Uplizna: Uses, Side Effects and Dosage

What UPLIZNA is used for:

• UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
• UPLIZNA is used to treat adults with Immunoglobulin G4-related disease (IgG4-RD) to reduce the frequency of flares. IgG4-RD is a rare condition which can affect multiple organs and tissues in the body.
• UPLIZNA is used together with standard therapy to treat adults with generalized Myasthenia Gravis (gMG) who are antibody positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK). Generalized MG causes weakness of muscles, including those involved in movement and/or breathing. This is an “autoimmune disorder” which means that it is caused by your antibodies. These antibodies target and destroy proteins that are responsible for communication between nerves and muscles. This then results in muscle weakness.
• It is not known if UPLIZNA is safe or effective in children.

How UPLIZNA works:

Inebilizumab is a monoclonal antibody (a type of protein) that attaches to immune cells called B cells and destroys them. In most people with NMOSD, B cells produce antibodies that attack AQP4, a protein involved in nerve cell function. By reducing the numbers of B cells, the medicine is expected to prevent damage to nerve cells and reduce the symptoms of the condition.

In people with IgG4-RD, the immune system damages the body’s own tissues. Patients with IgG4-RD may have high levels of a specific type of antibody called IgG4. B cells producing IgG4 build up in affected tissues and contribute to organ damage. UPLIZNA reduces the number of B cells in IgG4-RD patients.

UPLIZNA targets a marker called CD19 found on many B cells, a type of immune cell which makes antibodies that attack healthy tissue in autoimmune diseases such as gMG. By lowering these B cells, the medicine helps reduce the immune system’s attack on the nerve–muscle connection, which can improve muscle function and reduce disease activity.

The ingredients in UPLIZNA are:

Medicinal ingredient(s): inebilizumab

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, trehalose dihydrate, and water for injection

UPLIZNA comes in the following dosage form(s):

Injection: 3 vials of 100 mg/10 mL (10 mg/mL)

Do not use UPLIZNA if:

• you are hypersensitive to the drug or to any of the ingredients within the drug.
• you have had a life-threatening infusion reaction to UPLIZNA.
• you have a severe active infection or a chronic active infection such as hepatitis B virus infection.
• you have active or untreated inactive (latent) tuberculosis.
• you have a history of progressive multifocal leukoencephalopathy (PML).
• you are in a severely immunocompromised state.
• you have active malignancy.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take UPLIZNA. Talk about any health conditions or problems you may have, including if you:

• have or think you have an infection.
• are severely immunocompromised, including HIV 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 hepatitis C.
• have or have ever had tuberculosis.
• have had progressing multifocal leukoencephalopathy (PML).
• have active malignancy.
• 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.

• have a baby and you were exposed to UPLIZNA during pregnancy. It is important to tell your baby’s healthcare professional, so they can decide when your baby should receive any vaccinations.

• are pregnant or plan to become pregnant. It is not known if UPLIZNA will harm your unborn baby. Females should use effective birth control (contraception) during treatment with UPLIZNA and for 6 months after your last infusion of UPLIZNA.
• Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to UPLIZNA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking UPLIZNA, you are encouraged to enroll in the pregnancy registry by calling 1-303-724-4644.
• are breastfeeding or plan to breastfeed. It is not known if UPLIZNA passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive UPLIZNA.

Other warnings you should know about:

Allergic Reactions:

UPLIZNA can cause infusion reactions, including anaphylaxis. Tell your healthcare professional immediately if you get any of these symptoms during your UPLIZNA infusion:

Headache, nausea, drowsiness, shortness of breath, fever, aches, palpitations or other signs or symptoms.

Decreased Immunoglobulins

UPLIZNA may cause a decrease in immunoglobulins (proteins in your blood that help your immune system fight infection). Your healthcare professional will do blood tests to check your blood immunoglobulin levels.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with UPLIZNA:

No relevant drug-drug interactions are known however, use of UPLIZNA with drugs that suppress your immune system may increase the risk of infection. Inform healthcare professional of any other medications you are taking.

How to take UPLIZNA:

• UPLIZNA will be given to you by a qualified healthcare professional.
• UPLIZNA is given through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Before treatment with UPLIZNA, your healthcare professional will complete specific screening tests and will give you a corticosteroid medicine, an antihistamine, and a fever prevention medicine to help infusion reactions become less frequent or less severe.

Usual dose:

• Each dose of UPLIZNA consists of 300 mg of the drug.
• Your first dose of UPLIZNA will be given as 2 separate infusions, 2 weeks apart.
• Your next doses of UPLIZNA will be 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 professional for at least 1 hour.

Overdose:

UPLIZNA is given by a healthcare professional only. This minimizes the chance of an overdose.

If you think you, or a person you are caring for, have taken too much UPLIZNA contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss an appointment for an infusion, contact your healthcare professional to make another one right away.

Possible side effects from using UPLIZNA:

These are not all the possible side effects you may have when taking UPLIZNA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Urinary tract infection
• Common cold
• Joint pain
• Upper respiratory tract infection
• Headache
• Back pain
• Infusion related reactions
• Fever
• Muscle pain
• Lung infection (pneumonia)
• Cough

Serious side effects and what to do about them:

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store UPLIZNA in a refrigerator at 2°C to 8°C in original carton.

Protect from light. Do not freeze. Do not shake.

Store vials upright.

Keep out of reach and sight of children.

If you want more information about UPLIZNA:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database

  • website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.amgen.ca, or by calling 1-866-502-6436.

Date of Authorization: 2026-05-19