Class Name(s):

• 92:20 Immunomodulatory Agents

Pronunciation:

• (in eb" i liz' ue mab)

Brand Name(s):

• Uplinza^®

WHY is this medicine prescribed?

Inebilizumab-cdon injection is used to treat a certain type of neuromyelitis optic spectrum disorder (NMOSD; a condition in which the immune system attacks nerves in the eyes and the spinal cord) and immunoglobulin G4-related disease (IgG4-RD; a condition in which the immune system attacks healthy organs and tissues in the body causing damage to organs). Inebilizumab-cdon is in a class of medications called monoclonal antibodies. It works by decreasing a certain natural substance in the body that causes the symptoms of NMOSD and IgG4-RD.

HOW should this medicine be used?

Inebilizumab-cdon injection comes as a solution (liquid) to be slowly injected intravenously (into a vein) over at least 90 minutes by a doctor or a nurse in a hospital or medical facility. The first dose of inebilizumab-cdon injection is given as 2 separate infusions 2 weeks apart. Afterwards, it is given once every 6 months.

Inebilizumab-cdon injection may cause serious reactions during the infusion. A doctor or nurse will watch you closely during and for 1 hour after finishing the infusion. You may be given other medications to prevent or treat reactions to inebilizumab-cdon injection. Tell your doctor or nurse immediately if you experience any of the following symptoms: headache; sleepiness; rash; hives; fever; nausea; shortness of breath; muscle pain; shortness of breath or difficulty breathing; or fast, irregular, or pounding heartbeat. Your doctor may slow or stop your infusion if you have a reaction to the medication.

You will be given the Medication Guide when you begin treatment with inebilizumab-cdon injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving inebilizumab-cdon injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving inebilizumab-cdon injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had tuberculosis (TB; a serious lung infection) or hepatitis B (HBV; a virus that affects the liver). Your doctor will test you to see if you have TB or HBV before you begin your treatment. If you have TB or HBV, your doctor will probably tell you not to receive inebilizumab-cdon injection.
• tell your doctor if you have or think you have an infection or if you have or have ever had low blood cell counts (leukopenia, neutropenia).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving inebilizumab-cdon injection. Use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. If you become pregnant during your treatment with inebilizumab-cdon injection, call your doctor immediately. Inebilizumab-cdon injection may harm the fetus.
• tell your doctor if you have had a recent vaccination. Do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of inebilizumab-cdon injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Inebilizumab-cdon injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint, muscle, or back pain
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately:

• fever, chills, body aches, runny nose, sore throat, cough, painful or frequent urination, or other signs of infection
• rash; hives; itching; feeling faint or lightheaded; swelling of the face, eyes, lips, mouth, throat, or tongue; trouble breathing; or chest or throat tightness
• decreased strength or weakness on one side of the body, loss of balance or coordination, vision changes, confusion, trouble understanding or thinking, memory loss, or personality changes

Inebilizumab-cdon injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to inebilizumab-cdon injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2025.