Zydelig 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zydelig 100 mg film-coated tablets

idelalisib

Read the entire 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, ask your doctor.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Zydelig is and what it is used for
2. What you need to know before taking Zydelig
3. How to take Zydelig
4. Possible side effects
5. How to store Zydelig
6. Contents of the pack and other information

1. What Zydelig is and what it is used for

Zydelig is an anticancer medicine that contains the active substance idelalisib. It works by blocking the effects of an enzyme involved in the multiplication and survival of certain white blood cells called lymphocytes. Since this enzyme is overactive in certain cancerous white blood cells, blocking it enables Zydelig to eliminate cancer cells and reduce their number.

Zydelig may be used to treat two different cancers in adults:

Chronic lymphocytic leukemia

Chronic lymphocytic leukemia (CLL) is a cancer of a type of white blood cells known as B-lymphocytes. In this disease, the lymphocytes multiply too quickly and live too long, resulting in too many circulating in the blood.

In CLL, treatment with Zydelig is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has recurred after at least one prior treatment.

Follicular lymphoma

Follicular lymphoma (FL) is a cancer of a type of white blood cells called B-lymphocytes. In follicular lymphoma, B-lymphocytes multiply too rapidly and live too long, resulting in an excessive number accumulating in the lymph nodes. In FL, Zydelig is used alone in patients whose cancer has not responded to two previous cancer treatments.

2. What you need to know before starting to take Zydelig

Do not take Zydelig

• if you are allergic to idelalisib or to any of the other ingredients of this medicine (listed in section 6).

→ Consult your doctor if this applies to you.

Warnings and precautions

Talk to your doctor before starting to take Zydelig. Inform your doctor:

• if you have liver problems
• if you have any other illness or medical condition (especially an infection or fever)

Serious and fatal infections have occurred in patients treated with Zydelig. You will need to take an additional medicine prescribed by your doctor while taking Zydelig to prevent a certain type of infection. Your doctor will monitor you for signs of infection. Immediately inform your doctor if you become ill (especially if you have fever, cough, or difficulty breathing) while taking Zydelig.

Immediately inform your doctor if you or someone else notices in you: memory loss, confusion, difficulty walking, or loss of vision – these may be due to a very rare but serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML).

You will need to have periodic blood tests before and during treatment with Zydelig. These tests are to check that you do not have an infection, that your liver is functioning properly, and that your blood counts are normal. If necessary, your doctor may decide to temporarily interrupt treatment, before restarting it at the same or a lower dose. Your doctor may also decide to permanently stop treatment with Zydelig.

Zydelig may cause severe diarrhea. Immediately inform your doctor at the first sign of diarrhea.

Zydelig may cause inflammation of the lungs. Immediately inform your doctor:

• if you develop a new cough or worsening cough
• if you experience shortness of breath or difficulty breathing

Severe, blistering skin reactions have been reported in some people treated with Zydelig who were also receiving other medicines known to cause these potentially life-threatening conditions. Blistering may also affect the lining of the mouth, genitals, and/or eyes. Skin peeling may lead to serious infection. Immediately inform your doctor:

• if you develop redness and blistering of the skin
• if you develop swelling and blistering of the lining of the mouth, genitals, and/or eyes

Laboratory tests may show an increase in white blood cells (called "lymphocytes") in the blood during the first few weeks of treatment. This is expected, may last for several months, and usually does not mean that your blood cancer is worsening. Your doctor will monitor your blood counts before and during treatment with Zydelig, and in rare cases may need to prescribe another medicine. Talk to your doctor about what your test results mean.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Zydelig

Zydelig must not be used with other medicines unless your doctor has told you it is safe to do so.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. This is extremely important, as taking more than one medicine at the same time may increase or reduce their effects.

Taking Zydelig with certain medicines may cause them to work improperly or worsen their side effects. In particular, inform your doctor if you are taking any of the following:

• alfuzosin, a medicine used to treat enlarged prostate
• dabigatran, warfarin, medicines used to thin the blood
• amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
• dihydroergotamine, ergotamine, medicines used to treat migraines
• cisapride, a medicine used to relieve certain stomach problems
• pimozide, a medicine used to treat abnormal thoughts or feelings
• midazolam, triazolam, when taken orally to help sleep and/or relieve anxiety
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder, and major depression
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
• bosentan, a medicine used to treat pulmonary hypertension
• sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
• budesonide, fluticasone, medicines used to treat hay fever and asthma, and salmeterol, used to treat asthma
• rifabutin, a medicine used to treat bacterial infections, including tuberculosis
• itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections
• boceprevir, telaprevir, medicines used to treat hepatitis C
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
• rifampicin, a medicine used to prevent and treat tuberculosis and other infections
• St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used to relieve pain
• cyclosporine, sirolimus, tacrolimus, medicines used to control the body’s immune response after transplantation
• colchicine, a medicine used to treat gout
• trazodone, a medicine used to treat depression
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
• hormonal oral or implanted contraceptives, used to prevent pregnancy
• clarithromycin, telithromycin, medicines used to treat bacterial infections
• atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol

Zydelig may be prescribed in combination with other medicines for the treatment of CLL. It is very important that you also read the package leaflets provided with these medicines.

