Rituximab-arrx (Intravenous)

Rituximab-arrx injection is used alone 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 blood vessels to become inflamed.

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) but 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 closely monitor your progress during regular visits to ensure that this medicine is working properly. You may need blood and urine tests to check for 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 infusion-related reactions, which can be life-threatening and need immediate medical attention. Tell your doctor right away if you experience fever, chills or shaking, dizziness, trouble 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 occur during treatment with this medicine. Contact your doctor immediately if you notice blistering, peeling, or loosening of the skin, red skin lesions, severe acne or 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 have any symptoms of liver problems, including yellowing of the skin or eyes, dark brown urine, right-sided abdominal or stomach pain, fever, or severe 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 the legs.

This medicine may cause a serious reaction known as tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you notice decreased or changed urine output, 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 infections (such as viral, bacterial, or fungal) during or after treatment. Avoid being around sick people while receiving this medicine. Wash your hands frequently. Inform your doctor if you have lupus or any kind of infection before starting this medicine. Also, let your doctor know if you have ever had a persistent or recurrent infection.

Call your doctor immediately if you develop a persistent cough, weight loss, night sweats, fever, chills, flu-like symptoms (such as runny or stuffy nose, headache, blurred vision, or general feeling of illness), painful or difficult urination, or sores, ulcers, or white spots in your mouth or on your lips. These could be signs of an infection.

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

Contact your doctor immediately if you notice bloody urine, a decrease in how often you urinate or the amount of urine, increased 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 indicate a serious kidney problem.

This medicine may cause serious stomach and bowel issues, especially when used with other cancer medicines. Contact your doctor right away if you start experiencing stomach pain while being treated with this medicine.

Non-live vaccines may be given at least 4 weeks before starting rituximab-arrx. However, do not receive any immunizations (vaccinations) while you are being treated with rituximab-arrx and after you stop treatment with it, unless your doctor approves. Rituximab-arrx may lower your body's resistance, increasing the risk of getting the infection the immunization is meant to prevent. Additionally, others in your household should avoid live vaccines (such as the nasal flu virus vaccine). Try to stay away from people who have received live vaccines. Do not stay in close contact with them or share a room for long periods. If you cannot take these precautions, wear a protective face mask that covers 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, it's important to look at the risks of taking it compared to the benefits it may provide. You and your doctor will make this decision 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 allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the ingredients on the label or package carefully.

Pediatric

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

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of rituximab-arrx injection. However, older patients may be 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 this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, in other cases, two different medicines may be used together even if there could be an interaction. In those cases, your doctor may need to adjust the dose, or other precautions may be necessary. When receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen 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 medication or change some of the other medicines you are taking.

• 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 needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both 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 still be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Influenza Virus Vaccine (Subvirion)
• Pneumococcal Vaccine Polyvalent

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to 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. Be sure to inform your doctor if you have any other medical issues, especially:

• 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 infection risk.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately 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 be able to tell you about 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may 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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