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Rituxan® (Rituximab) In Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia

First approved for the treatment of relapsed indolent non-Hodgkin's lymphoma in 1997, Rituxan® (rituximab) was the first targeted cancer medicine approved by the U.S. Food and Drug Administration (FDA).¹ For more than 13 years, the efficacy and safety of Rituxan has been documented in more than 300 Phase II/III clinical studies,² and has been approved for the treatment of several blood cancers, specifically, certain types of non-Hodgkin's lymphoma and for people with chronic lymphocytic leukemia.¹ Rituxan continues to be studied in other types of CD20-positive blood cancers and disease areas.² Rituxan, discovered by Biogen Idec, is marketed in collaboration with Genentech in the United States.

Most types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia are caused by abnormal B-cells, a type of white blood cell that, when healthy, helps the body fight infection.³,⁴ Non-Hodgkin's lymphoma is the seventh most frequently diagnosed cancer in the United States, while chronic lymphocytic leukemia is the most common form of adult leukemia in Western countries, accounting for one-third of all leukemias in the United States.⁵

How Rituxan Works

Rituxan targets a specific protein called CD20 on the surface of B-cells. Rituxan is believed to work with the body's immune system to eliminate CD20-positive B-cells.₁
Rituxan does not target cells that develop into healthy B-cells (B-cell progenitors) or those that produce antibodies (plasma cells). Therefore, B-cells can regenerate after Rituxan treatment and may eventually return to normal levels.₁

Rituxan "Firsts"

Follicular, CD20-positive, B-cell non-Hodgkin's lymphoma: Rituxan is the first biologic medicine when combined with chemotherapy to help people with follicular lymphoma live longer without their disease worsening (improved progression-free survival or PFS). In 2006, the FDA approved Rituxan in combination with a type of chemotherapy called CVP (cyclophosphamide, vincristine and prednisone) for people with follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (a slow-growing form of the disease) who had not received a prior medicine.₁
Diffuse large B-cell lymphoma: Rituxan is the first FDA-approved medicine since the introduction of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone) in 1972 for the treatment of diffuse large B-cell lymphoma (an aggressive form of non-Hodgkin's lymphoma). Rituxan when combined with CHOP chemotherapy helps people with diffuse large B-cell lymphoma who had not received prior treatment live longer (improved overall survival or OS) compared to CHOP alone.₁

Rituxan Indications

Rituxan is indicated for the treatment of patients with:

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent
Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy
Non-progressing (including stable disease), low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent after first-line CVP chemotherapy
Previously untreated diffuse large B-cell, CD20-positive non-Hodgkin's lymphoma in combination with CHOP or other anthracycline based chemotherapy regimens
Previously untreated and previously treated CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide (FC)

Rituxan is not recommended for use in patients with severe, active infections.

Rituxan's Clinical Studies in Non-Hodgkin's Lymphoma

Previously Untreated Follicular Lymphoma in Combination With First-Line Chemotherapy and as Single-Agent Maintenance Therapy Following Rituxan Plus Chemotherapy

RITUXAN INDICATION	CLINICAL TRIAL DATA
Rituxan plus CVP chemotherapy increased the time patients with previously untreated follicular non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)	In a Phase III study, patients who received Rituxan plus CVP chemotherapy improved the time they lived without the disease worsening by 71 percent (2.4 years vs. 1.4 years) versus chemotherapy alone at 1.5-year median follow up¹ In the same study, patients who received Rituxan plus CVP chemotherapy improved the time they lived without the disease worsening by 113 percent (2.67 years vs. 1.25 years) versus chemotherapy alone at 2.5-year median follow up⁶ Patients in the Rituxan plus CVP arm had higher incidences of infusional toxicity and of neutropenia compared with those in the CVP arm¹ The following adverse reactions occurred more frequently (>5 percent) in patients receiving Rituxan plus CVP compared with CVP alone: rash (17 percent vs. 5 percent), cough (15 percent vs. 6 percent), flushing (14 percent vs. 3 percent), rigors (10 percent vs. 2 percent), pruritus (10 percent vs. 1 percent), neutropenia (8 percent vs. 3 percent), and chest tightness (7 percent vs. 1 percent)¹
Maintenance treatment with Rituxan as a single agent following Rituxan plus chemotherapy, increased the time patients with previously untreated, advanced, follicular non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)	A Phase III study showed that Rituxan maintenance therapy administered every two months for two years in patients with previously untreated advanced follicular lymphoma who achieved a clinical response with Rituxan plus chemotherapy, nearly doubled the likelihood of them living without their disease worsening (progression-free survival or PFS) compared to patients who did not receive maintenance treatment (based on a hazard ratio of 0.54, 95 percent CI, 0.42–0.70; p<0.0001)¹ In patients receiving Rituxan as single-agent maintenance therapy following Rituxan plus chemotherapy, infections were reported more frequently compared to the observation arm (37 percent vs. 22 percent)¹ Grade 3-4 adverse reactions occurring at a higher incidence (≥2 percent) in the Rituxan group were infections (4 percent vs. 1 percent) and low white blood cell count (4 percent vs. <1 percent)¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

