About Relapsed CLL

You've always known this could happen, and now it has. Your Chronic Lymphocytic Leukemia (CLL) has returned, or relapsed. That means that your leukemia cells are, once again, growing and crowding out the normal, healthy blood cells.

This time around though, your doctor has decided to try something different for your relapsed CLL — an alternative treatment approach. With ZYDELIG. ZYDELIG is a prescription medicine used to treat adults with Chronic Lymphocytic Leukemia (CLL) in combination with Rituxan® (rituximab) when the disease comes back after prior cancer treatment. It is used in patients who may otherwise be treated with Rituxan alone due to other health concerns.

How was I diagnosed?

It's not uncommon for a relapse diagnosis to take you by surprise. You may be feeling relatively well, with no or few symptoms, when you hear the news. Chances are your doctor confirmed your diagnosis through a combination of your medical history and one or more of the following tests:

  • a physical examination
  • blood and/or bone marrow tests
  • genetic analysis
  • computed tomography (CAT scan)

Staging my CLL

Once your healthcare team has confirmed that you have relapsed CLL, they will have to determine how advanced it is, in order to develop the best treatment plan for you. Having been through this before, you may already be familiar with the different CLL stages and their symptoms.

The Rai Staging System

EARLY

STAGE 0
  • High blood lymphocyte count

INTERMEDIATE

STAGE I
  • High blood lymphocyte count
  • Swollen lymph nodes
STAGE II
  • High blood lymphocyte count
  • Swollen spleen or liver
  • Possibility of swollen lymph nodes

ADVANCED

STAGE III
  • High blood lymphocyte count
  • Low red blood cell count (anemia)
  • Possibility of swollen lymph nodes, spleen, or liver
STAGE IV
  • High blood lymphocyte count
  • Too few blood platelets
  • Possibility of anemia or swollen lymph nodes, spleen, or liver

Ways to Treat

Before beginning treatment for your relapsed CLL, it's important that you understand the goals of therapy. They include:

  • slowing the growth of your CLL cells
  • providing you with periods of remission
  • living longer without your disease getting worse

Having had CLL before, you're probably familiar with more conventional treatments. These include chemotherapy, where one or more medications are used to destroy fast-growing cells (including your cancer cells), and antibody therapy, which kills tumor cells directly or indirectly.

New ways to treat chronic lymphocytic leukemia

However, CLL treatment continues to evolve. With promising results from clinical trials, the outlook for patients with this disease is looking better and better. In fact, nowadays, there are new classes of treatments designed to block the growth and survival of B cells, some of which are cancerous. One such drug is a Phosphoinositide 3-Kinase (PI3K) delta inhibitor.

Taking ZYDELIG

General Do's and Don'ts of taking ZYDELIG as well as general dosing information and what to do if you miss a dose.

Learn More

Patient and Caregiver Resources

Staying informed about your disease and treatment can help you feel more confident in your fight.

See Patient Resources

Important Safety Information

What is the most important information I should know about ZYDELIG?

ZYDELIG can cause serious side effects that can lead to death, including:

  • Liver problems. Abnormal liver blood test results are common during treatment with ZYDELIG. ZYDELIG can cause severe 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 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), or bleeding or bruising more easily than normal.
  • Severe diarrhea. Diarrhea is common during treatment 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 6 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.
  • Infections. Tell your doctor right away if you have a fever or any signs of an infection while taking ZYDELIG.
  • 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 right away if you get painful sores or ulcers on your skin, lips, or in your mouth; a severe rash with blisters or peeling skin, or a rash with itching.

If you have any of the above serious side effects during treatment with ZYDELIG, your doctor may completely stop your treatment, stop your treatment for a period of time, or change your dose of ZYDELIG.

Who should not take ZYDELIG?

  • Those with a history of serious allergic or skin reactions, as determined by a doctor.

What are the other possible side effects of ZYDELIG?

ZYDELIG can cause serious side effects, including:

  • Serious allergic reaction. Tell your doctor or get medical help right away
  • Low white blood cell count (neutropenia). Neutropenia is common during treatment with ZYDELIG and can sometimes be severe. 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.

The most common side effects of ZYDELIG when used in combination with Rituxan include pneumonia, fever, feeling tired, rash, cough, and nausea.

What should I tell my doctor before taking ZYDELIG?

  • All of your medical conditions, including if you have liver, lung, or breathing problems or an infection.
  • If you are pregnant or plan to become pregnant. ZYDELIG may harm your unborn baby. Women who are able to become pregnant should use effective birth control (contraception) during treatment with ZYDELIG and for at least 1 month after the last dose of ZYDELIG. Talk to your doctor about birth control methods. Tell your doctor right away if you become pregnant or think you are pregnant during treatment with ZYDELIG.
  • If you are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take ZYDELIG or breastfeed. You should not do both.
  • 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You can also call 1‑800‑GILEAD‑5 (1‑800‑445‑3235).

Please see full Prescribing Information, including Medication Guide with important warnings.

Gilead, the Gilead logo, ZYDELIG, the ZYDELIG logo, and AccessConnect are trademarks of Gilead Sciences, Inc., or one of its related companies. Other brands noted herein are the property of their respective owners. © 2017 Gilead Sciences, Inc. All rights reserved. ZYDC0182 (02/2017)