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Rituxan®
(Rituximab)
WARNINGS
Fatal Infusion Reactions: Deaths within 24 hours of Rituxan infusion have been reported. These fatal reactions followed an infusion reaction complex, which included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. (See WARNINGS and ADVERSE REACTIONS.)
Patients who develop severe infusion reactions should have Rituxan infusion discontinued and receive medical treatment.
Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of non‑Hodgkin's lymphoma (NHL) patients with Rituxan. (SeeWARNINGS.)
Severe Mucocutaneous Reactions: Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with Rituxan treatment. (See WARNINGS and ADVERSE REACTIONS.)
Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in patients treated with Rituxan (See WARNINGS and ADVERSE REACTIONS.)
DESCRIPTION
The Rituxan® (Rituximab) antibody is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids (based on cDNA analysis) and has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.
The chimeric anti-CD20 antibody is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. The anti‑CD20 antibody is purified by affinity and ion exchange chromatography. The purification process includes specific viral inactivation and removal procedures. Rituximab Drug Product is manufactured from bulk Drug Substance manufactured by Genentech, Inc. (US License No. 1048).
Rituxan is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. Rituxan is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials. The product is formulated for IV administration in 9 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dihydrate, 0.7 mg/mL polysorbate 80, and Water for Injection. The pH is adjusted to 6.5.
CLINICAL PHARMACOLOGY
General
Rituximab binds specifically to the antigen CD20 (human B‑lymphocyte‑restricted differentiation antigen, Bp35), a hydrophobic transmembrane protein with a molecular weight of approximately 35 kD located on pre‑B and mature B lymphocytes. 1, 2 The antigen is also expressed on > 90% of B‑cell non‑Hodgkin's lymphomas (NHL), 3 but is not found on hematopoietic stem cells, pro‑B‑cells, normal plasma cells or other normal tissues. 4 CD20 regulates an early step(s) in the activation process for cell cycle initiation and differentiation, 4 and possibly functions as a calcium ion channel. 5 CD20 is not shed from the cell surface and does not internalize upon antibody binding.6 Free CD20 antigen is not found in the circulation. 2
B‑cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, B‑cells may be acting at multiple sites in the autoimmune/inflammatory process, including through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T cell activation, and/or pro‑inflammatory cytokine production. 7
Preclinical Pharmacology and Toxicology
Mechanism of Action: The Fab domain of Rituximab binds to the CD20 antigen on B lymphocytes, and the Fc domain recruits immune effector functions to mediate B‑cell lysis in vitro. Possible mechanisms of cell lysis include complement‑dependent cytotoxicity (CDC) 8 and antibody-dependent cell mediated cytotoxicity (ADCC). The antibody has been shown to induce apoptosis in the DHL‑4 human B‑cell lymphoma line. 9
Normal Tissue Cross-reactivity: Rituximab binding was observed on lymphoid cells in the thymus, the white pulp of the spleen, and a majority of B lymphocytes in peripheral blood and lymph nodes. Little or no binding was observed in the non-lymphoid tissues examined.
Pharmacokinetics
In patients with NHL given single doses at 10, 50, 100, 250 or 500 mg/m2 as an IV infusion, serum levels and the half-life of Rituximab were proportional to dose. 10 In 14 patients given 375 mg/m2 as an IV infusion for 4 weekly doses, the mean serum half-life was 76.3 hours (range, 31.5 to 152.6 hours) after the first infusion and 205.8 hours (range, 83.9 to 407.0 hours); after the fourth infusion. 11, 12, 13 The wide range of half-lives may reflect the variable tumor burden among patients and the changes in CD20‑positive (normal and malignant) B‑cell populations upon repeated administrations.
Rituxan at a dose of 375 mg/m2 was administered as an IV infusion at weekly intervals for 4 doses to 203 patients with NHL naive to Rituxan. 13, 14 The mean Cmax following the fourth infusion was 486µg/mL (range, 77.5 to 996.6 µg/mL). The peak and trough serum levels of Rituximab were inversely correlated with baseline values for the number of circulating CD20‑positive B‑cells and measures of disease burden. Median steady-state serum levels were higher for responders compared with nonresponders; however, no difference was found in the rate of elimination as measured by serum half-life. Serum levels were higher in patients with International Working Formulation (IWF) subtypes B, C, and D as compared with those with subtype A. 11, 14 Rituximab was detectable in the serum of patients 3 to 6 months after completion of treatment.
