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.
1. Why am I using Lorviqua?
Lorviqua contains the active ingredient lorlatinib. Lorviqua is used to treat a rare
type of lung cancer that is caused by defects in a gene called anaplastic lymphoma
kinase (ALK).
2. What should I know before I use Lorviqua?
Do not use if you have ever had an allergic reaction to Lorviqua or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you take any other medicines, or before starting any new medicines
as Lorviqua can interact with some medicines. Talk to your doctor if you have any
other medical conditions, or are pregnant or plan to become pregnant or are breastfeeding.
Do not give this medicine to a child.
3. What if I am taking other medicines?
Some medicines may interfere with Lorviqua and affect how it works.
4. How do I use Lorviqua?
Lorviqua is taken orally (by mouth) once a day. You are encouraged to swallow the
tablet whole (do not chew, crush or split), and take it at approximately the same
time each day
Your doctor will advise how much Lorviqua to take prior to starting treatment
5. What should I know while using Lorviqua?
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Things you should do
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Remind any doctor, pharmacist or dentist you visit that you are using Lorviqua
Tell your doctor immediately if you become pregnant while using this medicine, or
if you develop changes in your heartbeat, lightheadedness, fainting, dizziness or
shortness of breath
Keep all of your doctors appointments so that your dose and progress can be monitored
regularly
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Things you should not do
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Do not stop using this medicine or change the dosage without talking with your doctor
Do not give Lorviqua to anyone else, even if they have the same condition as you
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Driving or using machines
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Be careful driving or operating machinery until you know how Lorviqua affects you
as you as you may experience neurological symptoms
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Looking after your medicine
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Keep your tablets in the pack/bottle until it is time to take them
Store them out of reach of children, in a cool dry place where the temperature stays
below 30°C, heat and dampness (e.g., bathroom, window sill or car) may destroy them
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6. Are there any side effects?
Lorviqua may cause serious side effects, including: liver problems due to interactions
with other medicines; neurological problems such as changes in mood, speech or sleep,
seizures, hallucinations, or confusion; increases in the cholesterol, triglycerides,
or sugar levels in your blood; heart problems, specifically irregular heartbeats;
severe swelling (inflammation) of the lungs.
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 .
Active ingredient(s):
lorlatinib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lorviqua. It does not contain
all the available information. It does not take the place of you talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Lorviqua against the benefits they expect it will have for you.
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 Lorviqua.
Where to find information in this leaflet:
1. Why am I using Lorviqua?
Lorviqua contains the active ingredient lorlatinib.
Lorviqua blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms
of this enzyme (due to the fault in the ALK gene) help encourage cancer cell growth.
Lorviqua is used to treat a rare type of lung cancer that is caused by defects in
a gene called anaplastic lymphoma kinase (ALK).
Lorviqua may slow down or stop the growth of your cancer. It may also help to shrink
your cancer.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Lorviqua is available only with a doctor's prescription.
It is not addictive.
There is not enough information to recommend the use of this medicine for children.
2. What should I know before I use Lorviqua?
Warnings
Do not use Lorviqua if:
1.
You are allergic to lorlatinib, or any of the ingredients listed at the end of this
leaflet. Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
2.
You are taking any of the following medicines:
rifampicin, a medicine used to treat tuberculosis
carbamazepine, phenytoin, medicines used to treat epilepsy
enzalutamide, a medicine used to treat cancer of the adrenal glands
mitotane, a medicine used to treat prostate cancer
medicines containing St John's wort (hypericum perforatum, a herbal preparation)
Check with your doctor if:
you have been told that you cannot tolerate or digest some sugars. Lorviqua contains lactose, a type of sugar found in milk or dairy products. Always
check the ingredients to make sure you can use this medicine
you have allergies to any other medicines, food, preservatives or dyes
take any medicines for any other condition
you have or have had any of the following medical conditions:
high levels of blood cholesterol or triglycerides
high blood pressure
high blood sugar levels (eg., diabetes)
heart problems, including reduced heart rate, or if the results of an electrocardiogram
(ECG) have shown that you have an abnormality of the electrical activity of your heart
known as "prolonged PR interval" or "AV block"
high levels of the enzymes known as amylase or lipase in the blood or a condition
such as pancreatitis that can raise the levels of these enzymes
cough, chest pains, shortness of breath, or worsening of respiratory symptoms or ever
had a lung condition called pneumonitis
liver problems
kidney problems
neurological problems
Your doctor should perform blood tests to check the level of cholesterol and triglcerides
in your blood before you start treatment with Lorviqua and regularly during treatment
Your blood pressure and blood sugar levels should be controlled before starting treatment
with Lorviqua. Your doctor should continue to monitor your levels regularly during
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?
Pregnancy and breastfeeding
Do not take Lorviqua if you are pregnant, it may affect your developing baby.
Do not breast-feed while taking Lorviqua or for 7 days after the last dose. The active ingredient in Lorviqua may pass into breast milk and there is a possibility
that your baby may be affected
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
You should avoid falling pregnant while using this medicine.
Use highly effective contraception (e.g. double-barrier contraception such as condom
and diaphragm) during treatment and for at least 21 days after stopping treatment.
Lorviqua may reduce the effectiveness of hormonal contraceptive methods (e.g. birth
control pill). If hormonal contraception is unavoidable it must be used with a form
of barrier contraception such as a condom.
If your male partner is being treated with Lorviqua, he must use a condom during treatment
and for at least 14 weeks after stopping treatment.
Talk to your doctor about the right methods of contraception for you and your partner.
Lorviqua may affect male fertility.
Talk to your doctor about fertility preservation before taking Lorviqua.
If you become pregnant when taking Lorviqua or during the 3 weeks after taking your
last dose, tell your doctor straight away.
If you have not told your doctor about any of the above, tell him/her before you start
taking Lorviqua.
Do not give this medicine to a child
Safety and effectiveness in children have not been established.
3. What if I am taking other medicines?
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 and Lorviqua may interfere with each other. These include:
boceprivir, a medicine used to treat hepatitis C
medicines used to treat AIDS/HIV such as efavirenz, cobicistat, ritonavir, paritaprevir
in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination
with either danoprevir, elvitegravir, indinavir, lopinavir, saquinavir or tipranavir
medicines used to treat fungal infections such as itraconazole, ketoconazole, posaconazole,
voriconazole, fluconazole
troleandomycin, a medicine used to treat certain types of bacterial infections
quinidine, a medicine used to treat irregular heartbeat and other heart problems
medicines used to treat severe pain such as alfentanil and fentanyl
medicines used to prevent organ transplant rejection such as ciclosporin, sirolimus
and tacrolimus
Some medicines may interfere with Lorviqua or affect how it works.
You may need different amounts of your medicines, or you may need to take different
medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Lorviqua.
4. How do I use Lorviqua?
How much to take
The recommended dose is 100 mg taken orally once daily
Your doctor may lower your dose, stop your treatment for a short time or stop your
treatment completely if you feel unwell
Swallow the tablets whole and do not crush, chew or split the tablets
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist
for help.
When to take Lorviqua
Take your medicine at about the same time each day to have the best effect and to help you remember when to take it.
It does not matter if you take this medicine before or after food. However, you should
avoid eating grapefruit or drinking grapefruit juice while taking Lorviqua.
How long to take Lorviqua
Continue taking your medicine for as long as your doctor tells you.
If you forget to take Lorviqua
Lorviqua should be taken regularly at the same time each day.
If you miss your dose at the usual time, if it is less than 4 hours before your next
dose, skip the dose you missed and take your next dose when you are meant to.
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 are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much Lorviqua
If you think that you have taken too much Lorviqua, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(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.
5. What should I know while using Lorviqua?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Lorviqua
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine
If you become pregnant while taking this medicine, tell your doctor immediately
Call your doctor straight away if you develop:
changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness or
shortness of breath.
