Understanding the Rituxan Safety Information
Understanding the Rituxan Safety Information
When considering any treatment, it’s important to understand the potential risks and benefits and to weigh them with your healthcare provider. A treatment’s safety information, which can be found in its Medication Guide, is provided to inform you about the potential risks.
Among the risks associated with Rituxan® (rituximab) are some potentially serious and life-threatening side effects (see below). It’s important to know that while they are all considered risks in the treatment of RA, some of these side effects have only occurred in people with non-Hodgkin’s lymphoma (NHL).
Serious infections
Rituxan can increase the chances of getting infections. In clinical studies, serious infections occurred in 2% of patients taking Rituxan. And the most common of these infections was pneumonia.
A rare brain infection called progressive multifocal leukoencephalopathy, or PML, has occurred in patients taking Rituxan. While PML is rare in patients taking Rituxan for RA, it is still a risk, and you should discuss this risk with your doctor. There is no known treatment, prevention, or cure for PML. PML can occur during treatment with Rituxan or after treatment has finished.
Severe infusion reactions
Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your doctor should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction.
In Rituxan studies, less than 1% of all infusion reactions were serious, and most were managed by slowing or stopping the infusion and/or giving an antihistamine or corticosteroid. To date, there have been no reports of fatal infusion reactions in the treatment of RA with Rituxan. It is still a risk in RA, and you should discuss this risk with your doctor.
TLS and severe skin reactions
TLS and severe skin reactions have occurred in patients taking Rituxan for NHL, but have not been reported in patients with RA. TLS is a condition that can lead to kidney failure and the need for dialysis.
Other serious, potentially life threatening side effects
Low blood cell counts. Your doctor may do a blood test during treatment with Rituxan to check your blood cell counts.
Hepatitis B virus reactivation. Receiving Rituxan® (rituximab) could cause the hepatitis B virus to become an active infection again. This may cause serious liver problems.
Heart problems. Rituxan can cause chest pain and irregular heartbeats, which may require treatment.
For more information, please see the Rituxan full Prescribing Information, including Medication Guide, and discuss any questions you may have with your doctor.
