Uplizna (inebilizumab)
An approved treatment for Neuromyelitis Optica Spectrum Disorder.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Inebilizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Inebilizumab
- Brand name
- Uplizna
- Development code
- MEDI-551
- Drug class
- Anti-CD19 monoclonal antibody
- Manufacturer
- Amgen (via its 2023 acquisition of Horizon Therapeutics)
- How it's taken
- IV infusion of about 90 minutes: 2 starting doses 2 weeks apart, then once every 6 months.
A B-cell depleting antibody approved on June 11, 2020 for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD was its first approval. After 2 starting infusions 2 weeks apart, it is given once every 6 months. In its main trial, 11.2% of AQP4-positive patients on Uplizna had a relapse against 42.3% on placebo.
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Where Inebilizumab fits
Uplizna is among the 4 FDA-approved drugs for AQP4-positive NMOSD and the one given least often. By Trial Friend's count from the 3 IV labels' schedules, a new adult patient gets 3 Uplizna infusions in the first year and 2 a year after that, against 8 for Ultomiris and 28 for Soliris in the first year; Enspryng is a shot at home every 4 weeks. Uplizna has no boxed warning and no meningococcal vaccine requirement, but it needs hepatitis B and tuberculosis screening. No trial has compared the 4 drugs directly.
How Inebilizumab works
In AQP4-positive NMOSD, the immune system makes antibodies against aquaporin-4, a water channel protein in the optic nerve, spinal cord and brain. B cells and the plasmablasts they turn into make those antibodies.
Inebilizumab is a lab-made antibody that binds CD19, a protein found on B cells at most stages, including pre-B cells and mature B cells. Once it binds, the immune system destroys those cells (antibody-dependent cellular cytolysis). The label says this is presumed to be how it works in NMOSD[1]. This acts further upstream than the complement inhibitors Soliris and Ultomiris, which block the damage AQP4 antibodies trigger, and differs from satralizumab (Enspryng), which blocks the interleukin-6 receptor.
Side effects and safety
- Infusion reactions. Occurred in 9.3% of NMOSD patients in the placebo-controlled period, including anaphylaxis. Premedication before every infusion and at least 1 hour of observation afterward.
- Infections. Serious, including fatal, bacterial, fungal and viral infections have occurred with B-cell depleting therapies. Infusions are delayed during an active infection.
- Hepatitis B reactivation. Can cause liver failure and death. Hepatitis B screening before the first dose; not given with active hepatitis B.
- PML. A rare brain infection seen with other B-cell therapies. Uplizna is withheld at the first sign while it is checked.
- Low antibody levels. IgG and IgM can fall over time. In NMOSD, 13% had low IgG and 42% had low IgM by year 2.
- Pregnancy. May harm an unborn baby. Effective birth control during treatment and for 6 months after the last dose.
- Hepatitis B, tuberculosis and immunoglobulin tests before the first dose
- Check for active infection before every infusion
- Corticosteroid, antihistamine and fever reducer before every infusion
- Immunoglobulin levels during treatment and after stopping until B cells recover
- Live vaccines at least 4 weeks before starting, and not during treatment
Uplizna has no boxed warning. In the NMOSD trial, side effects more common than placebo were urinary tract infection (11% vs 10%), joint pain (10% vs 4%), headache (8% vs 8%) and back pain (7% vs 4%). Across the placebo-controlled and open-label periods, the most common were urinary tract infection (20%), nasopharyngitis (13%), infusion reaction (12%), joint pain (11%) and headache (10%)[1].
Infusion reactions, including anaphylaxis, occurred in 9.3% of NMOSD patients during the placebo-controlled period, most often with the first infusion. Because Uplizna removes B cells, it can raise the risk of serious and fatal infections, reactivate hepatitis B and lower antibody levels over time. The label also describes PML, a rare brain infection seen with other B-cell therapies; no confirmed case occurred in Uplizna trials, but 1 trial patient died after new brain lesions for which PML was among the possible causes[1].
Uplizna must not be used in people with active hepatitis B, active or untreated latent tuberculosis, or a past life-threatening reaction to an Uplizna infusion. It may harm an unborn baby, so the label advises effective birth control during treatment and for 6 months after the last dose[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Inebilizumab
Uplizna is given as a 300mg IV infusion, a second 300mg infusion 2 weeks later, then a single 300mg infusion every 6 months, counted from the first infusion. Each infusion is diluted in a 250mL bag and run at increasing speed over about 90 minutes. Patients are watched closely during the infusion and for at least 1 hour afterward[1].
About 30 minutes before every infusion, patients get a corticosteroid (such as methylprednisolone 80mg to 125mg IV), and 30 to 60 minutes before, an antihistamine (such as diphenhydramine 25mg to 50mg by mouth) and a fever reducer (such as acetaminophen 500mg to 650mg by mouth). Before the first dose, the label requires tests for hepatitis B, tuberculosis and antibody (immunoglobulin) levels. Live vaccines should be given at least 4 weeks before starting[1].
Availability and cost
Only available as the brand-name product.
Help paying for Uplizna
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 per dose of UPLIZNA through the Amgen Commercial Co-Pay Program. Not for Medicare, Medicaid, VA, DOD, TRICARE or other government insurance.
For: private insurance · source - Insurance and case manager help
A dedicated Patient Access Liaison helps with insurance approval, prior authorization and scheduling infusions.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Official UPLIZNA pages do not describe a free drug program, and UPLIZNA was not on the Amgen Safety Net Foundation product list. Ask Amgen By Your Side about options if uninsured.
- From a charity · Good DaysNeuromyelitis Optica Spectrum Disorder fundOpen
Pays for: Copays for FDA-approved medications (plus travel for some funds), up to $2,100 per year. Requires health insurance (any kind).
The foundation says: “Program Status: open.” - From a charity · NORD RareCareNMOSD Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting Applications” - From a charity · NORD RareCareNMOSD Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting Applications” - From a charity · The Assistance FundNeuromyelitis Optica Spectrum Disorder (NMOSD) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
- From a charity · TotalAssist (formerly PAN Foundation)Neuromyelitis Optica Spectrum Disorder fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires health insurance (any kind).
Every program and charity fund for Neuromyelitis Optica Spectrum Disorder →
Access and eligibility
Approved for adults with NMOSD who test positive for anti-aquaporin-4 (AQP4) antibodies. The trial found no evidence of benefit in AQP4-negative patients, and the label says safety and effectiveness in children have not been established. It cannot be used with active hepatitis B, active or untreated latent tuberculosis, or after a life-threatening reaction to an Uplizna infusion.
Source: Amgen By Your Side
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
N-MOmentum (NCT02200770) randomly assigned adults with NMOSD 3 to 1 to Uplizna or placebo. It enrolled 213 AQP4-positive patients (161 on Uplizna, 52 on placebo) and 17 AQP4-negative patients. Other immune-suppressing drugs and routine steroids were not allowed during the blinded period[1][3].
In AQP4-positive patients, 18 of 161 (11.2%) on Uplizna had a confirmed relapse by day 197, about 28 weeks, against 22 of 52 (42.3%) on placebo. That was a 77.3% lower risk of relapse (hazard ratio 0.227). Yearly hospital stays were 0.11 on Uplizna and 0.50 on placebo. The label says there was no evidence of benefit in the AQP4-negative patients[1].
Development history
Inebilizumab was developed by MedImmune (AstraZeneca) as MEDI-551 and advanced by Viela Bio. The FDA approved Uplizna for AQP4-positive NMOSD in adults on June 11, 2020, its first approval[2]. Horizon Therapeutics acquired Viela in 2021, and Amgen acquired Horizon in 2023. The FDA later approved Uplizna for IgG4-related disease in April 2025 and for generalized myasthenia gravis in December 2025[2]. A study in children and teens aged 2 to 17 with NMOSD is listed on ClinicalTrials.gov as recruiting (NCT05549258)[4].
Explore Neuromyelitis Optica Spectrum Disorder trials
Other Neuromyelitis Optica Spectrum Disorder treatments
AQP4-positive NMOSD has 4 FDA-approved drugs. Eculizumab (Soliris, plus biosimilars Bkemv and Epysqli) and ravulizumab (Ultomiris) block complement C5. Inebilizumab (Uplizna) removes CD19-positive B cells that make the antibodies. Satralizumab (Enspryng) blocks the interleukin-6 receptor. Rituximab, azathioprine and mycophenolate are used off label.
Common questions about Inebilizumab
▸What is Inebilizumab (Uplizna)?
A B-cell depleting antibody approved on June 11, 2020 for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD was its first approval. After 2 starting infusions 2 weeks apart, it is given once every 6 months. In its main trial, 11.2% of AQP4-positive patients on Uplizna had a relapse against 42.3% on placebo.
▸How does Inebilizumab work?
In AQP4-positive NMOSD, the immune system makes antibodies against aquaporin-4, a water channel protein in the optic nerve, spinal cord and brain. B cells and the plasmablasts they turn into make those antibodies.
Inebilizumab is a lab-made antibody that binds CD19, a protein found on B cells at most stages, including pre-B cells and mature B cells. Once it binds, the immune system destroys those cells (antibody-dependent cellular cytolysis). The label says this is presumed to be how it works in NMOSD[1]. This acts further upstream than the complement inhibitors Soliris and Ultomiris, which block the damage AQP4 antibodies trigger, and differs from satralizumab (Enspryng), which blocks the interleukin-6 receptor.
▸What are the side effects of Inebilizumab?
Uplizna has no boxed warning. In the NMOSD trial, side effects more common than placebo were urinary tract infection (11% vs 10%), joint pain (10% vs 4%), headache (8% vs 8%) and back pain (7% vs 4%). Across the placebo-controlled and open-label periods, the most common were urinary tract infection (20%), nasopharyngitis (13%), infusion reaction (12%), joint pain (11%) and headache (10%)[1].
Infusion reactions, including anaphylaxis, occurred in 9.3% of NMOSD patients during the placebo-controlled period, most often with the first infusion. Because Uplizna removes B cells, it can raise the risk of serious and fatal infections, reactivate hepatitis B and lower antibody levels over time. The label also describes PML, a rare brain infection seen with other B-cell therapies; no confirmed case occurred in Uplizna trials, but 1 trial patient died after new brain lesions for which PML was among the possible causes[1].
Uplizna must not be used in people with active hepatitis B, active or untreated latent tuberculosis, or a past life-threatening reaction to an Uplizna infusion. It may harm an unborn baby, so the label advises effective birth control during treatment and for 6 months after the last dose[1].
▸How is Inebilizumab taken?
Uplizna is given as a 300mg IV infusion, a second 300mg infusion 2 weeks later, then a single 300mg infusion every 6 months, counted from the first infusion. Each infusion is diluted in a 250mL bag and run at increasing speed over about 90 minutes. Patients are watched closely during the infusion and for at least 1 hour afterward[1].
About 30 minutes before every infusion, patients get a corticosteroid (such as methylprednisolone 80mg to 125mg IV), and 30 to 60 minutes before, an antihistamine (such as diphenhydramine 25mg to 50mg by mouth) and a fever reducer (such as acetaminophen 500mg to 650mg by mouth). Before the first dose, the label requires tests for hepatitis B, tuberculosis and antibody (immunoglobulin) levels. Live vaccines should be given at least 4 weeks before starting[1].
▸Is Inebilizumab FDA approved?
Yes, Inebilizumab (Uplizna) is FDA approved (2020) for the treatment of Neuromyelitis Optica Spectrum Disorder.
