FDA-filed SPL labeling · retrieved through openFDA

Hyaluronidase / Ocrelizumab

Hyaluronidase / Ocrelizumab (Ocrevus Zunovo) is a subcutaneous injection used to treat relapsing forms of multiple sclerosis and primary progressive multiple sclerosis in adults.

Brand name Ocrevus Zunovo
Drug classes Cd20-directed Cytolytic Antibody
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 28, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 17, 2026
AvailabilityRx
Earliest approval/marketing year 2024
FDA-listed product records 2
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 20, 2026
Hyaluronidase / Ocrelizumab at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ocrevus Zunovo is a twice-yearly subcutaneous injection that treats relapsing forms of MS and primary progressive MS in adults by reducing the B-cells that drive nerve damage. It is given by a healthcare professional with premedication and monitoring, since injection reactions and serious infections are the most important risks to watch for. Keeping all scheduled appointments and reporting any new or unusual symptoms promptly will help you get the most benefit from this treatment safely.

📖 Hyaluronidase / Ocrelizumab: Patient Information Guide

A plain-language walkthrough of Hyaluronidase / Ocrelizumab — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Ocrevus Zunovo (hyaluronidase / ocrelizumab) subcutaneous injection is approved for adults with multiple sclerosis (MS). Here are the specific conditions it treats:

  • Ocrevus Zunovo treats relapsing forms of MS in adults, including:
    • Clinically isolated syndrome (a first episode of MS-like symptoms)
    • Relapsing-remitting MS (periods of attacks followed by recovery)
    • Active secondary progressive MS (a progressing form that still has relapses)
  • Ocrevus Zunovo also treats primary progressive MS (PPMS) in adults — a form where disability steadily worsens from the start without clear relapses
⚙️How it works

Ocrelizumab is an antibody that targets a protein called CD20 on B lymphocytes — immune cells that play a role in attacking the myelin (protective coating) around nerves in MS. By binding to these B-cells, ocrelizumab triggers their destruction, which is believed to reduce the immune-driven nerve damage that causes MS symptoms. Hyaluronidase, the second ingredient, temporarily breaks down a substance in the tissue under the skin, creating a pathway that allows the large ocrelizumab molecule to be absorbed efficiently after a subcutaneous injection; this effect reverses on its own within 24 to 48 hours.

💊How it's taken

Ocrevus Zunovo is given as a subcutaneous (under-the-skin) injection into the abdomen by a healthcare professional approximately every 6 months — doses must be separated by at least 5 months. Before every dose, you will take premedication by mouth (a steroid and antihistamine, and optionally acetaminophen) at least 30 minutes beforehand to lower the risk of a reaction.

  • If a dose is missed, take it as soon as possible and reset the 6-month schedule from that point — do not simply wait for the next scheduled date
  • After your first injection, you will be observed for at least one hour; after later injections, for at least 15 minutes
  • Ocrevus Zunovo has different dosing instructions than intravenous ocrelizumab — they are not interchangeable without guidance from your prescriber
🤒Side effects — in detail

The most commonly reported side effect with Ocrevus Zunovo is injection reactions — experienced by about half of patients after the first dose.

  • Local injection reactions: redness, pain, swelling, or itching at the injection site
  • Systemic injection reactions: headache and nausea
  • Upper respiratory tract infections (colds, sinusitis)
  • Lower respiratory tract infections (bronchitis)
  • Herpes virus infections (cold sores, shingles, genital herpes)
  • Skin infections
  • Depression
  • Back pain or pain in the extremities

Serious reactions — including life-threatening infections, PML (a rare brain infection), liver injury, and immune-mediated colitis — have been reported. Contact your doctor or seek emergency care if you develop severe or unusual symptoms.

⚠️Warnings & precautions
  • Serious and fatal infections: Because Ocrevus Zunovo depletes B-cells, it weakens your immune system. Bacterial, viral, fungal, and parasitic infections — including serious herpes infections, respiratory infections, and hepatitis B reactivation — have been reported. Treatment should be delayed if you have an active infection.
  • Injection reactions: Nearly half of patients experience a reaction with the first injection. Reactions can occur during or within 24 hours after the injection. Life-threatening reactions require immediately stopping the medication permanently.
  • Progressive multifocal leukoencephalopathy (PML): A rare but often fatal or severely disabling brain infection caused by the JC virus has been reported. New neurological symptoms should prompt immediate evaluation and possibly stopping the drug.
  • Falling immunoglobulin (antibody) levels: Prolonged use can lower your body's antibody levels, raising the risk of serious infections. Levels are monitored before and during treatment.
  • Malignancy: An increased risk of cancer, including breast cancer, may exist with this medication.
  • Immune-mediated colitis and liver injury: Inflammation of the colon and clinically significant liver injury have been reported; monitor for new digestive symptoms or signs of liver problems.
  • Vaccines: Live or live-attenuated vaccines must not be given during treatment or until B-cells recover. Non-live vaccines may be less effective during treatment.
🔀What it interacts with

Ocrevus Zunovo can interact with other medications that affect the immune system, and it can also reduce how well vaccines work.

