Hyaluronidase Human, Recombinant (hye-al-ure-ON-i-dase HUE-man, ree-KOM-bi-nant), Rituximab (ri-TUX-i-mab)

Treats follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

Brand Name(s):

Rituxan Hycela

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach area.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 12 months after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 6 months after the last dose.
• Tell your doctor if you have kidney disease, heart disease, lung problems (including lung tumor), electrolyte imbalance, an infection, or a history of hepatitis B infection or heart rhythm problems.
• This medicine may cause the following problems:
  • Serious skin reactions
  • Hepatitis B infection reactivation
  • Progressive multifocal leukoencephalopathy (a brain infection that can be life-threatening)
  • Infusion reactions, which could be severe
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Increased risk for infection
  • Changes in heart rhythm
  • Kidney problems
  • Bowel problems (including blockage and perforation)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or loosening of the skin, red, scaly patches on the skin
• Bloody vomit or vomit that looks like coffee grounds, severe stomach pain
• Change in how much or how often you urinate, cloudy urine
• Confusion, problems with vision, speech, or walking, dizziness, weakness on one side of the body
• Dark-colored urine or pale stools, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Diarrhea, nausea, vomiting, unusual tiredness
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle was placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088