Rituxan plus CVP chemotherapy increased the time patients with previously untreated follicular non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)

In a Phase III study, patients who received Rituxan plus CVP chemotherapy improved the time they lived without the disease worsening by 71 percent (2.4 years vs. 1.4 years) versus chemotherapy alone at 1.5-year median follow up¹
In the same study, patients who received Rituxan plus CVP chemotherapy improved the time they lived without the disease worsening by 113 percent (2.67 years vs. 1.25 years) versus chemotherapy alone at 2.5-year median follow up⁶
Patients in the Rituxan plus CVP arm had higher incidences of infusional toxicity and of neutropenia compared with those in the CVP arm¹
The following adverse reactions occurred more frequently (>5 percent) in patients receiving Rituxan plus CVP compared with CVP alone: rash (17 percent vs. 5 percent), cough (15 percent vs. 6 percent), flushing (14 percent vs. 3 percent), rigors (10 percent vs. 2 percent), pruritus (10 percent vs. 1 percent), neutropenia (8 percent vs. 3 percent), and chest tightness (7 percent vs. 1 percent)¹

Maintenance treatment with Rituxan as a single agent following Rituxan plus chemotherapy, increased the time patients with previously untreated, advanced, follicular non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)

A Phase III study showed that Rituxan maintenance therapy administered every two months for two years in patients with previously untreated advanced follicular lymphoma who achieved a clinical response with Rituxan plus chemotherapy, nearly doubled the likelihood of them living without their disease worsening (progression-free survival or PFS) compared to patients who did not receive maintenance treatment (based on a hazard ratio of 0.54, 95 percent CI, 0.42–0.70; p<0.0001)¹
In patients receiving Rituxan as single-agent maintenance therapy following Rituxan plus chemotherapy, infections were reported more frequently compared to the observation arm (37 percent vs. 22 percent)¹
Grade 3-4 adverse reactions occurring at a higher incidence (≥2 percent) in the Rituxan group were infections (4 percent vs. 1 percent) and low white blood cell count (4 percent vs. <1 percent)¹

Ongoing Treatment Following First-Line CVP Chemotherapy

RITUXAN INDICATION	CLINICAL TRIAL DATA
When used by itself following first-line CVP chemotherapy, Rituxan increased the time patients with low-grade non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)	A Phase III study showed Rituxan monotherapy, when used after CVP chemotherapy, improved the time patients lived without the disease worsening by 104 percent versus observation alone at 2.3-year median follow up (based on a hazard ratio of 0.49)¹,⁷ The following common adverse reactions were reported more frequently (≥5 percent) in patients receiving Rituxan following CVP compared with those who received no further therapy: fatigue (39 percent vs. 14 percent), anemia (35 percent vs. 20 percent), peripheral sensory neuropathy (30 percent vs. 18 percent), infections (19 percent vs. 9 percent), pulmonary toxicity (18 percent vs. 10 percent), hepatobiliary toxicity (17 percent vs. 7 percent), rash and/or pruritus (17 percent vs. 5 percent), arthralgia (12 percent vs. 3 percent), and weight gain (11 percent vs. 4 percent)¹ Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (>2 percent) in the Rituxan arm compared with those who received no further therapy (4 percent vs. 1 percent)¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

