NDC 50242-0554-01 — Ocrevus Zunovo ocrelizumab and hyaluronidase

🆔 Identity & classification

FDA NDC (as labeled) 50242-554-01

Product NDC 50242-554

11-digit billing NDC 50242055401

NCPDP billing unit ML — per mL (volume)

RxCUI 2693458, 2693465

UNII A10SJL62JY, 743QUY4VD8

Application # BLA761371

SPL Set ID b216af61-99d0-42a3-afc2-b5bf86df1ec0

Established class (EPC) CD20-directed Cytolytic Antibody; Endoglycosidase

Mechanism of action CD20-directed Antibody Interactions

Chemical class Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Glycoside Hydrolases

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-09-13

Route SUBCUTANEOUS

Dosage form INJECTION, SOLUTION

Substance OCRELIZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)

GCN Seq No 086514

GCN 56236

HICL code 049868

Ingredient (HICL) Ocrelizumab-Hyaluronidase-Ocsq

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H0

Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System

HIC3 code H0E

Therapeutic class — specific (HIC3) Agents To Treat Multiple Sclerosis

AHFS code 92:20.00.00

AHFS class Immunomodulatory Agents

FDB label name OCREVUS ZUNOVO 920 MG-23,000

FDB brand name Ocrevus Zunovo

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 50242-554-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50242-0554-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine 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

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGenentech, Inc.

FDA applicationBLA761371 (BLA)

Labeler code50242

First marketedSep 2024

Product typeHuman Prescription Drug

Portfolio93 products on file

🔎 All NDCs from Genentech, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OCREVUS ZUNOVO 920 MG-23,000 Ingredient Ocrelizumab-Hyaluronidase-Ocsq

📖 What it is MedlinePlus · NLM

Ocrelizumab and hyaluronidase-ocsq injection is used to treat various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control. Ocrelizumab is in a class of medications called monoclonal antibodies. It works by stopping certain cells of the immune system from causing damage. Hyaluronidase is in a class of medications called endoglycosidase. It helps to keep ocrelizumab in the body longer so that the medication will have a greater effect...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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) th...
What exactly is Ocrevus Zunovo and why has my doctor prescribed it for my MS?
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. Befor...
How is this injection given, and do I do it myself at home?

📖 Read our full Hyaluronidase / Ocrelizumab guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

5.5 mg / 23 mL UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
34.3 mg / 23 mL UNII AE28F7PNPL
Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
13.8 mg / 23 mL UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
30.2 mg / 23 mL UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
1889.5 mg / 23 mL UNII 7YIN7J07X4
A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$1,613.95	$37,120.78 / 23 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2351	$48.060 / J2351 unit	—

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)50242-554-01

11-digit billing NDC50242-0554-01

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ2351

DescriptorINJECTION, OCRELIZUMAB, 1 MG AND HYALURONIDASE-OCSQ

Billing units / pkg40 units

Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ocrevus Zunovo 920 mg/23mL; 23000 U/23mLthis 50242-0554-01	Genentech,	1 vial	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

2024

First FDA approval

Sep 2024

📍

2026

Currently FDA-listed

2 years listed

🛡️

2036

Latest patent/protection listed

not a guaranteed launch date

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2036. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.

📅 FDA approved Sep 13, 2024 ⏳ ~10 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Ocrevus Zunovoocrelizumab and hyaluronidase-ocsq

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Patents & exclusivity — FDA Purple Book

Exclusivity RefProduct

2024 2026 2028 2030 2032 2034 2036

Today

LOE

Biologic patent Exclusivity

🏛️Reference-product exclusivity

A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.

🧪Listed biologic patents

Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.

🔁Interchangeability

An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.

🛈 What do these terms mean?

Biologic patent: A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity: A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity: The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE): The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity

Code	What it grants	Expires
RefProduct	Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date	Sep 13, 2036

Common questions

Is there a biosimilar for OCREVUS ZUNOVO 920 MG-23,000?

No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.

Why do different websites show different biosimilar dates?

Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.

Can a biosimilar launch before the last patent expires?

Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.

What does “current Purple Book estimate” mean?

It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.

What does “FDA listed” mean?

It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.

Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 50242-0554-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

15

Units reimbursed last 4 qtrs

343

Gross reimbursed last 4 qtrs

$553.6K

Avg / prescription

$36,905.58

Avg / unit

$1,612.42

Latest quarter Q4 2025

15Rx

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 15 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.90.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 0.9 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 vial this page50242-0554-01 15 Rx · $553,584

1 vial50242-0554-86 No Medicaid data

Drug total (last 4 qtrs): 15 Rx · 343 units · $553,584 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ocrevus Zunovo — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ocrevus Zunovo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$4.64M

Claims incl. refills

109

Beneficiaries

109

Spend / beneficiary

$42,545.48

Spend / claim

$42,545.48

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ocrevus Zunovo (this brand).

Top reported reactions

Injection Site Pain59

Injection Site Erythema45

Fatigue41

Pain32

Contusion23

Headache22

Multiple Sclerosis Relapse21

Age at onset

Adolescent1

Adult217

Elderly11

Reporter sex

Male · 28%

Female · 72%

Serious outcomes

Hospitalization19

Disabling3

Life-threatening1

Death1

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50242-0554-01 You're viewing this	1 VIAL, SINGLE-USE in 1 CARTON (50242-554-01) / 23 mL in 1 VIAL, SINGLE-USE	2024-09-13	Active
50242-0554-86	1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE	2024-09-13	Active

Pack size FAQ

What quantity is in NDC 50242-0554-01?

NDC 50242-0554-01 is listed by the FDA — 1 vial, single-use in 1 carton / 23 ml in 1 vial, single-use.

What NDC number is used to bill for this package of Ocrevus Zunovo ocrelizumab and hyaluronidase 920 mg/23mL; 23000 U/23mL Injection, Solution?

Bill NDC 50242-0554-01 — the 11-digit billing format is 50242055401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 50242-554-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50242-0554-01, written without dashes as 50242055401. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50242-0554-01, the first segment (50242) is the labeler code FDA assigned to Genentech, Inc.; the middle segment (0554) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (50242-0554-86). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Genentech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J2351 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE OCREVUS ZUNOVO is indicated for the treatment of: 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 OCREVUS ZUNOVO is a CD20-directed cytolytic antibody indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ) Primary progressive MS, in adults ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION OCREVUS ZUNOVO should be administered by a healthcare professional ( 2.1 ) For subcutaneous use in the abdomen only ( 2.1 ) OCREVUS ZUNOVO has different dosage and administration instructions than intravenous ocrelizumab ( 2.1 ) Before initiating OCREVUS ZUNOVO, screen for Hepatitis B virus and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin ( 2.2 ) Pre-medicate orally with dexamethasone (or an equivalent corticosteroid) and an antihistamine (e.g., desloratadine) at least 30 minutes prior to each injection ( 2.3 ) Administer 23 mL of OCREVUS ZUNOVO (920 mg ocrelizumab and 23,000 units hyaluronidase) subcutaneously in the abdomen over approximately 10 minutes every 6 months ( 2.4 ) Monitor patients closely during all injections, for at least one hour after the initial injection, and for at least 15 minutes after subsequent injections ( 2.4 )

2.1Important 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.

2.2Assessments Prior to First Dose of OCREVUS ZUNOVO 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 [see Warnings and Precautions (5.2) ] .

Serum Immunoglobulins Prior to initiating ocrelizumab treatment, perform testing for quantitative serum immunoglobulins [see Warnings and Precautions (5.4) ] . 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 [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2) ] .

Liver Function Tests Prior to initiating OCREVUS ZUNOVO, obtain serum aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), alkaline phosphatase, and bilirubin levels [see Warnings and Precautions (5.7) ] .

2.3Assessments and Premedication Prior to Every Dose 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 [see Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.1) ] .

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

2.4Recommended Dosage The recommended dosage of OCREVUS ZUNOVO is 920 mg/23,000 units (920 mg ocrelizumab and 23,000 units of hyaluronidase) administered as a single 23 mL subcutaneous injection in the abdomen over approximately 10 minutes every 6 months. Monitor the patient closely during injections, with access to appropriate medical support to manage severe injection reactions . For the initial dose, monitor the patient for at least one hour post-injection.

