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Indication and Important Safety Information

 

  • Rituxan® (rituximab), in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagonist therapies
  • Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
  • Rituxan® (rituximab), is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris

Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan.

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

  • Tumor lysis syndrome (TLS): Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
  • Infections: Withhold Rituxan and institute appropriate anti-infective therapy. Rituxan is not recommended for use in patients with severe, active infections
  • Cardiovascular adverse reactions: Discontinue infusions in case of serious or life-threatening events
  • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria
  • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Immunizations: Live virus vaccinations prior to or during Rituxan treatment are not recommended
  • Embryo-Fetal toxicity: Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception
  • Patients with RA should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
  • The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended
  • Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA, MPA, or PV patients exhibiting peripheral B-cell depletion following treatment with Rituxan
  • The safety and efficacy of retreatment with Rituxan have not been established in patients with GPA and MPA

Rheumatoid Arthritis (RA)
Most common adverse reactions (≥10%) in clinical trials: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Other important adverse reactions include infusion reactions, serious infections, and cardiovascular events.

Granulomatosis With Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Most common adverse reactions (≥15%) in the clinical study were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion reactions.

Pemphigus Vulgaris (PV)
Most common adverse reactions (≥15%) in the clinical trial were infusion reactions and depression. Other important adverse reactions include infections.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional Important Safety Information, please see the Rituxan full Prescribing Information, including BOXED WARNINGS.

ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

RISK OF SERIOUS INFECTIONS:

Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.

Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations. Use ACTEMRA with caution in patients who may be at risk for GI perforations.

Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.

Hypersensitivity reactions, including anaphylaxis and death, have occurred.

  • If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently.

Avoid use of live vaccines concurrently with ACTEMRA, as clinical safety has not been established.

Other potential risks of ACTEMRA include demyelinating disorders and malignancies.
Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.

Common adverse reactions included upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, diarrhea and injection-site reactions (SC only).

Common adverse reactions in SJIA studies included upper respiratory tract infections, headache, nasopharyngitis, and diarrhea.

In general, the types of adverse drug reactions in patients with PJIA were consistent with those seen in RA and SJIA patients.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information, including BOXED WARNING, for additional important safety information.