Pronunciation:

ri-TUX-i-mab - arrx

Brand Names:

• Riabni

Dosage Forms:

• Solution

Warnings:

Warning: Fatal Infusion-Related Reactions, Severe Mucocutaneous Reactions, Hepatitis B Virus Reactivation, and Progressive Multifocal LeukoencephalopathyFatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab-arrx infusion for severe reactions.Severe mucocutaneous reactions, some with fatal outcomes.Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.Progressive multifocal leukoencephalopathy (PML) resulting in death .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Rituximab

Uses of This Medicine:

Rituximab-arrx injection is used alone or together with other medicines (eg, 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 together with other medicines (eg, fludarabine and cyclophosphamide) to treat chronic lymphocytic leukemia (CLL).

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

Rituximab-arrx injection is also used together with other medicines (eg, methotrexate) to reduce the symptoms of moderate to severe rheumatoid arthritis in patients who have been previously treated with other medicines (eg, 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rituximab-arrx injection to treat NHL, RA, or CLL in children and to treat GPA and MPA in children younger than 2 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab-arrx injection in the elderly. However, elderly patients are more likely to have age-related heart and lung problems, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine, Live
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Belimumab
• Cholera Vaccine, Live
• Cisplatin
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire 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 Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 12 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Serious skin reactions (eg, paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis) can occur during treatment with this medicine. Check with your doctor right away 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 you are receiving this medicine.

This medicine can cause a hepatitis B infection to come back. Check with your doctor right away if you have any symptoms of liver problems, including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

This medicine may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

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

This medicine may increase your risk of developing infections (eg, viral, bacterial, or fungal) during or after treatment with this medicine. Avoid being near people who are sick or have infections while you are receiving this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start receiving this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you start to have a cough that would not go away, weight loss, night sweats, fever, chills, flu-like symptoms (eg, runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

This medicine may cause heart and heart rhythm problems (eg, heart attack, arrhythmia, cardiogenic shock). Check with your doctor if you have 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 frequency or amount of urine, an increase in 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 symptoms of a serious kidney problem.

This medicine may cause serious stomach and bowel problems, especially when used with other cancer medicines. Check with your doctor right away if you start having 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 have any immunizations (vaccinations) while you are being treated with rituximab-arrx and after you stop treatment with it, without your doctor's approval. Rituximab-arrx may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (eg, nasal flu virus vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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

headache, severe and throbbing

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care 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.