When used by itself following first-line CVP chemotherapy, Rituxan increased the time patients with low-grade non-Hodgkin's lymphoma lived without the disease worsening (improved PFS)

A Phase III study showed Rituxan monotherapy, when used after CVP chemotherapy, improved the time patients lived without the disease worsening by 104 percent versus observation alone at 2.3-year median follow up (based on a hazard ratio of 0.49)¹,⁷
The following common adverse reactions were reported more frequently (≥5 percent) in patients receiving Rituxan following CVP compared with those who received no further therapy: fatigue (39 percent vs. 14 percent), anemia (35 percent vs. 20 percent), peripheral sensory neuropathy (30 percent vs. 18 percent), infections (19 percent vs. 9 percent), pulmonary toxicity (18 percent vs. 10 percent), hepatobiliary toxicity (17 percent vs. 7 percent), rash and/or pruritus (17 percent vs. 5 percent), arthralgia (12 percent vs. 3 percent), and weight gain (11 percent vs. 4 percent)¹
Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (>2 percent) in the Rituxan arm compared with those who received no further therapy (4 percent vs. 1 percent)¹

Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

RITUXAN INDICATION	CLINICAL TRIAL DATA
In three pivotal studies, Rituxan alone helped patients with low-grade or follicular non-Hodgkin's lymphoma who didn't respond to (refractory), or whose disease returned (relapsed) after previous therapy, achieve and sustain a response over specific periods of time (durable clinical response)	One pivotal study showed retreatment with Rituxan monotherapy in patients with low-grade or follicular lymphoma who previously responded to Rituxan experienced a 38 percent overall response rate (28 percent partial response rate and 10 percent complete response rate), with a duration of response of 15 months¹,⁸ In another trial, patients treated with Rituxan monotherapy who have low-grade or follicular lymphoma and either failed to respond to prior therapy or relapsed after prior therapy with chemotherapy experienced a 48 percent overall response rate (42 percent partial response rate and 6 percent complete response), with a duration of response of 11.2 months¹,⁹ A third study showed patients with previously treated low-grade or follicular non-Hodgkin's lymphoma experienced a 57 percent overall response rate (43 percent partial response rate and 14 percent complete response rate), with a duration of response of 13.4 months with Rituxan monotherapy¹,¹⁰ Across all three studies, the most common adverse reactions of Rituxan (incidence >25 percent) observed in patients with relapsed or refractory, low-grade or follicular non-Hodgkin's lymphoma were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Grade 3 and 4 cytopenias were reported in 48 percent of patients and included lymphopenia (40 percent), neutropenia (6 percent), leukopenia (4 percent), anemia (3 percent), and thrombocytopenia (2 percent)¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

In three pivotal studies, Rituxan alone helped patients with low-grade or follicular non-Hodgkin's lymphoma who didn't respond to (refractory), or whose disease returned (relapsed) after previous therapy, achieve and sustain a response over specific periods of time (durable clinical response)

One pivotal study showed retreatment with Rituxan monotherapy in patients with low-grade or follicular lymphoma who previously responded to Rituxan experienced a 38 percent overall response rate (28 percent partial response rate and 10 percent complete response rate), with a duration of response of 15 months¹,⁸
In another trial, patients treated with Rituxan monotherapy who have low-grade or follicular lymphoma and either failed to respond to prior therapy or relapsed after prior therapy with chemotherapy experienced a 48 percent overall response rate (42 percent partial response rate and 6 percent complete response), with a duration of response of 11.2 months¹,⁹
A third study showed patients with previously treated low-grade or follicular non-Hodgkin's lymphoma experienced a 57 percent overall response rate (43 percent partial response rate and 14 percent complete response rate), with a duration of response of 13.4 months with Rituxan monotherapy¹,¹⁰
Across all three studies, the most common adverse reactions of Rituxan (incidence >25 percent) observed in patients with relapsed or refractory, low-grade or follicular non-Hodgkin's lymphoma were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Grade 3 and 4 cytopenias were reported in 48 percent of patients and included lymphopenia (40 percent), neutropenia (6 percent), leukopenia (4 percent), anemia (3 percent), and thrombocytopenia (2 percent)¹