For subsequent doses, monitor the patient for at le…

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 920 mg ocrelizumab and 23,000 units hyaluronidase per 23 mL (40 mg and 1,000 units per mL) solution in a single-dose vial ( 3 ) Injection: 920 mg ocrelizumab and 23,000 units hyaluronidase per 23 mL (40 mg and 1,000 units per mL) clear to slightly opalescent, and colorless to pale brown solution in a single-dose vial.

⛔ Contraindications 91 words ▾

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 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Injection Reactions: Management recommendations for injection reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS ZUNOVO if a life-threatening injection reaction occurs ( 4 , 5.1 ) Infections: Serious, including life-threatening and fatal, infections have occurred in patients treated with ocrelizumab. Delay OCREVUS ZUNOVO administration in patients with an active infection until the infection is resolved.

Vaccination with live-attenuated or live vaccines is not recommended during treatment with OCREVUS ZUNOVO and after discontinuation, until B-cell repletion ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold OCREVUS ZUNOVO at the first sign or symptom suggestive of PML ( 5.3 ) Reduction in Immunoglobulins: Monitor the level of immunoglobulins at the beginning of treatment. Monitor during and after discontinuation of treatment with OCREVUS ZUNOVO, until B-cell repletion, and especially when recurrent serious infections are suspected.

Consider discontinuing OCREVUS ZUNOVO in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins ( 2.1 , 5.4 ) Malignancies: An increased risk of malignancy, including breast cancer, may exist with OCREVUS ZUNOVO ( 5.5 ) Immune-Mediated Colitis: Immune-mediated colitis has been reported in the postmarketing setting. Monitor patients for new or persistent diarrhea or other gastrointestinal symptoms, and evaluate promptly if colitis is suspected ( 5.6 ) Liver Injury: Clinically significant liver injury has occurred.

Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating OCREVUS ZUNOVO, and during treatment as clinically indicated. Discontinue OCREVUS ZUNOVO in patients with evidence of liver injury in the absence of an alternative etiology ( 5.7 )

5.1Injection Reactions OCREVUS ZUNOVO can cause injection reactions, which can be local or systemic. Common symptoms of local injection reactions reported by patients treated with OCREVUS ZUNOVO in multiple sclerosis (MS) clinical trials included erythema, pain, swelling, and pruritus. Common symptoms of systemic injection reactions reported by patients included headache and nausea.

In an open-label, active-controlled trial, injection reactions were more frequently reported with the first injection; 49% of patients experienced an injection reaction with the first injection [see Adverse Reactions (6.1) ] . In MS clinical trials where ocrelizumab was administered intravenously, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other premedication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion.

There were no fatal infusion reactions, but 0.3% of intravenous ocrelizumab-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization. Symptoms of infusion reactions 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. Monitor patients during and after injections [see Dosage and Administration (2.4) ] .

Inform patients that injection reactions can occur during or within 24 hours of the injection. Reducing the Risk of Injection Reactions and Managing Injection Reactions Administer oral premedication (e.g., dexamethasone or an equivalent corticosteroid, and an antihistamine) at least 30 minutes prior to each OCREVUS ZUNOVO injection to reduce the risk of injection reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered [see Dosage and Administration (2.3) ].

Management recommendations for injection reactions depend on the type and severity of th…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Injection Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Malignancies [see Warnings and Precautions (5.5) ] Immune-Mediated Colitis [see Warnings and Precautions (5.6) ] Liver Injury [see Warnings and Precautions (5.7) ] The most common adverse reactions in patients treated with intravenous ocrelizumab were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence ≥10% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections ( 6.1 ) The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction 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 ocrelizumab has been evaluated in active-controlled clinical trials of ocrelizumab administered intravenously in patients with relapsing forms of MS (RMS) (Study 1 and Study 2) [see Clinical Studies (14.1) ] and primary progressive MS (PPMS) (Study 3) [see Clinical Studies (14.2) ] , and in an open-label, active-controlled trial of OCREVUS ZUNOVO administered subcutaneously in patients with RMS and PPMS (Study 4) [see Clinical Studies (14.3) ] .

