LORVIQUA 25 mg FILM-COATED TABLETS

2. What you need to know before you take 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 that contain St. John's Wort (Hypericum perforatum, a herbal medicine).

Warnings and precautions

Tell your doctor before you start taking Lorviqua:

• if you have high levels of cholesterol or triglycerides in your blood
• if you have high levels of enzymes called amylase or lipase in your blood or a condition such as pancreatitis that may increase the levels of these enzymes
• if you have heart problems such as heart failure, slow heart rate, or if the results of your electrocardiogram (ECG) show that you have an abnormality in the electrical activity of your heart known as a prolonged PR interval or AV block
• if you have a cough, chest pain, difficulty breathing, or worsening of respiratory symptoms or have ever had a lung disease called pneumonia
• if you have high blood pressure
• if you have a high level 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 notice:

• heart problems. Tell your doctor immediately about changes in your heart rate (fast or slow), dizziness, fainting, dizziness, or difficulty breathing. These symptoms may be signs of heart problems. Your doctor may monitor your heart problems during treatment with Lorviqua. If the results are abnormal, your doctor may decide to reduce the dose of Lorviqua or stop treatment
• speech problems, difficulty speaking, including slurred or slow speech. Your doctor may continue to investigate and decide to reduce the dose of Lorviqua or stop treatment
• changes in mental status, mood problems, or memory problems such as changes in mood (such as depression, euphoria, and mood swings), irritability, aggression, nervousness, anxiety, or a change in personality, and episodes of confusion or loss of contact with reality, such as believing you see or hear things that are not real. Your doctor may continue to investigate and decide to reduce the dose of Lorviqua or stop treatment
• back pain or abdominal pain (belly), yellowing of the skin and eyes (jaundice), nausea, or vomiting. These symptoms may be signs of pancreatitis. Your doctor may continue to investigate and decide to reduce the dose of Lorviqua
• cough, chest pain, or worsening of existing respiratory symptoms. Your doctor may continue to investigate and treat you with other medicines such as antibiotics and steroids. Your doctor may decide to reduce the dose of Lorviqua or stop treatment
• headaches, dizziness, blurred vision, chest pain, or difficulty breathing. These symptoms may be signs of high blood pressure. Your doctor may continue to investigate and treat you with medicines that control your blood pressure. Your doctor may decide to reduce the dose of Lorviqua or stop treatment
• feeling very thirsty, needing to urinate more often than usual, feeling very hungry, stomach upset, weakness, or tiredness, or confusion. These symptoms may be signs of a high level of sugar in your blood. Your doctor may continue to investigate and treat you with medicines that control your blood sugar level. Your doctor may decide to reduce the dose of Lorviqua or stop treatment.

Your doctor may perform additional tests and decide to reduce the dose of Lorviqua or stop treatment if:

• liver problems appear. Tell your doctor immediately if you feel more tired than usual, your skin and the whites of your eyes turn yellow, your urine turns dark or brown (the color of tea), you have nausea, vomiting, or loss of appetite, you have pain in the right side of your stomach, you have itching or bruising more easily than usual. Your doctor may perform blood tests to check your liver function
• you have kidney problems.

For more information, see Possible side effectsin section 4.

Children and adolescents

This medicine is only indicated in adults and should not be given to children or adolescents.

Tests and checks

You will have blood tests before you start treatment and during treatment. These tests are to check the level of cholesterol, triglycerides, and amylase or lipase enzymes in your blood before you start 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 obtained without a prescription. This is because Lorviqua may affect the way other medicines work. Also, certain medicines may affect the way Lorviqua works.

Do not take Lorviqua with certain medicines. These are listed in the section Do not take Lorviquaat 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 headaches.
• 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 HIV/AIDS.
• ketoconazole, itraconazole, voriconazole, posaconazole: medicines used to treat fungal infections. Also, troleandomycin, a medicine used to treat certain types of bacterial infections.
• quinidine: a medicine used to treat irregular heartbeats and other heart problems.
• pimozide: a medicine used to treat mental health problems.
• alfentanil and fentanyl: medicines used to treat acute pain.
• cyclosporin, sirolimus, and tacrolimus: medicines used in organ transplantation to prevent rejection.

Taking Lorviqua with food and drinks

Do not drink grapefruit juice or eat grapefruit while you are being treated with Lorviqua, as it may change the amount of Lorviqua in your body.

