Uplizna (inebilizumab-cdon) is a prescription drug approved to treat certain autoimmune disorders. Uplizna comes as a solution for intravenous (IV) infusion into a vein.

Specifically, Uplizna is used in adults to treat:

To learn more about Uplizna’s uses, see the “Uses for Uplizna” section.

Uplizna basics

Uplizna contains the active ingredient inebilizumab-cdon.

Uplizna is a biologic medication. A biologic is made from parts of living organisms. Uplizna is available only as a brand-name drug and is not available in a biosimilar form.

Biosimilars are like generic drugs. Just as generic drugs are alternatives to brand-name medications, biosimilars are alternatives to biologics.

Biosimilars will have the same active ingredient core name as the brand-name drug, but with unique suffixes. This is why “-cdon” appears at the end of the name of the active ingredient. This shows it is distinct from biosimilars that may be developed in the future.

Uplizna’s manufacturer is Horizon Therapeutics Ireland DAC. The drug is marketed by Amgen.

Uplizna has two approved uses, as follows.

Neuromyelitis optica spectrum disorder (NMOSD)

Doctors prescribe Uplizna for adults to treat NMOSD. NMOSD is a rare and chronic (ongoing) condition.

Your immune system is your body’s defense system. It has many different parts, including B cells, which are a type of white blood cell. B cells produce antibodies that help protect you from infection.

But with NMOSD, the antibodies that the B cells produce attack nerves in the eyes and spinal cord. This attack stops these nerves from working correctly and causes symptoms such as:

  • eye pain
  • blurred vision
  • loss of motor functions or movement
  • weakness in the legs
  • pain in the spine or limbs
  • numbness or loss of sensation
  • loss of bowel or urinary control
  • loss of autonomic functions, such as breathing rate and body temperature
  • reduced reflexes
  • headache
  • stiff neck

Immunoglobulin G4-related disease (IgG4-RD)

Doctors prescribe Uplizna for adults to treat IgG4-RD.

With IgG4-RD, the B cells make unusually high numbers of antibodies called IgG4. The body’s immune system produces B cells. Antibodies help protect you from infection. But the IgG4 antibodies attack healthy tissues and one or more organs throughout your body. This causes swelling, masses, and lumps to form, which leads to inflammation that spreads widely.

In many people, IgG4-RD symptoms don’t occur for several months. Once symptoms do occur, they will depend on the organ or organs affected. Symptoms can include:

  • a mass resembling cancer
  • weight loss
  • fatigue (low energy)
  • breathlessness
  • nerve problems in the neck and head
  • bulges in one or both eyes, below the chin, or on the side of the face
  • headache
  • thyroiditis, which is an inflamed thyroid gland
  • inflamed blood vessel walls
  • blocked urine flow from the kidneys
  • kidney swelling
  • jaundice, which is the yellowing of the white of the eyes or the skin
  • belly pain

How it works

Uplizna works to treat NMOSD and IgG4-RD by attaching to a specific protein on the surface of B cells. Once it attaches, the drug destroys these B cells. This process is the drug’s mechanism of action or MOA. It reduces the number of antibodies that can attack healthy tissue in your body.

With NMOSD, the MOA of Uplizna helps stop the immune system from attacking and damaging your nerves. With IgG4-RD, the MOA of Uplizna helps stop the immune system from attacking and damaging your organs and tissues. Uplizna also helps prevent your condition from recurring (relapsing).

Like most drugs, Uplizna may cause mild to serious side effects. The following list contains some of the more common side effects Uplizna may cause, but it doesn’t include all the side effects possible.

Keep in mind that the side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Uplizna. They can also suggest ways to help reduce side effects.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone. It gives doctors and researchers more information about how the drug works in real life. If you develop a side effect while receiving Uplizna and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Uplizna can cause mild side effects. Some that have been reported include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

To learn about other mild side effects, talk with your doctor or pharmacist or read Uplizna’s prescribing information.

Serious side effects

Serious side effects from Uplizna can occur, but they aren’t common. Serious side effects of Uplizna that have been reported include:

  • increased risk of serious infection
  • leukopenia, which is a low white blood cell count
  • infusion-related reaction, such as shortness of breath, fever, or anaphylaxis
  • flare-up of tuberculosis or hepatitis B if you’ve ever had either infection
  • progressive multifocal leukoencephalopathy, which is a rare brain infection

If you have serious side effects from Uplizna, call your doctor right away. If you think you’re having a medical emergency, you should call 911. Or call your local emergency number right away.

Allergic reaction

For some people, Uplizna can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. They can also determine whether you should continue Uplizna treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911. Or call your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

Your doctor can confirm whether you’ve had a serious allergic reaction to Uplizna. If you have, they may switch you to a different treatment.

The Uplizna dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition Uplizna is treating
  • your age
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. But be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Form and strength

Uplizna comes as a liquid solution that’s given as an intravenous (IV) infusion into a vein. It’s available in one strength of 100 milligrams (mg) per 10 milliliters (mL) of solution. This is also written as 100 mg/10 mL or 10 mg/mL.

Recommended dosage

For treatment of NMOSD or IgG4-RD, your doctor will likely prescribe the following recommended dosage:

  • Initial dose: 300 mg initially, followed by a second 300-mg dose 2 weeks later
  • Subsequent doses: 300 mg every 6 months, beginning 6 months after the first infusion

To learn more, see this Uplizna dosage article.

How to receive

Before each infusion, your doctor will determine whether you have an active infection. If you do, they’ll delay your infusion until the infection clears.

You’ll receive your infusions at a clinic or your doctor’s office.

When you’re ready for your infusion, your doctor or healthcare professional will give you certain medications before Uplizna. These premedications will help reduce the severity and frequency of an infusion reaction. They may include:

Then your doctor or healthcare professional will give you your dose of Uplizna by intravenous (IV) infusion. This is an injection into your vein over a period of time.

The premedications will take about 1 hour or less. The Uplizna infusion will take about 1 1/2 hours.

About receiving Uplizna

The following are some common questions about receiving Uplizna.

  • What if I miss a dose of Uplizna? If you miss an appointment for your infusion of Uplizna, call your doctor’s office as soon as possible to reschedule it.
  • Will I need to receive Uplizna long term? Uplizna is typically received as a long-term treatment. You and your doctor can determine whether it’s safe and effective for your condition. If you agree that it is, you’ll likely receive it long term.
  • How long does Uplizna take to work? Uplizna begins to work after you receive your first dose. But you likely won’t feel the drug working in your body. Your doctor will order tests throughout your treatment to check whether Uplizna is working to treat your condition.

Uplizna can interact with certain medications and vaccines.

Before recieving Uplizna, talk with your doctor. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, or supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications and vaccines

The following table highlights medications and vaccines that can interact with Uplizna. This table does not contain all drugs that may interact with Uplizna. If you have questions about interactions that may affect you, ask your doctor.

Medications that can interact with Uplizna• corticosteroids, such as prednisone and methylprednisolone (Medrol) (See the note following the table.)

• other immunosuppressants that weaken your immune system, such as cyclosporine (Neoral, others) and rituximab (Rituxan)
Vaccines that can interact with Uplizna• live vaccines such as the chickenpox vaccine (Varivax), the nasal spray flu vaccine (FluMist), and the measles, mumps, and rubella (MMR) vaccine

If you have questions about interactions that may affect you, talk with your doctor or pharmacist.

Note: Because of how methylprednisolone works, it may increase the risk of infection if taken with Uplizna. But, as noted earlier, you may receive methylprednisolone before your Uplizna doses. This short-term and medically supervised use helps reduce infusion reactions. Doctors agree that the benefit of this short-term use outweighs the drug’s potential interaction concerns.

Uplizna and alcohol

Alcohol is not known to interact with Uplizna. It’s likely safe to consume alcohol while receiving Uplizna.

Whether or not you have health insurance, cost may be a factor when you’re considering Uplizna. What you’ll pay for Uplizna may depend on several things, such as your treatment plan and the pharmacy you use.

If you have questions about how to pay for your prescription, talk with your doctor. A program called Amgen By Your Side may also be available. This patient support program offers information on insurance, financial assistance, and other services.

You can also check these coupons.

The following is important information to consider and discuss with your doctor or pharmacist before starting Uplizna treatment.

Pregnancy and Uplizna

Uplizna may cause fetal harm when received during pregnancy. Uplizna might lower the level of white blood cells in the developing fetus. But it’s not known whether this could affect a child’s risk of infection or their response to vaccines after birth.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting treatment with Uplizna.

If you do receive Uplizna while pregnant, you’re encouraged to join the pregnancy registry. This pregnancy registry gathers information about the health of pregnant people who have received inebilizumab-cdon (Uplizna) and the health of their babies. For more information about the registry, call 303-724-4644 or talk with your doctor.

Birth control and Uplizna

Uplizna may cause fetal harm when received during pregnancy. Females should use birth control during treatment with Uplizna. They also should continue it for 6 months after their last infusion of Uplizna.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options during Uplizna treatment.

Note: The use of binary terms such as “male” and “female” or “men” and “women” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.

Uplizna and breastfeeding

It’s not known whether Uplizna should be received while breastfeeding. It’s likely that the drug passes into breast milk. But it’s not known what effect that may have on a child who’s breastfed.

If you’re currently breastfeeding or planning to do so, talk with your doctor before starting treatment with this drug.

Before starting Uplizna, discuss your health history with your doctor. Uplizna may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

For more information about the potential negative effects of Uplizna, see the “Side effects of Uplizna” section.

Here are answers to some commonly asked questions about Uplizna.

What should I know about Uplizna vs. rituximab?

Both Uplizna and rituximab (Rituxan) are prescription medications that lower certain immune cells (B cells) in the body. By doing this, they help prevent the immune system from attacking healthy tissues or nerves.

Uplizna is FDA approved to treat NMOSD and IgG4-RD. Rituximab is approved for other conditions, but some doctors also use it off-label to treat NMOSD and IgG4-RD. Off-label use is when doctors prescribe a drug for a purpose other than what it’s approved to treat or help prevent.

A doctor or healthcare professional gives either Uplizna or rituximab by IV infusion. Both medications can increase the risk of infection. But rituximab also may affect the heart or kidneys.

Talk with your doctor if you’d like to learn more about either medication.

Can Uplizna treat myasthenia gravis?

Uplizna is not FDA-approved to treat myasthenia gravis. Some early research suggests Uplizna may help improve the ability to perform daily activities in people with the condition. This research also suggests the drug may reduce symptoms in some people with myasthenia gravis.

Researchers need to confirm Uplizna’s long-term benefits and safety for this condition through more studies.

Other drugs are available that can treat your condition. If you’d like to explore an alternative to Uplizna, talk with your doctor. They can tell you about other medications that might work well for you.

The following drugs are similar to Uplizna:

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.