Previously Untreated Diffuse Large B-Cell Lymphoma With Chemotherapy

RITUXAN INDICATION	CLINICAL TRIAL DATA
Rituxan plus CHOP chemotherapy has been shown to improve survival (overall survival or OS) in patients with previously untreated diffuse large B-cell, CD20-positive lymphoma in three separate Phase III studies	In one study, 58 percent of patients who received Rituxan plus CHOP chemotherapy were alive after five years compared to 46 percent of patients who received CHOP chemotherapy alone¹ In another study, 74 percent of patients who received Rituxan plus CHOP chemotherapy were alive after two years compared to 63 percent of patients who received CHOP chemotherapy alone¹ An additional study showed 95 percent of patients who received Rituxan plus CHOP-like chemotherapy were alive after two years compared to 86 percent of patients who received chemotherapy alone¹ Detailed safety data collection in these trials was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5 percent) in patients ≥60 years of age receiving Rituxan plus CHOP as compared with CHOP alone: pyrexia (56 percent vs. 46 percent), lung disorder (31 percent vs. 24 percent), cardiac disorder (29 percent vs. 21 percent), and chills (13 percent vs. 4 percent)¹ Across all three studies, the following Grade 3 or 4 adverse reactions occurred more frequently among patients in the Rituxan plus CHOP arm compared with those in the CHOP arm: thrombocytopenia (9 percent vs. 7 percent) and lung disorder (6 percent vs. 3 percent). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving Rituxan plus CHOP in these trials were viral infection, neutropenia and anemia¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

Rituxan plus CHOP chemotherapy has been shown to improve survival (overall survival or OS) in patients with previously untreated diffuse large B-cell, CD20-positive lymphoma in three separate Phase III studies

In one study, 58 percent of patients who received Rituxan plus CHOP chemotherapy were alive after five years compared to 46 percent of patients who received CHOP chemotherapy alone¹
In another study, 74 percent of patients who received Rituxan plus CHOP chemotherapy were alive after two years compared to 63 percent of patients who received CHOP chemotherapy alone¹
An additional study showed 95 percent of patients who received Rituxan plus CHOP-like chemotherapy were alive after two years compared to 86 percent of patients who received chemotherapy alone¹
Detailed safety data collection in these trials was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5 percent) in patients ≥60 years of age receiving Rituxan plus CHOP as compared with CHOP alone: pyrexia (56 percent vs. 46 percent), lung disorder (31 percent vs. 24 percent), cardiac disorder (29 percent vs. 21 percent), and chills (13 percent vs. 4 percent)¹
Across all three studies, the following Grade 3 or 4 adverse reactions occurred more frequently among patients in the Rituxan plus CHOP arm compared with those in the CHOP arm: thrombocytopenia (9 percent vs. 7 percent) and lung disorder (6 percent vs. 3 percent). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving Rituxan plus CHOP in these trials were viral infection, neutropenia and anemia¹

Previously Untreated Diffuse Large B-Cell Lymphoma With Chemotherapy

RITUXAN INDICATION	CLINICAL TRIAL DATA
Rituxan plus FC increased the time patients with previously untreated chronic lymphocytic leukemia lived without the disease worsening (improved PFS)	Patients who received Rituxan plus FC lived a median of 39.8 months without the disease worsening compared to 31.5 months for patients who received FC alone¹ Grade 3 or 4 adverse reactions that occurred more frequently (>2 percent) in patients treated with Rituxan plus FC vs. FC were neutropenia (30 percent vs. 19 percent), febrile neutropenia (9 percent vs. 6 percent), leukopenia (23 percent vs. 12 percent), and pancytopenia (3 percent vs. 1 percent)¹ Grade 3 or 4 infusion-related adverse reactions occurred in 9 percent of patients treated with Rituxan plus FC¹ Although the clinical trial was not designed to evaluate Rituxan plus FC in patient supgroups, an exploratory analysis defined by age indicated that in patients 70 years of age and older, no clinical benefit was observed. This supgroup analysis showed that patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan. The dose intensity of Rituxan was similar in older and younger patients¹ Grade 3 and 4 adverse reactions was higher among patients receiving Rituxan plus FC who were 70 years or older compared to younger patients for neutropenia (44 percent vs. 31 percent), febrile neutropenia (16 percent vs. 6 percent), anemia (5 percent vs. 2 percent) and pancytopenia (7 percent vs. 2 percent) ¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

