LORVIQUA 100 mg Film-Coated Tablets

Зміст інструкції

1. Lorviqua 25 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Lorviqua and what is it used for
   2. What you need to know before taking Lorviqua
   3. How to take Lorviqua
   4. Possible side effects
   5. How to store Lorviqua
   6. Contents of the pack and other information

Lorviqua 25 mg film-coated tablets, 100 mg film-coated tablets

lorlatinib

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Lorviqua is and what it is used for
• 2. What you need to know before you take Lorviqua
• 3. How to take Lorviqua
• 4. Possible side effects
• 5. How to store Lorviqua
• 6. Contents of the pack and other information

1. What is Lorviqua and what is it used for

What is Lorviqua
Lorviqua contains the active ingredient lorlatinib, a medicine used to treat adults with advanced stages of a type of lung cancer called non-small cell lung cancer ( Non-

Small Cell Lung Cancer,NSCLC). Lorviqua belongs to a group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK). Lorviqua is only given to patients who have an alteration in the ALK gene, see How Lorviqua worksbelow.

What is Lorviqua used for
Lorviqua is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used if the lung tumor:

• is ALK-positive, meaning the cancer cells have a defect in a gene that makes an enzyme called ALK (anaplastic lymphoma kinase), see How Lorviqua worksbelow, and
• is in an advanced stage. Lorviqua may be prescribed if:
• you have not previously been treated with an ALK inhibitor; or
• you have previously been treated with a medicine called alectinib or ceritinib, which are ALK inhibitors; or
• you have previously been treated with crizotinib followed by another ALK inhibitor.

How Lorviqua works
Lorviqua inhibits a type of enzyme called tyrosine kinase and activates the death of cancer cells in patients with alterations in the genes for ALK. Lorviqua is only given to patients whose disease is due to an alteration in the ALK tyrosine kinase gene.
If you have questions about how Lorviqua works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before taking Lorviqua

Do not take Lorviqua

• If you are allergic to lorlatinib or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of these medicines: rifampicin, used to treat tuberculosis; carbamazepine, phenytoin (used to treat epilepsy); enzalutamide (used to treat prostate cancer); mitotane (used to treat adrenal gland cancer); medicines containing St John’s wort ( Hypericum perforatum, a herbal preparation).

Warnings and precautions
Talk to your doctor before taking Lorviqua:

• If you have high levels of cholesterol or triglycerides in your blood.
• If you have high levels of enzymes known as amylase or lipase in your blood or a condition like “pancreatitis”, which can increase the levels of these enzymes.
• If you have heart problems, including heart failure, a slow heart rate, or if the results of an electrocardiogram (ECG) show an abnormality in the electrical activity of the heart known as “prolonged PR interval” or “AV block”.
• If you suffer from cough, chest pain, shortness of breath or worsening of respiratory symptoms or if you have had a lung condition called pneumonia in the past.
• If you suffer from high blood pressure.
• If you have high levels of sugar in your blood.

If you are not sure, talk to your doctor, pharmacist or nurse before taking Lorviqua.
Tell your doctor immediately if you develop:

• Heart problems. Tell your doctor immediately if you experience changes in your heartbeat (fast or slow), feeling dizzy, fainting, lightheadedness or shortness of breath. These symptoms may be signs of heart problems. During treatment with Lorviqua, your doctor may check that there are no problems with your heart. If the results are abnormal, your doctor may decide to reduce the dose of Lorviqua or stop treatment.
• Problems with speech, difficulty speaking, including slurred or slow speech. Your doctor may perform further investigations and decide to reduce the dose of Lorviqua or stop treatment.
• Changes in mental state, mood or memory problems, such as changes in mood (including depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or personality changes, and episodes of confusion or loss of contact with reality, such as believing, seeing or hearing things that are not real. Your doctor may perform further investigations and decide to reduce the dose of Lorviqua or stop treatment.
• Back or abdominal (stomach) pain, yellowing of the skin and eyes (jaundice), nausea or vomiting. These symptoms may be signs of pancreatitis. Your doctor may perform further investigations and decide to reduce the dose of Lorviqua.
• Cough, chest pain or worsening of existing respiratory symptoms. Your doctor may perform further investigations and prescribe treatment with other medicines such as antibiotics and steroids. Your doctor may decide to reduce the dose of Lorviqua or stop treatment.
• Headache, dizziness, blurred vision, chest pain or shortness of breath. These symptoms may be signs of high blood pressure. Your doctor may perform further investigations and treat it with medicines to control blood pressure. Your doctor may decide to reduce the dose of Lorviqua or stop treatment.
• Excessive thirst, needing to urinate more than usual, excessive hunger, stomach pain, weakness or fatigue or confusion. These symptoms may be signs of high blood sugar. Your doctor may perform further investigations and treat it with medicines to control blood sugar (glycaemia). Your doctor may decide to reduce the dose of Lorviqua or stop treatment.

