This medicine has provisional approval in Australia for some patients with non small cell lung cancer. The decision to approve
this medicine has been made on the basis of promising results from preliminary studies.
More evidence is required to be submitted when available to fully confirm the benefit
and safety of the medicine for this use.
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. Please report side effects. See the full CMI for further details.
1. Why am I using LUMAKRAS?
LUMAKRAS contains the active ingredient sotorasib. LUMAKRAS is used to treat a type
of lung cancer. For more information, see Section
1. Why am I using LUMAKRAS? in the full CMI.
2. What should I know before I use LUMAKRAS?
Your doctor has tested your tumour (cancer) to make sure that this medicine is right
for you. Your doctor may ask you to do some other tests from time to time to check
your progress. Do not use if you have ever had an allergic reaction to sotorasib 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.
For more information, see Section
2. What should I know before I use LUMAKRAS? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with LUMAKRAS and affect how it works. LUMAKRAS may interfere
with how some medicines work. A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How do I use LUMAKRAS?
The recommended dose is 8 tablets taken by mouth once daily with or without food.
Your doctor may have prescribed a lower dose. More instructions can be found in Section
4. How do I use LUMAKRAS? in the full CMI.
5. What should I know while using LUMAKRAS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking LUMAKRAS.
Keep all your doctor's appointments so that your progress can be checked.
Tell your doctor if you become pregnant while taking LUMAKRAS.
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Things you should not do
|
Do not change your dose or stop taking LUMAKRAS unless your healthcare provider tells
you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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LUMAKRAS should not affect your ability to drive and use machines.
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Drinking alcohol
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There is no information on the effects of drinking alcohol while taking this medicine.
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Looking after your medicine
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Store LUMAKRAS below 30°C.
Keep away from children.
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6. Are there any side effects?
Very common side effects include diarrhoea, nausea, vomiting, stomach pain, fatigue,
and some abnormal blood test results. Serious side effects can include liver problems
or new/ worsening shortness of breath, cough, or fever. 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 .
This medicine has provisional approval in Australia for some patients with non small cell lung cancer. The decision to approve
this medicine has been made on the basis of promising results from preliminary studies.
More evidence is required to be submitted when available to fully confirm the benefit
and safety of the medicine for this use.
Active ingredient(s):
sotorasib (so-tor-a-sib)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using LUMAKRAS. 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 LUMAKRAS.
Where to find information in this leaflet:
1. Why am I using LUMAKRAS?
LUMAKRAS contains the active ingredient sotorasib.
It is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
The cancer is caused by an abnormal protein, called KRAS G12C that is involved in the growth of cells.
LUMAKRAS binds to the KRAS G12C protein and blocks the function of the protein in tumour cells. This may slow down
or stop the growth of your lung cancer.
LUMAKRAS can only be prescribed if you have been previously treated for your lung
cancer with other medicines, and your cancer is advanced or has spread to other parts
of your body.
If you have any questions about how LUMAKRAS works or why it has been prescribed for
you, ask your healthcare provider.
2. What should I know before I use LUMAKRAS?
Your healthcare provider will test your tumour (cancer) to make sure that LUMAKRAS
is right for you.
Your healthcare provider may do further assessments including blood tests to check
your liver function. If you have abnormal liver test results, your healthcare provider
may decide to reduce the dose of LUMAKRAS or stop your treatment.
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?
Before taking LUMAKRAS
Talk to your healthcare provider before taking this medicine. Tell them if you have:
liver problems.
lung or breathing problems.
an intolerance to some sugars, such as lactose, or a rare genetic disorder (such as
galactosaemia, or glucose-galactose intolerance or congenital lactase deficiency).
Warnings
Do not use LUMAKRAS if:
You are allergic to sotorasib, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. The effects
of LUMAKRAS in pregnant women are not known. Your healthcare provider will help you
weigh the benefit against the risk of taking LUMAKRAS while you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if the ingredients in LUMAKRAS pass into breast milk. Do not breastfeed during treatment
with LUMAKRAS and for 1 week after the final dose.
Use in children or adolescents
LUMAKRAS has not been studied in patients younger than 18 years of age.
3. What if I am taking other medicines?
Tell your healthcare provider 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect LUMAKRAS.
Medicines that may
reduce
the effect of LUMAKRAS include:
Rifampin, an antibiotic, used to treat tuberculosis
Medicines used to treat epilepsy called phenytoin, carbamazepine, or phenobarbital
St. John’s wort, which is herbal medicine used to treat depression
Enzalutamide, a medicine that is used for prostate cancer
Medicines used to reduce stomach acid and to treat stomach ulcers, indigestion, and
heartburn such as: esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, or
rabeprazole (medicines known as ‘proton pump inhibitors’); famotidine, nizatidine
(medicines known as ‘H2 receptor antagonists’). See special instructions in When to
take LUMAKRAS.
LUMAKRAS may
increase
the effectiveness of some medicines including:
Digoxin, a medicine used to treat heart failure.
