Treatment for Diffuse Large B-Cell Lymphoma (DLBCL)

Your DLBCL journey begins with initial treatment

RITUXAN, along with CHOP chemotherapy, can be used as initial treatment for DLBCL. The goal in using this combination of drugs is to improve your chances of survival.

In one study, patients who received RITUXAN (rituximab) plus CHOP chemotherapy spent an average of 2.9 years without their cancer advancing or the need for a change in therapy, compared with an average of 1.1 years for patients who received CHOP chemotherapy by itself. Adding RITUXAN to CHOP chemotherapy as initial therapy reduced the risk of death by 32% compared to receiving CHOP chemotherapy alone. These results were from a clinical trial and may not be the same as what you experience.

You will have up to 8 cycles, or rounds, of treatment. Each cycle will last 21 days. Treatment occurs on the first day of each cycle and is followed by 20 days of rest and recovery. This means that most people will complete their treatment in about 6 months.

Initial treatment infusion schedule for DLBCL

PATIENTS MAY RECEIVE FEWER THAN 8 CYCLES OF RITUXAN IN COMBINATION WITH CHEMOTHERAPY.

Select Important Safety Information

RITUXAN for the treatment of CD20-positive diffuse-large B-cell non-Hodgkin's lymphoma as an initial treatment in combination with CHOP chemotherapy

Severe side effects reported more often in patients receiving RITUXAN and CHOP chemotherapy vs. CHOP chemotherapy alone were decreased blood cell counts, including decreases in white blood cells, red blood cells, and platelets; lung disorder; and viral infections. In studies of elderly patients, the most common severe side effects reported more often in patients receiving RITUXAN and CHOP chemotherapy vs. CHOP chemotherapy alone were fever, lung disorder, heart disorder, and chills.

NEXT: RITUXAN Side Effects

RITUXAN is available by prescription only.

INDICATIONS

What is RITUXAN?

RITUXAN is a prescription medicine used to treat adults with:

Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.

It is not known if RITUXAN is safe and effective in children with CLL.

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 infusion or within 24 hours after your infusion of RITUXAN. Your healthcare provider should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion-related reactions. Tell your healthcare provider or get medical help right away if you 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 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 receive your RITUXAN treatment, your healthcare provider will do blood tests to check for HBV infection. If you 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. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN.
Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your 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 have 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, such as blurred vision or loss of vision

What should I tell my healthcare provider before receiving RITUXAN?

Before receiving RITUXAN, tell your healthcare provider if you:

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 had an infection, currently have an infection, or have a 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 should not receive certain vaccines before or during treatment with RITUXAN
Have any other medical conditions
Are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RITUXAN during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with RITUXAN and for 12 months after the last dose of RITUXAN. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you 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 last dose of RITUXAN
Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What are the possible side effects of RITUXAN?

RITUXAN can cause serious side effects, including:

Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
- Kidney failure and the need for dialysis treatment
- Abnormal heart rhythm
TLS can happen within 12 to 24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:
- Nausea
- Vomiting
- Diarrhea
- Lack of energy
Serious Infections: Serious infections can happen during and after treatment with RITUXAN, and can lead to death. RITUXAN can increase your risk of getting infections and can lower the ability of your 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 for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive RITUXAN. Tell your healthcare provider right away if you 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
- Earache or headache
- 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 heart during and after treatment with RITUXAN if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heart-beats during treatment with RITUXAN
Kidney Problems: especially if you 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 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 receive RITUXAN with chemotherapy medicines. Tell your healthcare provider right away if you have any 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.

What are the most common side effects during treatment with RITUXAN?

Infusion-related reactions
Infections (may include fever, chills)
Body aches
Tiredness
Nausea

Other side effects include:

Aching joints during or within hours of receiving an infusion
More frequent upper respiratory tract infections

These are not all of the possible side effects with RITUXAN.

Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional Important Safety Information.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.