Ocrevus Zunovo^™

ocrelizumab and hyaluronidase-ocsq

Indications & Important Safety Information

Indications

OCREVUS ZUNOVO 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

Treatment with ocrelizumab is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening administration reactions to ocrelizumab. OCREVUS ZUNOVO is also contraindicated in patients with a history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO.

Warnings and Precautions

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

Serious, including life-threatening or fatal, bacterial, viral, parasitic and fungal infections have occurred with intravenous ocrelizumab. An increased risk of serious infections has been observed in patients who have received anti-CD20 B-cell depleting therapies. Delay OCREVUS ZUNOVO 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 ZUNOVO and after discontinuation, until B-cell repletion.

A higher proportion of intravenous ocrelizumab-treated patients experienced respiratory tract infections compared to patients taking REBIF or placebo. The infections were predominantly mild to moderate and consisted mostly of upper respiratory tract infections and bronchitis.

In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in intravenous ocrelizumab-treated patients than in REBIF-treated patients. In the placebo-controlled (PPMS) clinical trial, oral herpes was reported more frequently in the intravenous ocrelizumab-treated patients than in the patients on placebo.

Hepatitis B virus (HBV) reactivation has been reported in MS patients treated with intravenous ocrelizumab in the postmarketing setting. Perform HBV screening in all patients before initiation of treatment with OCREVUS ZUNOVO.

When initiating OCREVUS ZUNOVO after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab, consider the potential for increased immunosuppressive effect.

Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of OCREVUS ZUNOVO for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of OCREVUS ZUNOVO for non-live vaccines.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients with MS treated with intravenous ocrelizumab in the postmarketing setting. At the first sign or symptom suggestive of PML, withhold OCREVUS ZUNOVO and perform an appropriate diagnostic evaluation. Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. If PML is confirmed, treatment with OCREVUS ZUNOVO should be discontinued.

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

An increased risk of malignancy, including breast cancer, may exist with OCREVUS ZUNOVO.

Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, has been reported in patients receiving intravenous ocrelizumab in the postmarketing setting. Some cases of colitis were serious, requiring hospitalization, with a few patients requiring surgical intervention. Systemic corticosteroids were required in many of these patients. Monitor patients for immune-mediated colitis during OCREVUS ZUNOVO treatment and evaluate promptly if signs and symptoms such as new or persistent diarrhea or other gastrointestinal signs and symptoms occur.

Most Common Adverse Reactions

In patients treated with OCREVUS:

• 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.

You may report side effects to the FDA at 1-800-FDA-1088. or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

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