Rituxan Clinical Data

REFLEX Trial: End Points
Clinical Trial Safety Data

Most common adverse events in RA pooled placebo controlled studies1

Incidence of Rituxan adverse events greater than or equal to 2% and at least 1% greater than placebo[1] View Full Size

Coded using MedDRA.
These data are based on 938 patients treated in Phase 2 and Phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered in combination with MTX.
Adapted from Rituxan full prescribing information.

Infusion Reactions

IMPORTANT SAFETY INFORMATION

  • Rituxan can cause severe, including fatal, infusion reactions
  • Severe reactions typically occurred during the first infusion with time to onset of 30 to 120 minutes
  • Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed

Rituxan RA pooled placebo-controlled studies1

Acute infusion reactions from first infusion to second infusion[2] View Full Size

Infection Data1

IMPORTANT SAFETY INFORMATION

  • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy
  • Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure)
  • New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C
  • Discontinue Rituxan for serious infections and institute appropriate anti-infective therapy

Rituxan RA pooled placebo-controlled studies1

Serious infection[1] View Full Size

These data are based on 938 patients treated in Phase 2 and Phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered with MTX.1

REFLEX Infection Data

Infections of any type were experienced by 39% of patients taking Rituxan vs 34% of patients taking placebo.1

The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis.1

REFERENCE
1.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc., and Genentech USA, Inc.; February 2012.
REFLEX Trial: Radiographic Data
Efficacy Over Multiple Courses
How Rituxan Works
Important Safety Information
Patient Selection Registry Data

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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