Inebilizumab

Pronunciation: in-EB-i-LIZ-ue-mab
Generic name: inebilizumab-cdon
Brand name: Uplizna
Dosage form: injection for intravenous use (100 mg/10 mL)
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on May 19, 2025.

What is inebilizumab?

Inebilizumab is used to treat adults with NMOSD (neuromyelitis optica spectrum disorder) who are anti-aquaporin-4 (AQP4) antibody positive, or adults with IgG4-RD (immunoglobulin G4-related disease). It is given by IV infusion once every 6 months.

Inebilizumab works by targeting a specific marker called CD19, found on pre-B and mature B lymphocytes, which are a type of immune cell. Once inebilizumab binds to the surface of these cells, it triggers their destruction, which helps to calm down an overactive immune system, although exactly how inebilizumab works for NMOSD and IgG4-RD is not known. Inebilizumab belongs to the drug class called CD19-directed cytolytic antibodies.

Inebilizumab-cdon first gained FDA approval on June 11, 2020, under the brand name Uplizna, made by Horizon Therapeutics, a subsidiary of Amgen. There is no generic or biosimilar.

Side effects

The most common side effects of inebilizumab in NMOSD are:

• Urinary tract infections
• Joint pain.

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

• Urinary tract infections
• Low white blood cell counts.

Serious side effects and warnings

Inebilizumab may cause the following serious side effects:

• Infusion reactions. Inebilizumab can cause infusion reactions, including anaphylaxis, 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 dose 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
  • palpitations.

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 inebilizumab. 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.

Inebilizumab 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 inebilizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with inebilizumab. 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 inebilizumab
• Progressive Multifocal Leukoencephalopathy (PML). PML may happen with inebilizumab. 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 inebilizumab. Talk to your healthcare provider before receiving any vaccinations. If you have a baby and you were receiving inebilizumab during pregnancy, it is important to tell your baby’s healthcare provider about your inebilizumab use so they can decide when your baby should receive any vaccine
• Low blood cell counts. Inebilizumab 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 inebilizumab is safe or effective in children.

These are not all the possible side effects of inebilizumab. 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 inebilizumab if you have:

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

Before receiving inebilizumab, 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 inebilizumab
• 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 inebilizumab will harm your unborn baby. Females should use birth control (contraception) during treatment and for 6 months after their last infusion.

Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to inebilizumab during pregnancy. The purpose of this registry is to collect information about your and your baby's health. If you become pregnant while taking inebilizumab, you are encouraged to enroll in the pregnancy registry by calling 1-303-724-4644 or by visiting online at www.upliznapregnancyregistry.com. 

Breastfeeding

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

How will I receive inebilizumab?

Inebilizumab is administered as an intravenous infusion once every 6 months after an initial dosing period.

• During the initial dosing period, you will receive 2 separate infusions, 2 weeks apart.
• Your next dose will be given as one infusion in 6 months, and then every 6 months thereafter as a maintenance dose.
• Each infusion will last about 90 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 premedications to reduce your risk of an allergic reaction or an infusion reaction. The premedications may include a corticosteroid, an antihistamine, and acetaminophen.

Dosing information

Inebilizumab should be administered over approximately 90 minutes and must be diluted in 250 mL of 0.9% Sodium Chloride before administration.

Initial inebilizumab dose for NMOSD or IgG4-RD: 300 mg via IV infusion, followed two weeks later by a second 300 mg IV infusion.

Subsequent inebilizumab doses for NMOSD or IgG4-RD: 300 mg IV infusion every 6 months.

• Start 6 months from the first infusion.

What other drugs will affect inebilizumab?

Tell your doctor about all your other medicines, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect inebilizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ingredients

Inebilizumab is only available as the brand Uplizna.

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

Available as a 100 mg/10 mL (10 mg/mL) solution in a single-dose vial for intravenous infusion. Dilute in 250 mL of 0.9% Sodium Chloride before administration.

Manufacturer

Inebilizumab-cdon is made by Horizon Therapeutics, a subsidiary of Amgen, under the brand name Uplizna. Amgen's headquarters are in Thousand Oaks, California.

Inebilizumab 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 inebilizumab.

Further information

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

Medical Disclaimer