Leaflet: information for the user

Lorviqua 25 mg film-coated tablets

Lorviqua 100 mg film-coated tablets

lorlatinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Lorviqua

Lorviqua contains the active ingredient lorlatinib, a medication used for the treatment of adults with advanced stages of a type of lung cancer called non-microcitic lung cancer (NMCL). Lorviqua belongs to a group of medications that inhibit an enzyme called anaplastic lymphoma kinase (ALK). Lorviqua is only administered to patients who have an alteration in the ALK gene, see the sectionHow Lorviqua worksbelow.

How is Lorviqua used

Lorviqua is used to treat adults with a type of lung cancer called non-microcitic lung cancer (NMCL). It is used if your lung cancer:

• is positive for ALK. This means that the cancer cells have a defect in a gene that produces an enzyme called ALK (anaplastic lymphoma kinase); see more information below“How Lorviqua works”; and
• is advanced.

You may be prescribed Lorviqua if:

• you have not been previously treated with an ALK inhibitor; or
• you have been previously treated with a medication called alectinib or ceritinib, both ALK inhibitors; or
• you have been previously treated with crizotinib followed by another ALK inhibitor.

How Lorviqua works

Lorviqua inhibits a type of enzyme called tyrosine kinase and causes the death of cancer cells in patients with alterations in the ALK gene. Lorviqua is only administered to patients whose disease is due to an alteration in the ALK tyrosine kinase gene.

If you have any questions about how Lorviqua works or why you have been prescribed this medication, consult your doctor.

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 the following 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 medicinal plant).

Warnings and precautions

Consult your doctor before starting to take 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 these enzyme levels
• if you have heart problems such as heart failure, slow heart rate, or if the electrocardiogram (ECG) results show that you have an abnormality in the electrical activity of your heart known as prolonged PR interval or AV block
• if you have cough, chest pain, difficulty breathing, or worsening of respiratory symptoms or if you have ever had a lung disease called pneumonia
• if you have high blood pressure
• if you have high blood sugar levels.

If you are unsure, consult your doctor, pharmacist, or nurse before taking Lorviqua.

Inform your doctor immediately if you experience:

• heart problems. Inform your doctor immediately about changes in heart rhythm (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 discontinue treatment
• speech problems, difficulty speaking, including slurred or slow speech. Your doctor may investigate further and decide to reduce the dose of Lorviqua or discontinue treatment
• changes in mental state,mental problems or memory problems such as, for example, changes in mood (such as depression, euphoria, and mood swings), irritability, aggression, nervousness, anxiety, or a change in personality, and episodes of confusionor loss of contact with reality, such as believing to see or hear things that are not real. Your doctor may investigate further and decide to reduce the dose of Lorviqua or discontinue treatment
• back or abdominal pain (stomach), yellowing of the skin and eyes (jaundice), nausea, or vomiting. These symptoms may be signs of pancreatitis. Your doctor may investigate further and decide to reduce the dose of Lorviqua
• cough, chest pain, or worsening of existing respiratory symptoms. Your doctor may investigate further and treat you with other medicines such as antibiotics and steroids. Your doctor may decide to reduce the dose of Lorviqua or discontinue treatment
• headaches, dizziness, blurred vision, chest pain, or difficulty breathing. These symptoms may be signs of high blood pressure. Your doctor may investigate further and treat you with medicines that control your blood pressure. Your doctor may decide to reduce the dose of Lorviqua or discontinue treatment
• feeling thirsty, frequent urination, feeling hungry, stomach discomfort, weakness, or fatigue, or confusion. These symptoms may be signs of high blood sugar levels. Your doctor may investigate further and treat you with medicines that control blood sugar levels. Your doctor may decide to reduce the dose of Lorviqua or discontinue treatment.

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

• you experienceliver problems. Inform your doctor immediately if you feel more tired than usual, your skin and the white of your eyes turn yellow, your urine becomes dark or brown (like tea), you have nausea, vomiting, or decreased appetite, you have pain in the right side of your stomach, you have itching, or you develop bruises more easily than usual. Your doctor may perform blood tests to monitor your liver function
• you have kidney problems.

For more information, seeUndesirable effectsin section 4.

Children and adolescents

This medicine is only indicated for adults and should not be administered to children or adolescents.