  • Immunosuppressants and immune-modulating drugs: Combining Ocrevus Zunovo with other drugs that suppress immunity increases the risk of serious infections — this includes high-dose corticosteroids and other MS therapies
  • Specific MS drugs requiring careful transition: Fingolimod, natalizumab, daclizumab, teriflunomide, and mitoxantrone all have prolonged immune effects; your doctor will factor this in when switching to Ocrevus Zunovo
  • Live or live-attenuated vaccines: Not recommended during treatment or until B-cells recover; ideally given at least 4 weeks before starting Ocrevus Zunovo
  • Non-live vaccines (flu, tetanus, pneumococcal): Ocrevus Zunovo reduces the immune response to these vaccines, potentially making them less protective

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use Ocrevus Zunovo if you have an active hepatitis B virus (HBV) infection
  • Do not use it if you have had a life-threatening reaction to ocrelizumab in the past
  • Do not use it if you have a known severe allergy (hypersensitivity) to ocrelizumab, hyaluronidase, or any ingredient in Ocrevus Zunovo
  • Tell your doctor if you are a hepatitis B carrier or have been exposed to hepatitis B in the past — liver specialist consultation may be needed before starting
  • Tell your doctor if your immunoglobulin (antibody) levels are low — an immunology consultation may be needed first
  • Pregnancy: Based on animal data, this medication may harm a fetus. Women who can become pregnant should use effective contraception during treatment and for 6 months after the last dose
  • Breastfeeding: It is unknown whether ocrelizumab passes into human milk; discuss the risks and benefits with your doctor
  • Infants born to mothers who used Ocrevus Zunovo during pregnancy should not receive live vaccines until their B-cell counts have recovered
  • Children: Safety and effectiveness in pediatric patients have not been established
  • Older adults (65+): Not enough data are available to know if older patients respond differently
  • Mild kidney or liver impairment: Included in clinical trials without significant pharmacokinetic changes, but discuss your full medical history with your doctor
📡Pharmacodynamics — effects in the body

Ocrevus Zunovo works by depleting B lymphocytes — a type of immune cell — in the blood. Within 14 days of an injection, measurable CD19+ B-cell counts drop significantly. After stopping the medication, B-cell counts typically begin to recover; the median time for counts to return to baseline or the lower limit of normal is about 72 weeks after the last dose, and 90% of patients see recovery within 2.5 years. Prolonged treatment is associated with decreasing immunoglobulin (antibody) levels, particularly IgM, and lower IgG levels have been linked to a higher rate of serious infections.

🔬Pharmacokinetics — how your body processes it

After a subcutaneous injection of Ocrevus Zunovo, ocrelizumab reaches peak blood levels in about 4 days and has an estimated bioavailability of 81%, meaning the body absorbs most of the dose. The terminal elimination half-life — the time it takes for blood levels to fall by half — is approximately 20 days, and the drug is cleared primarily through natural protein breakdown (catabolism) rather than kidney or liver metabolism. Pharmacokinetic studies showed that the subcutaneous dose of Ocrevus Zunovo and the intravenous ocrelizumab dose produced exposures that were not clinically meaningfully different. Mild kidney or mild liver impairment did not significantly change how the body handles ocrelizumab.

📦How to store it

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

📄 Written from Hyaluronidase / Ocrelizumab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Hyaluronidase / Ocrelizumab — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Ocrevus Zunovo and why has my doctor prescribed it for my MS?
Ocrevus Zunovo is a medication that contains two ingredients — ocrelizumab and hyaluronidase. Ocrelizumab is an antibody that targets and depletes certain immune cells (B-cells) that are thought to drive the nerve damage in MS. The hyaluronidase helps the drug get absorbed when it's injected under the skin. Your doctor has prescribed it because it's approved to treat relapsing forms of MS and primary progressive MS in adults, and it's given just twice a year, which many people find convenient.
How is this injection given, and do I do it myself at home?
No — Ocrevus Zunovo is always given by a healthcare professional, not at home by yourself. It's injected under the skin of your abdomen over about 10 minutes, every 6 months. Before the injection, you'll take premedication — usually a steroid tablet and an antihistamine — at least 30 minutes beforehand to reduce the chance of a reaction. After your very first injection, you'll be monitored for at least an hour; for later doses, at least 15 minutes. It's a quick appointment but the monitoring time is important.
What side effects should I expect, and which ones mean I need to call someone right away?
The most common thing people experience is an injection reaction — redness, swelling, or itching at the site, and sometimes headache or nausea. About half of patients have some kind of reaction with the first dose, and most are mild to moderate. What you need to watch for more seriously are signs of infection — fever, chills, difficulty breathing, or sores that won't heal — since this medication lowers your immune defenses. Also call your doctor right away if you notice any new or unusual neurological symptoms like weakness on one side, vision changes, or confusion — those need prompt evaluation.
Will I need any vaccines or blood tests before or during treatment?
Yes — before your first dose, your doctor will check your hepatitis B status, your immunoglobulin (antibody) levels, and your liver function. If you need any vaccines, it's best to get live vaccines at least 4 weeks before starting, and non-live vaccines (like flu or tetanus) at least 2 weeks before if possible. Once you're on Ocrevus Zunovo, live vaccines are not recommended, and non-live vaccines may work less well because the medication reduces your immune response. Your care team will monitor your blood levels throughout treatment.
Is this medication safe to take if I'm pregnant or thinking about becoming pregnant?
This is a really important conversation to have with your doctor before starting or while you're on it. Animal studies showed potential harm to developing fetuses, so women who can become pregnant are advised to use reliable contraception during treatment and for 6 months after the last dose. If you're already pregnant, the risks and benefits need to be carefully weighed together with your neurologist. If you do become pregnant while on it, let your doctor know right away, and be aware that babies born to mothers who took this medication may need extra care before receiving certain vaccines.
Are there other medications I need to be careful about while taking Ocrevus Zunovo?
Yes — because Ocrevus Zunovo suppresses part of your immune system, combining it with other drugs that do the same thing can raise the risk of serious infections. This includes other MS medications like fingolimod, natalizumab, or mitoxantrone. If you're switching from one of those to Ocrevus Zunovo, your doctor will plan the timing carefully. Always give your full medication list — including supplements — to your care team so they can check for any concerns before you start.
Is Hyaluronidase / Ocrelizumab available over the counter?
Hyaluronidase / Ocrelizumab is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Hyaluronidase / Ocrelizumab first available?
Hyaluronidase / Ocrelizumab has been available in the United States since at least 2024, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Hyaluronidase / Ocrelizumab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Hyaluronidase / Ocrelizumab comes