Rituxan at a dose of 375 mg/m2 was administered as an IV infusion at weekly intervals for 8 doses to 37 patients with NHL. 15 The mean Cmax after 8 infusions was 550 µg/mL (range, 171–1177 µg/mL). The mean Cmax increased with each successive infusion through the eighth infusion (Table 1).
| Infusion Number | Mean Cmax µg/mL | Range µg/mL |
|---|---|---|
| 1 | 242.6 | 16.1–581.9 |
| 2 | 357.5 | 106.8–948.6 |
| 3 | 381.3 | 110.5–731.2 |
| 4 | 460.0 | 138.0–835.8 |
| 5 | 475.3 | 156.0–929.1 |
| 6 | 515.4 | 152.7–865.2 |
| 7 | 544.6 | 187.0–936.8 |
| 8 | 550.0 | 170.6–1177.0 |
The pharmacokinetic profile of Rituxan when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with Rituxan alone. 16
Following the administration of 2 doses of Rituximab in patients with rheumatoid arthritis, the mean Cmax values were 183 mcg/mL (CV=24%) for the 2 × 500 mg dose and 370 mcg/mL (CV=25%) for the 2× 1000 mg dose, respectively. Following 2× 1000 mg Rituximab dose, mean volume of distribution at steady state was 4.3 L (CV=28%). Mean systemic serum clearance of Rituximab was 0.01 L/h (CV=38%), and mean terminal elimination half‑life after the second dose was 19 days (CV=32%).
Special Populations
Gender: The female patients with RA (n=86) had a 37% lower clearance of Rituximab than male patients with RA (n=25). The gender difference in Rituximab clearance does not necessitate any dose adjustment because safety and efficacy of Rituximab do not appear to be influenced by gender.
The pharmacokinetics of Rituximab have not been studied in children and adolescents. No formal studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of Rituximab.
Pharmacodynamics
Administration of Rituxan resulted in a rapid and sustained depletion of circulating and tissue‑based B‑cells. Lymph node biopsies performed 14 days after therapy showed a decrease in the percentage of B‑cells in seven of eight patients with NHL who had received single doses of Rituximab ≥100 mg/m2.10 Among the 166 patients in the pivotal NHL study, circulating B‑cells (measured as CD19‑positive cells) were depleted within the first three doses with sustained depletion for up to 6 to 9 months post-treatment in 83% of patients. 14 Of the responding patients assessed (n = 80), 1% failed to show significant depletion of CD19‑positive cells after the third infusion of Rituximab as compared to 19% of the nonresponding patients. B‑cell recovery began at approximately 6 months following completion of treatment. Median B‑cell levels returned to normal by 12 months following completion of treatment. 14
There were sustained and statistically significant reductions in both IgM and IgG serum levels observed from 5 through 11 months following Rituximab administration. However, only 14% of patients had reductions in IgM and/or IgG serum levels, resulting in values below the normal range.14
In RA patients, treatment with Rituxan induced depletion of peripheral B lymphocytes, with all patients demonstrating near complete depletion within 2 weeks after receiving the first dose of Rituxan. The majority of patients showed peripheral B‑cell depletion for at least 6 months, followed by subsequent gradual recovery after that timepoint. A small proportion of patients (4%) had prolonged peripheral B‑cell depletion lasting more than 3 years after a single course of treatment.
In RA studies, total serum immunoglobulin levels, IgM, IgG, and IgA were reduced at 6 months with the greatest change observed in IgM. However, mean immunoglobulin levels remained within normal levels over the 24‑week period. Small proportions of patients experienced decreases in IgM (7%), IgG (2%), and IgA (1%) levels below the lower limit of normal. The clinical consequences of decreases in immunoglobulin levels in RA patients treated with Rituxan are unclear.
Treatment with Rituximab in patients with RA was associated with reduction of certain biologic markers of inflammation such as interleukin-6 (IL 6), C‑reactive protein (CRP), serum amyloid protein (SAA), S100 A8/S100 A9 heterodimer complex (S100 A8/9), anti‑citrullinated peptide (anti‑CCP) and RF.
