Rituxan Hycela

Approved Uses

Rituxan Hycela is used to treat adults with specific types of cancer that affect the white blood cells. These conditions include:

• Follicular Lymphoma (FL): This includes cases where the cancer has returned or did not respond to previous treatment, as well as newly diagnosed cases. It may also be used as a maintenance treatment to keep the cancer from returning.
• Diffuse Large B-Cell Lymphoma (DLBCL): It is used for patients who have not been treated before, typically in combination with chemotherapy.
• Chronic Lymphocytic Leukemia (CLL): It is used for both newly diagnosed and previously treated patients, usually alongside specific chemotherapy drugs.

Administration Requirements

This medication is not intended for the initial start of treatment. It is only prescribed for patients who have already safely completed at least one full dose of a rituximab product given by intravenous (IV) infusion. Once the initial IV dose is tolerated, healthcare providers may switch the patient to this subcutaneous (under the skin) injection for subsequent treatments.

Rituxan Hycela contains two active components that work together to treat certain types of blood cancers:

• Rituximab: This is a monoclonal antibody designed to recognize and attach to a specific protein called CD20. This protein is found on the surface of B-lymphocytes (B-cells), which are a type of white blood cell. When rituximab binds to these cells, it triggers the body's immune system to attack and destroy them.
• Hyaluronidase: This is an enzyme that helps the body absorb the rituximab. It works by temporarily breaking down hyaluronan, a substance that naturally occurs in the tissues under the skin. By breaking this barrier, the enzyme allows the medicine to be injected and absorbed more effectively into the bloodstream.

By targeting and reducing the number of both normal and cancerous B-cells, the medication helps manage conditions like non-Hodgkin lymphoma and chronic lymphocytic leukemia. The body eventually replaces the healthy B-cells that were destroyed during treatment.

Common Side Effects

Many people experience mild to moderate side effects while receiving Rituxan Hycela. These may include:

• Nausea, vomiting, or constipation
• Feeling unusually tired or weak
• Headache
• Muscle, bone, or joint pain
• Hair loss
• Swelling in the hands, ankles, or feet
• Cold-like symptoms such as a cough or sore throat
• Redness, itching, swelling, or pain at the site of the injection

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Signs of infection: Fever, chills, persistent cough, or flu-like symptoms.
• Severe skin reactions: Painful sores, ulcers, blisters, or peeling skin.
• Heart problems: Chest pain, shortness of breath, or a racing or irregular heartbeat.
• Infusion or injection reactions: Hives, rash, swelling of the lips or tongue, or dizziness during or shortly after the injection.
• Kidney issues: Changes in the amount or color of urine.
• Liver problems: Yellowing of the skin or the whites of the eyes, or dark-colored urine.
• Neurological changes: Confusion, vision loss, or trouble walking or talking.

Boxed Warnings

Rituxan Hycela carries boxed warnings for the following serious conditions:

• Severe Mucocutaneous Reactions: Fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred in patients treated with rituximab products.
• Hepatitis B Virus (HBV) Reactivation: The virus can become active again in people who have had it before, potentially leading to liver failure or death. Screening for HBV is required before starting treatment.
• Progressive Multifocal Leukoencephalopathy (PML): This is a rare, serious brain infection caused by the JC virus that can lead to death or severe disability.

Severe Reactions

While Rituxan Hycela is administered as an injection under the skin, it can still cause severe administration-related reactions. These may include dizziness, reddening of the skin, or breathing difficulties. Most severe reactions occur during the first dose. Local skin reactions, such as pain, swelling, or redness at the injection site, are also common.

Infections and Immune System

This medication can increase the risk of serious, sometimes fatal, bacterial, fungal, or viral infections. It may also reduce the effectiveness of vaccinations. Live vaccines should not be administered during treatment.

Tumor Lysis Syndrome (TLS)

TLS is caused by the rapid breakdown of cancer cells, which releases waste products into the blood. This can lead to kidney failure and abnormal heart rhythms. Monitoring of blood work and hydration is often necessary during treatment.

Other Serious Risks

• Heart Problems: Some patients may experience chest pain (angina) or irregular heartbeats during or after treatment.
• Kidney Toxicity: Severe kidney damage has been reported, often associated with TLS or severe administration reactions.
• Bowel Problems: There is a risk of bowel obstruction or perforation (a hole in the intestine), which may require surgery.

Pregnancy and Breastfeeding

Rituxan Hycela can cause harm to an unborn baby. Effective birth control is recommended during treatment and for several months after the final dose. Breastfeeding is generally not recommended during and for a period after treatment.

Pregnancy

Rituxan Hycela can cause harm to a fetus if used during pregnancy. It may lead to a decrease in B-cells, which are white blood cells important for the immune system, in the unborn baby. If you are pregnant or planning to become pregnant, it is important to discuss the potential risks and benefits of this medication with your healthcare provider.

Individuals who can become pregnant are typically advised to use effective birth control (contraception) during treatment and for 12 months after the final dose of Rituxan Hycela.

Breastfeeding

It is not known if Rituxan Hycela passes into human breast milk. Because of the potential for serious adverse reactions in a nursing infant, healthcare providers recommend that you do not breastfeed during treatment and for at least 6 months after your last dose.

Available Forms

Rituxan Hycela is supplied as a sterile, preservative-free liquid solution. It is administered as a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

This medication is provided in single-dose vials and contains a combination of rituximab and hyaluronidase human. It is intended for use by a healthcare provider in a clinical setting.

FDA Approval

The U.S. Food and Drug Administration (FDA) approved Rituxan Hycela in June 2017. It is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an enzyme that increases the permeability of subcutaneous tissue to allow for the injection of large volumes of medication.

Approved Indications

Rituxan Hycela is approved for the treatment of adult patients with the following conditions:

• Follicular Lymphoma (FL): Used as a single agent for relapsed or refractory FL, in combination with chemotherapy for previously untreated FL, or as maintenance therapy.
• Diffuse Large B-Cell Lymphoma (DLBCL): Used in combination with CHOP or other anthracycline-based chemotherapy regimens for previously untreated DLBCL.
• Chronic Lymphocytic Leukemia (CLL): Used in combination with fludarabine and cyclophosphamide for both previously untreated and previously treated CLL.

A regulatory requirement for this medication is that patients must receive at least one full dose of a rituximab product by intravenous infusion before they can safely transition to Rituxan Hycela injections.

Boxed Warnings

Rituxan Hycela carries Boxed Warnings, the most serious type of warning issued by the FDA, for several risks:

• Severe Mucocutaneous Reactions: Fatal skin and mouth reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred.
• Hepatitis B Virus (HBV) Reactivation: The virus can become active again in patients who previously had it, which may lead to liver failure and death. Screening for HBV is required before starting treatment.
• Progressive Multifocal Leukoencephalopathy (PML): A rare and often fatal brain infection caused by the JC virus.
• Serious Administration Reactions: Severe and sometimes fatal reactions can occur during or within 24 hours of administration. Facilities must be equipped to provide immediate resuscitation if needed.

Insurance and Coverage

The cost of Rituxan Hycela is largely determined by your health insurance plan. Most insurance providers, including Medicare, provide coverage for this medication when it is used for approved conditions. Your specific out-of-pocket expenses, such as deductibles and copayments, will depend on your individual policy. It is often necessary for your healthcare provider to obtain prior authorization from your insurance company before starting treatment.

Administration Fees

Rituxan Hycela is administered as a subcutaneous injection by a healthcare professional in a clinical setting. Consequently, the total cost of treatment often includes additional charges beyond the medication itself, such as:

• Facility fees for the hospital or clinic where the injection is given.
• Professional fees for the healthcare provider who administers the drug.
• Costs for any pre-medications or monitoring required during the appointment.

Financial Assistance

If you are concerned about the cost of treatment, financial assistance may be available. Many manufacturers offer support programs or co-pay cards for eligible patients to help reduce the financial burden. You may also want to speak with a financial counselor at your treatment facility to explore available resources or charitable foundations that provide assistance for specialty medications.