The doctor may perform further investigations and decide to reduce the dose of Lorviqua or stop
treatment if:

• You develop liver problems. Tell your doctor immediately if you feel more tired than usual, if the skin and whites of your eyes become yellow, if your urine becomes dark or brown (tea-colored), if you have nausea, vomiting or loss of appetite, if you have pain on the right side of your stomach, itching or if you bruise more easily than usual. Your doctor may perform blood tests to check liver function.
• You have kidney problems.

See Possible side effectsin section 4 for more information.

Children and adolescents
This medicine is only indicated for adults and should not be given to children and
adolescents.

Tests and checks
You will have blood tests before starting treatment and during treatment. These
tests are to check the level of cholesterol, triglycerides and the enzymes amylase or lipase in
your blood before starting treatment with Lorviqua and regularly during treatment.

Other medicines and Lorviqua
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including herbal medicines and medicines available without a prescription.
This is because Lorviqua can affect how some other medicines work. Also, some
medicines can affect how Lorviqua works.
You must not take Lorviqua with certain medicines. These are listed in Do not take Lorviqua,
at the beginning of section 2.
In particular, tell your doctor, pharmacist or nurse if you are taking any of
the following medicines:

• boceprevir, a medicine used to treat hepatitis C;
• bupropion, a medicine used to treat depression or to help people stop smoking;
• dihydroergotamine, ergotamine, medicines used to treat migraine;
• efavirenz, cobicistat, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir and ritonavir in combination with elvitegravir, indinavir, lopinavir or tipranavir, medicines used to treat AIDS/HIV;
• ketoconazole, itraconazole, voriconazole, posaconazole, medicines used to treat fungal infections. Also, troleandomycin, a medicine used to treat some types of bacterial infections;
• quinidine, a medicine used to treat irregular heartbeat and other heart problems;
• pimozide, a medicine used to treat mental health problems;
• alfentanil and fentanyl, medicines used to treat severe pain;
• cyclosporine, sirolimus and tacrolimus, medicines used in organ transplantation to prevent rejection.

Lorviqua with food and drink
Do not drink grapefruit juice or eat grapefruit while taking Lorviqua
as it may change the amount of Lorviqua in your body.

Pregnancy, breastfeeding and fertility

• Contraception: information for womenDo not become pregnant while taking this medicine. If you are of childbearing potential, you must use very effective contraception (e.g., dual barrier contraception such as condom and diaphragm) during treatment and for at least 5 weeks after stopping treatment. Lorlatinib can reduce the effectiveness of hormonal contraceptive methods (e.g., the contraceptive pill); therefore, hormonal contraceptives should not be considered highly effective. If hormonal contraception is unavoidable, it should be used in combination with a condom. Talk to your doctor about the most appropriate methods of contraception for you and your partner.
• Contraception: information for menDo not father a child during treatment with Lorviqua because this medicine could harm the baby. If there is a possibility that you could father a child during treatment with this medicine, you must use a condom during treatment and for at least 14 weeks after completing therapy. Talk to your doctor about the most appropriate methods of contraception for you and your partner.
• Pregnancy
• Do not take Lorviqua if you are pregnant. This is because it could harm your baby.
• If your male partner is being treated with Lorviqua, he must use a condom during treatment and for at least 14 weeks after completing therapy.
• If you become pregnant while taking the medicine or during the 5 weeks after taking the last dose, tell your doctor immediately.
• BreastfeedingDo not breastfeed while taking this medicine and for 7 days after the last dose. This is because it is not known whether Lorviqua can pass into breast milk and could therefore harm your baby.
• FertilityLorviqua may affect male fertility. Talk to your doctor about fertility preservation before taking Lorviqua.

Driving and using machines
Be particularly careful when driving and using machines while taking Lorviqua, due to
its effects on mental state.

