Ocrevus Zunovo Dosage

Hepatitis B Virus Screening

Prior to initiating ocrelizumab treatment, perform Hepatitis B virus (HBV) screening. OCREVUS ZUNOVO is contraindicated in patients with active HBV confirmed by positive results for HBsAg and anti-HBV tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.

Serum Immunoglobulins

Prior to initiating ocrelizumab treatment, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with ocrelizumab.

Vaccinations

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 ocrelizumab treatment for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ocrelizumab treatment for non-live vaccines.

Infection Assessment

Prior to every dose of OCREVUS ZUNOVO, determine whether there is an active infection. In case of active infection, delay administration of OCREVUS ZUNOVO until the infection resolves.

Recommended Premedication

Pre-medicate orally with 20 mg of dexamethasone (or an equivalent corticosteroid) and an antihistamine (e.g., desloratadine) administered at least 30 minutes prior to each OCREVUS ZUNOVO administration to reduce the risk of local and systemic injection reactions.

The addition of an antipyretic (e.g., acetaminophen) may also be considered.

Preparation of the Syringe

OCREVUS ZUNOVO should be prepared by a healthcare professional.

• Immediate use is recommended, as OCREVUS ZUNOVO does not contain any antimicrobial preservative. If the dose is not administered immediately, refer to "Storage of the Syringe" below.
• Remove the vial from refrigerated storage and allow the solution to acclimate to room temperature at or below 25°C (77°F).
• Withdraw the entire contents of OCREVUS ZUNOVO solution from the vial with a syringe and transfer needle (21G needle recommended).
• Do not dilute.
• Remove the transfer needle from the syringe and replace with a subcutaneous infusion set (e.g., winged/butterfly) containing a 24G-26G needle for injection. Use a subcutaneous infusion set with a priming volume NOT to exceed 0.8 mL for administration.
• Prime the subcutaneous infusion line with the drug product solution to eliminate the air in the infusion line and stop before the fluid reaches the needle.
• Ensure the syringe contains exactly 23 mL of drug product solution after priming and expelling any excess volume from the syringe.
• Administer immediately to avoid needle clogging. DO NOT store the prepared syringe that has been attached to the already primed subcutaneous infusion set.

Administration

• Administer 23 mL of OCREVUS ZUNOVO subcutaneously in the abdomen over approximately 10 minutes. DO NOT administer the remaining priming volume in the subcutaneous infusion set to the patient.
• The recommended injection site is the abdomen, except for 2 inches (5 cm) around the navel. Do not administer OCREVUS ZUNOVO injections into areas where the skin is red, bruised, tender, or hard, or areas where there are moles or scars.

Storage of the Syringe

• If the dose is not to be administered immediately, use aseptic technique to withdraw the entire OCREVUS ZUNOVO contents from the vial into the syringe to account for the dose volume (23 mL) plus the priming volume for the subcutaneous infusion set. Replace the transfer needle with a syringe closing cap. DO NOT attach a subcutaneous infusion set.
• If not used immediately, the closed syringe can be refrigerated (2°C to 8°C [36°F to 46°F]) for up to 72 hours followed by 8 hours at ambient temperatures at or below 25°C (77°F) in diffuse daylight.
• If the prepared syringe was stored at 2°C to 8°C (36°F to 46°F), allow the syringe to acclimate to room temperature prior to administration.