Inebilizumab is used in adults with a condition called neuromyelitis optica (NOO-roe-mye-LYE-tis OP-ti-ka) spectrum disorder (NMOSD), and who are positive for a certain antibody.

NMOSD, also called Devic's disease, is a central nervous system disorder that occurs when your immune system attacks cells in your eyes, spinal cord, or brain. NMOSD may cause vision loss, weakness or paralysis in your arms or legs, numbness or pain, uncontrollable vomiting or hiccups, or loss of bowel or bladder control.

Inebilizumab can help lower your risk of having these symptoms or developing a permanent disability.

Inebilizumab may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Inebilizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Inebilizumab must be given slowly, and the infusion can take at least 90 minutes to complete.

Before each infusion, your doctor will perform tests to make sure you do not have tuberculosis, hepatitis B, or other infections.

Inebilizumab infusions are usually given 2 weeks apart at first, and then once every 6 months.

You will be given other medications 30 to 60 minutes before each infusion, to help prevent serious side effects or an allergic reaction.

You will be watched closely for at least 1 hour after each infusion, to make sure you do not have an allergic reaction.

If you've ever had hepatitis B, it may become active or get worse while receiving inebilizumab or after you stop using it. You may need frequent liver function tests for several months.

You will need frequent medical tests to check your blood levels of certain antibodies called immunoglobulins (proteins made by your immune cells to help your body fight infections).

If your immunoglobulin levels get too low or you develop an infection, further doses may be postponed or not given at all.

Usual Adult Dose for Neuromyelitis Optica:

Initial dose: 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.
Maintenance dose: Single 300 mg intravenous infusion every 6 months (starting 6 months from the first infusion).

Comments:
-Determine whether there is an active, clinically significant infection before each infusion and do not administer in the presence of an active infection.
-Pre-medicate with a corticosteroid (methylprednisolone or equivalent), antihistamine (diphenhydramine or equivalent), and an anti-pyretic (acetaminophen or equivalent) before each infusion.
-Observe the patient for at least one hour after the completion of the infusion

Use: Neuromyelitis Optica Disorder Spectrum (NMOSD)

You should not be treated with inebilizumab if you have:

• active hepatitis B;

• active or untreated tuberculosis; or

• a history of life-threatening reaction to an inebilizumab injection.

Tell your doctor if you think you have an infection, or if you have ever had:

• hepatitis B (or if you are a carrier);

• tuberculosis; or

• if you have recently received or are scheduled to receive a vaccine.

Make sure you are current on all vaccines at least 4 weeks before you start treatment with inebilizumab.

Inebilizumab may harm an unborn baby. Use effective birth control to prevent pregnancy while using inebilizumab and for at least 6 months after your last dose.

If you use inebilizumab while you are pregnant, make sure any doctor caring for your new baby knows that you used this medicine during pregnancy. Being exposed to inebilizumab in the womb could affect your baby's vaccination schedule during the first few months of life.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your inebilizumab injection.

Since inebilizumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Do not receive a "live" vaccine without your doctor's advice. You will need blood tests before you receive any live vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You may still need blood tests before receiving a live vaccine for a short time after you stop using inebilizumab. Follow your doctor's instructions.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel drowsy, nauseated, feverish, or have a headache, skin rash, muscle pain, or trouble breathing.

Inebilizumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Inebilizumab may cause serious side effects. Call your doctor at once if you have:

• fever, chills, body aches;

• stuffy nose, cough, sore throat;

• pain or burning when you urinate;

• urinating more than usual; or

• right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well.

Your doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects of inebilizumab may include:

• painful urination; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.