Rituxan Side Effects

Generic name: rituximab

Note: This document contains side effect information about rituximab. Some of the dosage forms listed on this page may not apply to the brand name Rituxan.

Some side effects of Rituxan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rituximab: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking rituximab (the active ingredient contained in Rituxan) hives; chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a rituximab injection have had a reaction to the infusion (within 24 hours after the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, light-headed, short of breath, or if you have chest pain, wheezing, sudden cough, or pounding heartbeats or fluttering in your chest.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have symptoms such as confusion, trouble concentrating, problems with speech or walking, vision problems, or weakness on one side of your body.

Call your doctor at once if you have any of these other serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

• fever, chills, body aches, flu symptoms, feeling weak or tired;

• ongoing cold symptoms such as stuffy nose, sneezing, sore throat;

• headache, earache, painful mouth ulcers, skin sores, warmth or swelling with skin redness;

• pain or burning when you urinate, urinating less than usual;

• severe skin rash with blistering, itching, peeling, or pus;

• weak pulse, fainting, overactive reflexes;

• muscle weakness, tightness, or contraction; or

• lower back pain, blood in your urine, numbness or tingly feeling around your mouth.

Other common side effects may include:

• mild stomach pain, nausea, or diarrhea;

• muscle or joint pain;

• back pain; or

• night sweats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rituximab: intravenous solution

General

General side effects have included fever (49%), chills (32%), asthenia (16%), headache (14%), and abdominal pain (6%).

In general, severe side effects from rituximab (the active ingredient contained in Rituxan) may be more likely in patients with higher circulating white counts or a greater tumor burden. Severe and life-threatening (Grade 3 and 4) events have been reported in 10% of patients. The Grade 3 and 4 adverse events included neutropenia (1.9%), chills (1.6%), leukopenia (1.3%), thrombocytopenia (1.3%), hypotension (1%), anemia (1%), bronchospasm (1%), urticaria (1%), headache (0.6%), abdominal pain (0.6%), and arrhythmia (0.6%). A fatal case of septicemia has also been reported.

A cytokine-release syndrome consisting mainly of fever, chills, and stiffness during the first infusion has also been reported when the drug has been administered systemically.

Other

In almost all cases, the infusion related event was reported in relation to the first infusion.

Fatal outcomes were most frequently associated with female patients, patients with pulmonary infiltrates, and patients CLL or mantle cell lymphoma.

Other side effects have included death within 24 hours of infusion (0.04% to 0.07%). Death has occurred as part of an infusion related complex which included hypoxia, pulmonary infiltrates, adult respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock.

A case of serum sickness has also been reported.

Immunologic

Immunologic side effects have included B-cell depletion in 70% to 80% of patients. This was associated with decreased serum immunoglobulins in a minority of patients. An increase in fatal infection in HIV-related lymphoma patients has been reported when rituximab (the active ingredient contained in Rituxan) was used in combination with CHOP chemotherapy compared to CHOP alone. One fatal case of a reactivation of a cytomegalovirus has been reported.

Serious viral infections, either new, reactivated or exacerbated, have been identified. The majority of patients received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. These viral infections included JC virus [progressive multifocal leukoencephalopathy (PML)], cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, hepatitis B, and hepatitis C. In some cases, the viral infections occurred up to one year following discontinuation of rituximab and have resulted in death.

An increased incidence of grade 3 and 4 infections has been reported in patients with previously treated lymphoma without known HIV infection.

In general, the incidence of infection was not increased.

The signs of PML include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. Recognition of these warning signs of PML may be obscured by the fact that these warning signs are also associated with the underlying diseases for which rituximab may be prescribed. Reactivation or exacerbation of viral infections including JC virus leading to PML may occur when patients receive rituximab for any reason. Physicians should maintain a high degree of suspicion for the development of PML in patients under treatment with rituximab. Patients who have been treated with rituximab and present or develop new neurological signs or symptoms should be evaluated for PML.

Hepatic

The majority of the patients received rituximab (the active ingredient contained in Rituxan) in combination with chemotherapy. Median time to the diagnosis of hepatitis was approximately four months after the initiation of rituximab and approximately one month after the last dose.

Patients at high risk of hepatitis B virus infection should be screened before initiation of rituximab. Carriers of hepatitis B should be closely monitored for clinical and laboratory signs of active hepatitis B virus infection and for signs of hepatitis during and for up to several months following rituximab therapy.

In patients who develop viral hepatitis, rituximab and any concomitant chemotherapy should be discontinued and appropriate treatment including antiviral therapy should be initiated. There are insufficient data regarding the safety of resuming rituximab therapy in patients who develop hepatitis subsequent to hepatitis B virus reactivation.

Hepatic side effects including hepatitis B virus reactivation with fulminant hepatitis, hepatic failure, and death have been reported in some patients with hematologic malignancies treated with rituximab.

Cardiovascular

Cardiovascular side effects have included myocardial infarction, ventricular fibrillation, and cardiogenic shock (as parts of an infusion related reaction). Hypotension (10%) has also been reported.

Respiratory

Respiratory side effects have included rhinitis (8%), bronchospasm (8%), throat irritation (6%), hypoxia, pulmonary infiltrates, fatal bronchiolitis obliterans, pneumonitis (including interstitial pneumonitis), adult respiratory distress syndrome (as parts of an infusion related reaction), and pneumocystis pneumonia.

Gastrointestinal

Gastrointestinal side effects have included nausea (18%) and vomiting (7%).

Hematologic

Hematological side effects have included leukopenia (11%), thrombocytopenia (8%), and neutropenia (7%). Severe cytopenias include neutropenia (1.9%), thrombocytopenia (1.3%), anemia (1%), and hypogammaglobulinemia. Postmarketing reports of grade 3 to 4 prolonged or late onset neutropenia have been received.

Metabolic

Metabolic side effects have included angioedema (13%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (7%).

Nervous system

Nervous system side effects have included dizziness (7%).

Dermatologic

The major clinical features of the cutaneous cytokine-release syndrome are pain in the nodules and/or urticarial reaction at the tumor sites.

Dermatologic side effects have included pruritus (10%), rash (10%), and urticaria (8%). Several cases of psoriasis have been reported. A cutaneous cytokine-release syndrome has been reported when the drug was administered locally for cutaneous B-cell lymphoma.

Renal

The risk of TLS has been higher in patients with high numbers of circulating malignant cells.

Renal side effects have included tumor lysis syndrome (TLS) (0.04% to 0.05%) within the first 12 to 24 hours following the first rituximab infusion. TLS is characterized by a rapid reduction in tumor volume and includes renal insufficiency, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia.

Oncologic

Oncologic side effects have included disease progression of Kaposi's sarcoma. A case of eccrine squamous syringometaplasia has also been reported.

Ocular

Ocular side effects including a case of bilateral conjunctivitis have been reported.

Genitourinary

Genitourinary side effects including a case of pyelonephritis have been reported.

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