100 mg film-coated tablets
idelalisib
What Zydelig is and what it is used for
Zydelig is a cancer medicine that contains the active substance idelalisib. It works by blocking the effects of an enzyme involved in the proliferation and survival of certain white blood cells called lymphocytes. Because this enzyme is overactivated in some cancerous white blood cells, Zydelig kills and reduces the number of cancer cells by blocking the enzyme et.
Zydelig can be used to treat two different types of cancer in adults:
Chronic lymphocytic leukemia
Chronic lymphocytic leukemia ( CLL ) is a form of cancer in a type of white blood cell called B lymphocyte. In this disease, the lymphocytes multiply too quickly and live too long, so there are too many of them circulating in the blood.
In CLL, treatment with Zydelig is used in combination with another drug (rituximab) in patients who have certain high-risk factors or in patients whose cancer has returned after at least one previous treatment.
Follicular lymphoma
Follicular lymphoma (FL) is a form of cancer in a type of white blood cell called B lymphocyte. In follicular lymphoma, B lymphocytes multiply too quickly and live too long, so there are too many of them in the lymph nodes. In FL, Zydelig is used alone in patients whose cancer has not responded to treatment with two previous cancer treatments.
What you need to know before taking Zydelig
Do not take Zydelig
- if you are allergic to idelalisib or any of the other ingredients of this medicine (listed in section 6).
→ Talk to your doctor if this applies to you.
Warnings and precautions
Talk to your doctor before taking Zydelig. Tell doctor:
- if you have liver problems
- if you have any other medical conditions or illnesses (especially an infection or fever).
Serious and fatal infections have occurred in patients taking Zydelig. You should take additional medicines that your doctor gives you while you are taking Zydelig to prevent a type of infection. The doctor will check you for signs of infection. Tell your doctor immediately if you become ill (especially if you develop a fever, cough, or difficulty breathing) while taking Zydelig.
Tell your doctor immediately if you or anyone else notices the following in you: memory loss, difficulty thinking, difficulty walking, or loss of vision – this may be due to a very rare but serious brain infection that can be fatal ( progressive multifocal leukoencephalopathy or PML).
You will have regular blood tests before and during treatment with Zydelig. This is done to check that you do not have an infection, that the liver is working as it should, and that you have a normal number of blood cells. If necessary, the doctor may decide to stop the treatment for some time before starting the treatment again with the same or a lower dose. The doctor may also decide to stop treatment with Zydelig permanently.
Zydelig can cause severe diarrhea. Talk to a doctor immediately at the first sign of diarrhea.
Zydelig can cause pneumonia. Tell a doctor immediately:
- if you develop a new or worsening cough
- if you have shortness of breath or difficulty breathing.
Serious blistering skin conditions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with idelalisib treatment. Stop using idelalisib and seek medical attention immediately if you experience any of the symptoms described in section 4.
Tell a doctor immediately:
- if you get redness and blisters on the skin
- if you get swelling and blisters in the mucous membrane of the mouth, throat, nose, genitals, and/or eyes.
Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood during the first few weeks of treatment. This is expected and may last for a few months. It usually does not mean that your blood cancer is getting worse. Your doctor will check the number of blood cells in your blood before or during treatment with Zydelig and in rare cases, another medicine may need to be given. Talk to your doctor about what your test results mean.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age as it has not been studied in this age group.
Other medicines and Zydelig
Zydelig should not be used with any other medicine unless your doctor has told you it is safe to do so.
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is extremely important because the use of more than one drug at the same time can strengthen or weaken their effect.
