Uses of Rituximab-pvvr:

• It is used to treat types of leukemia and lymphoma.
• It is used to treat Wegener's granulomatosis.
• It is used to treat microscopic polyangiitis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Rituximab-pvvr?

• If you are allergic to rituximab-pvvr; any part of rituximab-pvvr; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are allergic to mouse proteins, talk with the doctor.
• If you have an infection.
• If you have active hepatitis B infection.
• If you have recently had a live vaccine
• If you are breast-feeding. Do not breast-feed while you take rituximab-pvvr or within 6 months after your last dose.

This is not a list of all drugs or health problems that interact with rituximab-pvvr.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take rituximab-pvvr with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Rituximab-pvvr?

For all uses of rituximab-pvvr:

• Tell all of your health care providers that you take rituximab-pvvr. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Talk with your doctor before getting any vaccines. Use of some vaccines with rituximab-pvvr may either raise the chance of an infection or make the vaccine not work as well.
• Make sure you are up to date with all your vaccines before treatment with rituximab-pvvr.
• Heart problems like heart failure and certain very bad abnormal heartbeats have happened with rituximab-pvvr. Sometimes, these heart problems have been deadly. Call your doctor right away if you have a fast or abnormal heartbeat; very bad dizziness or passing out; or shortness of breath, a big weight gain, or swelling in the arms or legs.
• If you are 65 or older, use rituximab-pvvr with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Women must use birth control while taking rituximab-pvvr and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• If you used rituximab-pvvr when you were pregnant, tell your baby's doctor.

Cancer treatment:

• Patients with cancer who take rituximab-pvvr may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS).This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.
• People who took rituximab-pvvr with some cancer drugs have had bowel block or tears in the bowel. Sometimes this has been deadly. Call your doctor right away if you have very bad stomach pain; very bad constipation; throwing up, throwing up blood, or throw up that looks like coffee grounds; or black, tarry, or bloody stools.

How is this medicine (Rituximab-pvvr) best taken?

Use rituximab-pvvr as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs will be given with rituximab-pvvr to help avoid side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Chest pain or pressure.
• Dizziness.
• Any unexplained bruising or bleeding.
• Swelling.
• Kidney problems have happened with rituximab-pvvr, especially in people with lymphoma. Sometimes, these have been deadly. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.
• Some people have had lung problems with rituximab-pvvr. Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.

What are some other side effects of Rituximab-pvvr?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Headache.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Runny or stuffy nose.
• Muscle spasm.
• Back, muscle, or joint pain.
• Trouble sleeping.
• Night sweats.
• Throat irritation.
• Flushing.
• Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Rituximab-pvvr?

• If you need to store rituximab-pvvr at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time rituximab-pvvr is refilled. If you have any questions about rituximab-pvvr, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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