25 mg, 100 mg film-coated tablets
erlotinib
What Lorviqua is and what it is used for
What Lorviqua is
Lorviqua contains the active substance lorlatinib, a medicine used to treat advanced-stage adults 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 a change in the ALK gene, see
How Lorviqua works below.
What Lorviqua is used for
Lorviqua can be prescribed to you if:
- you have previously been treated with a drug called alektinib or ceritinib, which are ALK inhibitors; or
- you have previously been treated with crizotinib followed by another ALK inhibitor.
How Lorviqua works
Lorviqua inhibits an enzyme called ALK (an enzyme of the type tyrosine kinase ), allowing cancer cells to die in patients with alterations in the ALK gene. Lorviqua is only given to patients whose disease is due to a change in the gene for ALK.
If you have any further questions on the use of Lorviqua or why you have been prescribed this medicine, ask your doctor.
What you need to know before taking Lorviqua
Do not use 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 (for the treatment of tuberculosis )
- carbamazepine, phenytoin (for the treatment of epilepsy )
- enzalutamide (for the treatment of prostate cancer)
- mitotane (for the treatment of adrenal cancer)
- medicines containing St. John’s wort ( Hypericum perforatum , a (traditional) herbal medicine).
Warnings and cautions
Talk to your doctor before taking Lorviqua:
- if you have high cholesterol or triglyceride levels in your blood.
- If you have high levels of the enzyme an amylase or lipase in your blood or have pancreatitis which is a disease that can raise the levels of these enzymes .
- if you have heart problems e.g. heart failure , slow heart rate or if ECG ( electrocardiogram ) results show that you have an abnormal electrical activity in the heart called prolonged PR interval or AV block .
- if you have a cough, chest pain, are short of breath or have worsening respiratory symptoms or if you have ever had the lung disease pneumonitis (a type of pneumonia with a cause other than bacterial infection ).
- 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 get:
- heart problems. Tell your doctor immediately if you experience changes in your heartbeat (faster or slower), feel unsteady, faint, dizzy or short of breath. These symptoms may be signs of heart problems. Your doctor may check for any problems with your heart during treatment with Lorviqua. If the results are not normal, your doctor may decide to reduce your dose or stop you taking Lorviqua.
- speech problems, difficulty speaking, slurred speech or slow speech. Your doctor may investigate this further and possibly decide that your dose should be reduced or that you should stop taking Lorviqua.
- changes in your mental state, problems with mood or memory, e.g. altered mood (including depression, elation and mood swings), irritability, aggression, agitation, anxiety or a changed personality and episodes of confusion or lost perception of reality, such as believing, seeing or hearing things that are not real. Your doctor may investigate this further and possibly decide that your dose should be reduced or that you should stop taking Lorviqua.
- back and abdominal pain (stomach), yellowing of the skin and eyes (jaundice), nausea or vomiting. These symptoms may be signs of pancreatitis. Your doctor may investigate this further and may decide to reduce your dose of Lorviqua.
- cough, chest pain, or worsening of pre-existing respiratory problems. Your doctor may investigate this further and treat you with other medicines, e.g. antibiotics and steroids . Your doctor may decide to reduce your dose or to stop you taking Lorviqua.
- headache, dizziness, blurred vision, chest pain or shortness of breath. These symptoms may be signs of high blood pressure . Your doctor may investigate this further and treat you with medication to control your blood pressure . Your doctor may decide to reduce your dose or to stop you taking Lorviqua.
- thirst, need to urinate more than usual, feeling very hungry, nausea, weakness or tiredness, or confusion. These symptoms may be signs of high blood sugar. Your doctor may investigate this further and treat you with medicines to control your blood sugar. Your doctor may decide to reduce your dose or to stop you taking Lorviqua.
Your doctor may take more samples and may decide to reduce your dose or stop you taking Lorviqua if you:
- have liver problems. Tell your doctor immediately if you feel more tired than usual, if your skin and whites of your eyes turn yellow, your urine becomes dark or brown (tea-colored), you feel unwell, vomit or have a poor appetite, if you have pain on the right side of the stomach, if it itches or if you get bruises more easily than usual. Your doctor may take blood samples to check your liver function.
- have kidney problems.
See the Possible side effects of section 4 for further information.
Children and young people
This medicine is for adults only and should not be given to children and adolescents.
Sampling and inspections
You will be given blood samples before treatment and during treatment. These tests should check the levels of cholesterol, triglycerides, and the enzymes amylase and lipase in the blood before starting treatment with Lorviqua and at regular intervals 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 (traditional) herbal and herbal medicines and over-the-counter medicines. Lorviqua can affect the way other medicines work. In addition, some medicines may affect the way Lorviqua works.
You must not take Lorviqua with certain medicines. These are listed under the heading Do not take Lorviqua at the beginning of section 2.
You must tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- boceprevir – for the treatment of hepatitis C
- bupropion – used to treat depression or to help people quit smoking
- dihydroergotamine, ergotamine – used to treat migraine headaches
- efavirenz; kobicistat; ritonavir; paritaprevir in combination with ritonavir and ombitasvir and / or dasabuvir; or ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir – used to treat AIDS / HIV
- ketoconazole , itraconazole, voriconazole, posaconazole – for the treatment of fungal infections. Also troleandomycin, a drug used to treat certain bacterial infections
- quinidine – for the treatment of irregular heartbeats and other heart problems
- pimozide – for the treatment of mental problems
- alfentanil and fentanyl – for severe pain
- ciclosporin, sirolimus and tacrolimus – used in organ transplants to prevent organ rejection.
