What is ZYDELIG (Idelalisib)?
Zydelig is a prescription medicine used to treat people with:
- Chronic Lymphocytic Lymphoma (CLL) in combination with rituximab when CLL comes back after prior cancer treatment when rituximab treatment alone may be used due to other health problems.
- Follicular B-cell non-Hodgkin Lymphoma (FL) when the disease has come back after treatment with at least two prior medicines
- Small Lymphocytic Lymphoma (SLL) when the disease comes back after treatment with at least two prior medicines.
It is not known if Zydelig is safe and effective in children less than 18 years of age.
What is the most important information I should know about ZYDELIG?
ZYDELIG can cause serious side effects. These serious side effects include:
- Liver problems. Your doctor will do blood tests before and during your treatment with Zydelig to check for liver problems. Tell your doctor right away if you get any of the following symptoms of liver problems:
- Yellowing of your skin or the white part of your eyes (jaundice)
- Dark or brown (tea colored) urine
- Pain in the upper right side of your stomach area (abdomen)
- Bleeding or bruising more easily than normal
- Severe diarrhea. Diarrhea is common with Zydelig and can sometimes be severe. Tell your doctor right away if the number of bowel movements you have in a day increases by six or more. Ask your doctor about medicines you can take to treat your diarrhea
- Lung or breathing problems. Your doctor may do tests to check your lungs if you have breathing problems during treatment with Zydelig. Tell your doctor right away if you get new or worsening cough, shortness of breath, difficulty breathing, or wheezing
- Tear in intestinal wall (perforation). Tell your doctor or get medical help right away if you get new or worsening stomach area (abdomen) pain, chills, fever, nausea, or vomiting.
- Severe skin reactions. Tell your doctor if you get any of the following symptoms during treatment with Zydelig:
- Painful sores or ulcers on your skin, lips, or in your mouth
- Severe rash with blisters or peeling skin
- Anaphylaxis. Tell your doctor or get medical help right away if you have a serious allergic reaction while taking Zydelig
- Low white blood cell count (neutropenia). Your doctor will check your blood counts regularly during treatment with Zydelig. Tell your doctor right away if you have a fever or any signs of an infection while taking Zydelig.
- The most common side effects of Zydelig include:
- Fever
- Feeling tired
- Nausea
- Cough
- Chills
How should I take Zydelig?
- Take Zydelig exactly as your doctor tells you to take it.
- Your doctor may change your dose of Zydelig or tell you to stop taking Zydelig. Do not change your dose or stop taking Zydelig without first talking to your doctor.
- Take Zydelig 2 times a day
- You may take Zydelig with or without food
- Take Zydelig tablets whole.
- Do not miss a dose of Zydelig. If you miss a dose of Zydelig by less than 6 hours, take the missed dose right away. Then take your next dose as usual. If you miss a dose of Zydelig by more than 6 hours, wait and take the next dose of Zydelig at your usual time.
Important Safety Information
Zydelig can cause serious side effects that can lead to death, including:
- Liver problems
- Severe diarrhea.
- Tear in intestinal wall (perforation)
- Lung or breathing problems
- Severe skin reactions
- Anaphylaxis.
- Low white blood cell count (neutropenia).
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking Zydelig?
Before taking Zydelig, tell your doctor about all of your medical conditions, including if you:
- Have liver problems
- Have lung or breathing problems
- Are pregnant or plan to become pregnant. Zydelig may harm your unborn baby. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Zydelig and for 1 month after stopping treatment. Talk to your doctor about birth control methods that may be right for you. Tell your doctor right away if you become pregnant during treatment with Zydelig.
- Are breastfeeding or plan to breastfeed. It is not known if Zydelig passes into your breast milk. You and your doctor should decide if you will take Zydelig or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zydelig and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
General information about Zydelig
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zydelig for a condition for which it was not prescribed. Do not give Zydelig to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in Zydelig,?
Active ingredient: Idelalisib
Inactive ingredient: Microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate.