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

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

Brand Name(s):

Ruxience

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 30 to 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.

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-pvvr works. Tell your doctor if you are using medicine to treat arthritis 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. You may receive non live vaccines at least 4 weeks before starting treatment with this medicine.

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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before giving you this medicine. Use an effective form of birth control during treatment with this medicine and for 12 months after the last dose.
• Do not breastfeed during treatment with this medicine and for 6 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B), chest pain (angina), 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 of serious infections
  • 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 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
• 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, runny or stuffy nose, sore throat, body aches
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• 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

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