Taking Zydelig with certain other medicines can lead to the medicines not working as they should or to some side effects becoming worse. In particular, tell the 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, a medicine used to treat migraine headaches
- cisapride, a drug used to relieve certain stomach problems
- pimozide, a medicine used to treat abnormal thoughts or feelings
- midazolam, triazolam, when taken by mouth to help you sleep and/or reduce 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 arterial hypertension
- sildenafil, and tadalafil, drugs used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
- budesonide, fluticasone, drugs used to treat hay fever and asthma, and salmeterol, used to treat asthma
- rifabutin, a medicine used to treat bacterial infections such as 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 medicine used for mild depression and mild anxiety
- alfentanil, fentanyl, methadone, buprenorphine/naloxone, drugs used for pain relief
- ciclosporin, 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 disorders of the nervous system
- dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer
- oral or implanted hormonal contraceptives used to prevent pregnancy
- clarithromycin, telithromycin, medicines used to treat bacterial infections
- atorvastatin, lovastatin, and simvastatin are drugs used to lower cholesterol.
Zydelig can be prescribed in combination with other medicines for the treatment of CLL. It is very important that you also read the leaflets that come with these medicines.
Contact your doctor if you have any questions about any of your medicines.
Pregnancy, breastfeeding, and fertility
- Zydelig should not be used during pregnancy. There is no information on the safety of this medicine in pregnant women.
- Use a safe method of contraception to prevent pregnancy while being treated with Zydelig and for 1 month after the last treatment.
- Zydelig may mean that the pill and implanted hormonal contraceptives do not work as well. You must use a barrier contraceptive such as a condom or IUD while taking Zydelig and for 1 month after the last treatment.
- Tell your doctor immediately if you become pregnant.
You should not breastfeed while taking Zydelig. If you are currently breastfeeding, talk to your doctor before starting treatment with Zydelig. It is unknown whether the active substance in Zydelig passes into breast milk.
Driving ability and use of machinery
Zydelig is unlikely to affect your ability to drive or use machines.
Zydelig contains para-orange (E110)
Tell the doctor if you are allergic to para-orange (E110). Zydelig contains para-orange (E110) which can cause allergic reactions.
How to take Zydelig
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
The recommended dose is 150 mg by mouth twice a day. However, if you experience certain side effects, the doctor may lower the dose to 100 mg twice a day.
Zydelig can be taken with or without food.
Swallow the tablet whole. Do not chew or crush the tablet. Tell the doctor if you have problems swallowing tablets.
If you have taken too much Zydelig
If you accidentally take more than the recommended dose of Zydelig, you may be at greater risk of side effects from this medicine (see section 4 Possible side effects ).
Immediately contact a doctor or the nearest emergency department for advice. Take the can and this leaflet with you so you can easily tell what you have taken.
If you forget to take Zydelig
Be careful not to miss a dose of Zydelig. If you forget to take a dose by less than 6 hours, take the missed dose immediately. Then take the next dose as usual. If you miss a dose by more than 6 hours, wait and take the next dose at the usual time.
Do not stop taking Zydelig
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
STOP taking Zydelig and seek medical attention immediately if you experience any of the following:
- reddish spots on the trunk; small demarcated areas of discolored skin, often with blisters in the center; skin peeling; ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome, toxic epidermal necrolysis ).
- widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
Other side effects are
Very common side effects are
(may affect more than 1 in 10 people)
- diarrhea/inflammation of the colon
- rash
- changed the number of white blood cells
- infection _
- fever
Blood tests may also show:
- increased blood levels of liver enzymes
Common side effects are
(may affect up to 1 in 10 people)
- inflammation of the lungs
- liver damage
Blood tests may also show:
- elevated blood levels of fats
By reporting side effects, you can contribute to increasing information about drug safety.
How to store Zydelig
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is idelalisib. Each film-coated tablet contains 100 mg of idelalisib.
Other ingredients are:
Tablet core:
Microcrystalline cellulose, hydroxypropyl cellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.
Film coating:
Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), para-orange (E110) (see section 2, What you need to know before you take Zydelig ).
Appearance and package sizes of the medicine
The film-coated tablets are orange, oval tablets, debossed with “GSI” on one side and “100” on the other side.
The following pack size is available: outer carton containing 1 plastic bottle with 60 film-coated tablets.
Marketing Authorisation Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland