Ocrelizumab

What is ocrelizumab?

ocrelizumab (OCREVUS) is a CD20-directed cytolytic antibody for the treatment of multiple sclerosis (MS).

What are the uses of this medicine?

This medicine used to treat:

• 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.

How does this medicine work?

• Ocrelizumab (ok" re liz' ue mab) is a humanized IgG1 monoclonal antibody to CD20, a cell surface antigen found on pre-B cells, mature B cells and memory B cells. 
• Engagement of CD20 causes cell lysis resulting in B cell depletion which may be beneficial in autoimmune conditions mediated by autoantibodies.  Ocrelizumab like rituximab is directed against CD20 but has a broader reactivity and is a humanized monoclonal, unlike rituximab that is a mouse-human chimeric molecule for which reason ocrelizumab may be less likely than rituximab to cause hypersensitivity reactions.  Ocrelizumab was found to be beneficial in multiple sclerosis, decreasing rates of relapse as well as slowing progression. 

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Active HBV infection
• A history of life-threatening infusion reaction to OCREVUS

What drug interactions can this medicine cause?

The concomitant use of OCREVUS and other immune-modulating or immunosuppressive therapies, including immunosuppressant doses of corticosteroids, is expected to increase the risk of immunosuppression. The safety and effectiveness of live or live-attenuated vaccines administered concomitantly with OCREVUS have not been assessed.

Is this medicine FDA approved?

• Ocrelizumab was approved for use in the United States in 2017 for both progressive and relapsing multiple sclerosis. 
• Ocrelizumab is under evaluation in other autoimmune and malignant conditions but is not approved for these uses. 

How should this medicine be used?

Hepatitis B virus and quantitative serum immunoglobulin screening are required before the first dose. Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of OCREVUS for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of OCREVUS for non-live vaccines. Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion.

Recommended Dosageː

• Administer OCREVUS by intravenous infusion
• Start dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
• Subsequent doses: 600 mg intravenous infusion every 6 months

Administration

• Must be diluted prior to administration.
• OCREVUS is given through a needle placed in your vein (intravenous infusion) in your arm.
• Before treatment with OCREVUS, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions.
• Your first full dose of OCREVUS will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours and 30 minutes.
• Your next doses of OCREVUS will be given as 1 infusion every 6 months. These infusions will last about 2 hours to 3 hours and 30 minutes depending on the infusion rate prescribed by your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• OCREVUS

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infections
• infusion reactions
• skin infections
• lower respiratory tract infections

OCREVUS can cause serious side effects, including:

• Infusion reactions
• Infection
• Decreased immunoglobulins

What special precautions should I follow?

• OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. 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.
• OCREVUS may increases the risk of 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.
• Decreased immunoglobulin levels are observed with OCREVUS treatment. 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.
• An increased risk of malignancy, including breast cancer, may exist with OCREVUS.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with use of OCREVUS in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to OCREVUS during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com.

Can this medicine be used in children?

• Safety and effectiveness of OCREVUS in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ocrelizumab.
• Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate.

Who manufactures and distributes this medicine?

• Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco.

What should I know about storage and disposal of this medication?

• Store OCREVUS vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light.
• Do not freeze or shake.

• Dailymed label info on Ocrelizumab
• FDA Ocrelizumab

Ocrelizumab Resources
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