Safety Profile

Important Safety Information
Infusion Reactions
Infections
Post-Rituxan Safety

Safety follow-up analysis1

Patients receiving rituximab in global clinical trials View Full Size
*
Patients may have received multiple biologic DMARDs in follow-up.
†
Two patients in each group subsequently received a TNF inhibitor.
‡
Three patients received tocilizumab and 2 received experimental drug.
Patients receiving Rituxan plus methotrexate within an international clinical trial program entered safety follow-up. Peripheral B-cell counts were monitored for ≥48 weeks. Patients were permitted to receive biologic DMARDs. All serious adverse events or infections that required IV antibiotics were collected.
 

Median time to subsequent treatment post Rituxan: 8 months (range 0.1 month to 52 months).1

Serious infections per 100 patient-years before another biologic and after another biologic, respectively (n=283) View Full Size
*
Defined as the period following receipt of first dose of Rituxan.
Adapted from ACR 2010.1
  • The rates of serious infections in patients who received their first subsequent biologic DMARD <6 months (n=87) and ≥6 months (n=196) after their last Rituxan dose were 5.04 and 4.94 events per 100 patient-years, respectively
  • 83% of patients had peripheral B-cell levels below the lower limit of normal at time of subsequent treatment1
  • Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B-cell depletion following treatment with rituximab
  • Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly
 

Safety of biologics in B-cell depleted patients

Dr. Daniel Furst hosts a video presentation on the safety of biologics used after Rituxan, from findings by Dr. Mark Genovese and Colleagues.

 

Click here to view other Rituxan videos

REFERENCE
1.
Genovese MC, Breedveld F, Emery P, et al. Rate of serious infections in RA patients who subsequently receive other biologic therapies after discontinuing rituximab treatment. Presented at the Annual Scientific Meeting of the American College of Rheumatology. November 6-11, 2010, Atlanta, GA. Poster 403.

May we also suggest

INDICATION

Rituxan (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Rituxan is not recommended for treatment of patients with severe active infections.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Rituxan administration can result in serious, including fatal, adverse reactions. These include:

WARNINGS AND PRECAUTIONS

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

Patients should be closely observed for signs of infection if biologic agents and /or DMARDs other than methotrexate are used concomitantly.

Common adverse reactions include infusion reactions and infections.

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to Rituxan infusion.

Indication & Safety INFORMATION

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