Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lorviqua

Document Subject

Generated Narrative: MedicinalProductDefinition mp421c345b23392c1be16e7fe1f7c5111b

identifier: http://ema.europa.eu/identifier/EU/1/19/1355/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lorviqua 25 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-421c345b23392c1be16e7fe1f7c5111b

identifier: http://ema.europa.eu/identifier/EU/1/19/1355/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lorviqua

Attesters

What is in 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

What Lorviqua is Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Lorviqua belongs to the 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 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 your cancer cells have a fault in a gene that makes an enzyme called ALK (anaplastic lymphoma kinase), see How Lorviqua works, below; and

is advanced. Lorviqua can be prescribed to you if:

you have not been previously treated with an ALK inhibitor; or

you have been previously treated with a medicine called alectinib or ceritinib, which are 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 triggers the death of cancer cells in patients with alterations in genes for ALK. Lorviqua is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase. If you have any questions about how Lorviqua works or why this medicine has been prescribed for you, ask 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 these medicines:

rifampicin (used to treat tuberculosis)

carbamazepine, phenytoin (used to treat epilepsy)

enzalutamide (used to treat prostate cancer)

mitotane (used to treat cancer of the adrenal glands)

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 blood cholesterol or triglycerides

if you have 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

if you have problems with your heart, including heart failure, slow heart rate, or if electrocardiogram (ECG) results show that you have an abnormality of the electrical activity of your heart known as prolonged PR interval or AV block.

if you have cough, chest pain, shortness of breath, or worsening of respiratory symptoms or have ever had a lung condition called pneumonitis.

if you have high blood pressure.

if you have high blood sugar. 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 right away about changes in your heart beat (fast or slow), light-headedness, fainting, dizziness or shortness of breath. These symptoms could be signs of heart problems. Your doctor may check for problems with your heart during treatment with Lorviqua. If the results are abnormal, your doctor may decide to reduce the dose of Lorviqua or stop your treatment.

speech problems, difficulty speaking, including slurred or slow speech. Your doctor may investigate further and may decide to reduce your dose of Lorviqua or stop your treatment.

mental status changes, mood or memory problems, such as change in your mood (including depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or a change in your personality and episodes of confusion or loss of contact with reality, such as believing, seeing or hearing things that are not real. Your doctor may investigate further and may decide to reduce your dose of Lorviqua or stop your treatment.

pain in the back or abdomen (belly), yellowing of the skin and eyes (jaundice), nausea or vomiting. These symptoms could be signs of pancreatitis. Your doctor may investigate further and may decide to reduce the dose of Lorviqua.

cough, chest pain, or a 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 your dose of Lorviqua or stop your treatment.

headaches, dizziness, blurred vision, chest pain or shortness of breath. These symptoms could 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 your dose of Lorviqua or stop your treatment.

feeling very thirsty, a need to urinate more than usual, feeling very hungry, feeling sick to your stomach, weakness or tiredness, or confusion. These symptoms could be signs of high blood sugar. Your doctor may investigate further and treat you with medicines to control your blood sugar. Your doctor may decide to reduce your dose of Lorviqua or stop your treatment. Your doctor may do further assessments and may decide to reduce the dose of Lorviqua or stop your treatment if you:

develop liver problems. Tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual. Your doctor may do blood tests to check your liver function.

have kidney problems. See Possible side effects in section 4 for more information. Children and adolescents This medicine is only indicated in adults, and it is not to be given to children and adolescents. Tests and checks You will have blood tests before you start treatment and during your treatment. These tests are to check the level of cholesterol, triglycerides and the enzymes amylase or lipase 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 over the counter. This is because Lorviqua can affect the way some other medicines work. Also some medicines can affect the way Lorviqua works. You must not take Lorviqua with certain medicines. These are listed under Do not take Lorviqua, at the start 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 quit smoking.

dihydroergotamine, ergotamine medicines used to treat migraine headaches.

efavirenz, cobicistat, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either 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 certain 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.

ciclosporin, sirolimus, and tacrolimus medicines used in organ transplantation to prevent organ rejection. Lorviqua with food and drink You must not drink grapefruit juice or eat grapefruit while on treatment with Lorviqua as they may change the amount of Lorviqua in your body. Pregnancy, breast-feeding and fertility

Contraception information for women You should not become pregnant while taking this medicine. If you are able to have children, you must use highly effective contraception (for example, double-barrier contraception such as condom and diaphragm) while on treatment and for at least 5 weeks after stopping treatment. Lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective. If hormonal contraception is unavoidable it must be used in combination with a condom. Talk to your doctor about the right methods of contraception for you and your partner.

Contraception information for men You should not father children during treatment with Lorviqua because this medicine could harm the baby. If there is any possibility that you may father a child while taking this medicine, you must use a condom during treatment, and for at least 14 weeks after completing therapy. Talk to your doctor about the right methods of contraception for you and your partner.

Pregnancy

Do not take Lorviqua if you are pregnant. This is because it may 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 when taking the medicine or during the 5 weeks after taking your last dose, tell your doctor straight away.

Breast-feeding Do not breast-feed while taking this medicine and for 7 days after the last dose. This is because it is not known if Lorviqua can pass into breast milk and could therefore harm your baby.

Fertility Lorviqua may affect male fertility. Talk to your doctor about fertility preservation before taking Lorviqua. Driving and using machines You should take special care when driving and using machines when taking Lorviqua because of its effects on your 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 sodium (23 mg) per 25 mg or 100 mg tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is one tablet of 100 mg taken by mouth once daily.

Take the dose at about 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 and do not crush, chew or dissolve the tablets.

Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell. 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, tell your doctor, pharmacist or nurse right away. You may require medical attention. If you forget to take Lorviqua What to do if you forget to take a tablet depends on how long it is until your next dose.

If your next dose is in 4 hours or more, take the missed tablet as soon as you remember. Then take the next tablet at the usual time.

If your next dose is in less than 4 hours away, skip the missed tablet. Then take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Lorviqua It is important to take Lorviqua every day, for as long as your doctor asks you to. If you are not able to take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with your doctor right away. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects could be serious. Tell your doctor straight away if you notice any of the following side effects (also section 2 What you need to know before you take Lorviqua). Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:

cough, shortness of breath, chest pain or worsening breathing problems

slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint or losing consciousness

abdominal (belly) pain, back pain, nausea, vomiting, itching or yellowing of the skin and eyes

mental status 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, seeing or hearing things that are not real Other side effects of Lorviqua may include: Very common: may affect more than 1 in 10 people

increase in cholesterol and triglycerides (fats in your blood that would be detected during blood tests)

limb or skin swelling

problems with your eyes, such as difficulty seeing out of one or both eyes, double vision, or perceived flashes of light

problems with the nerves in your arms and legs, such as pain, numbness, unusual sensations like burning or pins and needles, difficulty walking, or difficulty with usual activities of daily living such as writing

increased level of enzymes called lipase and/or amylase in the blood that would be detected during blood tests

low number of red blood cells known as anaemia that would be detected during blood tests

diarrhoea

constipation

pain in your joints

weight gain

headache

rash

muscle pain

increase in blood pressure Common: may affect up to 1 in 10 people

increase in blood sugar

excess protein in the urine Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 foil and carton 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 package is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Lorviqua contains

The active substance is lorlatinib. Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib. Lorviqua 100 mg: each film-coated tablet (tablet) contains 100 mg 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), iron oxide black (E172), and iron oxide red (E172). See Lorviqua contains lactose and Lorviqua contains sodium in section 2. What Lorviqua looks like and contents of the pack Lorviqua 25 mg is supplied as round light pink film-coated tablets, debossed with Pfizer on one side and 25 and LLN on the other side. Lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets (9 blisters). Lorviqua 100 mg is supplied as oval dark pink film-coated tablets, debossed with Pfizer on one side and LLN 100 on the other side. Lorviqua 100 mg is provided in blisters of 10 tablets, which are 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 1050 Bruxelles Belgium Manufacturer Pfizer Manufacturing Deutschland GmbH Betriebsst tte Freiburg Mooswaldallee 1 79090 Freiburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4 ,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36-1-488-37- esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: +421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 K Pfizer . . (Cyprus Branch) : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616Latvija Pfizer Luxembourg SARL fili le Latvij Tel: +371 670 35 This leaflet was last revised in {MM/YYYY}. This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: