Rituximab

What it is used for

RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy Diffuse Large B-cell Lymphoma (DLBCL) Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens Chronic Lymphocytic Leukemia (CLL) Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC) Limitations of Use: Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of a rituximab product by intravenous infusion.

( 1.4, 2.1, 5.4 ). RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions. 1.1 Follicular Lymphoma (FL) RITUXAN HYCELA is indicated for the treatment of adult patients with: Relapsed or refractory, follicular lymphoma as a single agent. Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.

Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. 1.2 Diffuse Large B-Cell Lymphoma (DLBCL) RITUXAN HYCELA is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

1.3 Chronic Lymphocytic Leukemia (CLL) RITUXAN HYCELA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CLL. 1.4 Limitations of Use Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of a rituximab product by intravenous infusion.

RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions.

The most important thing to know

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 itching swelling of your lips, tongue, throat or face sudden cough shortness of breath, difficulty breathing, or wheezing weakness dizziness or feel faint 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 are a 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 dizziness or loss of balance difficulty walking or talking decreased strength or weakness on one side of your body vision problems See "

Side effects, and when to stop

" for more information about side effects. 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 chemotherapy medicines.

Adults with Chronic Lymphocytic Leukemia (CLL): with the chemotherapy 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, or in children with conditions other than GPA, MPA, B-cell NHL and B-AL. 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 heart beat 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) Hepatitis C virus (HCV) Cytomegalovirus (CMV) Herpes simplex virus (HSV) Parvovirus B19 Varicella zoster virus (chickenpox or shingles) West Nile Virus 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 12 months 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 breast milk. Do not breastfeed during treatment and for 6 months 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. 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 chil