Zydelig 150 mg comprimidos recubiertos con pelicula

Prescribing Information for the Patient

Zydelig 150 mg Film-Coated Tablets

idelalisib

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed to you alone, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prescribing information. See section 4.

Zydelig is a cancer medication that contains the active ingredient idelalisib. It works by blocking the effects of an enzyme that participates in the multiplication and survival of certain white blood cells called lymphocytes. Since this enzyme is excessively activated in certain cancerous white blood cells, by blocking it, Zydelig will eliminate cancer cells and reduce their number.

Zydelig can be used for the treatment of two different types of cancer in adults:

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia (CLL) is a cancer of a type of white blood cells called lymphocytes B. In this disease, the lymphocytes multiply too quickly and live too long, so there are too many circulating in the blood.

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

Follicular Lymphoma

Follicular Lymphoma (FL) is a cancer of a type of white blood cells called lymphocytes B. In follicular lymphoma, the lymphocytes B multiply too quickly and live too long, so there are too many in the lymph nodes. In FL, Zydelig is used alone in patients whose cancer has not responded to two previous cancer treatments.

Do not take Zydelig

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

→ Consult your doctorif this is the case.

Warnings and precautions

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

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

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

Inform your doctor immediately if you notice or someone notices in you: memory loss, confusion, difficulty walking, or loss of vision – these may be due to a rare but severe and potentially fatal brain infection (progressive multifocal leukoencephalopathy or PML).

You will need to have blood tests periodicallybefore and during the course of treatment withZydelig. This is to check that you do not have an infection, that your liver is functioning correctly, and that your blood counts are normal. If necessary, your doctor may decide to suspend treatment for some time, before restarting it at the same dose or a lower dose. Your doctor may also decide to suspend treatment with Zydelig permanently.

Zydelig may cause severe diarrhea. Inform your doctor immediately at the first sign of diarrhea.

Zydelig may cause lung inflammation. Inform your doctor immediately:

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

Severe skin blistering has been reported in some people treated with Zydelig while also receiving other medicines known to cause these potentially life-threatening conditions. Skin blistering may also affect the lining of the mouth, genitals, and/or eyes. Skin peeling may cause a severe infection. Inform your doctor immediately:

• 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 in the first few weeks of treatment. This is predictable and may last for months, and usually does not mean that your blood cancer is getting worse. Your doctor will review your blood counts before treatment or during treatment with Zydelig and in rare cases may need to administer another medicine. Discuss the meaning of the test results with your doctor.

Children and adolescents

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

Other medicines and Zydelig

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

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

Taking Zydelig with certain medicines may make them not work properly or worsen their side effects. In particular, inform your doctor if you are taking any of the following:

• alfuzosin,a medicine used to treat an enlarged prostate
• dabigatran, warfarin,medicines used to make blood less thick
• 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 by mouth to help sleep and/or alleviate 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 it difficult to breathe
• budesonide, fluticasone,medicines used to treat pollen allergy and asthma, andsalmeterol,used to treat asthma
• rifabutin,a medicine used to treat bacterial infections, including tuberculosis
• itraconazole, ketoconazole, posaconazole, voriconazole,medicines used to treat fungal infections (fungi)
• 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 to treat depression and anxiety
• alfentanil, fentanyl, methadone, buprenorphine/naloxone,medicines used toalleviate pain
• ciclosporin, sirolimus, tacrolimus,medicines used to control the body's immune response after a transplant
• colchicine,a medicine used to treat gout
• trazodone,a medicine used to treat depression
• buspirone, chlorazepate, diazepam, estazolam, flurazepam, zolpidem,medicinesused to treat nervous system disorders
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine,medicines used to treatcaner
• oral or implanted hormonal contraceptives,used to prevent pregnancy
• clarithromycin, telithromycin,medicines used to treat bacterial infections
• atorvastatin, lovastatin, simvastatin,medicines used to reduce cholesterol

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

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

Pregnancy and breastfeeding

• Zydelig should not be used during pregnancy.No information is available on thesafety of this medicine in pregnant women.

• Use a reliable method of contraceptionto avoid becoming pregnant while taking Zydelig and for one month after your last treatment.
• Zydelig may make the "pill" and implanted hormonal contraceptives work less well.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 treatment.
• Inform your doctor immediately if you become pregnant.

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

Driving and operating machines

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

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

Consult your doctor again if you are unsure.

The recommended doseis 150 mg by mouth twice a day. However, your doctor mayreduce this dose to 100 mg twice a day if you experience certain adverse effects.

Zydelig can be taken with or without food.

Swallow the tablet whole.Do not chew or crush the tablet. Inform your doctor ifyou have trouble swallowing the tablets.

If you take more Zydelig than you should

If you accidentally take a larger amount of Zydelig than the recommended dose, you may be at a higher risk of adverse effects with this medication (see section 4,Possible Adverse Effects).

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

If you forget to take Zydelig

Do not miss any dose of Zydelig. If you miss a dose and it has been less than 6 hours, take the missed dose immediately. Then, take the next dose as usual. If you miss a dose and it has been more than 6 hours, wait and take the next dose at the usual time.

Do not stop taking Zydelig

Do not stop taking this medication unless your doctor tells you to.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Some adverse effects could be severe.

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

• redness and blistering of the skin
• swelling and blistering of the mucous membranes in the mouth, genitals, and/or eyes

Other Adverse Effects

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• diarrhea/inflammation of the large intestine
• skin rash
• changes in the number of white blood cells
• infections
• fever

Blood tests may also show:

• increased concentration of liver enzymes in the blood

Common Adverse Effects

(may affect up to 1 in 10 people)

• inflammation of the lungs
• liver damage

Blood tests may also show:

• increased concentration of fats in the blood

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after {CAD}. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines 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 Zydelig

• The active ingredient isidelalisib. Each film-coated tablet contains 150 mg ofidelalisib.

• The other components are:Tablet core:

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

Coating:

Polivinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).

Appearance of the product and contents of the pack

The film-coated tablets are pink, oval-shaped tablets with “GSI” engraved on one side and “150” on the other.

The following pack size is available: outer carton with 1 plastic bottle of 60 film-coated tablets.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet

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