Tests and monitoring

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

Other medicines and Lorviqua

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medicine, including herbal medicines and over-the-counter medicines. This is because Lorviqua may affect how other medicines work. Similarly, certain medicines may affect how Lorviqua works.

You should not take Lorviqua with certain medicines. These are listed in the sectionDo not take Lorviquaat the beginning of section 2.

In particular, inform 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 quit 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.
• ciclosporin, sirolimus, and tacrolimus: medicines used in organ transplantation to prevent rejection.

Taking Lorviqua with food and drink

You should not drink grapefruit juice or eat grapefruit while taking Lorviqua, as it may alter the amount of Lorviqua in your body.

Pregnancy, breastfeeding, and fertility

• Contraception – information for women

You should not become pregnant while taking this medicine. If you can become pregnant, you should use highly effective contraceptive methods (such as barrier methods like condoms and diaphragms) 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.

Consult your doctor about the appropriate contraceptive methods for you and your partner.

• Contraception – information for men

You should not father children during treatment with Lorviqua, as this medicine may be harmful to the baby. If there is any possibility that you may father a child while taking this medicine, you should use a condom during treatment and for at least 14 weeks after stopping treatment. Consult your doctor about the appropriate contraceptive methods for you and your partner.

• Pregnancy

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

• Breastfeeding

You should not breastfeed while taking this medicine or for 7 days after the last dose. It is unknown whether Lorviqua can pass into breast milk and, therefore, may be harmful to your baby.

• Fertility

Lorviqua may affect male fertility. Consult your doctor about fertility preservation before starting to take Lorviqua.

Driving and operating machines

Be careful when driving or operating machines while taking Lorviqua due to its effects on mental state.

Lorviqua contains lactose

If your doctor has told you thatyou have alactose intolerance, consult with 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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

• The recommended dose is a 100 mg tablet taken orally once a day.
• Take the dose approximately at 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, suspend treatment for a brief period, or discontinue it 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, simply take your 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. You may require medical attention.

If you forget to take Lorviqua

The procedure to follow if you forget to take a tablet depends on how much time is left until your next dose.

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

Then take the next tablet at the usual time.

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

If you interrupt treatment with Lorviqua

It is essential to take Lorviqua every day, for the time your doctor prescribes. If you cannot take the medication as prescribed by your doctor, or if you feel you no longer need it, speak with your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious.

Inform your doctor immediately if you notice any of the following side effects(also see section 2What you need to know before starting to take Lorviqua). Your doctor may reduce the dose, suspend treatment for a short period of time or discontinue it:

• Cough, difficulty breathing, chest pain, or worsening of respiratory problems
• Slow pulse (50 beats per minute or less), fatigue, dizziness, fainting, or loss of consciousness
• Abdominal pain (stomach), back pain, nausea, vomiting, itching, or yellow discoloration of the skin and eyes
• Mental changes; 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 to 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 known as lipase and/or amylase in the blood, which are detected in blood tests
• Decreased number of red blood cells, known as anemia, which is detected in blood tests
• Diarrhea
• Constipation
• Joint pain
• Weight gain
• Headache
• Rash
• Muscle pain
• Increased blood pressure

Common: may affect up to 1 in 10 peoplepeople

• Increased blood sugar
• Excess protein in the urine

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the container after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe that the container is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lorviqua

• The active ingredient is lorlatinib.

Lorviqua 25 mg: Each film-coated tablet contains 25 mg of lorlatinib.

Lorviqua 100 mg: Each film-coated tablet contains 100 mg of lorlatinib.

• The other components are:

Tablet core: Microcrystalline cellulose, calcium hydrogen phosphate, sodium glycolate starch and magnesium stearate.

Film coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172) and iron oxide red (E172).

SeeLorviqua contains lactoseandLorviqua containssodium in section 2.

Appearance of the product and contents of the pack

Lorviqua 25 mg is presented as pinkish-colored, 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 pinkish-colored, 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 Bruxelles

Belgium

Responsible Person

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:{MM/AAAA}

This medicinal product has been granted a conditional approval. This type of approval means that further information about this medicinal product is expected.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this summary of product characteristics will be updated as necessary.

Other sources of information

Further information about this medicinal product can be found on the website of the European Medicines Agency:http://www.ema.europa.eu.