Lorviqua 100 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Lorviqua is and what it is 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

1. What Lorviqua is and what it is used for

What Lorviqua is

Lorviqua contains the active substance lorlatinib, a medicine used to treat adults with advanced stages of a type of lung cancer called 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 section How Lorviqua works below.

What Lorviqua is 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 your lung cancer:

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

Lorviqua may be prescribed to you if:

• you have not previously been treated with an ALK inhibitor; or
• you have previously been treated with a medicine called alectinib or ceritinib, both of 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 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 this medicine has been prescribed for you, consult 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 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 containing St John’s wort (Hypericum perforatum, a herbal remedy).

Warnings and precautions

Talk to your doctor before starting Lorviqua if:

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

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

Tell your doctor immediately if you experience:

• heart problems. Inform your doctor immediately about changes in heart rhythm (fast or slow), dizziness, fainting, lightheadedness, or shortness of breath. These symptoms may be signs of heart problems. Your doctor may monitor your heart problems during treatment with Lorviqua. If test 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 investigate further and decide to reduce the dose of Lorviqua or stop treatment
• changes in mental state, mood or memory, such as changes in mood (such as depression, euphoria, or mood swings), irritability, aggression, nervousness, anxiety, or a change in personality, and episodes of confusion or loss of touch with reality, such as believing you see or hear things that are not real. Your doctor may investigate further 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 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 stop 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 to control your blood pressure. Your doctor may decide to reduce the dose of Lorviqua or stop treatment
• feeling very thirsty, needing to urinate more than usual, feeling very hungry, stomach discomfort, weakness or tiredness, or confusion. These symptoms may be signs of high blood sugar levels. Your doctor may investigate further and treat you with medicines to control your blood sugar. Your doctor may decide to reduce the dose of Lorviqua or stop treatment.

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

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

For more information, see Possible side effects in section 4.

Children and adolescents

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

Tests and monitoring

You will have blood tests before starting treatment and during treatment. These tests are to check your cholesterol, triglyceride, and amylase or lipase enzyme levels in the 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 need to take any other medicines, including herbal remedies and medicines obtained without a prescription. This is because Lorviqua may affect how other medicines work. Likewise, certain medicines may affect how Lorviqua works.

You must not take Lorviqua with certain medicines. These are listed in the section Do not take Lorviqua at 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 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 conditions
• alfentanil and fentanyl: medicines used to treat acute pain
• cyclosporine, sirolimus and tacrolimus: medicines used in organ transplantation to prevent rejection.

Taking Lorviqua with food and drink

You must not drink grapefruit juice or eat grapefruit while being treated with Lorviqua, as it may alter the amount of Lorviqua in your body.

Pregnancy, breastfeeding and fertility

• Contraception – information for women

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

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

• Contraception – information for men

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

• Pregnancy

• Do not take Lorviqua if you are pregnant, as it could harm your baby.

• If your partner is being treated with Lorviqua, you must use a condom during treatment and for at least 14 weeks after stopping treatment.

• If you become pregnant while taking the medicine or within 3 weeks after the last dose, inform your doctor immediately.

• Breastfeeding

Do not breastfeed while taking this medicine or for 7 days after the last dose. It is unknown whether Lorviqua passes into breast milk and therefore it could be harmful to your baby.

• Fertility

Lorviqua may affect male fertility. Talk to your doctor about fertility preservation before starting treatment with Lorviqua.

Driving and using machines

Exercise special caution when driving or operating machinery while taking Lorviqua due to its effects on mental state.

Lorviqua contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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; hence, it is essentially “sodium-free”.

3. How to take Lorviqua

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

• The recommended dose is one 100 mg tablet taken orally once daily.
• Take the dose at approximately the same time each day.
• You may take the tablets with food or between meals, but always avoid grapefruit and grapefruit juice.
• Swallow the tablets whole and do not crush, chew, or dissolve them.
• Your doctor may reduce your dose, temporarily interrupt treatment, or stop it completely if you do not feel 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 action to take if you forget to take a tablet depends on how long it is until your next dose.

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

Then take your next tablet at the usual time.

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

If you stop taking Lorviqua

It is important to take Lorviqua every day for as long as your doctor has instructed. If you are unable to take the medicine as prescribed, or if you feel you no longer need it, speak to your doctor immediately.

If you have any further 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 everyone 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 starting to take Lorviqua). Your doctor may reduce the dose, temporarily interrupt treatment, or stop it completely:

• cough, difficulty breathing, chest pain, or worsening of breathing problems
• slow pulse (50 beats per minute or less), tiredness, dizziness, fainting, or loss of consciousness
• abdominal (stomach) pain, back pain, nausea, vomiting, itching, or yellowing of the skin and eyes
• changes in mental state; 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 detected in blood tests)
• swelling of a limb or the 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 like burning or tingling, difficulty walking, or difficulty performing usual daily activities such as writing
• increased levels of enzymes known as lipase and/or amylase in the blood, detected in blood tests
• decreased number of red blood cells, known as anemia, 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 people

• increased blood sugar
• excess protein in the urine

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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. Storage of Lorviqua

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

Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month indicated.

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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lorviqua

• The active substance 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 lactose and Lorviqua contains sodium in section 2.

Appearance of the product and contents of the pack

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

Lorviqua 25 mg is available in blisters of 10 tablets, with packs available containing 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 available in blisters of 10 tablets, with packs available containing 30 tablets (3 blisters).

Some pack sizes may not be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review 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.euopa.eu.