CLINICAL STUDIES
Relapsed or Refractory, Low‑Grade or Follicular, CD‑20 Positive, B‑Cell, NHL
Rituxan regimens tested include treatment weekly for 4 doses and treatment weekly for 8 doses. Results for studies with a collective enrollment of 296 patients are summarized below (Table 2):
| Study 1 Weekly× 4 N = 166 | Study 2 Weekly× 8 N = 37 | Study 1 and Study 3 Bulky disease, Weekly× 4 N = 39 | Study 3 Retreatment, Weekly × 4 N = 60 | |
|---|---|---|---|---|
| Overall Response Rate | 48% | 57% | 36% | 38% |
| Complete Response Rate | 6% | 14% | 3% | 10% |
| Median Duration Of
Response (Months) [Range] | 11.2 [1.9 to 42.1+] | 13.4 [2.5 to 36.5+] | 6.9 [2.8 to 25.0+] | 15.0 [3.0 to 25.1+] |
Weekly for 4 Doses
Weekly for 8 Doses
Retreatment Weekly for 4 Doses
Previously Untreated, Follicular, CD‑20 Positive, B‑Cell NHL
Previously Untreated, Low Grade, CD‑20 Positive, B‑Cell NHL
Diffuse Large B‑Cell NHL (DLBCL)
The safety and effectiveness of Rituxan were evaluated in three, randomized, active‑controlled, open‑label, multicenter studies with a collective enrollment of 1854 patients. Patients with previously untreated diffuse large B‑cell NHL received Rituxan in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or other anthracycline‑based chemotherapy regimens.
INDICATIONS AND USAGE
CONTRAINDICATIONS
None.
WARNINGS
(See BOXED WARNINGS)
Severe Infusion Reactions
(see BOXED WARNINGS and ADVERSE REACTIONS)
Rituxan has caused severe infusion reactions. In some cases, these reactions were fatal. These severe reactions typically occurred during the first infusion with time to onset of 30–120 minutes. Signs and symptoms of severe infusion reactions may include urticaria, hypotension, angioedema, hypoxia, or bronchospasm, and may require interruption of Rituxan administration. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. In the reported cases, the following factors were more frequently associated with fatal outcomes: female gender, pulmonary infiltrates, and chronic lymphocytic leukemia or mantle cell lymphoma.
PRECAUTIONS
Immunization
The safety of immunization with live viral vaccines following Rituxan therapy has not been studied and vaccination with live virus vaccines is not recommended. The ability to generate a primary or anamnestic humoral response to vaccination is currently being studied.
Physicians should review the vaccination status of patients with RA being considered for Rituxan treatment and follow the Centers for Disease Control and Prevention (CDC) guidelines for adult vaccination with non-live vaccines untended to prevent infectious disease, prior to therapy. For patients with NHL, the benefits of primary and/or booster vaccinations should be weighted against the risks of delay in initiation of Rituxan therapy.
OVERDOSAGE
There has been no experience with overdosage in human clinical trials. Single doses of up to 500 mg/m2 have been given in dose‑escalation clinical trials. 10
DOSAGE AND ADMINISTRATION
Relapsed or Refractory, Low-Grade or Follicular, CD20‑Positive, B‑Cell Non-Hodgkin’s Lymphoma
The recommended dose of Rituxan is 375 mg/m2 IV infusion once weekly for 4 or 8 doses.
Instructions for Administration
Administration
DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS
Infusion reactions may occur (see BOXED WARNINGS,WARNINGS, andADVERSE REACTIONS). Premedication consisting of acetaminophen and an antihistamine should be considered before each infusion of Rituxan. Premedication may attenuate infusion reactions. Since transient hypotension may occur during Rituxan infusion, consideration should be given to withholding antihypertensive medications 12 hours prior to Rituxan infusion.
HOW SUPPLIED
Rituxan® (Rituximab) is supplied as 100 mg and 500 mg of sterile, preservative-free, single-use vials.
Single unit 100 mg carton: Contains one 10 mL vial of Rituxan (10 mg/mL).
NDC 50242‑051‑21
Single unit 500 mg carton: Contains one 50 mL vial of Rituxan (10 mg/mL).
NDC 50242‑053‑06
REFERENCES
- Valentine MA, Meier KE, Rossie S, et al. Phosphorylation of the CD20 phosphoprotein in resting B lymphocytes.J Biol Chem 1989;264(19): 11282–7.
- Einfeld DA, Brown JP, Valentine MA, et al. Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains.EMBO J 1988;7(3):711–7.
- Anderson KC, Bates MP, Slaughenhoupt BL, et al. Expression of human B cell‑associated antigens on leukemias and lymphomas: A model of human B‑cell differentiation. Blood 1984;63(6):1424–33.
- Tedder TF, Boyd AW, Freedman AS, et al. The B cell surface molecule B1 is functionally linked with B‑cell activation and differentiation. J Immunol 1985;135(2):973–9.