Adverse Reactions With Ocrelizumab Intravenous in Patients With RMS and PPMS The safety of intravenous ocrelizumab has been evaluated in 1311 patients across the MS clinical studies, which included 825 patients in active-controlled clinical trials in patients with RMS and 486 patients in a placebo-controlled study in patients with PPMS. RMS In active-controlled intravenous ocrelizumab clinical trials (Study 1 and Study 2), 825 patients with RMS received ocrelizumab 600 mg intravenously every 24 weeks (initial treatment was given as two separate 300 mg infusions at Weeks 0 and 2) [see Clinical Studies (14.1) ].

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 1 summarizes the adverse reactions that occurred in active-controlled intravenous ocrelizumab RMS trials (Study 1 and Study 2).

Table 1 Adverse Reactions in Adult Patients With RMS With an Incidence of at least 5% for Intravenous Ocrelizumab and Higher than REBIF Adverse Reactions Studies 1 and 2 Ocrelizumab 600 mg IV Every 24 Weeks The first dose was given as two separate 300 mg infusions at Weeks 0 and 2. (n=825) % REBIF 44 mcg SQ 3 Times per Week (n=826) % Upper respiratory tract infections 40 33 Infusion reactions 34 10 Depression 8 7 Lower respiratory tract infections 8 5 Back pain 6 5 Herpes virus- associated infections 6 4 Pain in extremity 5 4 PPMS In a placebo-controlled intravenous ocrelizumab clinical trial (Study 3), a total of 486 patients with PPMS received one course of ocrelizumab (600 mg of ocrelizumab administered as two 300 mg infusions two weeks apart) given intravenously every 24 weeks and 239 patients received placebo intravenously [see Clinical Studies (14.2) ].

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 infe…

🔄 Drug Interactions 205 words ▾

7 DRUG INTERACTIONS

7.1Immunosuppressive 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) ].

7.2Vaccinations 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) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy 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 tested in monkey are 2 and 10 times the recommended human dose of 600 mg intravenous ocrelizumab, on a mg/kg basis. Hyaluronidase: - In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (human recombinant) at dose levels up to 2,200,000 U/kg, which is > 5,700 times higher than the human dose.

The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which is > 940 times higher than the human dose. - In a pre-and postnatal development study, mice have been dosed daily by subcutaneous injection, with hyaluronidase (human recombinant) from implantation through lactation and weaning at dose levels up to 1,100,000 U/kg, which is > 2,800 times higher than the human dose. The study found no adverse effects on sexual maturation, learning and memory, or fertility of the offspring.

8.2Lactation Risk Summary There are no data on the presence of ocrelizumab or hyaluronidase, from administration of OCREVUS ZUNOVO, in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Ocrelizumab was excreted in the milk of ocrelizumab-treated monkeys. Human IgG is excreted in huma…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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 tested in monkey are 2 and 10 times the recommended human dose of 600 mg intravenous ocrelizumab, on a mg/kg basis. Hyaluronidase: - In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (human recombinant) at dose levels up to 2,200,000 U/kg, which is > 5,700 times higher than the human dose.

The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which is > 940 times higher than the human dose. - In a pre-and postnatal development study, mice have been dosed daily by subcutaneous injection, with hyaluronidase (human recombinant) from implantation through lactation and weaning at dose levels up to 1,100,000 U/kg, which is > 2,800 times higher than the human dose. The study found no adverse effects on sexual maturation, learning and memory, or fertility of the offspring.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of OCREVUS ZUNOVO in pediatric patients have not been established.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical studies of OCREVUS ZUNOVO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis. Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue.

It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days. Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan.

In the doses administered, hyaluronidase in OCREVUS ZUNOVO acts transiently and locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

12.2Pharmacodynamics For B-cell counts, assays for CD19 + B-cells are used because the presence of ocrelizumab interferes with the CD20 assay. In clinical studies with OCREVUS ZUNOVO and intravenous ocrelizumab, CD19 + B-cell counts in blood were reduced by 14 days after administration. In clinical studies with intravenous ocrelizumab, B-cell counts rose to above the lower limit of normal (LLN) or above baseline counts between infusions of ocrelizumab at least one time in 0.3% to 4.1% of patients.

In a clinical study of 51 patients treated with intravenous ocrelizumab, the median time for B-cell counts to return to either baseline or LLN was 72 weeks (range 27-175 weeks) after the last ocrelizumab infusion. Within 2.5 years after the last infusion, B-cell counts rose to either baseline or LLN in 90% of patients.

12.3Pharmacokinetics After subcutaneous administration of 920 mg ocrelizumab, the estimated mean exposure (AUC over the 24-week dosing interval) was 3730 µg/mL∙day. The mean C max was 132 µg/mL and t max was reached after approximately 4 days (range 2 – 13 days). The estimated absolute bioavailability following subcutaneous administration was 81%.

In Study 4, the differences in pharmacokinetic exposures following the administration of OCREVUS ZUNOVO subcutaneously at 920 mg/23,000 units and ocrelizumab intravenously at 600 mg in MS patients were not clinically significant. Pharmacokinetics (PK) of ocrelizumab in MS clinical studies fit a two-compartment model with time-dependent clearance. Distribution The population PK estimate of the central volume of distribution was

2.78L. Peripheral volume and inter-compartment clearance were estimated at

2.68 L and

0.55L/day, respectively. Elimination Constant clearance was estimated at

0.17 L/day, and initial time-dependent clearance at

0.05L/day, which declined with a half-life of 33 weeks. The terminal elimination half-life was 20 days. Metabolism The metabolism of OCREVUS ZUNOVO has not been directly studied because antibodies are cleared principally by catabolism.

Specific Populations Renal Impairment Patients with mild renal impairment were included in clinical trials. No significant change in the pharmacokinetics of ocrelizumab was observed in those patients. Hepatic Impairment Patients with mild hepatic impairment were included in clinical trials.

No significant change in the pharmacokinetics of ocrelizumab was observed in those patients.

12.6Immunogenicity 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 ZUNOVO with the incidence of antibodies to other products ma…

🧬 Mechanism of Action 134 words ▾

12.1Mechanism of Action The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis. Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue.

It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days. Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan.

In the doses administered, hyaluronidase in OCREVUS ZUNOVO acts transiently and locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

📦 How Supplied / Storage and Handling 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) injection for subcutaneous use is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 920 mg and 23,000 units/23 mL (40 mg and 1,000 units/mL) single-dose vial (NDC 50242-554-01). 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.

If necessary, OCREVUS ZUNOVO can be removed and placed back into the refrigerator. Unopened OCREVUS ZUNOVO vials may be stored in the original carton for a cumulative time of up to 12 hours without refrigeration at a temperature up to 25°C (77°F).

📦 Storage and Handling 67 words ▾

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. If necessary, OCREVUS ZUNOVO can be removed and placed back into the refrigerator. Unopened OCREVUS ZUNOVO vials may be stored in the original carton for a cumulative time of up to 12 hours without refrigeration at a temperature up to 25°C (77°F).

📋 Description 152 words ▾

11 DESCRIPTION Ocrelizumab is a recombinant humanized monoclonal antibody directed against CD20-expressing B-cells. Ocrelizumab is a glycosylated immunoglobulin G1 (IgG1) with a molecular mass of approximately 145 kDa. Hyaluronidase (human recombinant) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously.

It is a glycosylated single-chain protein produced by mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (human recombinant) has a molecular weight of approximately 61 kDa. OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) injection for subcutaneous use is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brown solution supplied in single-dose vials.

Each 23 mL of solution contains 920 mg ocrelizumab, 23,000 units of hyaluronidase (human recombinant), glacial acetic acid (5.5 mg), methionine (34.3 mg), polysorbate 20 (13.8 mg), sodium acetate (30.2 mg), trehalose (1889.5 mg), and water for injection at pH 5.3.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Injection Reactions Inform patients that the signs and symptoms of injection reactions can be local or systemic, and that injection reactions can occur up to 24 hours after injection. Advise patients to contact their healthcare provider immediately for signs or symptoms of injection reactions [see Warnings and Precautions (5.1) ] .

Infection Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose [see Clinical Pharmacology (12.2) ]. Signs include fever, chills, constant cough, dysuria, or signs of herpes such as cold sores, shingles, or genital sores [see Warnings and Precautions (5.2) ] . Advise patients that OCREVUS ZUNOVO may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.2) ] .

