From the Guidelines
Rituxan (rituximab) is associated with several long-term injuries, including lung injury, hepatitis B reactivation, and hypogammaglobulinemia, which can increase the risk of infections and other complications. The evidence suggests that rituximab can cause lung injury, specifically interstitial pneumonitis, which can be fatal in some cases 1. Additionally, rituximab has been linked to hepatitis B reactivation, particularly in patients with a history of hepatitis B infection, which can lead to liver failure and mortality 1. Hypogammaglobulinemia, a condition characterized by low levels of immunoglobulins, has also been reported in patients receiving rituximab, which can increase the risk of infections 1.
Some of the key long-term injuries associated with rituximab include:
- Lung injury, such as interstitial pneumonitis
- Hepatitis B reactivation
- Hypogammaglobulinemia
- Increased risk of infections, such as progressive multifocal leukoencephalopathy
- Serum sickness, particularly in pediatric patients with idiopathic thrombocytopenic purpura (ITP)
The mechanism of these injuries is not fully understood, but it is thought to involve an inflammatory reaction triggered by the medication. Symptoms can develop within a few weeks of treatment, but can also occur after multiple courses or even after the first dose. Management typically involves discontinuation of rituximab, supportive care, and often corticosteroid treatment. Patients receiving Rituxan should be monitored for respiratory symptoms, and any new or worsening breathing problems should prompt immediate medical evaluation. Healthcare providers should consider these potential complications when assessing respiratory symptoms in patients who have received rituximab 1.
From the FDA Drug Label
In patients who develop reactivation of HBV while on RITUXAN, immediately discontinue RITUXAN and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming RITUXAN treatment in patients who develop HBV reactivation JC virus infection resulting in PML and death can occur in RITUXAN-treated patients with hematologic malignancies or with autoimmune diseases. Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy. Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving RITUXAN. Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy.
Long-term injuries associated with Rituxan (rituximab) include:
- Hepatitis B reactivation
- Progressive Multifocal Leukoencephalopathy (PML)
- Serious infections
- Cardiac adverse reactions
- Renal toxicity
- Bowel obstruction and perforation These injuries can be severe and potentially fatal, and may occur during or after treatment with RITUXAN 2.
From the Research
Long-term Injuries Associated with Rituxan (Rituximab)
- Rituximab has been associated with an increased risk of infections, including hepatitis B reactivation, Pneumocystis pneumonia, and progressive multifocal leukoencephalopathy (PML) 3, 4, 5, 6, 7
- PML is a rare and usually fatal central nervous system disorder characterized by infection-induced demyelination of white matter due to the opportunistic reactivation of John Cunningham virus in an immunocompromised patient 4, 5, 7
- The risk of PML is difficult to quantify due to confounding factors, such as concomitant use of immunosuppressive or chemotherapeutic agents and underlying conditions, as well as under-reporting 3, 5
- Other long-term injuries associated with rituximab include late-onset neutropenia, defects of immune reconstitution with associated immune compromise, reactivation of hepatitis, intestinal perforation, and interstitial pneumonitis 6
- The development of these adverse events is likely due to the prolonged B-lymphocyte depletion caused by rituximab, which can allow opportunistic infections to occur 3, 5, 7
Specific Adverse Events
- Hepatitis B reactivation: a serious and potentially fatal infection that can occur in patients treated with rituximab, particularly those with a history of hepatitis B infection 3, 6
- Pneumocystis pneumonia: a rare but potentially life-threatening infection that can occur in patients treated with rituximab, particularly those with underlying immunodeficiency 3
- Progressive multifocal leukoencephalopathy (PML): a rare and usually fatal central nervous system disorder that can occur in patients treated with rituximab, particularly those with underlying immunodeficiency 4, 5, 7