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Indication and Important Safety Information

Indications

OCREVUS is indicated for the treatment of:

  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Primary progressive MS, in adults.

Contraindications

OCREVUS is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reaction to OCREVUS.

Warnings and Precautions

Infusion reactions:
Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs.

Infections:
Delay OCREVUS administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with OCREVUS and after discontinuation, until B-cell repletion

Reduction in Immunoglobulins:
Monitor the level of immunoglobulins at the beginning of treatment. Monitor during and after discontinuation of treatment with OCREVUS, until B-cell repletion, and especially when recurrent serious infections are suspected. Consider discontinuing OCREVUS in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins

Malignancies:
An increased risk of malignancy, including breast cancer, may exist with OCREVUS

Most Common Adverse Reactions
RMS: The most common adverse reactions (≥10% and >REBIF): upper respiratory tract infections and infusion reactions.
PPMS: The most common adverse reactions (≥10% and >placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections.

For additional safety information, please see the [accompanying] full Prescribing Information and Medication Guide.