What is Rituximab-Pvvr?

Fatal infusion-related reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with the first infusion. Monitor patients and discontinue rituximab infusion after severe reactions. Severe and potentially fatal mucocutaneous reactions can occur. Reactivation of hepatitis B virus (HBV) may occur; in some cases, it results in fulminant hepatitis, hepatic failure, or death. Screen patients for HBV infection prior to treatment. Progressive multifocal leukoencephalopathy (PML) and death can also occur .

Warning: Fatal Infusion 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 infusion reactions occurred with first infusion. Monitor patients and discontinue rituximab-pvvr infusion for severe reactions.Severe mucocutaneous reactions, some with fatal outcomesHepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and deathProgressive multifocal leukoencephalopathy (PML) resulting in death

Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with the first infusion. Monitor patients and discontinue rituximab-abbs infusion for severe reactions. Severe and potentially fatal mucocutaneous reactions can occur. Reactivation of hepatitis B virus (HBV) may occur with some cases resulting in fulminant hepatitis, hepatic failure, or death. Screen patients for HBV infection prior to treatment. Progressive multifocal leukoencephalopathy (PML), including fatal PML, can also occur .

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 .

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

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

Rituximab injection is used together with methotrexate to treat the symptoms of rheumatoid arthritis. It helps to keep joint damage from getting worse after other medicines (eg, adalimumab, etanercept, or infliximab) did not work well.

Rituximab 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 injection is also used to treat moderate to severe pemphigus vulgaris (PV), an immune disorder that causes painful blisters on the skin and mucous membranes.

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

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.

Rituximab injection must be given slowly, so the needle will have to remain in place for at least 90 minutes. You may also receive other medicines (eg, fever medicine, allergy medicine, or steroid) at least 30 minutes 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.

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:

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.

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rituximab injection to treat GPA and MPA in children 2 years of age and older. However, use of rituximab injection is not indicated in children younger than 2 years of age with GPA or MPA.

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

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.

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
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Cisplatin
• Dengue Tetravalent Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Tofacitinib
• 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

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.

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 (eg, asthma, bronchitis), history of 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.

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. 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.

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 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 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 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 using 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 won't 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, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. If you have rheumatoid arthritis, non-live virus vaccines should be given at least 4 weeks before receiving this medicine. Rituximab 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, troubled 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.