Ocrelizumab Injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving ocrelizumab injection,

• tell your doctor and pharmacist if you are allergic to ocrelizumab, any other medications, or any of the ingredients in ocrelizumab injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications that supress your immune system such as the following: corticosteroids including dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); cyclosporine (Gengraf, Neoral, Sandimmune); daclizumab (Zinbryta); fingolimod (Gilenya); mitoxantrone; natalizumab (Tysabri); tacrolimus (Astagraf, Prograf); or teriflunomide (Aubagio). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had hepatitis B (HBV; a virus that infects the liver and may cause severe liver damage or liver cancer). Your doctor will probably tell you not to receive ocrelizumab.
• tell your doctor if you have any type of infection before you begin your treatment with ocrelizumab injection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Use effective birth control during your treatment with ocrelizumab and for 6 months after the final dose. If you become pregnant while receiving ocrelizumab, call your doctor.
• check with your doctor to see if you need to receive any vaccinations. Tell your doctor if you have received a vaccine within the past 6 weeks. Do not have any vaccinations without talking to your doctor during your treatment.

Ocrelizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

1. swelling or pain in hands, arms, legs, or feet
2. diarrhea

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• fever, chills, persistent cough, or other signs of infection
• mouth sores
• shingles (a rash that can occur in people who have had chickenpox in the past)
• sores around the genitals or rectum
• skin infection
• weakness on one side of the body; clumsiness of arms and legs; vision changes; changes in thinking, memory, and orientation; confusion; or personality changes

Ocrelizumab may increase your risk of certain cancers, including breast cancer. Talk to your doctor about the risks of receiving this medication.

Ocrelizumab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Dosage Forms And Strengths

Injection: 300 mg/10 mL (30 mg/mL) clear or slightly opalescent, and colorless to pale brown solution in a single-dose vial.

Storage And Handling

OCREVUS (ocrelizumab) injection is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 300 mg/10 mL (30 mg/mL) single-dose vial (NDC 50242-150-01).

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

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: Mar 2017

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Infusion Reactions [see WARNINGS AND PRECAUTIONS]
• Infections [see WARNINGS AND PRECAUTIONS]
• Malignancies [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of OCREVUS has been evaluated in 1311 patients across MS clinical studies, which included 825 patients in active-controlled clinical trials in patients with relapsing forms of MS (RMS) and 486 patients in a placebo-controlled study in patients with primary progressive MS (PPMS).

In active-controlled clinical trials (Study 1 and Study 2), 825 patients with RMS received OCREVUS 600 mg intravenously every 24 weeks (initial treatment was given as two separate 300 mg infusions at Weeks 0 and 2) [see Clinical Studies]. The overall exposure in the 96-week controlled treatment periods was 1448 patient-years.

The most common adverse reactions in RMS trials (incidence ≥ ; 10%) were upper respiratory tract infections and infusion reactions. Table 2 summarizes the adverse reactions that occurred in RMS trials (Study 1 and Study 2).

Table 2 : Adverse Reactions in Adult Patients with RMS with an Incidence of at least 5% for OCREVUS and Higher than REBIF

In a placebo-controlled clinical trial (Study 3), a total of 486 patients with PPMS received one course of OCREVUS (600 mg of OCREVUS administered as two 300 mg infusions two weeks apart) given intravenously every 24 weeks and 239 patients received placebo intravenously [see Clinical Studies]. The overall exposure in the controlled treatment period was 1416 patient-years, with median treatment duration of 3 years.

The most common adverse reactions in the PPMS trial (incidence ≥ ; 10%) were upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections. Table 3 summarizes the adverse reactions that occurred in the PPMS trial (Study 3).

Table 3 : Adverse Reactions in Adult Patients with PPMS with an Incidence of at least 5% for OCREVUS and Higher than Placebo

Laboratory Abnormalities

OCREVUS decreased total immunoglobulins with the greatest decline seen in IgM levels. In MS clinical trials, there was no apparent association between immunoglobulin decrease and risk for serious infections.

In the active-controlled (RMS) trials (Study 1 and Study 2), the proportion of patients at baseline reporting IgG, IgA, and IgM below the lower limit of normal (LLN) in OCREVUS-treated patients was 0.5%, 1.5%, and 0.1%, respectively. Following treatment, the proportion of OCREVUS-treated patients reporting IgG, IgA, and IgM below the LLN at 96 weeks was 1.5%, 2.4%, and 16.5%, respectively.

In the placebo-controlled (PPMS) trial (Study 3), the proportion of patients at baseline reporting IgG, IgA, and IgM below the LLN in OCREVUS-treated patients was 0.0%, 0.2%, and 0.2%, respectively. Following treatment, the proportion of OCREVUS-treated patients reporting IgG, IgA, and IgM below the LLN at 120 weeks was 1.1%, 0.5%, and 15.5%, respectively.

In the PPMS clinical trial (Study 3), decreased neutrophil counts occurred in 13% of OCREVUS-treated patients compared to 10% in placebo patients. The majority of the decreased neutrophil counts were only observed once for a given patient treated with OCREVUS and were between LLN - 1.5 x 109/L and 1.0 x 109/L. Overall, 1% of the patients in the OCREVUS group had neutrophil counts less than 1.0 x 109/L and these were not associated with an infection.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity data are highly dependent on the sensitivity and specificity of the test methods used. Additionally, the observed incidence of a positive result in a test method may be influenced by several factors, including sample handling, timing of sample collection, drug interference, concomitant medication, and the underlying disease. Therefore, comparison of the incidence of antibodies to OCREVUS with the incidence of antibodies to other products may be misleading.

Patients in MS trials (Study 1, Study 2, and Study 3) were tested at multiple time points (baseline and every 6 months post-treatment for the duration of the trial) for anti-drug antibodies (ADAs). Out of 1311 patients treated with OCREVUS, 12 (~1%) tested positive for ADAs, of which 2 patients tested positive for neutralizing antibodies. These data are not adequate to assess the impact of ADAs on the safety and efficacy of OCREVUS.

Read the entire FDA prescribing information for Ocrevus (Ocrelizumab Injection)

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© Ocrevus Patient Information is supplied by Cerner Multum, Inc. and Ocrevus Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.