Rituximab-abbs (Intravenous)

Rituximab-abbs injection is used alone or with other cancer medicines to treat a type of cancer called non-Hodgkin's lymphoma (NHL). It helps the immune system kill cancer cells. Rituximab-abbs is a monoclonal antibody.

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

Rituximab-abbs injection is used with methotrexate to help treat the symptoms of moderate-to-severely-active rheumatoid arthritis. It helps prevent joint damage from getting worse after other medicines (for example, adalimumab, etanercept, or infliximab) did not work well. Using rituximab-abbs injection in rheumatoid arthritis without trying these other medicines first is not recommended.

Rituximab-abbs 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.

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

It is very important that your doctor checks 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 prevent pregnancy 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.

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.

Serious skin reactions 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 may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). The risk of getting this infection is higher if you have rheumatoid arthritis. Talk to your doctor about the benefits of receiving this medicine and the risk for this infection. Check with your doctor right away if you are having more than one of these symptoms: 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, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may increase your risk of developing infections (e.g., 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 (e.g., 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.

Non-live vaccines may be given at least 4 weeks before starting rituximab-abbs. However, do not have any immunizations (vaccinations) while you are being treated with rituximab-abbs and after you stop treatment with it, without your doctor's approval. Rituximab-abbs 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 people living in your household should not get live vaccines (e.g., 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 your nose and mouth.

This medicine may cause heart and heart rhythm problems (e.g., 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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision will be made between you and your doctor. 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, inform your healthcare professional if you have any other 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 performed on how age affects the effects of rituximab-abbs injection in children. Safety and efficacy have not been established.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the effectiveness of rituximab-abbs injection.

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or take other precautions. When you are receiving this medicine, it is 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 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 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 around the time of eating food or eating specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure you tell 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 the risk for infections.

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

Along with its required effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need 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
• Chest pain or tightness
• Chills
• Confusion
• Difficulty breathing
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• 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
• Lower back or side pain
• Nausea
• Nervousness
• Noisy breathing
• Nosebleed
• 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
• Troubled breathing
• Troubled breathing with exertion
• Unexplained weight loss
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting

Incidence not known

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

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you how 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

• Lack or loss of strength
• Night sweats
• Throat irritation

Less common

• Anxiety
• Difficulty in moving
• Feeling of warmth
• Muscle cramps or stiffness
• Redness of the face, neck, arms, and sometimes, upper chest

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 may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Truxima

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 30 to 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-abbs 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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