Your doctor may do some tests (electrocardiograms) to check that there are no problems
with your heart during treatment with Lorviqua. If the results are abnormal he/she
may decide to reduce your dose or stop your treatment.
difficulty speaking, including slurred or slow speech
change in your mood (including depression, euphoria and mood swings), feelings of
irritability, aggression, agitation, anxiety or a change in your personality, memory
loss or impairment, episodes of confusion
Tell your doctor if you notice any of the following:
you feel more tired than usual
your skin and whites of your eyes turn yellow
your urine turns dark brown (tea colour)
you have nausea, vomiting or decreased appetite
you have pain in the upper area of and/or on the right side of your stomach
you have itching
you bruise more easily than usual
you develop a fever
you develop a cough, chest pains, shortness of breath, or worsening of respiratory
symptoms.
Your doctor may do some tests (blood tests, scans) to check your liver function and
pancreas. If the results are abnormal he/she may decide to reduce your dose or stop
your treatment.
Your doctor should continue to monitor your blood pressure and blood sugar levels
regularly during treatment.
Keep all of your doctor's appointments so that your progress can be checked.
Remind any doctor or dentist you visit that you are using Lorviqua.
Things you should not do
Do not stop using this medicine suddenly or lower the dosage without checking with your doctor
Do not take Lorviqua to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
If you are not able to take the medicine as your doctor has prescribed, contact your
doctor right away.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Lorviqua
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly
Keep your tablets in the pack/bottle until it is time to take them
Store it in a cool dry place away from moisture, heat or sunlight; below 30°C. For
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Keep it where young children cannot reach it.
Keep Lorviqua in a locked cupboard at least one-and-a-half metres above the ground.
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.
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.
Serious side effects
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Serious side effects
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What to do
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Allergic type reactions
swelling of the skin or limbs
Nervous system
feeling of pain, numbness, burning, or pins and needles in your arms or legs
problems with your eyes such as difficulty seeing out of one or both eyes, double
vision or perceived flashes of light
seizures
difficulty walking or performing usual activities such as writing
changes in speech, including difficulty speaking, such as slurred or slow speech
effects on memory, including confusion, memory loss and disturbance of attention
Psychiatric disorders
changes in mood, including mood swings
seeing or hearing things that are not real (hallucinations)
Vascular disorders
high blood pressure*
Muscle related issues
pain in your joints
Stomach related issues
Diarrhea
Constipation
Metabolism
weight gain
changes in cholesterol and/or triglyceride levels*
high blood sugar levels*
General disorders
tiredness
*These side effects may show up when you have a blood test.
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Call your doctor straight away 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.
7. Product details
This medicine is only available with a doctor's prescription.
What Lorviqua contains
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Active ingredient
(main ingredient)
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lorlatinib
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
calcium hydrogen phosphate
sodium starch glycollate
magnesium stearate
hypromellose (E464)
lactose monohydrate
macrogol 3350
triacetin
titanium dioxide (E171)
iron oxide black (E172)
iron oxide red (E172)
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Do not take this medicine if you are allergic to any of these ingredients.
What Lorviqua looks like
Lorviqua 25 mg tablets are round tan coloured film-coated tablets debossed with "Pfizer" on one
side and "25" and "LLN" on the other side.
Lorviqua 25 mg tablets are available as blister packs containing 90 or 120 tablets
and in bottles containing 30 tablets.
(AUST R 310778 (blister pack)
(AUST R 310781 (bottle)
Lorviqua 100 mg tablets are oval lavender coloured film-coated tablets debossed with "Pfizer" on
one side and "LLN 100" on the other side.
Lorviqua 100 mg tablets are available as blister packs and in bottles containing 30
tablets.
(AUST R 310780 (blister pack)
(AUST R 310779 (bottle)
Who distributes Lorviqua
Lorviqua is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au
This leaflet was prepared in December 2021.