Pronunciation: up-liz-nah
Generic name: inebilizumab-cdon
Dosage form: injection for intravenous use
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2025.

What is Uplizna?

Uplizna is used to treat adults with neuromyelitis optic spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive or adults with immunoglobulin G4-related disease (IgG4-RD). It is given by intravenous infusion once every 6 months after an initial dosing period.

Uplizna gained FDA approval on June 11, 2020. There is no generic or biosimilar.

• Approval was extended on April 3, 2025, to include IgG4-RD.

Side effects

The most common side effects of Uplizna in NMOSD are:

• urinary tract infections
• joint pain.

The most common side effects of Uplizna in IgG4-RD are

• urinary tract infections
• low white blood cell counts.

Serious side effects and warnings

Uplizna may cause the following serious side effects:

• Infusion reactions. Uplizna can cause infusion reactions that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Uplizna for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms:
  • headache
  • nausea
  • sleepiness
  • shortness of breath
  • fever
  • muscle aches
  • rash

If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

• Infections. Infections can happen during treatment with Uplizna. Tell your healthcare provider right away if you have an infection or get any of these symptoms:
  • painful and frequent urination
  • nasal congestion, runny nose, sore throat, fever, chills, cough, body aches.

Uplizna taken before or after other medicines that weaken the immune system may increase your risk of getting infections.

• Hepatitis B virus (HBV) reactivation. Before starting treatment with Uplizna, 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 Uplizna. 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 Uplizna
• Progressive Multifocal Leukoencephalopathy (PML). PML may happen with Uplizna. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks. Call your healthcare provider right away if you get any of these symptoms:
  • weakness on one side of the body
  • loss of coordination in your arms and legs
  • changes in your vision
  • changes in thinking or memory
  • confusion
  • changes in your personality.
• Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB
• Vaccinations. Certain vaccines, called “live” or “live attenuated” vaccines, are not recommended in people receiving Uplizna. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving Uplizna during pregnancy, it is important to tell your baby’s healthcare provider about your Uplizna use so they can decide when your baby should receive any vaccine
• low blood cell counts. Uplizna may cause a decrease in some types of blood cells. Your healthcare provider will do blood tests to check your blood cell counts.

It is not known if Uplizna is safe or effective in children.

These are not all the possible side effects of Uplizna. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving

Do not receive Uplizna if you have:

• had a life-threatening infusion reaction to Uplizna.
• an active hepatitis B virus infection.
• active or untreated inactive (latent) tuberculosis.

Before receiving Uplizna, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection
• have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD. These medicines may increase your risk of getting an infection
• have or have ever had hepatitis B or are a carrier of the hepatitis B virus
• have or have ever had tuberculosis
• have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with Uplizna
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Pregnancy

It is not known if Uplizna will harm your unborn baby. Females should use birth control (contraception) during treatment, and for 6 months after your last infusion.

Breastfeeding

It is not known if Uplizna passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive Uplizna.

How will I receive Uplizna?

Uplizna is administered as an intravenous infusion (a needle is placed into a vein in your arm).

• Your first dose will be given as 2 separate infusions, 2 weeks apart.
• Your next doses are given as one infusion every 6 months.
• Each infusion will last about 1 hour and 30 minutes. After each infusion, you will be monitored by a healthcare provider for at least 1 hour.

Before treatment, your healthcare provider will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help prevent infusion reactions from becoming less frequent and less severe. See Important information.

Ingredients

Active ingredient: inebilizumab-cdon.
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, α,α-trehalose dihydrate, and water for injection.

Manufacturer

Uplizna (inebilizumab) is made by Horizon Therapeutics, which is now part of Amgen following an acquisition. Horizon Therapeutics was headquartered in Dublin, Ireland, with U.S. operations based in Deerfield, Illinois. After Amgen's acquisition of Horizon in October 2023, Amgen's headquarters are in Thousand Oaks, California.

Uplizna Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Uplizna.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer