FDA-filed SPL labeling · retrieved through openFDA

Ocrelizumab Injection

Ocrelizumab is an intravenous medication used to treat relapsing forms of multiple sclerosis and primary progressive multiple sclerosis in adults, and relapsing-remitting multiple sclerosis in certain pediatric patients.

Brand name Ocrevus
Drug class Cd20-directed Cytolytic Antibody
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 effectiveMay 14, 2026
AvailabilityRx
Earliest approval/marketing year 2017
FDA-listed product records 3
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Ocrelizumab Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ocrevus (ocrelizumab) is a proven IV treatment for multiple sclerosis that works by targeting and depleting certain immune cells (B-cells) involved in MS-related damage. It requires careful monitoring for infusion reactions, infections, and long-term immune effects, so it is always given in a clinical setting by trained professionals. Staying current on recommended screenings and vaccinations before starting — and reporting any new symptoms promptly — is key to using it safely.

📖 Ocrelizumab Injection: Patient Information Guide

A plain-language walkthrough of Ocrelizumab Injection — 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

Ocrelizumab (given as the brand Ocrevus by intravenous infusion) is approved for the following conditions:

  • Relapsing forms of multiple sclerosis (MS) in adults — including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS
  • Primary progressive MS (PPMS) in adults
  • Relapsing-remitting MS in pediatric patients 10 years of age and older who weigh at least 25 kg (about 55 lbs)
⚙️How it works

Ocrelizumab is a monoclonal antibody — a lab-made protein designed to seek out a specific target. It locks onto a protein called CD20 on the surface of B lymphocytes (B-cells), a type of immune cell. Once attached, it triggers the destruction of those B-cells through two processes: antibody-dependent cellular cytolysis and complement-mediated lysis (essentially, signaling the immune system to break down those cells). Reducing these B-cells is believed to dampen the immune attacks on the brain and spinal cord that cause MS damage, though the exact way this translates into clinical benefit is not fully known.

💊How it's taken

Ocrevus is given only as an intravenous (IV) infusion in a clinical setting — never at home or self-administered. The first course is two separate infusions given two weeks apart; after that, one infusion is given every six months. Dosing for pediatric patients is adjusted based on body weight. If a scheduled infusion is missed, it should be given as soon as possible and the six-month schedule restarted from that point — doses must always be at least five months apart.

  • Pre-medications (a steroid, antihistamine, and possibly a fever reducer) are given before every infusion to reduce reaction risk
  • Patients are observed during infusion and for at least one hour afterward
  • There are no food or drink restrictions, since the medication is given by IV
🤒Side effects — in detail

The most common side effects of Ocrevus include:

  • Infusion reactions — itching, rash, flushing, headache, nausea, or difficulty breathing during or shortly after the IV
  • Upper respiratory tract infections (colds, sinus infections)
  • Lower respiratory tract infections (bronchitis, pneumonia)
  • Skin infections
  • Herpes virus infections — including cold sores, shingles, and in rare cases more serious herpes complications
  • Depression
  • Back pain
  • Decreased immunoglobulin (antibody) levels, especially IgM, with longer-term use

Serious reactions to watch for include signs of severe infection, symptoms of a rare brain infection called PML (sudden weakness, vision changes, confusion), signs of liver injury (jaundice, dark urine), or new/worsening bowel symptoms suggesting colitis. Seek medical attention promptly for any of these.

⚠️Warnings & precautions
  • Infusion reactions: Very common, especially with the first infusion. Ranging from mild (flushing, itching) to life-threatening (throat swelling, breathing difficulty). A life-threatening reaction requires permanently stopping Ocrevus.
  • Serious infections: Ocrevus suppresses the immune system. Bacterial, viral, fungal, and parasitic infections — some fatal — have been reported. Delay treatment if you have an active infection.
  • PML (progressive multifocal leukoencephalopathy): A rare but potentially fatal brain infection caused by the JC virus. Report any new neurological symptoms immediately — weakness, vision problems, or confusion.
  • Hepatitis B reactivation: Ocrevus can cause dangerous reactivation of a dormant hepatitis B infection, including liver failure and death. All patients must be screened before starting.
  • Low immunoglobulin levels: Long-term use can reduce antibody levels, further raising the risk of serious infections. Levels should be monitored.
  • Possible increased cancer risk: There may be a higher risk of malignancies, including breast cancer.
  • Liver injury: Clinically significant liver injury has been reported. Liver function is checked before starting and monitored during treatment.
  • Immune-mediated colitis: Bowel inflammation has been reported after Ocrevus. Tell your doctor about persistent diarrhea or new GI symptoms.
🔀What it interacts with

Ocrevus can interact with other medications and vaccines that affect the immune system:

