Zydelig

Approved Uses

Zydelig is used to treat several types of cancer that affect the blood and lymphatic system. It is generally prescribed for patients who have already tried other therapies that did not work or whose cancer has returned.

Chronic Lymphocytic Leukemia (CLL)

Zydelig is used in combination with another medicine called rituximab to treat CLL. This combination is typically used when the leukemia has come back after previous treatment and when rituximab alone would be appropriate.

Follicular B-cell Non-Hodgkin Lymphoma (FL)

This medication is used for patients with FL whose cancer has returned after receiving at least two prior systemic treatments.

Small Lymphocytic Lymphoma (SLL)

Zydelig is used to treat patients with SLL who have already received at least two prior systemic treatments for their condition.

Mechanism of Action

Zydelig is a type of medication called a kinase inhibitor. It works by interfering with the signals that tell cancer cells to grow and multiply.

The medication specifically targets a protein known as phosphoinositide 3-kinase (PI3K) delta. This protein is found in certain white blood cells called B-cells. In some types of cancer, this protein becomes overactive, causing the B-cells to grow uncontrollably and survive longer than they should.

By blocking the PI3K delta protein, Zydelig helps to:

• Interrupt the growth cycle of cancer cells.
• Prevent cancer cells from receiving survival signals.
• Reduce the overall number of cancer cells in the body.

Common Side Effects

Many people taking Zydelig experience mild to moderate side effects. These may include:

• Diarrhea
• Fever
• Fatigue or unusual tiredness
• Nausea
• Cough
• Stomach pain
• Rash
• Joint or muscle pain

Serious Side Effects

Zydelig can cause severe or life-threatening conditions. Seek medical attention immediately for any of the following:

• Severe diarrhea or colitis: Frequent, watery, or bloody stools, often accompanied by stomach cramps.
• Liver problems: Yellowing of the skin or eyes, dark-colored urine, or pain in the upper right side of the stomach.
• Lung problems: New or worsening shortness of breath, cough, or wheezing.
• Infections: Fever, chills, or other signs of a new infection.
• Bowel perforation: Intense stomach pain, swelling, nausea, or vomiting.
• Severe skin reactions: Red or purple skin rash that spreads and causes blistering or peeling.

Boxed Warnings

Zydelig includes boxed warnings for several severe conditions that can be fatal. Healthcare providers monitor patients closely for these risks during treatment.

• Liver Toxicity: Serious liver injury can occur. Blood tests to monitor liver function are typically performed before and during treatment.
• Severe Diarrhea or Colitis: This medication can cause severe inflammation of the colon, leading to life-threatening diarrhea.
• Pneumonitis: Inflammation of the lungs has been reported. Patients should be evaluated immediately for new or worsening respiratory symptoms like cough or shortness of breath.
• Infections: There is an increased risk of serious and fatal infections, including Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV). Preventive medications for PJP are often required.
• Intestinal Perforation: Serious or fatal holes in the wall of the stomach or intestines have occurred.

Other Serious Precautions

Severe Skin Reactions

Life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Symptoms may include a progressive skin rash, peeling, or painful sores in the mouth or throat.

Neutropenia

A significant decrease in white blood cell counts (neutropenia) can occur, which increases the risk of infection. Regular blood count monitoring is necessary throughout therapy.

Embryo-Fetal Toxicity

Zydelig can cause harm to a fetus. Effective contraception is recommended for females of reproductive potential and for males with female partners of reproductive potential during treatment and for a period after the final dose.

Hypersensitivity

Serious allergic reactions, including anaphylaxis, may occur. Treatment is typically discontinued permanently if a severe hypersensitivity reaction happens.

Pregnancy

Zydelig may cause fetal harm when administered to a pregnant woman. Based on findings from animal studies, this medication can cause birth defects or death to an unborn baby. It is important to tell your healthcare provider if you are pregnant or plan to become pregnant before starting this treatment.

Contraception

Because of the risks to a developing fetus, healthcare providers typically recommend the following precautions:

• Females: Women who are able to become pregnant should use effective birth control during treatment and for at least 1 month after the final dose.
• Males: Men with female partners who are able to become pregnant should use effective birth control during treatment and for at least 3 months after the final dose.

Breastfeeding

It is not known whether Zydelig passes into human breast milk. Due to the potential for serious side effects in a nursing infant, breastfeeding is not recommended during treatment and for at least 1 month after the last dose. Discuss alternative feeding options with your healthcare provider if you are taking this medication.

Dosage Forms

Zydelig is supplied as a film-coated tablet for oral administration. These tablets are designed to be swallowed whole and can be taken with or without food.

The medication is available in different strengths. Each strength is distinguished by a specific color and unique markings on the tablet surface to help identify the correct dose prescribed by a healthcare provider.

FDA Approval and Indications

Zydelig (idelalisib) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed chronic lymphocytic leukemia (CLL). It is used in combination with rituximab for patients for whom rituximab alone would be considered appropriate therapy. While Zydelig previously held accelerated approvals for follicular lymphoma and small lymphocytic lymphoma, those specific indications were voluntarily withdrawn from the U.S. market by the manufacturer.

Boxed Warning

The FDA has issued a Boxed Warning for Zydelig, which is the most serious type of warning for a medication. This warning alerts healthcare providers and patients to the risk of fatal and serious toxicities, including:

• Liver toxicity: Severe and sometimes fatal liver injury.
• Diarrhea and colitis: Severe or fatal diarrhea or inflammation of the colon.
• Pneumonitis: Serious or fatal inflammation of the lungs.
• Intestinal perforation: Fatal or serious tears in the wall of the intestine.

Safety Alerts and Monitoring

The FDA has issued safety communications regarding clinical trials that showed an increased risk of death and serious infections when Zydelig was combined with other cancer treatments. Because of these risks, the FDA recommends that patients be monitored closely for signs of infection and receive preventive medication for specific types of pneumonia during treatment. Healthcare providers are also required to perform regular blood tests to monitor liver function.

Factors Affecting Cost

The price of Zydelig can vary significantly based on the following:

• Insurance Coverage: Your out-of-pocket expenses will depend on your specific insurance plan, including Medicare Part D or private insurance, and which tier the drug occupies on your plan's formulary.
• Specialty Pharmacy Requirements: Zydelig is often classified as a specialty medication. Many insurance providers require that you obtain these drugs through a specific specialty pharmacy rather than a local retail pharmacy.
• Dosage: The total cost may be influenced by the strength and quantity of tablets prescribed by your healthcare provider.

Financial Assistance

Because Zydelig is a high-cost specialty medication, there are often programs available to help manage the expense:

• Co-pay Assistance: The manufacturer may offer co-pay cards or coupons for patients with commercial insurance to help reduce monthly out-of-pocket costs.
• Patient Assistance Programs: For patients who are uninsured or underinsured, non-profit organizations or the drug manufacturer may provide the medication at a lower cost or for free to those who meet specific financial eligibility criteria.

There is currently no generic version of Zydelig available. Brand-name medications typically cost more than generic alternatives. To get an accurate estimate of your costs, it is best to contact your insurance provider or a specialty pharmacy.