Riabni (Intravenous)

Rituximab-arrx injection is used by itself or with other medicines (for example, cyclophosphamide, doxorubicin, vincristine, prednisone, or anthracycline medicine) to treat relapsed (cancer that has come back), refractory (cancer that did not respond to treatment), previously untreated, or non-progressing non-Hodgkin's lymphoma (NHL). It helps the immune system destroy cancer cells. Rituximab-arrx is a monoclonal antibody.

Rituximab-arrx injection is also used with other medicines (for example, fludarabine and cyclophosphamide) to treat chronic lymphocytic leukemia (CLL).

Rituximab-arrx injection is used with steroids to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). These are immune disorders that cause inflammation in blood vessels.

Rituximab-arrx injection is also used with other medicines (for example, methotrexate) to reduce the symptoms of moderate to severe rheumatoid arthritis in patients who have been previously treated with other medicines (for example, tumor necrosis factor [TNF] antagonist) that did not work well.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important for your doctor to monitor your progress closely and regularly to ensure that this medicine is working correctly. Blood and urine tests may be necessary to check for any unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for at least 12 months after your last dose. If you think you might be pregnant while receiving this medicine, tell your doctor immediately.

This medicine may cause severe infusion-related reactions that can be life-threatening and need immediate medical help. Tell your doctor right away if you experience fever, chills or shaking, dizziness, difficulty breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

Serious skin reactions (such as paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis) can happen during treatment with this medicine. Contact your doctor immediately if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while receiving this medicine.

This medicine can cause a hepatitis B infection to return. Contact your doctor right away if you notice any liver problem symptoms, including yellowing of the skin or eyes, dark brown urine, pain in the right side of your abdomen or stomach, fever, or extreme tiredness.

This medicine may lead to a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Contact your doctor immediately if you have changes in vision, loss of coordination, clumsiness, memory loss, trouble speaking or understanding others, or weakness in your legs.

This medicine may result in a serious reaction known as tumor lysis syndrome (TLS). Your doctor may give you medication to help prevent this. Call your doctor right away if you notice a decrease or change in the amount of urine, joint pain, stiffness or swelling, pain in the lower back, side, or stomach, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may increase your risk of getting infections (such as viral, bacterial, or fungal) during or after treatment. Avoid being around people who are sick or have infections while receiving this medicine. Wash your hands frequently. Inform your doctor if you have lupus or any kind of infection before starting treatment with this medicine. Also, let your doctor know if you have ever had an infection that wouldn’t go away or a recurring infection.

Contact your doctor immediately if you develop a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as runny or stuffy nose, headache, blurred vision, or feeling unwell), painful or difficult urination, or sores, ulcers, or white spots in your mouth or on your lips. These may indicate an infection.

This medicine may cause heart problems and heart rhythm issues (such as heart attack, arrhythmia, cardiogenic shock). Contact your doctor if you experience chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, fast, slow, or irregular heartbeat, cool, sweaty skin, or trouble breathing.

Check with your doctor right away if you have bloody urine, a decrease in how often or how much you urinate, high blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney issue.

This medicine may cause serious stomach and bowel problems, especially when combined with other cancer treatments. Contact your doctor immediately if you start having stomach pain while being treated with this medicine.

Non-live vaccines can be given at least 4 weeks before starting rituximab-arrx. However, do not receive any vaccinations while being treated with rituximab-arrx or after you finish treatment, unless your doctor approves. Rituximab-arrx may weaken your immune system, and you could get the infection that the vaccine is meant to prevent. Also, people in your household should not receive live vaccines (such as the nasal flu virus vaccine). Try to avoid individuals who have had live vaccines. Do not get too close to them, and avoid spending a long time in the same room with them. If you cannot take these precautions, you should wear a protective face mask covering your nose and mouth.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how age affects the use of rituximab-arrx injection for treating NHL, RA, or CLL in children and for treating GPA and MPA in children younger than 2 years old. Safety and effectiveness have not been established.

Geriatric

Appropriate studies so far have not found any specific problems in elderly patients that would limit the usefulness of rituximab-arrx injection in older adults. However, older patients are more likely to have age-related heart and lung issues, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of an interaction. In these situations, your doctor might change the dose or take other precautions. When you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Belimumab
• Cholera Vaccine, Live
• Cisplatin
• Dengue Tetravalent Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer)
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Influenza Virus Vaccine (Subvirion)
• Pneumococcal Vaccine Polyvalent

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, particularly:

• Angina (chest pain), history of or
• Heart disease or
• Heart rhythm problems (e.g., arrhythmia), history of or
• Hepatitis B, or history of or
• Infection (e.g., bacteria, fungus, or virus) or
• Kidney disease or
• Lung problems or
• Stomach or bowel problems (e.g., intestinal blockage, perforation, ulcers)—Use with caution. May worsen these conditions.

• Hypogammaglobulinemia (immune system disorder), prolonged—Use with caution. May increase risk for infections.

• Infection, severe and active—Should not be used in patients with this condition.

Along with its intended effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody urine
• Blurred vision
• Body aches or pain
• Chest pain or tightness
• Chills
• Clay-colored stools
• Confusion
• Dark urine
• Diarrhea
• Difficulty breathing
• Difficulty in moving
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Ear congestion
• Fever
• Flushed, dry skin
• Fruit-like breath odor
• Headache
• Hoarseness
• Increased cough
• Increased hunger
• Increased thirst
• Increased urination
• Itching, skin rash
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• Loss of voice
• Lower back or side pain
• Muscle pain or stiffness
• Nausea
• Nervousness
• Noisy breathing
• Nosebleed
• Pain in the joints
• Pain or tenderness around the eyes and cheekbones
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin
• Pounding in the ears
• Rapid weight gain
• Slow or fast heartbeat
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain
• Stuffy or runny nose
• Swollen glands
• Tingling of the hands or feet
• Trouble breathing
• Unexplained weight loss
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting
• Vomiting of blood
• Yellow eyes or skin

Less common

• Fear
• Severe and throbbing headache
• Lack or loss of strength

Incidence not known

• Back pain
• Blindness
• Blistering, peeling, or loosening of the skin
• Blue-yellow color blindness
• Chest discomfort
• Cough producing mucus
• Decreased vision
• Dilated neck veins
• Drowsiness
• Dry cough
• Eye pain
• Feeling of discomfort
• General feeling of discomfort, illness, or weakness
• High fever
• Irregular breathing
• Irregular heartbeat
• Joint swelling
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Redness, soreness, or itching skin
• Seizures
• Sores, welts, or blisters
• Stomach pain or cramps
• Swelling of the face, fingers, feet, or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your healthcare professional may have ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Night sweats
• Throat irritation

Less common

• Acid or sour stomach
• Belching
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Feeling of warmth
• Heartburn
• Indigestion
• Muscle cramps
• Redness of the face, neck, arms, and occasionally, upper chest
• Stomach discomfort or upset

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Riabni

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Rituximab

Find detailed information on biosimilars for this medication.

Before receiving this medicine, make sure you understand all the risks and benefits from receiving the medicine. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 90 minutes.

You may receive other medicines (eg, fever medicine, allergy medicine) before starting treatment with this medicine to help prevent unwanted side effects.

You may also receive other medicines to prevent pneumonia and herpes virus infection during treatment with rituximab-arrx and for at least 6 months after the last dose for granulomatosis with polyangiitis and microscopic polyangiitis or for up to 12 months for chronic lymphocytic leukemia.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

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