Ruxience (Intravenous)

Rituximab-pvvr injection is used by itself or with other cancer treatments to treat a type of cancer called non-Hodgkin's lymphoma (NHL). It helps the immune system attack cancer cells. Rituximab-pvvr is a monoclonal antibody.

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

Rituximab-pvvr 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-pvvr injection is also used with other treatments (for example, methotrexate) to help reduce the symptoms of moderate to severe rheumatoid arthritis in patients who have already tried other treatments (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 check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for side effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to confirm that you are not pregnant before giving you this medicine. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for 12 months after the 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 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 return. Check with your doctor right away if you have any signs of liver problems, such as yellowing of the skin and eyes, dark brown urine, pain in the right side of your abdomen or stomach, fever, or extreme tiredness.

Serious skin reactions (for example, 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 notice blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness 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 of this infection. Check with your doctor right away if you have changes in vision, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding others, or weakness in your legs.

This medicine may cause a serious reaction called tumor lysis syndrome (TLS). Your doctor may provide medication to help prevent this. Call your doctor right away if you notice a decrease or change in urine output, joint pain, stiffness, or swelling, pain in your 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 developing infections (such as viral, bacterial, or fungal) during or after treatment with this medicine. Avoid being around people who are sick or have infections while using 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 an infection that would not go away or an infection that kept returning.

Call your doctor right away 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 feeling generally unwell), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may indicate an infection.

While you are being treated with rituximab-pvvr, and after stopping treatment, do not receive any immunizations (vaccinations) without your doctor's approval. You may receive non-live vaccines at least 4 weeks before starting treatment with this medicine. Rituximab-pvvr may lower your body's resistance, increasing the chance of getting the infection the immunization is meant to prevent. Additionally, others in your household should not receive live vaccines (for example, the nasal flu virus vaccine). Try to avoid those who have had live vaccines. Do not be around them for long periods. If you cannot avoid them, wear a protective face mask that covers your nose and mouth.

This medicine may cause heart and heart rhythm problems (such as heart attack, arrhythmia, or cardiogenic shock). Check with 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 and sweaty skin, or trouble breathing.

Check with your doctor right away if you have blood in your urine, a decrease in urine frequency or amount, increased blood pressure, increased thirst, loss of appetite, pain in your lower back or side, 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 problem.

This medicine may cause serious stomach and bowel issues, 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 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, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider for this medicine:

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 provider know about any other allergies you may have, like to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on the effects of rituximab-pvvr injection in children. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of rituximab-pvvr injection.

Breast Feeding

There are not enough studies to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication while nursing.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution, even if an interaction might happen. Your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions may be significant but are not a complete list.

Using this medicine with any of the following is not recommended. Your doctor may choose not to treat you with this medication or adjust your other medicines.

• 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 is usually not recommended but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both.

• 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 may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed, your doctor may adjust the dose or frequency for one or both.

• Influenza Virus Vaccine (Subvirion)
• Pneumococcal Vaccine Polyvalent

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, 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 risk for infections.

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

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

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

More common

• Back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• confusion
• cough or hoarseness
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fever or chills
• headache
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lower back, side, or stomach pain
• nervousness
• painful or difficult urination
• pinpoint red spots on the skin
• pounding in the ears
• seizures
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swelling of the feet or lower legs
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow skin or eyes

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 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

• Feeling of warmth
• hives or welts, itching skin, or rash
• lack or loss of strength
• pain or tenderness around the eyes and cheekbones
• redness of the face, neck, arms, and occasionally, upper chest
• stuffy or runny nose

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.

• Ruxience

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

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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