Lorviqua contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

Lorviqua contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 25 mg or 100 mg tablet, which
is essentially “sodium-free”.

3. How to take Lorviqua

Take this medicine exactly as your doctor, pharmacist or
nurse has told you. If you have any doubts, ask your doctor, pharmacist or nurse.

• The recommended dosage is one 100 mg tablet taken by mouth once a day.
• Take the dose at approximately the same time each day.
• You can take the tablets with food or between meals, always avoiding grapefruit and grapefruit juice.
• Swallow the tablets whole without crushing, chewing or dissolving them.
• Sometimes the doctor may reduce the dose, suspend treatment for a short period of time or discontinue treatment completely in case of feeling unwell.

If you vomit after taking Lorviqua
If you vomit after taking a dose of Lorviqua, do not take an extra dose, take the next
dose at the usual time.

If you take more Lorviqua than you should
If you accidentally take too many tablets, inform your doctor, pharmacist or
nurse immediately. Medical care may be needed.

If you forget to take Lorviqua
What to do if you forget to take a tablet depends on the time remaining until the next
dose.

• If the next dose is 4 hours or more away, take the forgotten tablet as soon as you remember. Then, take the next tablet at the usual time.
• If less than 4 hours remain until the next dose, skip the forgotten tablet. Then, take the next tablet at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Lorviqua
It is important to take Lorviqua every day, for as long as your doctor has told you. If you cannot
take the medicine as prescribed by your doctor, or if you think you no longer need it, contact
your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.

Tell your doctor immediately if you notice any of the following side effects(see also section 2 What you need to know before taking Lorviqua). The doctor may reduce the dose,
suspend treatment for a short period of time or stop treatment completely.

• Cough, shortness of breath, chest pain or worsening of breathing problems
• Slow heartbeat (50 beats per minute or less), fatigue, fainting, dizziness or loss of consciousness
• Abdominal pain (stomach ache), back pain, nausea, vomiting, itching or yellowing of the skin and eyes
• Changes in mental status; changes in cognitive functions including confusion, memory loss, reduced ability to concentrate; changes in mood including irritability and mood swings; changes in speech, including difficulty speaking, such as slurred or slow speech; or loss of contact with reality, such as believing, seeing or hearing things that are not real.

Other side effects with Lorviqua may include:

Very common(may affect more than 1 in 10 people):

• Increased cholesterol and triglycerides (fats in the blood that are detected during blood tests)
• Swelling of limbs or skin
• Problems with the eyes, such as difficulty seeing with one or both eyes, double vision or flashes of light perceived
• Problems with the nerves in the arms and legs, such as pain, numbness, sensations

unusual such as burning or tingling, difficulty walking or difficulty with normal
daily activities such as writing

• Increased levels of enzymes called lipase and/or amylase in the blood, which are detected during blood tests
• Low level of red blood cells known as anemia, which is detected during blood tests
• Diarrhea
• Constipation
• Joint pain
• Weight gain
• Headache
• Skin rash
• Muscle pain
• Increased blood pressure

Common (may affect up to 1 in 10 people)

• Increased blood sugar levels (hyperglycemia)
• Excess protein in the urine

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help to provide more
information on the safety of this medicine.

5. How to store Lorviqua

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the pack after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lorviqua contains

• The active ingredient is lorlatinib. Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg of lorlatinib. Lorviqua 100 mg: each film-coated tablet (tablet) contains 100 mg of lorlatinib.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate. Film coating: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), black iron oxide (E172) and red iron oxide (E172).

See Lorviqua contains lactoseand Lorviqua contains sodiumin section 2.

Description of Lorviqua and contents of the pack
Lorviqua 25 mg is supplied as light pink round film-coated tablets, imprinted
“Pfizer” on one side and “25” and “LLN” on the other side.
Lorviqua 25 mg is supplied in blisters of 10 tablets, available in packs containing 90
tablets (9 blisters).
Lorviqua 100 mg is supplied as dark pink oval film-coated tablets, imprinted "Pfizer"
on one side and "LLN 100" on the other side.
Lorviqua 100 mg is supplied in blisters of 10 tablets, available in packs containing
30 tablets (3 blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

България
Пфайзер Люксембург САРЛ, Клон България
Тел: +359 2 970 4333

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Kύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +357 22817690

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .