Rituximab Hyaluronidase

Trade Name(s): Rituxan Hycela^TM

Rituximab and hyaluronidase is the generic name for the trade name drug Rituxan Hycela^TM. In some cases, health care professionals may use the trade name Rituxan Hycela^TM when referring to the generic drug name rituximab and hyaluronidase.

Drug Type: Rituximab hyaluronidase is a "monoclonal antibody." (For more detail, see "How rituximab and hyaluronidase Works" below).

What Rituximab and Hyaluronidase Is Used For

• Treatment of Diffuse Large B-cell Lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone, or other anthracycline-based chemotherapy regimens for previously untreated patients
• Treatment of Chronic Lymphocytic Leukemia (CLL) in combination with fludarabine and cyclophosphamide.
• Treatment of Follicular Lymphoma (FL)

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Rituximab and Hyaluronidase Is Given

• All patients must receive at least one full dose of a Rituxan^TM as an infusion into a vein (intravenous) before receiving rituximab and hyaluronidase
• Rituximab and hyaluronidase is given as a subcutaneous injection under the skin of the abdomen, over approximately 5-7 minutes, depending on the dose, followed by a 15 minute observation period
• If the administration is interrupted or the needle clogs, rituximab and hyaluronidase can be given at the same site on the abdomen
• Premedications with acetaminophen and an anithistamine must be given just before each dose to reduce the occurrence of infusion-related symptoms

The amount of rituximab and hyaluronidase that you will receive depends on the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects

Important things to remember about the side effects of rituximab and hyaluronidase:

• Most people will not experience all of the rituximab and hyaluronidase side effects listed.
• Rituximab and hyaluronidase side effects are often predictable in terms of their onset, duration, and severity.
• Rituximab and hyaluronidase side effects will improve after therapy is complete.
• Rituximab and hyaluronidase side effects may be quite manageable. There are many options to minimize or prevent the side effects of rituximab and hyaluronidase.

The following side effects are common (occurring in greater than 30%) for patients taking rituximab and hyaluronidase:

• Low blood counts (your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding)
• Serious infections
• Fever
• Nausea

These are less common side effects (occurring in 10-29%) for patients receiving rituximab and hyaluronidase:

• Hypersensitivity reactions
• Redness at the injection site
• Allergic skin reaction
• Fatigue
• Abdominal pain
• Constipation
• Diarrhea
• Vomiting
• Cough
• Hair thinning or hair loss

These are rare but serious side effects of rituximab and hyaluronidase:

• Hepatitis B Virus (HBV) Reactivation
• If you previously have been exposed to HBV, reactivation of the virus may be possible. All patients should be screened for HBV infection before starting treatment monitored during treatment.
• Severe Skin and Mouth Reactions
• Severe, including deadly, reactions of the skin and mucous linings including pain, redness, swelling, rash, and blisters may occur.
• If any reactions occur, tell your healthcare provider or get medical help right away.
• Altered Mental Status
• Also known as progressive multifocal leukoencephalopathy (PML), this type of altered mental status is a rare, serious brain infection caused by a virus that can happen in people who receive rituximab and hyaluronidase.
• Mental status changes include confusion, dizziness, difficulty walking or talking, memory problems, or vision problems.

Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10 percent of patients - are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24-hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Pain or burning with urination
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

• Before starting rituximab and hyaluronidase treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking rituximab and hyaluronidase.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Rituximab containing products can cause fetal harm if taken during pregnancy.
• For both men and women: Use contraceptives and do not conceive a child (get pregnant) while taking rituximab and hyaluronidase. Barrier methods of contraception, such as condoms, are recommended for up to 12 months after last dose of rituximab and hyaluronidase.
• Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking rituximab and hyaluronidase and for 6 months after your last dose.

Self-Care Tips

• You may have a higher chance of getting an infection. Wash your hands often and stay away from people with infections, cold, or flu.
• Rituximab and hyaluronidase infrequently causes nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals. Sucking on lozenges and chewing gum may also help.
• You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
• In general, drinking alcoholic beverages should be avoided. You should discuss this with your doctor.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Rituximab and Hyaluronidase

You will be checked regularly by your doctor while you are taking rituximab and hyaluronidase to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC), electrolytes in your complete metabolic panel (CMP), as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

Due to the risk of HBV reactivation, patients should be screened for HBV infection prior to therapy initiation. Vital signs and blood pressure will be monitored while receiving the injection to monitor for a possible hypersensitivity reactions.

How Rituximab and Hyaluronidase Works

Rituximab and hyaluronidase has two components, rituximab and hyaluronidase. The rituximab portion is classified as a monoclonal antibody. Monoclonal antibodies are a relatively new type of "targeted" cancer therapy. Hyaluronidase is added to rituximab to increase absorption under the skin – hyaluronidase does not have any anti-cancer effects.

Antibodies are an important part of the body's immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually given only for cancers in which antigens (and the respective antibodies) have been identified already.

Rituximab and hyaluronidase works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.