Ruxience (Rituximab-pvvr Intravenous)

Generic name: Rituximab-pvvr
Drug class: CD20 monoclonal antibodies

Usage of Ruxience (Rituximab-pvvr Intravenous)

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

Rituximab-pvvr injection is also used together with other cancer medicines (eg, fludarabine and cyclophosphamide) to treat chronic lymphocytic leukemia (CLL).

Rituximab-pvvr 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-pvvr 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.

Ruxience (Rituximab-pvvr Intravenous) side effects

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

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 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

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.

Before taking Ruxience (Rituximab-pvvr Intravenous)

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rituximab-pvvr injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab-pvvr injection in the elderly.

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.

Interactions with 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

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 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

Interactions with Food/Tobacco/Alcohol

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.

Relate drugs

How to use Ruxience (Rituximab-pvvr Intravenous)

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.

Warnings

It is very important that your doctor check your progress 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before giving you this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 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 (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, 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 for 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 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 urine amount, 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 using 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.

While you are being treated with rituximab-pvvr, and after you stop treatment with it, do not have 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, 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.

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.

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.

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