WARNINGS
What is the most important information I should know about RITUXAN?
RITUXAN can cause serious side effects that can lead to death including:
Infusion-related reactions. Infusion-related reactions are very common side effects of RITUXAN treatment.
Serious infusion-related reactions can happen during your or your child’s infusion or within 24 hours after your or your child’s infusion of RITUXAN. Your healthcare provider should give you or your child medicines before your or your child’s infusion of RITUXAN to decrease your or your child’s chance of having a severe infusion related reaction.
Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms during or after an infusion of RITUXAN:
hives (red itchy welts) or rash
shortness of breath, difficulty breathing, or wheezing
itching
weakness
swelling of your lips, tongue, throat or face
dizziness or feel faint
sudden cough
palpitations (feel like your heart is racing or fluttering)
chest-pain
Severe skin and mouth reactions.
Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms at any time during your treatment with RITUXAN:
painful sores or ulcers on your skin, lips or in your mouth
blisters
peeling skin
rash
pustules
Hepatitis B virus (HBV) reactivation. Before you or your child receive RITUXAN treatment, your healthcare provider will do blood tests to check for HBV infection. If you or your child have had hepatitis B or area carrier of hepatitis B virus, receiving RITUXAN could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. You or your child should not receive RITUXAN if you or your child have active hepatitis B liver disease. Your healthcare provider will monitor you or your child for hepatitis B infection during and for several months after you or your child stop receiving RITUXAN.
Tell your healthcare provider right away if you or your child get worsening tiredness, or yellowing of your or your child’s skin or white part of your eyes, during treatment with RITUXAN.
Progressive Multifocal Leukoencephalopathy(PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
Tell your healthcare provider right away if you or your child have any new or worsening symptoms or if anyone close to you notices these symptoms:
confusion
decreased strength or weakness on one side of your body
dizziness or loss of balance
difficulty walking or talking
vision problems
See the section SIDE EFFECTS below.
USES
What is RITUXAN?
RITUXAN is a prescription medicine used to treat:
Adults with Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
Children 6 months of age and older with mature B-cell Non-Hodgkin’s Lymphoma (NHL) and mature B-cell acute leukemia (B-AL):in combination with chemo-therapy medicines.
Adults with Chronic Lymphocytic Leukemia (CLL): with the chemo-therapy medicines fludarabine and cyclophosphamide.
Adults with Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor(TNF) antagonist has been used and did not work well
Adults and children 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
Adults with Pemphigus Vulgaris (PV):to treat moderate to severe PV.
RITUXAN is not indicated in children less than 2 years of age with GPA or MPA, in children less than 6 months of age with mature B-cell NHL and B-AL, orin children with conditions other than GPA, MPA, B-cell NHL and B-AL.
HOW TO USE
How will I receive RITUXAN?
RITUXAN is given by infusion through your or your child’s central catheter or through a needle placed in a vein (intravenous infusion), in your or your child’s arm. Talk to your healthcare provider about how you or your child will receive RITUXAN.
Your healthcare provider may prescribe medicines before each infusion of RITUXAN to reduce infusion side effects such as fever and chills.
Your healthcare provider should do blood test regularly to check for side effects to RITUXAN.
Before each RITUXAN treatment, your healthcare provider or nurse will ask you questions about your or your child’s general health. Tell your healthcare provider or nurse about any new symptoms.
What are the possible side effects of RITUXAN?
RITUXAN can cause serious side effects, including:
See the section WARNINGS and PRECAUTIONS above.
Tumor Lysis Syndrome (TLS).
TLS is caused by the fast breakdown of cancer cells. TLS can cause you or your child to have:
kidney failure and the need for dialysis treatment
abnormal heart rhythm
TLS can happen within 12 to24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you or your child for TLS. Your healthcare provider may give you or your child medicine to help prevent TLS.