Ask your doctor if you have any questions about any of your medicines.

Pregnancy and breastfeeding

• Zydelig must not be used during pregnancy. There is no information available on the safety of this medicine in pregnant women.

• Use a reliable method of contraception to avoid becoming pregnant while being treated with Zydelig and for one month after your last dose.

• Zydelig may reduce the effectiveness of the oral contraceptive pill and implanted hormonal contraceptives. You should also use a barrier method of contraception such as condoms or an IUD while taking Zydelig and for one month after your last dose.

• Inform your doctor immediately if you become pregnant.

You must not breastfeed while taking Zydelig. If you are currently breastfeeding, consult your doctor before starting treatment. It is not known whether the active ingredient of Zydelig passes into breast milk.

Driving and using machines

It is unlikely that Zydelig will affect your ability to drive or use machines.

Zydelig contains sunset yellow FCF (E110)

Inform your doctor if you are allergic to sunset yellow FCF (E110). Zydelig contains sunset yellow FCF, which may cause allergic reactions.

3. How to take Zydelig

How to take this medicine

• Take this medicine exactly as your doctor has told you. Always follow the instructions given by your doctor or pharmacist.
• The usual dose is one 150 mg tablet taken twice a day (morning and evening), with food.
• Swallow the tablet whole with a glass of water. Do not crush, cut or chew the tablet.
• If you have difficulty swallowing the tablet, you may dissolve it in 100 mL of non-carbonated water. Stir until the tablet is completely dispersed (it may not dissolve completely) and drink immediately. Then add another 100 mL of non-carbonated water to the same glass, swirl and drink to ensure complete delivery of the dose. The tablet dispersion should not be stored and must be consumed within 20 minutes of preparation.
• If you take more Zydelig than you should, contact your doctor or pharmacist immediately.
• If you forget to take a dose, take it as soon as you remember, unless it is less than 6 hours before your next dose. In this case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
• Do not stop taking Zydelig unless your doctor tells you to. Even if you feel well, continue taking Zydelig as prescribed, as stopping treatment early may reduce its effectiveness.
• Your doctor will decide how long you should take Zydelig.
• Your doctor will monitor your response to treatment and may adjust your dose if necessary.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Follow exactly the administration instructions for this medicine as indicated by your doctor.

If in doubt, consult your doctor again.

The recommended dose is 150 mg orally twice daily. However, your doctor may reduce this dose to 100 mg twice daily if you experience certain adverse effects.

Zydelig may be taken with or without food.

Swallow the tablet whole. Do not chew or crush the tablet. Inform your doctor if you have difficulty swallowing tablets.

If you take more Zydelig than you should

If you accidentally take more Zydelig than the recommended dose, you may have an increased risk of adverse effects with this medicine (see section 4, Possible side effects).

Contact your doctor or the nearest emergency service immediately for advice. Take the bottle and this leaflet with you so that you can clearly describe what you have taken.

If you forget to take Zydelig

Try not to miss any doses of Zydelig. If you miss a dose and less than 6 hours have passed, take the missed dose immediately. Then take the next dose at the usual time. If you miss a dose and more than 6 hours have passed, wait and take the next dose at the usual time.

Do not stop taking Zydelig

Do not stop taking this medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Some side effects may be serious.

STOP taking Zydelig and seek immediate medical help if you experience any of the following symptoms:

• redness and blistering of the skin
• swelling and blistering of the lining of the mouth, genitals and/or eyes

Other side effects

Very common side effects
(may affect more than 1 in 10 people)

• diarrhoea/inflammation of the large intestine
• rash
• changes in white blood cell count
• infections
• fever

Blood tests may also show:

• increased blood levels of liver enzymes

Common side effects
(may affect up to 1 in 10 people)

• inflammation of the lungs
• liver damage

Blood tests may also show:

• increased blood levels of fats

Reporting of side effects

If you experience any type of side effect, talk to your doctor, 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 Zydelig

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

Do not use this medicine after the expiry date stated on the bottle and the carton after {EXP}. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the container and other information

Composition of Zydelig

• The active substance is idelalisib. Each film-coated tablet contains 100 mg of idelalisib.

• Other components are: Tablet core:

Microcrystalline cellulose, hydroxypropylcellulose (E463), sodium croscarmellose, sodium starch glycolate, magnesium stearate.

Film coating:

Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), orange yellow FCF (E110) (see section 2. What you need to know before starting to take Zydelig).

Appearance of the product and contents of the container

The film-coated tablets are orange, oval-shaped tablets, with "GSI" engraved on one side and "100" on the other.

Pack size available: outer carton containing 1 plastic bottle of 60 film-coated tablets.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.