Rituxan Side Effects

Generic Name: rituximab

Please note - some side effects for Rituxan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rituxan - for the Consumer

Rituxan

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rituxan:

Diarrhea; flushing; indigestion; lightheadedness; mild fever and chills, especially with the first dose; mild muscle or joint pain; nausea; night sweats; runny nose; sneezing; throat irritation; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in thinking or strength; chest pain; confusion; decreased amount of urine or dark urine; decreased balance or coordination; disorientation; dizziness; drowsiness; fainting; fast or irregular heartbeat; fever, chills, cough, or persistent sore throat; headache; numbness of an arm or leg; persistent muscle, back, or joint pain; red, swollen, peeling, or blistered skin; severe or persistent stomach pain; severe weakness or fatigue; shortness of breath; skin or mouth sores or ulcers; sudden leg pain; swelling of the hands, legs, or feet; trouble walking or talking; unusual bleeding or bruising; wheezing.

Side Effects by Body System

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 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 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 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), and adult respiratory distress syndrome (as parts of an infusion related reaction).

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%), and anemia (1.0%).

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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