unusual vaginal bleeding
Nose bleeds that happen often
Drowsiness or difficulty being awakened
Confusion
Headache
Change in speech
Liver problems:
Yellowing of skin or the white part of your eyes (jaundice)
Dark 'tea-coloured' urine
Sleepiness
Bleeding or bruising
Loss of appetite
Nausea or vomiting
Pain on the upper right side of your stomach
Changes in blood test results i.e. decreased white blood cell, red blood cell and
platelet counts; decreased levels of phosphate, calcium or sodium (salt) in the blood
Abnormal liver function blood tests
High blood pressure
GAVRETO can increase the occurrence of high blood pressure. Symptoms of high blood
pressure can include confusion, headaches, shortness of breathe, dizziness and/or
chest pain.
Abnormal ECG
GAVRETO may result in abnormal ECGs. Tell your Doctor if you feel light-headed or
experience palpitations as it may be a symptom of abnormal ECG.
Tumour Lysis Syndrome (TLS)
TLS is caused by fast breakdown of cancer cells, and may lead to serious side effects.
Symptoms include:
Nausea or vomiting
Weakness
Swelling
Shortness of breath
Seizures
Muscle cramps
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What GAVRETO contains
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Active ingredient
(main ingredient)
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pralsetinib
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Other ingredients
(inactive ingredients)
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citric acid anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose,
pregelatinized starch and sodium bicarbonate.
Capsule shell: Brilliant Blue FCF, hypromellose and titanium dioxide.
White printing ink: TekPrint™ SW-0012 White Ink (PI no. 13175)
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Do not take this medicine if you are allergic to any of these ingredients.
What GAVRETO looks like
GAVRETO 100 mg hard capsules are light blue, opaque hard capsules with "BLU-667" printed
on the capsule shell body and "100 mg" on the capsule shell cap in white ink (AUST
R 380812).
GAVRETO is available in a plastic bottle with child-resistant closure containing 60,
90 or 120 hard capsules and a desiccant sachet. Each carton contains one bottle.
Keep the desiccant sachet in the bottle. The desiccant is a moisture absorbing material
filled in a small sachet to protect the capsules from moisture. Do not swallow the
desiccant.