Hyaluronidase / Ocrelizumab is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Under the skin
Brands Ocrevus Zunovo
How this form is used
What it may be used for
  • Ocrevus Zunovo subcutaneous injection is used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Ocrevus Zunovo subcutaneous injection is used to treat primary progressive MS in adults
Important instructions
  • Ocrevus Zunovo is administered by a healthcare professional as a subcutaneous injection into the abdomen (not within 2 inches of the navel) only — not self-injected at home
  • Ocrevus Zunovo is given over approximately 10 minutes every 6 months; doses must be separated by at least 5 months
  • Before each Ocrevus Zunovo injection, take premedication (a steroid and antihistamine, and optionally a fever reducer) at least 30 minutes beforehand to reduce reaction risk
  • After the first Ocrevus Zunovo injection, remain monitored for at least one hour; after subsequent injections, for at least 15 minutes
Available strengths 2 strengths
2 FDA-listed product records

📊 Hyaluronidase / Ocrelizumab across the U.S. market

How Hyaluronidase / Ocrelizumab appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
2
FDA-listed product records
2024
First marketed

📈 How widely Hyaluronidase / Ocrelizumab is used

A general measure of how commonly Hyaluronidase / Ocrelizumab is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hyaluronidase / Ocrelizumab is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

15
Medicaid prescriptions filled (Q1–Q4 2025)
$553,584 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hyaluronidase / Ocrelizumab prescribed? Of the 1,596 medications we measure, Hyaluronidase / Ocrelizumab ranks #1,575 by Medicaid prescriptions — more than 1% of them.

Where Hyaluronidase / Ocrelizumab ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Hyaluronidase / Ocrelizumab product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

23 ML hyaluronidase-ocsq 1000 UNT/ML / ocrelizumab-ocsq 40 MG/ML Injection

15 Medicaid prescriptions (Q1–Q4 2025) 100% of Hyaluronidase / Ocrelizumab prescriptions shown $553,584 gross reimbursement (before rebates) ≈ $36,906 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693458

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hyaluronidase / Ocrelizumab, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Hyaluronidase / Ocrelizumab NDCs with Medicaid activity.

🔍 Compare Hyaluronidase / Ocrelizumab products

A representative set of FDA-listed product records for Hyaluronidase / Ocrelizumab — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
OCRELIZUMAB 920 mg/23 mL; HYALURONIDASE (HUMAN RECOMBINANT) 23000 U/23 mL Subcutaneous Genentech, Inc. BLA View NDC →
OCRELIZUMAB 23000 U/23 mL; HYALURONIDASE (HUMAN RECOMBINANT) 920 mg/23 mL Subcutaneous Genentech, Inc. BLA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Hyaluronidase / Ocrelizumab NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Hyaluronidase / Ocrelizumab RxCUI 2693453 1 dose form · 1 strength

Look up RxCUI 2693453 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ocrevus Zunovo

🏭 Manufacturers & labelers

Genentech, Inc. 2

RxNorm drug class

Hyaluronidase / Ocrelizumab belongs to the CD20-directed Cytolytic Antibody class.

Pharmacologic class CD20-directed Cytolytic Antibody
Drug family (ATC) Monoclonal antibodies
How it works CD20-directed Antibody Interactions

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 17, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hyaluronidase / Ocrelizumab.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hyaluronidase / Ocrelizumab after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label
Genentech, Inc.
Linked label effective
Aug 17, 2026
Composite sections available
22
Linked SPL Set ID
b216af61-99d0-42a3-afc2-b5bf86df1ec0
Linked SPL Document ID
7075d975-19b9-497b-9657-3a99a527ffd4
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.