LUMAKRAS may
reduce
the effectiveness of some medicines including:
Alfentanil or fentanyl (used to treat severe pain)
Medicines used to prevent organ rejection, such as cyclosporin, sirolimus, everolimus,
or tacrolimus
Medicines used to reduce cholesterol levels, such as simvastatin, or atorvastatin
Midazolam, a medicine used to treat acute seizures or as a sedative before or during
surgery or medical procedures
Medicines used to treat heart rhythm problems, such as amiodarone
Some medicines known as anticoagulants that stop your blood clotting, such as rivaroxaban
and apixaban.
4. How do I take LUMAKRAS?
How much to take
Take LUMAKRAS tablets exactly as your healthcare provider tells you to take it.
The recommended starting dose for LUMAKRAS dose is 8 tablets taken together once every
day. Your healthcare provider may decrease your dose or ask you to stop your medicine,
depending on how well you tolerate it.
How to take LUMAKRAS
LUMAKRAS can be taken with or without food.
Swallow your daily dose of LUMAKRAS tablets whole. Do not break, crush or chew tablets.
If you cannot swallow whole tablets
Place your daily dose of LUMAKRAS tablets in a drinking glass or cup with 120 mL of
room temperature tap water.
Do not use or any other liquids to disperse the tablets.
Do not crush the tablets.
Gently swirl the glass or cup until the tablets disperse into small pieces. The tablets
will not dissolve completely.
The appearance of the mixture may range from pale to bright yellow. Drink the mixture
right away.
Rinse the glass or cup with an additional half a glass of tap water and drink it straight
away to make sure that you have taken the full dose of LUMAKRAS.
If you do not drink the mixture immediately, stir the mixture again, and drink it
within 2 hours of preparation.
When to take LUMAKRAS
Take LUMAKRAS at about the same time each day.
If you need to take an antacid medicine, take LUMAKRAS tablets either 4 hours before
or 10 hours after the antacid.
If you throw up (vomit) after taking LUMAKRAS
If you vomit after taking a dose of LUMAKRAS, do not take an extra dose.
Take your next dose at your regular scheduled time.
If you forget to take LUMAKRAS
LUMAKRAS should be taken at the same time each day.
If you forget to take your dose at the usual time and it is:
less than 6 hours, take the dose as soon as you remember.
more than 6 hours, skip the missed dose. Take your next dose at the usual time on the next day.
Do not take a double dose to make up for the dose you missed.
If you use too much LUMAKRAS
If you think that you have used too much LUMAKRAS, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your healthcare provider, or
go to the Emergency Department at your nearest hospital and take the LUMAKRAS pack
with you.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using LUMAKRAS?
Things you should do
Keep all your doctor's appointments so that your progress can be checked. Your doctor
may ask you to have some tests from time to time to make sure the medicine is working.
Contact your doctor without delay if you become pregnant while taking LUMAKRAS.
Remind any doctor, dentist or pharmacist you visit that you are taking LUMAKRAS.
Call your doctor straight away if you:
Show signs of a serious allergic reaction.
Things you should not do
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not change your dose or stop taking LUMAKRAS unless your healthcare provider tells
you to.
Do not use this medicine after the expiry date (EXP) that is given on the blister
and carton.
Driving or using machines
LUMAKRAS has no marked influence on the ability to drive and use machines.
Be careful before you drive or use any machines or tools until you know how LUMAKRAS
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
There is no information on the effects of taking LUMAKRAS and drinking alcohol.
Looking after your medicine
Store LUMAKRAS tablets below 30°C in the original carton.
Store the pack 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.
Follow the instructions in the carton on how to take care of your medicine properly.
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.
6. Are there any side effects?
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 are very common.
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.
7. Product details
This medicine is only available with a doctor's prescription.
What LUMAKRAS tablets contain
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Active ingredient
(main ingredient)
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sotorasib
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose (E460), lactose monohydrate, croscarmellose sodium (E468),
magnesium stearate (vegetable-source, E470b), polyvinyl alcohol (E1203), titanium
dioxide (E171), polyethylene glycol (E1521), purified talc (E553b), iron oxide yellow
(E172).
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Potential allergens
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lactose 108 mg/tablet (as monohydrate)
|
LUMAKRAS is gluten-free.
Seek medical advice if you are allergic to any of the ingredients.
What LUMAKRAS looks like
LUMAKRAS is a yellow, oblong-shaped, film coated tablet, marked “AMG” on one side
and “120” on the reverse (AUST R 353210).
LUMAKRAS is packed in blister cartons of 56* and 240 tablets. Some pack sizes* may
not be marketed.
Who distributes LUMAKRAS
Amgen Australia Pty Ltd
Level 11, 10 Carrington Street,
Sydney NSW 2000
Ph: 1800 803 638
www.amgenmedinfo.com.au
® = trademark of Amgen.
This leaflet was prepared in June 2022.