Rituxan plus FC increased the time patients with previously untreated chronic lymphocytic leukemia lived without the disease worsening (improved PFS)

Patients who received Rituxan plus FC lived a median of 39.8 months without the disease worsening compared to 31.5 months for patients who received FC alone¹
Grade 3 or 4 adverse reactions that occurred more frequently (>2 percent) in patients treated with Rituxan plus FC vs. FC were neutropenia (30 percent vs. 19 percent), febrile neutropenia (9 percent vs. 6 percent), leukopenia (23 percent vs. 12 percent), and pancytopenia (3 percent vs. 1 percent)¹
Grade 3 or 4 infusion-related adverse reactions occurred in 9 percent of patients treated with Rituxan plus FC¹
Although the clinical trial was not designed to evaluate Rituxan plus FC in patient supgroups, an exploratory analysis defined by age indicated that in patients 70 years of age and older, no clinical benefit was observed. This supgroup analysis showed that patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan. The dose intensity of Rituxan was similar in older and younger patients¹
Grade 3 and 4 adverse reactions was higher among patients receiving Rituxan plus FC who were 70 years or older compared to younger patients for neutropenia (44 percent vs. 31 percent), febrile neutropenia (16 percent vs. 6 percent), anemia (5 percent vs. 2 percent) and pancytopenia (7 percent vs. 2 percent) ¹

Previously Treated Chronic Lymphocytic Leukemia With Chemotherapy

RITUXAN INDICATION	CLINICAL TRIAL DATA
Rituxan plus FC extended the time patients with previously treated chronic lymphocytic leukemia lived without the disease worsening (improved PFS)	Previously treated patients whose disease either returned or didn't respond to treatment and who received Rituxan plus FC lived a median of 26.7 months without the disease worsening compared to 21.7 months for patients who received FC alone¹ Grade 3 or 4 adverse reactions that occurred more frequently (>2 percent) in patients treated with Rituxan plus FC vs. FC were neutropenia (49 percent vs. 44 percent), febrile neutropenia (15 percent vs. 12 percent), thrombocytopenia (11 percent vs. 9 percent), hypotension (2 percent vs. 0 percent), and hepatitis B (2 percent vs. <1 percent)¹ Grade 3 or 4 infusion-related adverse reactions occurred in 7 percent of patients treated with Rituxan plus FC Although the clinical trial was not designed to evaluate Rituxan plus FC in patient supgroups, an exploratory analysis defined by age indicated that in patients 65 years of age and older, no clinical benefit was observed. This supgroup analysis showed that patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan. These older patients received a lower dose intensity of Rituxan than younger patients¹ Grade 3 and 4 adverse reactions occurring more frequently among patients receiving Rituxan plus FC who were 70 years or older compared to younger patients were neutropenia (56 percent vs. 39 percent), anemia (21 percent vs. 10 percent), thrombocytopenia (19 percent vs. 8 percent), pancytopenia (7 percent vs. 2 percent) and infections (30 percent vs. 14 percent)¹

RITUXAN INDICATION

CLINICAL TRIAL DATA

Rituxan plus FC extended the time patients with previously treated chronic lymphocytic leukemia lived without the disease worsening (improved PFS)

