Ocrelizumab and hyaluronidase (human recombinant)
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
CD20-directed Cytolytic Antibody, Endoglycosidase
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Important Administration Information OCREVUS ZUNOVO is for subcutaneous use in the abdomen only. OCREVUS ZUNOVO has different dosage and administration instructions than intravenous ocrelizumab. OCREVUS ZUNOVO should be administered via subcutaneous injection by a healthcare professional.
Preparation and Administration To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is OCREVUS ZUNOVO and not intravenous ocrelizumab. Visually inspect the vial for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use the vial if particulates or discoloration are present. Do not shake. Discard any unused portion remaining in the vial. OCREVUS ZUNOVO is compatible with polypropylene (PP), polycarbonate (PC), polyethylene (PE), stainless steel (SS), polyvinylchloride (PVC), and polyurethane (PUR). 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. Label the syringe with the peel-off label. 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.
Drug interactions
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- Ocrelizumab and hyaluronidase (human recombinant)
Label text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Immunosuppressive or Immune-Modulating Therapies The concomitant use of OCREVUS ZUNOVO and other immune-modulating or immunosuppressive therapies, including immunosuppressant doses of corticosteroids, is expected to increase the risk of immunosuppression. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with OCREVUS ZUNOVO. When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS ZUNOVO [see Warnings and Precautions (5.2) ].
7.2 Vaccinations A Phase 3b randomized, open-label study examined the concomitant use of intravenous ocrelizumab and several non-live vaccines in adults 18-55 years of age with relapsing forms of MS (68 subjects undergoing treatment with intravenous ocrelizumab at the time of vaccination and 34 subjects not undergoing treatment with intravenous ocrelizumab at the time of vaccination). Concomitant exposure to intravenous ocrelizumab attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide, pneumococcal conjugate vaccines, and seasonal inactivated influenza vaccines.
The impact of the observed attenuation on vaccine effectiveness in this patient population is unknown. The safety and effectiveness of live or live-attenuated vaccines administered concomitantly with ocrelizumab have not been assessed [see Warnings and Precautions (5.2) ].
Contraindications
4 CONTRAINDICATIONS OCREVUS ZUNOVO is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ] A history of life-threatening administration reaction to ocrelizumab [see Warnings and Precautions (5.1) ] A history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO [see Warnings and Precautions (5.1) ] . Active hepatitis B virus infection ( 4 ) History of life-threatening administration reactions to ocrelizumab ( 4 ) History of hypersensitivity to ocrelizumab, hyaluronidase, or to any component of OCREVUS ZUNOVO ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ocrelizumab and hyaluronidase (human recombinant). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary OCREVUS ZUNOVO is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS ZUNOVO or ocrelizumab-containing products in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to OCREVUS ZUNOVO or ocrelizumab-containing products have not been studied in clinical trials.
The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2) ] . Following administration of ocrelizumab to pregnant monkeys at doses similar to or greater than those used clinically, increased perinatal mortality, depletion of B-cell populations, and renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data OCREVUS ZUNOVO for subcutaneous injection contains ocrelizumab and hyaluronidase [see Description (11) ]. Ocrelizumab: - Following intravenous administration of ocrelizumab to monkeys during organogenesis (loading doses of 15 or 75 mg/kg on gestation days 20, 21, and 22, followed by weekly doses of 20 or 100 mg/kg), depletion of B-lymphocytes in lymphoid tissue (spleen and lymph nodes) was observed in fetuses at both doses.
- Intravenous administration of ocrelizumab (three daily loading doses of 15 or 75 mg/kg, followed by weekly doses of 20 or 100 mg/kg) to pregnant monkeys throughout the period of organogenesis and continuing through the neonatal period resulted in perinatal deaths (some associated with bacterial infections), renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe decreases in circulating B-lymphocytes in neonates. The cause of the neonatal deaths is uncertain; however, both affected neonates were found to have bacterial infections. Reduced testicular weight was observed in neonates at the high dose.
- A no-effect dose for adverse developmental effects was not identified; the doses…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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