Information Density: Gilead Sciences (ZYDELIG) – Signal Evidence & AI Readability

[H1] We're here to support your journey with ZYDELIG®

What is ZYDELIG?

Addressing your side effects

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[H2] What is ZYDELIG?

ZYDELIG (idelalisib) is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL), in combination with Rituxan® (rituximab), when CLL comes back after prior cancer treatment and when Rituxan treatment alone may be used due to other health problems.

ZYDELIG should not be used as the first medicine to treat anyone, including people with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other slow growing (indolent) non-Hodgkin lymphomas.

ZYDELIG should not be used in combination with bendamustine and Rituxan, or in combination with Rituxan to treat people with FL, SLL, and other indolent non-Hodgkin lymphomas.

What is ZYDELIG and what sets it apart?

It's an oral medication: ZYDELIG (idelalisib) is an FDA-approved medication used to treat relapsed chronic lymphocytic leukemia (CLL)1
It works differently: ZYDELIG was approved in 2014 and works by blocking PI3Kδ, a protein that contributes to CLL1-3

ZYDELIG for relapsed CLL
In relapsed CLL, ZYDELIG is used in combination with Rituxan® (rituximab) when CLL comes back after prior cancer treatment and when Rituxan treatment alone may be used due to other health problems. ZYDELIG should not be used as the first medicine to treat people who have been diagnosed with CLL.1
Although CLL is not curable, your doctor can use different therapies or combinations of therapies to slow the growth of your CLL cells and provide you with periods of remission. The ultimate goal of therapy is to help you live longer without your disease getting worse.1,4
[H2] How is ZYDELIG thought to work?

ZYDELIG works differently from chemotherapy because it blocks a specific protein in B cells called PI3Kδ. PI3Kδ sends signals to cancerous B cells, telling them to multiply and helping them survive. ZYDELIG blocks these signals, helping to slow the growth of leukemia cells.1-3
Your white blood cell count might go up when you begin treatment with ZYDELIG. Keep in mind the increased count doesn't mean that your ZYDELIG treatment isn't working or that your disease is getting worse. In most cases, this initial rise in white blood cell count decreases over time while you're taking ZYDELIG.1,4

PI3Kδ=phosphatidylinositol 3-kinase.

[H2] Proven effective in relapsed CLL1

[H5] ZYDELIG was studied in a clinical trial of:

220

people with relapsed CLL who were not able to tolerate chemotherapy

At least 50% had been treated with 3 or more prior therapies.

[H5] Of the 220 people with relapsed CLL:

84%
of those treated with ZYDELIG plus Rituxan responded to therapy

vs

16%
of those treated with Rituxan alone responded to therapy

The main goal, or primary endpoint, of the study was to measure how long people lived without their cancer getting worse while on treatment—also called progression-free survival. In the study, people taking ZYDELIG plus Rituxan had longer progression-free survival (19.4 months) than those taking Rituxan alone (6.5 months).1,3 In addition, 66% of those treated with ZYDELIG plus Rituxan experienced no disease progression at 1 year vs 13% of those treated with Rituxan alone.1,5

The safety profile of ZYDELIG has also been established in people with relapsed CLL.
View the safety profile

The tips included within this section come from organizations focused on supporting people with cancer.

[H2] Tips for managing & reporting certain side effects of ZYDELIG®

The tips included within this section come from advocacy organizations focused on supporting people with cancer.
This information is not meant to replace your doctor's advice. Be sure to talk to your doctor before you try any of these tips.
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.

Diarrhea
Fatigue
Nausea
Fever

Diarrhea
One common side effect of ZYDELIG® therapy is diarrhea, or frequent and watery bowel movements. Avoid using ZYDELIG with other drugs that cause diarrhea.1
Diarrhea can happen anytime, even several months after you begin treatment. Be sure to tell your doctor or nurse right away if you notice any increase in the number of bowel movements you have in a day. If you have severe diarrhea while taking ZYDELIG, your doctor may completely stop your treatment, stop your treatment for a period of time, or change your dose of ZYDELIG. Reporting diarrhea is especially important because some cases can be managed to allow you to stay on therapy. In a series of clinical trials, some patients stopped therapy. Of the patients who experienced severe diarrhea, 67% were started at a lower dose. Of those patients, 58% who restarted treatment didn't experience severe diarrhea again.1,2 Tell your doctor or nurse if you experience any increase in your number of daily bowel movements.
[H3] Tips to help manage diarrhea while taking ZYDELIG

Eat smaller meals more often3: Instead of 3 big meals, eat 6 to 8 small meals each day.

Drink more liquids each day3,4: Drink 8 to 12 cups of liquid per day. Clear broth, gelatin, or an electrolyte drink are good choices for most people. Talk to your doctor to make sure it is safe for you.

Avoid these foods and drinks3-5:

Coffee, tea, alcohol, and sweets
High-fiber foods, such as whole-grain breads, granola, and bran cereals
Raw vegetables and fruits. Most canned fruits and vegetables are okay
Foods that cause gas, like broccoli and cabbage
Fried, greasy, or spicy foods
Milk, cheese, and other dairy products

Anti-diarrhea medicine1: Severe diarrhea caused by ZYDELIG doesn't respond well to common anti-diarrhea medicines. Ask your doctor about other treatment options.

Make sure to tell your doctor or nurse if your diarrhea continues.

Fatigue
One of the most common side effects of ZYDELIG therapy is extreme tiredness, or fatigue. You may be experiencing fatigue if you can't seem to get enough sleep, have trouble focusing, or sometimes get confused.1,6 Be sure to tell your doctor or nurse as early as possible if you experience fatigue.
[H3] Tips to help manage fatigue while taking ZYDELIG

Be active7: Believe it or not, sometimes a little physical activity can go a long way toward relieving fatigue. Your doctor can tell you how to add exercise to your day.

“De-stress” your life7: If you're feeling stressed, talk to your doctor, a counselor, family member, friend, or support group about it. Doing some relaxation exercises may also help.

Get your sleep6: Having good sleep habits is another way to manage fatigue. Try to go to bed and wake up at the same time every day. Avoid taking long naps during the day.

Nausea
While taking ZYDELIG, you may experience nausea—the feeling of being sick to your stomach.1 Be sure to tell your doctor or nurse as early as possible if you experience nausea.
[H3] Tips to help manage nausea while taking ZYDELIG

Avoid certain foods8: If you're experiencing nausea, it's best to avoid greasy, fried, salty, sweet, or spicy foods. “Bland” choices are the best bet. If certain smells bother you, ask others to cook for you, and let your food cool down before eating it.

Eat and drink enough5,8: If you're having a hard time drinking a full glass of water at a time, try taking small sips throughout the day. Instead of eating 3 big meals per day, try having 5-6 small ones.

Take anti-nausea medicine8: Your doctor may prescribe you something to relieve your symptoms.

Fever
Tell your doctor or nurse right away if you have a fever while taking ZYDELIG. Fever may be a sign of infection.1 It is important to report fever or any signs of an infection to a doctor or nurse as early as possible.

[H2] Serious side effects

View serious side effects

[H2] Most common side effects

View most common side effects

ZYDELIG is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas.
ZYDELIG is not indicated and is not recommended in combination with bendamustine and Rituxan, or in combination with Rituxan for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.