Previously treated patients whose disease either returned or didn't respond to treatment and who received Rituxan plus FC lived a median of 26.7 months without the disease worsening compared to 21.7 months for patients who received FC alone¹
Grade 3 or 4 adverse reactions that occurred more frequently (>2 percent) in patients treated with Rituxan plus FC vs. FC were neutropenia (49 percent vs. 44 percent), febrile neutropenia (15 percent vs. 12 percent), thrombocytopenia (11 percent vs. 9 percent), hypotension (2 percent vs. 0 percent), and hepatitis B (2 percent vs. <1 percent)¹
Grade 3 or 4 infusion-related adverse reactions occurred in 7 percent of patients treated with Rituxan plus FC
Although the clinical trial was not designed to evaluate Rituxan plus FC in patient supgroups, an exploratory analysis defined by age indicated that in patients 65 years of age and older, no clinical benefit was observed. This supgroup analysis showed that patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan. These older patients received a lower dose intensity of Rituxan than younger patients¹
Grade 3 and 4 adverse reactions occurring more frequently among patients receiving Rituxan plus FC who were 70 years or older compared to younger patients were neutropenia (56 percent vs. 39 percent), anemia (21 percent vs. 10 percent), thrombocytopenia (19 percent vs. 8 percent), pancytopenia (7 percent vs. 2 percent) and infections (30 percent vs. 14 percent)¹

Important Safety Information and Serious Side Effects

Rituxan can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).

Infusion Reactions: Serious infusion reactions can happen during the infusion or within 24 hours of receiving Rituxan. The doctor should give the patient medicines before their infusion of Rituxan to decrease the chance of having a severe infusion reaction. If a serious reaction occurs, the infusion may be stopped and the patient should receive medical care. Patients must tell their doctor or get medical help right away if they get any of these symptoms: hives or rash, itching, swelling of the lips, tongue, throat, or face, sudden cough, shortness of breath, difficulty breathing or wheezing, weakness, dizziness or feel faint, palpitations, or chest pain.
Tumor Lysis Sydrome (TLS): TLS is caused by the fast breakdown of cancer cells and can occur after treatment with Rituxan. TLS can cause a person to have kidney failure and the need for dialysis treatment. TLS may also cause abnormal heart rhythm. The doctor may give the patient medicines to help prevent TLS and do blood tests to check the patient for TLS.
Severe Skin and Mouth Reactions: Severe skin and mouth reactions can occur in patients who receive Rituxan.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus. People with a weakened immune system can get PML. Patients must tell their doctor right away if they have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way they walk or talk, decreased strength or weakness on one side of their body, blurred vision or loss of vision.
Rituxan has also been associated with serious and life-threatening side effects, including: the return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death, other serious infections that can lead to death, heart problems, kidney problems, and stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death.
The most common side effects of Rituxan in patients with non-Hodgkin's lymphoma (NHL) include: infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness. The most common serious side effect in NHL patients was low white blood cells.
The most common side effects of Rituxan in patients with chronic lymphocytic leukemia (CLL) were infusion reactions and low white blood cells.
Most CLL patients treated with Rituxan plus FC chemotherapy had at least one serious side effect. In clinical trials, CLL patients 70 years or older who received Rituxan with FC chemotherapy were more likely to experience severe side effects compared with younger patients who received the same treatment.
Patients should tell their doctor about any side effects that bothers them or that does not go away. These are not all of the possible side effects with Rituxan.

Patients should read the Rituxan Full Prescribing Information including Boxed WARNINGS, and the Medication Guide at www.rituxan.com.

References

¹ Genentech. Rituxan. Full Prescribing Information. 2012.

² Data on file.

³ Lymphoma Information Network. B-cell Lymphomas. http://www.lymphomainfo.net/nhl/b-cell.html. Accessed May 21, 2012.

⁴ Leukemia and Lymphoma Society. Chronic Lymphocytic Leukemia. http://www.lls.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/causesriskfactors/. Accessed May 21, 2012.

⁵ American Cancer Society. Cancer Facts & Figures. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf. Accessed January 12, 2012.

⁶ Marcus et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105(4):1417-23.

⁷ Hochster et al. Results of E1496: A phase III trial of CVP with or without maintenance rituximab in advanced indolent lymphoma (NHL). Journal of Clinical Oncology. 2004; 22(14S): 6502

⁸ Davis et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. Journal of Clinical Oncology. 2000; 17(18):3135-43.

⁹ McLaughlin et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. Journal of Clinical Oncology.1998; 16(8):2825-33.

¹⁰ Piro et al. Extended rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Annals of Oncology. 1999; 10: 655-661