Lorviqua with food and drink
You must 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, breastfeeding and fertility
- Contraceptives – information for womenYou should not get pregnant while taking this medicine. If you are fertile , a very effective contraceptive must be used (eg double barriers such as condoms and diaphragms ) during the treatment and for at least 5 weeks after the end of the treatment. Lorlatinib may reduce the effectiveness of hormonal contraceptives (eg birth control pills ), therefore hormonal contraceptives may not be considered effective enough. If hormonal contraception can not be avoided, it must be used in combination with a condom. Talk to your doctor about suitable contraceptives for you and your partner.
- Contraceptives – information for menYou should not have children during treatment with Lorviqua. This medicine can harm the fetus. If there is a risk that you could make a woman pregnant while taking this medicine, you must use a condom during treatment and for at least 14 weeks after stopping treatment. Talk to your doctor about suitable contraceptives for you and your partner.
- Pregnancy
- Do not take Lorviqua if you are pregnant. It can harm the fetus.
- If your male partner is being treated with Lorviqua, he must use a condom during treatment and for at least 14 weeks after stopping treatment.
- If you become pregnant while taking this medicine or within 5 weeks after the last dose , you must tell your doctor immediately.
- Breast-feedingYou should not breast-feed while taking this medicine and for 7 days after the last dose . It is not known whether Lorviqua can pass into breast milk and thus harm the baby.
- FertilityLorviqua can affect male fertility . Talk to your doctor about fertility preservation measures before taking Lorviqua.
Driving and using machines
Take special care when driving or using machines during treatment with Lorviqua, given 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 (23 mg) sodium per 25 mg or 100 mg tablet, ie it is essentially ‘sodium-free’.
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 once a day. The tablet is taken by mouth.
- Take dose one at about the same time each day.
- You can take the tablets with food or between meals, but always avoid grapefruit and grapefruit juice.
- Swallow the tablets whole. The tablets must not be crushed, chewed or dissolved.
- Sometimes your doctor may lower your dose , interrupt your treatment for a short time, or stop your treatment altogether 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. Just take the 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 immediately. You may need medical attention.
If you forget to take Lorviqua
What to do if you forget to take a tablet depends on how much time is left until the next dose.
- If the next dose is to be taken in 4 hours or more, take the missed tablet as soon as possible. Then take the next tablet at the usual time.
- If the next dose is to be taken in less than 4 hours, 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
You must take Lorviqua every day for as long as your doctor tells you to. If you can not take the medicine as prescribed by your doctor, or if you no longer need it, talk to your doctor immediately.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 experience any of these side effects are (see also Section 2 What you need to know before you take Lorviqua ). Your doctor may reduce your dose, stop the treatment for a short time or stop the treatment altogether:
- cough, shortness of breath, chest pain or worsening of breathing problems
- slow heart rate (50 beats per minute or less), feeling tired, dizzy or fainting or unconsciousness
- abdominal pain, back pain, nausea, vomiting, itching or yellowing of the skin and whites of the eyes
- changes in mental status, cognitive changes which can be confusion, memory loss, decreased concentration, mood changes such as irritability and mood swings, change in speech including speech difficulties such as slurred or slow speech, or lost perception of reality, such as believing, seeing or hearing things that are not real.
Other side effects of Lorviqua can be:
Very common (may affect more than 1 user in 10)
- increased levels of cholesterol and triglycerides (fats in the blood, detected in blood samples)
- swollen arms / legs or swollen skin
- eye problems e.g. difficulty seeing with one or both eyes, double vision or flashes of light
- problems with the nerves in the arms and legs such as pain, numbness, unusual sensations such as burning sensation or tingling, difficulty walking or difficulty performing daily activities such as writing
- increased level of enzymes called lipase and / or amylase in the blood which is detected in blood samples
- low number of red blood cells , which is called anemia ( anemia ), is detected in blood samples
- diarrhea
- constipation
- joint pain
- weight gain
- headache
- rash
- muscle aches
- increased blood pressure
Common (may affect up to 1 in 10 people)
- elevated blood sugar
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 carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice that the packaging is damaged or appears to have been tampered with.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- 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.
- 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 lactose and Lorviqua contains sodium in section 2.
What the medicine looks like and contents of the pack
Lorviqua 25 mg are round, light pink film-coated tablets with “Pfizer” debossed on one side and “25” and “LLN” on the other side.
Lorviqua 25 mg is packaged in blister packs of 10 tablets and is available in packs containing 90 tablets (9 blister cards) or 120 tablets (12 blister cards).
Lorviqua 100 mg are oval, dark pink film-coated tablets with “Pfizer” debossed on one side and “LLN 100” on the other side.
Lorviqua 100 mg is packaged in blister packs of 10 tablets and is available in packs containing 30 tablets (3 blister cards).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Operating aid Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer NV / SATel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel: +370 52 51 4000 |
| BulgariaPfizer Luxembourg SARE, Clone of BulgariaTel: +359 2 970 4333 | HungaryPfizer Kft.Tel: + 36‑1‑488‑37‑00 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 | NorwayPfizer ASTel: +47 67 52 61 00 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15‑0 |
| GreecePfizer Aλλάς AE:Ηλ: +30 210 6785 800 | PolandPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: +385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: +421 2 3355 5500 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 43 00 40 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| ΎπροςPfizer Αλλάς Α.Ε. (Cyprus Branch):Ηλ: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: +371 670 35 775 |