Rituximab-arrx (ri-TUX-i-mab - arrx)

Treats granulomatosis with polyangiitis, microscopic polyangiitis (MPA), rheumatoid arthritis, and cancer, including lymphoma and leukemia.

Brand Name(s):

Riabni

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the needle will have to remain in place for at least 90 minutes.
• 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 may also give you other medicines (including allergy medicine or fever medicine) before starting treatment to help prevent unwanted side effects.
• 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.

• Some medicines can affect how rituximab-arrx works. Tell your doctor if you are using cisplatin or medicine that can weaken the immune system.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Non-live vaccines may be given at least 4 weeks before starting rituximab-arrx.

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 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, liver disease (including hepatitis B), heart disease, lung problems, immune system problems (including hypogammaglobulinemia), any type of infection, or a history of chest pain (angina) or heart rhythm problems.
• This medicine may cause the following problems:
  • Infusion reaction
  • Serious skin reactions, including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
  • Progressive multifocal leukoencephalopathy (brain infection that can be life-threatening)
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Increased risk for infection
  • Heart and heart rhythm problems
  • Kidney problems
  • Bowel problems (including blockage and perforation)
• 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.
• 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, red skin rash
• Bloody or cloudy urine, change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Bloody vomit or vomit that looks like coffee grounds, severe stomach pain
• Chest pain, uneven heartbeat, sudden fainting
• Confusion, body weakness, numbness or tingling in your hands, feet, or lips
• Cough producing mucus, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow eyes or skin
• Decrease in how much or how often you urinate, pain while urinating
• Dizziness, lightheadedness, drowsiness
• Fever, chills, cough, sore throat, body aches
• Problems with vision, coordination, or speech
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• Headache
• Joint or muscle pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is 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