Pregnancy, breast-feeding, and fertility

• Contraception – information for women

Do not become pregnant while you are taking this medicine. If you can become pregnant, you must use highly effective contraception (such as double-barrier contraception like a condom and a diaphragm) during treatment and for at least 5 weeks after stopping treatment. Lorlatinib may reduce the effectiveness of hormonal contraceptives (such as the pill); therefore, hormonal contraceptives cannot be considered highly effective. If the use of hormonal contraceptives is unavoidable, they should be used in combination with a condom.

Talk to your doctor about the contraceptive methods that are suitable for you and your partner.

• Contraception – information for men

Do not father a child while you are taking Lorviqua, as this medicine may harm the baby. If there is a possibility that you may father a child while you are taking this medicine, you must use a condom during treatment and for at least 14 weeks after stopping treatment. Talk to your doctor about the contraceptive methods that are suitable for you and your partner.

• Pregnancy

• Do not take Lorviqua if you are pregnant, as it may harm your baby.
• If your partner is taking Lorviqua, they must use a condom during treatment and for at least 14 weeks after stopping treatment.
• If you become pregnant while you are taking the medicine or within 3 weeks after the last dose, tell your doctor immediately.

• Breast-feeding

Do not breast-feed while you are taking this medicine and for 7 days after the last dose. It is not known if Lorviqua can pass into breast milk and may harm your baby.

• Fertility

Lorviqua may affect male fertility. Talk to your doctor about preserving fertility before you start taking Lorviqua.

Driving and using machines

Be careful when driving or using machines while you are taking Lorviqua due to its effects on mental status.

Lorviqua contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

Lorviqua contains sodium

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

3. How to take Lorviqua

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

• The recommended dose is one 100 mg tablet by mouth once a day.
• Take the dose at about the same time every day.
• You can take the tablets with food or between meals, always avoiding grapefruit and grapefruit juice.
• Swallow the tablets whole and do not crush, chew, or dissolve them.
• Your doctor may reduce the dose, stop treatment for a short period, or stop it completely if you are not feeling well.

If you vomit after taking Lorviqua

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

If you take more Lorviqua than you should

If you accidentally take too many tablets, talk to your doctor, pharmacist, or nurse immediately. You may need medical attention.

If you forget to take Lorviqua

The way to proceed if you miss a tablet depends on how much time is left until your next dose.

• If it is 4 hours or more until your next dose, take the missed tablet as soon as you remember. Then take the next tablet at the usual time.
• If it is less than 4 hours until your next dose, do not take the missed tablet.

Then take the next tablet at the usual time.

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

If you stop taking Lorviqua

It is important to take Lorviqua every day for as long as your doctor tells you to. If you cannot take the medicine as your doctor has prescribed, or if you feel that you no longer need it, talk to your doctor immediately.

If you have any other questions about 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 may 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 you take Lorviqua). Your doctor may reduce the dose, stop treatment for a short period, or stop it completely:

• cough, difficulty breathing, chest pain, or worsening of respiratory problems
• slow pulse (50 beats per minute or less), tiredness, dizziness, fainting, or loss of consciousness
• abdominal pain (belly), back pain, nausea, vomiting, itching, or yellowing of the skin and eyes
• changes in mental status; changes in cognition, 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 you see or hear things that are not real.

Other side effects of Lorviqua may include:

Very common:may affect more than 1 in 10 people

• increased cholesterol and triglycerides (fats in the blood that are detected in blood tests)
• swelling of a limb or skin
• eye problems, such as difficulty seeing with one or both eyes, double vision, or flashes of light
• nerve problems in the arms and legs, such as pain, numbness, unusual sensations such as burning or tingling, difficulty walking, or difficulty performing daily activities, such as writing
• increased levels of enzymes called lipase and/or amylase in the blood, which are detected in blood tests
• decrease in the number of red blood cells, which is known as anemia, detected in blood tests
• diarrhea
• constipation
• joint pain
• weight gain
• headache
• rash
• muscle pain
• high blood pressure

Common: may affect up to 1 in 10 people

• high blood sugar
• excess protein in the urine

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after “EXP”. The expiry date is the last day of the month stated.

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 deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Lorviqua Composition

• 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 components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, and 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 containssodium in section 2.

Product Appearance and Package Contents

Lorviqua 25 mg is presented as pink, round, film-coated tablets with "Pfizer" engraved on one side and "25" and "LLN" on the other.

Lorviqua 25 mg is presented in blisters of 10 tablets, which are available in packs of 90 tablets (9 blisters).

Lorviqua 100 mg is presented as dark pink, oval, film-coated tablets with "Pfizer" engraved on one side and "LLN 100" on the other.

Lorviqua 100 mg is presented in blisters of 10 tablets, which are available in packs of 30 tablets (3 blisters).

Only some pack sizes may be marketed.

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/YYYY}

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.