▸How often is Uplizna given for NMOSD?
Twice a year after 2 starting doses.
Starting doses: The first dose is 300mg by IV, then another 300mg 2 weeks later.
After that: A single 300mg dose every 6 months, counted from the first infusion.
Each visit: A steroid 30 minutes before and other premedicines 30 to 60 minutes before, an infusion of about 90 minutes, then at least 1 hour of observation.
Source: FDA label for Uplizna, DailyMed, effective December 2025
▸How well does Uplizna prevent NMOSD attacks?
In its main trial, it lowered the risk of a relapse by 77.3% in AQP4-positive patients compared with placebo.
Relapses: By about 28 weeks, 11.2% on Uplizna had a relapse against 42.3% on placebo.
Hospital stays: The yearly rate was 0.11 on Uplizna against 0.50 on placebo.
How it was tested: Uplizna was given on its own, without other immune-suppressing drugs, during the blinded period.
Source: FDA label for Uplizna, DailyMed, effective December 2025
▸Does Uplizna work for AQP4-negative NMOSD?
It is not approved for it, and the trial did not show a benefit.
What the label says: The 17 AQP4-negative patients in the trial showed no evidence of benefit, and the approval covers AQP4-positive adults only.
Source: FDA label for Uplizna, DailyMed, effective December 2025
▸What tests do I need before starting Uplizna?
Hepatitis B, tuberculosis and antibody (immunoglobulin) level tests.
Hepatitis B: Uplizna is not given with active hepatitis B, and people who had it in the past need a liver specialist involved.
Tuberculosis: Uplizna is not given to people with active or untreated latent TB.
Vaccines: Live vaccines are given at least 4 weeks before starting and are not recommended during treatment.
Before every infusion: A check for active infection.
Source: FDA label for Uplizna, DailyMed, effective December 2025
▸What are the side effects of Uplizna?
The most common in the NMOSD trial were urinary tract infection and joint pain.
Rates vs placebo: Urinary tract infection 11% vs 10%, joint pain 10% vs 4%, headache 8% vs 8%, back pain 7% vs 4%.
Infusion reactions: These occurred in 9.3% during the placebo-controlled period, most often with the first infusion.
Longer term: Antibody levels can fall; by year 2, 13% had low IgG and 42% had low IgM.
Source: FDA label for Uplizna, DailyMed, effective December 2025
▸Does Uplizna need a meningitis vaccine like Soliris?
No. The Uplizna label has no boxed warning and no meningococcal vaccine requirement.
What it does need: Hepatitis B and tuberculosis screening, premedication before each infusion, and watching for infections.
The complement drugs: Soliris and Ultomiris carry a boxed warning for meningococcal infections and require vaccination.
Source: FDA label for Uplizna, DailyMed; FDA label for Soliris, DailyMed
▸Is there Uplizna copay assistance?
Yes, for people with commercial insurance.
Copay program: Amgen says eligible commercially insured patients may pay as little as $0 per dose through the Amgen Commercial Co-Pay Program.
Not eligible: Medicare, Medicaid, VA, DOD, TRICARE and other government insurance.
Other help: A Patient Access Liaison from Amgen By Your Side helps with insurance review and scheduling infusions. Call 833-842-8477.
Source: Uplizna cost and savings page
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2025-12-11. UPLIZNA (inebilizumab-cdon) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=834db232-afb0-4dcf-93e0-009ce8245c20
- U.S. Food and Drug Administration. Drugs@FDA: UPLIZNA, BLA 761142, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761142
- ClinicalTrials.gov. N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. https://clinicaltrials.gov/study/NCT02200770
- ClinicalTrials.gov. Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder. https://clinicaltrials.gov/study/NCT05549258
- Amgen. Cost, Savings, and Support: UPLIZNA (inebilizumab-cdon). https://www.uplizna.com/cost-savings