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Overview: Uplizna is used to treat certain people with neuromyelitis optica spectrum disorder (NMOSD) or immunoglobulin G4-related disease (IgG4-RD). It may work by destroying certain immune cells, which helps prevent them from attacking healthy cells. Common side effects include kidney or bladder infection, joint pain, and low white blood cell levels. Tell your health care provider right away if you have an infection or symptoms of an infection, such as a cough, pain while peeing, or flu-like symptoms. Also tell your health care provider if you have had any serious infections in the past, such as hepatitis B or tuberculosis.

Uses

What is Uplizna used for?

Uplizna (inebilizumab-cdon) is commonly used to treat certain people with the following conditions. 

Uplizna may also be used for other conditions as determined by your health care provider.

How does Uplizna work (mechanism of action)?

In people with neuromyelitis optica spectrum disorder (NMOSD) or immunoglobulin G4-related disease (IgG4-RD), the immune system mistakes healthy cells as foreign substances and attacks them. Uplizna is thought to work by destroying certain immune cells, which can help prevent these attacks. 

How is Uplizna supplied (dosage forms)?

Brands and other names

  • Uplizna

Dosage forms and strengths

Uplizna is available in an injectable form that is given by a health care provider.

How should I store Uplizna?

Uplizna is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Uplizna?

The most common side effects of Uplizna are listed below. These side effects may vary based on why you are using Uplizna. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Uplizna that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Uplizna?

While less common, the most serious side effects of Uplizna are described below, along with what to do if they happen.

Severe Allergic Reactions. Uplizna may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infusion Reactions. Uplizna can cause serious or life-threatening reactions when it is given to you. Your health care provider will monitor you for these reactions during your infusion and for at least one hour afterward. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away if you have any of the following symptoms.

  • Trouble breathing
  • Headache
  • Nausea
  • Drowsiness
  • Fever
  • Muscle pain
  • Rash
  • Feeling of skipped heartbeats

Infections. Uplizna can increase your risk of infections, including serious infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Uplizna may also increase your risk of a latent microbe becoming active again, causing an infection. Tell your health care provider if you have ever had tuberculosis (TB) or any other serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Peeing more often than usual or burning pain when you pee
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Hepatitis B Virus Reactivation. If you have hepatitis B virus in your body or have had hepatitis B in the past, Uplizna could make the virus active again. Keep all appointments for blood work before starting Uplizna and during treatment. Call your health care provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Stool (poop) that is clay-colored

Progressive Multifocal Leukoencephalopathy (PML). People using Uplizna may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Low Antibodies. Uplizna may cause you to have low levels of certain types of antibodies, called immunoglobulins. Low immunoglobulin levels could increase your risk for infection. Keep all appointments to check your blood work before starting, during treatment, and after stopping this medicine.

Warnings & Precautions

Who should not use Uplizna?

Allergies to Ingredients. People who are allergic to any of the following should not use Uplizna.

  • Uplizna
  • Inebilizumab-cdon
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Uplizna.

Past Infusion Reaction. You should not use Uplizna if you have had a severe reaction while receiving it in the past. 

Hepatitis B. Do not use Uplizna if you have hepatitis B. Uplizna can make it harder for your body to fight infections. 

Tuberculosis. Do not use Uplizna if you have tuberculosis (TB) or latent TB. Latent TB is when you still have TB in your body, but the infection does not spread or cause any symptoms. Using Uplizna could make this condition worse. 

What should I know about Uplizna before using it?

Uplizna is given as an infusion into a vein (IV) by a health care provider in a hospital or clinic. 

Your health care provider will do blood work before you start using Uplizna and during treatment. It is important to attend all appointments so your health care provider can make sure it is safe for you to use Uplizna. If you miss any appointments, reschedule with your health care provider right away. 

You may be given certain medicines before or while receiving Uplizna to help prevent infusion reactions. Take these medicines exactly as your health care provider tells you to.

What should I tell my health care provider before using Uplizna?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Uplizna is right for you.

In particular, make sure that you discuss any of the following.

Infection. Tell your health care provider if you have an infection or have any symptoms of an infection, such as a fever, cough, or flu-like symptoms. Also tell them if you have been told you have the hepatitis B virus in your body or if you have ever had tuberculosis, even if it is not causing you any symptoms or problems. 

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines within four weeks before starting or while using Uplizna. Tell your health care provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Uplizna may interact with other medicines and supplements. Before using Uplizna, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Uplizna could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you can become pregnant, you should use effective birth control while using Uplizna and for at least six months after your last dose. Talk with your health care provider about the best birth control option for you.

If you become pregnant while using Uplizna, you can sign up for a pregnancy registry by calling 303-724-4644 or at www.upliznapregnancyregistry.com. This registry collects safety information about the use of Uplizna during pregnancy. If you used Uplizna while pregnant, also tell your baby’s health care provider that you received Uplizna. This may affect when your baby should get certain vaccines.

Breastfeeding. It is not known if Uplizna passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Uplizna while breastfeeding.

How can I get more information about Uplizna?

For more information about Uplizna, you can visit the drugmaker’s website at www.uplizna.com or call them at 833-842-8477.

Interactions

Does Uplizna interact with foods or drinks?

There are no known interactions between Uplizna and foods or drinks.

It is unknown if drinking alcohol will affect Uplizna.

Does Uplizna interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Uplizna.

  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • Any other medicine that can weaken or affect your immune system
  • A medicine for an infection

This may not be a complete list of medicines that can interact with Uplizna. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Uplizna?

If you or someone else has used too much Uplizna, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Uplizna?

If you miss an appointment to get your Uplizna dose, call to reschedule as soon as possible. 

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