Tell your healthcare provider right away if you or your child have any of the following signs or symptoms or TLS:
nausea
diarrhea
vomiting
lack of energy
. Serious infections. Serious infections can happen during and after treatment with RITUXAN, and can lead to death. RITUXAN can increase your or your child’s risk of getting infections and can lower the ability of your or your child’s immune system to fight infections. Types of serious infections that can happen with RITUXAN include bacterial, fungal, and viral infections. After receiving RITUXAN, some people have developed low levels of certain antibodies in their blood fora long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive RITUXAN. Tell your healthcare provider right away if you or your child have any symptoms of infection:
fever
cold symptoms, such as runny nose or sore throat that do not go away
flu symptoms, such as cough, tiredness, and body-aches
ear-ache or head-ache
pain during urination
cold sores in the mouth or throat
cuts, scrapes or incisions that are red, warm, swollen or painful
Heart problems. RITUXAN may cause chest-pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your or your child’s heart during and after treatment with RITUXAN if you or your child have symptoms or heart problems or have a history of heart problems. Tell your healthcare provider right away if you or your child have chest-pain or irregular heartbeats during treatment with RITUXAN.
. Kidney problems, especially if you or your child are receiving RITUXAN for NHL. RITUXAN can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your or your child’s kidneys are working.
. Stomach and Serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel can happen if you or your child receive RITUXAN with chemotherapy medicines. Tell your healthcare provider right away if you or your child have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN.
Your healthcare provider will stop treatment with RITUXAN if you have severe, serious or life-threatening side effects.
The most common side effects of RITUXAN include:
. infusion-related reactions (see the sections WARNINGS and PRECAUTIONS above.
. infections (may include fever, chills)
. body-aches
. tiredness
. nausea
In adults with GPA or MPA the most common side effects of RITUXAN also include:
. low white and red blood cells
. swelling
. diarrhea
. muscle spasms
In children with B-cell NHL or B-AL who receive RITUXAN with chemotherapy, the most common side effects include:
. decreased white blood cells with fever
. mouth sores
. inflammation of the upper intestine
. serious infection throughout the body and organs (sepsis)
. changes in liver function blood tests
. low level of potassium in the blood
Other side effects with RITUXAN include:
. aching joints during or within hours of receiving an infusion
. more frequent upper respiratory tract infection
These are not all of the possible side effects with RITUXAN.
Call your doctor for medical advice about side effects. You may report side effects to FDAat1-800-FDA-1088
General information about the safe and effective use of RITUXAN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your
Pharmacist or healthcare provider for information about RITUXAN that is written for healthcare providers.
What are the ingredients in RITUXAN?
Active ingredient: rituximab
Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store RITUXAN vials refrigerated at 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F). RITUXAN vials should be protected from direct sunlight. Do not freeze or shake.
NOTES
Medication Guide: revision date 04/2024
Prescribing Information: revision date 12/2021
Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab.
Please call your healthcare provider for more information.
Before you or your child receive RITUXAN, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
have had a severe reaction to RITUXAN or a rituximab product
have a history of heart problems, irregular heartbeat or chest-pain
have lung or kidney problems
have an infection or weakened immune system
have or have had any severe infections including:
Hepatitis B virus (HBV)
Parvovirus B19
Hepatitis C virus (HCV)
Varicella zostervirus (chickenpox or shingles)
Cytomegalovirus (CMV)
West Nile Virus
Herpes simplex virus (HSV)
have had a recent vaccination or are scheduled to receive vaccinations. You or your child should not receive certain vaccines before or during treatment with RITUXAN.
are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your or your child’s unborn baby if you or your child receive RITUXAN during pregnancy.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test to see if you or your child are pregnant before starting RITUXAN.
You or your child should use effective birth control (contraception) during treatment with RITUXAN and for 12months after your or your child’s last dose of RITUXAN. Talk to your healthcare provider about effective birth control.
Tell your healthcare provider right away if you or your child become pregnant or think that you or your child are pregnant during treatment with RITUXAN.
are breastfeeding or plan to breastfeed. RITUXAN may pass into your breastmilk. Do not breastfeed during treatment and for 6months after your or your child’s last dose of RITUXAN.
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child take or have taken:
a Tumor Necrosis Factor(TNF) inhibitor medicine
a Disease Modifying Anti-Rheumatic Drug (DMARD)
If you are not sure if your or your child’s medicine is one listed above, ask your healthcare provider.