- Tedder TF, Zhou LJ, Bell PD, et al. The CD20 surface molecule of B lymphocytes functions as a calcium channel.J Cell Biochem 1990;14D:195.
- Press OW, Applebaum F, Ledbetter JA, Martin PJ, Zarling J, Kidd P, et al. Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B-cell lymphomas. Blood 1987;69(2):584–91.
- Dorner, T, Rumester, G. The role of B-cells in rheumatoid arthritis: mechanisms and therapeutic targets. Curr Op Rheum 2003;15:246-52.
- Reff ME, Carner C, Chambers KS, Chinn PC, Leonard JE, Raab R, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood 1994;83(2):435–45.
- Demidem A, Lam T, Alas S, Hariharan K, Hanna N, and Bonavida B. Chimericanti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Biotherapy & Radiopharmaceuticals 1997;12(3):177–86.
- Maloney DG, Liles TM, Czerwinski C, Waldichuk J, Rosenberg J, Grillo López A, et al. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood 1994;84(8):2457–66.
- Berinstein NL, Grillo-López AJ, White CA, Bence-Bruckler I, Maloney D, Czuczman M, et al. Association of serum Rituximab (IDEC‑C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Annals of Oncology 1998;9:995–1001.
- Maloney DG, Grillo-López AJ, Bodkin D, White CA, Liles T-M, Royston I, et al. IDEC-C2B8: Results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol 1997;15(10):3266–74.
- Maloney DG, Grillo-López AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, et al. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997;90(6):2188–95.
- McLaughlin P, Grillo-López AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16(8):2825–33.
- Piro LD, White CA, Grillo-López AJ, Janakiraman N, Saven A, Beck TM, 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;10:655–61.
- Data on file.
- Davis TA, White CA, Grillo-López AJ, Velasquez WS, Lin B, Maloney DG, et al. Single-agent monoclonal antibody efficacy in bulky Non-Hodgkin’s lymphoma: results of a phase II trial of rituximab. JCO 1999;17:1851–7.
- Davis TA, Grillo-López AJ, White CA, McLaughlin P, Czuczman MS, Link BK, Maloney DG, Weaver RL, Rosenberg J, Levy R. Rituximab anti-CD20 monoclonal antibody therapy in non-hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol 2000;18(17):3135–43.
- Anhalt GJ, Kim SC, Stanley JR, Korman NJ, Jabs DA, Kory M, Izumi H, Ratrie H, Mutasim D, Ariss-Abdo L, Labib RS. Paraneoplastic Pemphigus, an autoimmune mucocutaneous disease associated with neoplasia. NEJM 1990;323(25): 1729–35.
- National Institutes of Health (US), National Cancer Institute. Common Toxicity Criteria. [Bethesda, MD.] : National Institutes of Health, National Cancer Institute; c1998;73p.
Jointly Marketed by: Biogen Idec Inc., and Genentech, Inc.
Rituxan®
(Rituximab)
Manufactured by: 4835500
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
Initial US Approval November 26, 1997
Revision Date February 21, 2007
©2007 Biogen Idec, Inc. and Genentech,
Inc.
Patient Information
Rituxan®
(ri-tuk'-san)
(Rituximab)
Read this patient information leaflet when you have been prescribed Rituxan and each time you are scheduled to receive a Rituxan infusion. This information does not take the place of talking to your doctor about your medical condition or your treatment. Talk with your doctor if you have any questions about your treatment with Rituxan.
What is the most important safety information I should know about Rituxan?
Rituxan can cause the following serious side effects, some of which could be life-threatening:
- Infusion reactions. Tell your doctor or get medical treatment right away if you get hives, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, or have trouble breathing while receiving or after receiving Rituxan.
- Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of certain blood cancers. TLS can cause kidney failure and the need for dialysis treatment. Patients receiving Rituxan for non‑Hodgkin’s lymphoma may get TLS.
- Severe skin reactions. Tell your doctor or get medical treatment right away if you get painful sores, ulcers, bulers, or peeling skin while receiving or after receiving Rituxan.
- Progressive Multifocal Leukoencephalopathy (PML). PML is a rare brain infection that usually causes death or severe disability.
- PML has been reported in patients during or after their treatment with Rituxan.
- There is no known treatment, prevention, or cure for PML.
- Call your doctor right away if you notice any new or worsening medical problems, such as a new or sudden change in thinking, walking, strength, vision, or other problems that have lasted over several days.
Also, see “What are possible side-effects with Rituxan?” for other serious side effects, some of which could be life-threatening.