  • Immunosuppressive drugs: Combining Ocrevus with other immune-suppressing medications (including high-dose corticosteroids) can compound immune suppression and raise infection risk
  • Other MS therapies (fingolimod, natalizumab, daclizumab, teriflunomide, mitoxantrone): These drugs have long-lasting immune effects; switching to or from Ocrevus requires careful timing to avoid additive immunosuppression
  • Live or live-attenuated vaccines: Must not be given during Ocrevus treatment or until B-cells have recovered after stopping — the safety of doing so has not been established
  • Non-live vaccines: Can be given but Ocrevus may reduce their effectiveness; timing vaccinations before starting Ocrevus is strongly preferred

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
  • You must be screened for hepatitis B virus (HBV) before starting — Ocrevus is contraindicated if you have active HBV, and can trigger dangerous reactivation in people who are carriers
  • Do not use Ocrevus if you have ever had a life-threatening infusion reaction to it
  • Get all recommended vaccines at least 4 weeks (live vaccines) or 2 weeks (non-live vaccines) before your first infusion
  • If you are pregnant or could become pregnant, discuss with your doctor — animal data suggest potential fetal harm; use reliable contraception during treatment and for 6 months after your last infusion
  • If you are breastfeeding, talk with your doctor — it is unknown whether Ocrevus passes into human milk or affects a nursing infant
  • Infants born to mothers who received Ocrevus during pregnancy should not receive live vaccines until their B-cell counts are confirmed to be recovered
  • Tell your doctor about any history of low antibody (immunoglobulin) levels, recurrent serious infections, liver disease, or kidney problems before starting
  • Older adults (65+): limited data exist on use in this age group; discuss any concerns with your doctor
  • Children under 10 years of age or weighing less than 25 kg: safety and effectiveness have not been established
📡Pharmacodynamics — effects in the body

Ocrevus works by rapidly reducing the number of B-cells (a type of immune cell) circulating in the blood — this reduction is measurable within 14 days of the first infusion in both adults and children. B-cell levels stay low during ongoing treatment. After the last infusion, B-cell counts typically begin recovering, with most adults (about 90%) returning to normal or baseline levels within about 2.5 years. This prolonged B-cell depletion is why live vaccines must be avoided not just during treatment but until B-cells have adequately recovered.

🔬Pharmacokinetics — how your body processes it

Ocrelizumab is given directly into the bloodstream by IV infusion, so absorption is immediate. It distributes into a relatively small volume, consistent with staying largely in the blood and lymphatic system. The drug is broken down (metabolized) through normal protein-catabolism pathways, not through the liver's drug-metabolizing enzymes. The terminal elimination half-life is approximately 26 days, meaning it takes several weeks for the body to clear a significant portion of the drug — which is why its effects on B-cells and the immune system persist long after the infusion is done.

📦How to store it

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

📄 Written from Ocrelizumab Injection’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 →

53

Supplements & herbs that interact with Ocrelizumab Injection

53 supplements and herbal products have documented interactions with Ocrelizumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 52
  • Minor · 1
Every supplement checked against Ocrelizumab Injection — ranked by severity The full interaction hub: 52 moderate · 1 minor · every one linked to its full report. Check Ocrelizumab Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What exactly is Ocrevus used for — is it only for one type of MS?
No, it actually covers several types of MS. For adults, Ocrevus is approved for relapsing forms of MS — which includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS — as well as primary progressive MS. For kids and teens 10 and older who weigh at least about 55 lbs, it's approved for relapsing-remitting MS specifically. Your doctor would have chosen it based on your particular type of MS.
What happens during an infusion — what should I expect?
Ocrevus is given through an IV drip at a clinic or infusion center, not at home. Before the infusion starts, you'll be given a steroid, an antihistamine, and possibly a fever-reducing medication to help prevent reactions. The infusion itself can take roughly 2 to 3.5 hours, and then you'll be monitored for at least an hour afterward. Infusion reactions — things like itching, flushing, headache, or feeling short of breath — are fairly common, especially with your first infusion. The care team is prepared to manage these. It's also worth knowing that reactions can sometimes happen up to 24 hours after you leave, so keep an eye out.
Will Ocrevus make me more likely to get sick?
Yes, it can. Ocrevus works by reducing certain immune cells (B-cells), and that does lower your immune defenses. In clinical studies, more patients on Ocrevus got infections compared to those on placebo or other MS drugs — mostly upper respiratory infections like colds, but also skin infections, herpes-related infections, and sometimes more serious ones. Call your doctor right away if you develop a high fever, unusual fatigue, painful sores, or symptoms that feel more than a typical cold. If you have an active infection, your infusion will be delayed until it's cleared up.
Can I still get vaccines while taking Ocrevus?
This is really important to sort out before you start. Live vaccines — like the live shingles vaccine or the MMR — should NOT be given while you're on Ocrevus or until your B-cells have recovered after stopping, because the suppressed immune system could make the live vaccine dangerous. Non-live vaccines (like the flu shot or pneumonia vaccines) can still be given, but Ocrevus may reduce how well your immune system responds to them. Ideally, try to get all recommended vaccines at least 2 to 4 weeks before your first infusion. Talk to your doctor or pharmacist about which ones you're due for.
Is it safe to get pregnant or breastfeed while on Ocrevus?
You should use effective birth control throughout your treatment and for 6 months after your last infusion. Animal studies showed that ocrelizumab can cause harm to developing fetuses, and there isn't enough human safety data yet to say it's safe in pregnancy. If you're planning a pregnancy, talk with your neurologist and OB well in advance. As for breastfeeding, it's unknown whether Ocrevus passes into breast milk or what effect it might have on a nursing baby, so discuss this carefully with your doctor. One more thing: if a baby was exposed to Ocrevus in the womb, live vaccines should be held off until the baby's B-cell counts are checked.
What warning signs should make me call my doctor or go to the ER right away?
A few things really can't wait. If you develop sudden weakness on one side of your body, vision changes, or confusion — call immediately, as these could point to a rare but serious brain infection called PML. Signs of a severe infusion reaction — throat tightening, serious trouble breathing, or passing out — are emergencies. Also call your doctor promptly if you notice yellowing of your skin or eyes (possible liver injury), new or worsening diarrhea, or any infection that seems serious. The sooner these are caught, the better the outcome.
Is Ocrelizumab Injection available over the counter?
Ocrelizumab Injection 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 Ocrelizumab Injection first available?
Ocrelizumab Injection has been available in the United States since at least 2017, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Ocrelizumab Injection’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 Ocrelizumab Injection comes

Ocrelizumab Injection 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

Into a vein
Brands Ocrevus
How this form is used
What it may be used for
  • Ocrevus is used intravenously to treat relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS) in adults
  • Ocrevus is used intravenously to treat primary progressive MS (PPMS) in adults
  • Ocrevus is used intravenously to treat relapsing-remitting MS in pediatric patients 10 years of age and older who weigh at least 25 kg
Important instructions
  • Ocrevus must be diluted and given only as an intravenous infusion by a healthcare professional; it is never taken by mouth or self-injected
  • Ocrevus infusions are given as a starting course of two doses two weeks apart, then a single infusion every 6 months thereafter (dosing adjusted by weight in pediatric patients)
  • Before every Ocrevus infusion, patients receive pre-medications (a corticosteroid and an antihistamine, and sometimes an antipyretic) to reduce infusion reaction risk
  • Patients must be monitored during the entire Ocrevus infusion and for at least one hour after it ends; infusion reactions can also occur up to 24 hours later
Available strengths 1 strength
3 FDA-listed product records

📊 Ocrelizumab Injection across the U.S. market

How Ocrelizumab Injection 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
3
FDA-listed product records
2017
First marketed

📈 How widely Ocrelizumab Injection is used

A general measure of how commonly Ocrelizumab Injection 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 Ocrelizumab Injection 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.

13,323
Medicaid prescriptions filled (Q1–Q4 2025)
$410.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ocrelizumab Injection prescribed? Of the 1,596 medications we measure, Ocrelizumab Injection ranks #882 by Medicaid prescriptions — more than 45% of them.

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

Utilization by Ocrelizumab Injection 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.

10 ML ocrelizumab 30 MG/ML Injection

13,323 Medicaid prescriptions (Q1–Q4 2025) 100% of Ocrelizumab Injection prescriptions shown $410.7M gross reimbursement (before rebates) ≈ $30,827 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876380

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 Ocrelizumab Injection, 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 1 listed Ocrelizumab Injection NDCs with Medicaid activity.

🔍 Compare Ocrelizumab Injection products

A representative set of FDA-listed product records for Ocrelizumab Injection — 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
300 mg/10 mL Intravenous Genentech, Inc. × 3 listings BLA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Ocrelizumab Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ocrelizumab Injection RxCUI 1876366 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1876379 In current FDA listings
    Clinical drug / strength (SCD) 10 ML ocrelizumab 30 MG/ML RxCUI 1876380

Look up RxCUI 1876366 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

🏭 Manufacturers & labelers

Genentech, Inc. 3

RxNorm drug class

Ocrelizumab Injection 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 May 14, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ocrelizumab Injection.
📈
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 Ocrelizumab Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
3
Distinct labelers/manufacturers represented
1
Linked representative label
Genentech, Inc.
Linked label effective
May 14, 2026
Composite sections available
22
Linked SPL Set ID
9da42362-3bb5-4b83-b4bb-b59fd4e55f0d
Linked SPL Document ID
00b80381-c728-47a0-bd9e-b1223a1c0a40
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.

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.