Advise patients that herpes infections, including serious herpes infections affecting the central nervous system, skin, and eyes, have occurred during treatment with ocrelizumab. Advise patients to promptly contact their healthcare provider if they experience any signs or symptoms of herpes infections including oral or genital symptoms, fever, skin rash, pain, itching, decreased visual acuity, eye redness, eye pain, headache, neck stiffness, or change in mental status [see Warnings and Precautions (5.2) ]. Vaccination Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible, non-live vaccinations at least 2 weeks prior to initiation of ocrelizumab treatment.

Administration of live-attenuated or live vaccines is not recommended during OCREVUS ZUNOVO treatment and until B-cell recovery [see Warnings and Precautions (5.2) ] . Progressive Multifocal Leukoencephalopathy Inform patients that PML has occurred in patients who received ocrelizumab, and may happen with OCREVUS ZUNOVO. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months.

Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.3) ]. Malignancies Advise patients that an increased risk of malignancy, including breast cancer, may exist with OCREVUS ZUNOVO.

Advise patients that they should follow standard breast cancer screening guidelines [see Warnings and Precautions (5.5) ] . Immune-Mediated Colitis Advise patients to promptly contact their healthcare provider if they experience any signs and symptoms of colitis, including diarrhea, abdominal pain, and blood in stool [see Warnings and Precautions (5.6) ]. Liver Injury Inform patients that liver injury has been reported with anti-CD20 B-cell depleting therapies, including ocrelizumab.

Instruct patients treated with OCREVUS ZUNOVO to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy, and during treatment as clinically indicated [see Warnings and Precautions (5.7) ] . Contraception Females of childbearing potential should use effective contraception while receiving OCREVUS ZUNOVO and for 6 months after the last injection of OCREVUS ZUNOVO [see Clinical Pharmacology (12.3) ] .

Instruct patients that if they are pregnant or plan to become pregnant while taking OCREVUS ZUNOVO, they should inform their healthcare provider [see Use in Specific Populations (8.1) ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 8/2025 MEDICATION GUIDE OCREVUS ZUNOVO ® (OH-creh-vus zoo-NOH-voh) (ocrelizumab and hyaluronidase-ocsq) injection, for subcutaneous use What is the most important information I should know about OCREVUS ZUNOVO? OCREVUS ZUNOVO can cause serious side effects, including: Injection reactions : Injection reactions are a common side effect of OCREVUS ZUNOVO, which can be serious and may require you to be hospitalized.

You will be monitored for signs and symptoms of an injection reaction when you receive OCREVUS ZUNOVO. This will happen during all injections, for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection. Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin rash hives tiredness coughing or wheezing trouble breathing throat irritation or pain feeling faint fever redness on your face (flushing) nausea headache swelling of the throat dizziness injection site pain, swelling or redness shortness of breath fatigue fast heart beat These injection reactions can happen during or up to 24 hours after your injection .

It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each injection. Infection: Infections are a common side effect. OCREVUS ZUNOVO increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections.

Serious infections can happen with OCREVUS ZUNOVO, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores shingles genital sores skin rash pain itching Signs of a more serious herpes infection include: changes in vision eye redness or eye pain severe or persistent headache stiff neck confusion Signs of infection can happen during treatment or after you have received your last dose of OCREVUS ZUNOVO.

Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS ZUNOVO until your infection is gone. Hepatitis B virus (HBV) reactivation : Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection.

If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS ZUNOVO. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS ZUNOVO.

Weakened immune system : OCREVUS ZUNOVO taken before or after other medicines that weaken the immune system could increase your risk of getting infections. Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks.

It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with: thinking eyesight strength balance weakness on 1 side of your body using your arms or legs Decreased immunoglobulins: OCREVUS ZUNOVO may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels. See " What are the possible side effects of OCREVUS ZUNOVO? " for more information about side effects.

What is OCREVUS ZUNOVO? OCREVUS ZUNOVO is a prescription medicine used to treat: relapsing forms of multiple scl…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressant: A medicine that lowers the activity of the immune system.

immunosuppressive: Describes something that lowers the activity of the immune system.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

dysuria: Pain, burning, or discomfort when passing urine.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immunogenicity: The tendency of a medicine to make the body produce antibodies against it, which can affect how well it works or cause reactions.

immunosuppression: A weakening of the body's defense system, which makes it harder to fight off infections.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reactivation: When a germ that has been quiet in the body for a long time becomes active again and causes an infection.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.