Riabni (rituximab-arrx)

What is RIABNI?

RIABNI is a prescription medicine used to treat adults with:

• Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
• Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
• Rheumatoid Arthritis (RA)
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA

RIABNI is not indicated for the treatment of children.

What should I tell my doctor before using RIABNI?

Before you receive RIABNI, tell your doctor about all of your medical conditions, including if you:

• have had a severe reaction to RIABNI or another rituximab product.

• have a history of irregular heartbeat, heart problems, or chest pain.

• have lung or kidney problems.

• have an infection or weakened immune system.

• have or have had any infections including:
  • Hepatitis B virus (HBV)
  • Parvovirus B19
  • Hepatitis C virus (HCV)
  • Varicella zoster virus (chickenpox or shingles)
  • Cytomegalovirus (CMV)
  • West Nile Virus
  • Herpes simplex virus (HSV)

• had a vaccination or are planning to receive a vaccination. You should not receive certain vaccines before or during treatment with RIABNI.

• are pregnant or planning to become pregnant. RIABNI can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment with RIABNI and for at least 12 months after the last dose of RIABNI. Talk to your doctor about effective birth control. Tell your doctor right away if you become pregnant or think that you are pregnant during treatment with RIABNI.

• are breastfeeding or planning to breastfeed. It is not known if RIABNI can pass into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of RIABNI.

• Tell your doctor about all the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken
  • Tumor Necrosis Factor (TNF) inhibitor medicine
  • Disease Modifying Anti-Rheumatic Drug (DMARD).

• RIABNI is given by infusion through a needle placed in a vein, in your arm. Talk to your doctor about how you will receive RIABNI.

• Your doctor may prescribe medicines before each infusion of RIABNI to reduce infusion side effects such as fever and chills.

• Your doctor should do blood tests regularly to check for side effects of RIABNI.

• Before each RIABNI treatment, your doctor will ask you questions about your general health. Tell your doctor about any new symptoms.

• Administer only as an intravenous infusion.

• Do not administer as an intravenous push or bolus.

• RIABNI should only be administered by a doctor with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur.

• The dose for NHL is 375 mg/m2 (2.2).

• The dose for CLL is 375 mg/m2 in the first cycle and 500 mg/m2 in cycles 2-6, in combination with FC, administered every 28 days.

• The dose as a component of the Zevalinâ (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m2.

• The induction dose for patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m2 once weekly for 4 weeks. The follow-up dose for patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.

The most common side effects of RIABNI include:

• infusion-related reactions:
  • infections (may include fever, chills)
  • body aches
  • tiredness
  • nausea

• In adult patients with GPA or MPA, the most common side effects of RIABNI also include:
  • low white and red blood cells
  • swelling
  • diarrhea
  • muscle spasms

• Other side effects of RIABNI include:
  • aching joints during or within hours of receiving an infusion
  • more frequent upper respiratory tract infection

• Infusion-related reactions: Infusion-related reactions are very common side effects of RIABNI. Serious infusion-related reactions can happen within 24 hours after you receive your RIABNI shot. Your doctor will give you medicines to reduce the serious side effects of RIABNI. If you experience any of these symptoms from an infusion of RIABNI, make sure to consult your doctor:
  • Hives or rash
  • Itching
  • Swelling of the face, lips, tongue, and throat
  • Sudden coughing
  • Shortness of breath, difficulty breathing, or wheezing
  • Feeling weakness
  • Dizziness or fainting
  • Palpitations (rising heartbeat), chest pain

• Severe skin and mouth reactions: if you experience any of these symptoms during your treatment with RIABNI:
  • Ulcers on your skin, painful sores, lips, or in your mouth.
  • peeling of the skin, blisters, rashes, and pustules on the skin.

• Hepatitis B virus Reactivation: before the RIABNI treatment, your doctor checks if you have HBV infection by conducting a blood test. If you have or had hepatitis B receiving RIABNI could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including death. If you get worsening tiredness, yellowing of your skin, or the white part of your eyes during treatment with RIABNI, contact your doctor. 

• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection that can happen in people who receive RIABNI. It can result in death or disability. There is no known treatment or cure for PML. Tell your doctor right away if you notice these symptoms:
  • Confusion
  • Dizziness
  • Difficulty in walking or talking
  • Decreased strength or feeling of weakness on one side of your body
  • Vision problems or blurred vision

• Tumor Lysis Syndrome (TLS): It is caused by the fast breakdown of cancer cells. TLS can cause you to have:
  • Kidney failure and the need for dialysis treatment
  • Abnormal heart rhythms can happen within 12 to 24 hours after receiving a dose of RIABNI. Your doctor may check if you have TLS by conducting a blood test. Your doctor may give you medicine to help prevent TLS. Your doctor will give you medicine if you have experienced any of the following symptoms of TLS:
  • Nausea, vomiting, diarrhea, lack of energy.

• Serious Infections: Serious infections (they include bacterial, fungal, and viral infections) can also happen during and after treatment with RIABNI, and can lead to death. RIABNI can increase your risk of getting infections and can weaken the immune system to fight infections. After receiving RIABNI, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months) and these patients have developed infections. Go to your doctor right away if you experience the following symptoms of infection:
  • Fever
  • Cold symptoms, (such as runny nose or sore throat) that do not go away
  • Flu symptoms
  • Earache, headache, pain during urination
  • Cold sores in the mouth or throat, scrapes, cuts, or incisions that are red, warm, swollen, or painful

• Heart Problems: RIABNI can cause heart problems (like chest pain, irregular heartbeats, and heart attack). Go to your doctor right away if you experience chest pain or irregular heartbeats during treatment with RIABNI.

• Kidney Problems: especially if you are receiving RIABNI for non-Hodgkin’s lymphoma (NHL). RIABNI can cause severe kidney problems that lead to death. Your doctor should do blood tests to check if your kidneys are working well.

• Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Bowel problems such as blockage or tears in the bowel can happen if you receive RIABNI with chemotherapy medicines. Go to your doctor right away if you have any abdominal pain or repeated vomiting during treatment with RIABNI.

Active ingredient: rituximab-arrx
Inactive ingredients: polysorbate 80, sodium citrate dihydrate, sodium chloride, and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH.