Inebilizumab-cdon (in-eb-i-LIZ-ue-mab - cdon)

Treats neuromyelitis optic spectrum disorder (NMOSD).

Brand Name(s):

Uplizna

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to stay in place for at least 1 hour and 30 minutes.
• A nurse or other health provider will give you this medicine.
• You may receive other medicines (including allergy medicine, fever medicine, steroids) before starting treatment to prevent infusion reactions.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how inebilizumab-cdon works. Tell your doctor if you are using medicine that can weaken your immune system (including steroid medicine).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should have completed any needed vaccines at least 4 weeks before treatment with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 6 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have any type of infection or a weak immune system.
• This medicine can cause an infusion reaction that can be life-threatening.
• This medicine may make you get infections more easily. You will be at risk for infections including hepatitis B infection reactivation, progressive multifocal leukoencephalopathy (PML), or tuberculosis (TB) infection. Take precautions to prevent illness and injury. Wash your hands often.
• You will need to have a TB skin test before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches, difficult or painful urination
• Headache, trouble breathing, drowsiness, muscle pain
• Weakness on one side of your body, changes in vision, problems with thinking or memory, confusion, changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain, difficulty moving
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088