What is Rituxan?
Rituxan is a biologic medicine used in adults:
- alone or with other anti‑cancer medicines to treat certain types of non‑Hodgkin’s lymphoma (NHL).
- with another medicine called methotrexate to reduce the signs and symptoms of Rheumatoid Arthritis (RA) after at least one other medicine called a tumor necrosis factor (TNF) inhibitor has been used and did not work well.
Rituxan has not been studied in children.
How does Rituxan work?
Rituxan works by getting rid of certain B‑cells in the blood. B‑cells are a type of white blood cell found in the blood. B‑cells usually help the body fight infection. B‑cells play an important role in diseases such as NHL and RA. Rituxan may also get rid of healthy B‑cells and this can give you a higher chance for getting infections.
Who should not receive
Rituxan?
Do not receive Rituxan if you ever had an allergic reaction to Rituxan
What should I tell my doctor
before treatment with Rituxan?
Tell your doctor about all of your medical conditions, including if you:
- have an infection or have an infection that will not go away or that keeps coming back.
- are scheduled to have surgery.
- have had hepatitis B virus infection or are a carrier of hepatitis B virus. Your doctor should check you closely for signs of a hepatitis infection during treatment with Rituxan and for several months after treatment ends.
- have any scheduled vaccinations. It is not known if Rituxan affects your ability to respond to vaccines.
- have heart or lung problems.
- are pregnant or planning to become pregnant. It is not known if Rituxan can harm your unborn baby.
- are breastfeeding. It is not known if Rituxan passes into human breast milk. You should not breastfeed while being treated with Rituxan.
Tell your doctor about all the other medicines you take, including prescription and nonprescription medicines, vitamins, or herbal supplements. If you have RA, tell your doctor if you are taking or took another biologic medicine called a TNF inhibitor or a DMARD (disease modifying anti‑rheumatic drug).
How do I receive Rituxan?
- Rituxan is given through a needle placed in a vein (IV infusion), in your arm. Rituxan therapy is given in different ways for NHL and RA. Talk to your doctor about how you will receive Rituxan.
- Your doctor may prescribe other medicines before each infusion of Rituxan to prevent or reduce pain, or to reduce fever and allergic reactions.
- Your doctor should do regular blood tests to check for side effects or reactions to Rituxan.
What are possible side effects with Rituxan?
Rituxan can cause the following serious side effects, some of which could be life-threatening side effects, including (See “What is the most important safety information I should know about Rituxan?”)
- Infusion reactions
- Tumor Lysis Syndrome (TLS)
- Severe skin reactions
- Progressive Multifocal Leukoencephalopathy (PML)
Other serious side effects with Rituxan include:
- Hepatitis B virus reactivation. Tell your doctor if you had Hepatitis B virus or are a carrier of Hepatitis B virus. Rituxan may make you sick with Hepatitis B virus again and cause serious liver problems. People with active liver disease due to Hepatitis B should stop receiving Rituxan.
- Heart Problems. Tell your doctor about any heart problems you have including chest pain (angina) and irregular heart beats. Rituxan can cause chest pain and irregular heart beats which may require treatment.
- Infections. Rituxan can increase your chances for getting infections. Call your doctor right away if you have a persistent cough, fever, chills, congestion, or any flu-like symptoms while receiving Rituxan. These symptoms may be signs of a serious infection.
- Stomach and bowel problems. Serious stomach and bowel problems have been seen when Rituxan has been used with anti-cancer medicines in some patients with non-Hodgkin’s lymphoma. Call your doctor right away if you have any stomach area pain during treatment with Rituxan.
Common side effects with Rituxan include:
Fever, chills, shakes, itching, hives, sneezing, swelling, throat irritation or tightness, and cough. These usually occur within 24 hours after the first infusion. Other common side effects include headache, nausea, upper respiratory tract infection, and aching joints. If you have any of these symptoms, tell your doctor or nurse.
What if I still have questions?
If you have any questions about Rituxan or your health, talk with your doctor. You can also visit the Rituxan internet sites at www.Rituxan.com or the companies’ internet sites at www.Gene.com or www.Biogenidec.com or call 1‑877‑4‑Rituxan (877‑474‑8892).
Jointly Marketed by: Biogen Idec Inc. and Genentech, Inc.
Manufactured by:
Genentech, Inc.
1 DNA Way
South San Francisco, CA
94080-4990
©2007 Biogen Idec Inc. and Genentech, Inc.
Patient Information Approval February 21, 2007