Pronunciation:

in-eb-i-LIZ-ue-mab - cdon

Brand Names:

• Uplizna

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Inebilizumab

Uses of This Medicine:

Inebilizumab-cdon injection is used to treat neuromyelitis optic spectrum disorder (NMOSD), a rare disorder that causes inflammation of the nerves of the eyes and spinal cord. It is used in patients who are anti-aquaporin-4 (AQP4) antibody positive.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of inebilizumab-cdon injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of inebilizumab-cdon injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B infection, active or
• Tuberculosis, active or untreated inactive (latent)—Should not be given to patients with these conditions.

• Infection—Use with caution. This medicine may decrease your body’s ability to fight infection.

• Weak immune system—Use with caution. May cause side effects to become worse and increase risk for infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will receive the first dose of this medicine as 2 separate infusions, 2 weeks apart. The next dose will be given as one infusion every 6 months. Each infusion takes about 1 hour and 30 minutes.

Your doctor may ask you to stay for at least 1 hour after each infusion to check for unwanted effects.

You may receive other medicines (eg, allergy medicine, fever medicine, steroids) before starting treatment to prevent infusion reactions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving the medicine to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Inebilizumab-cdon may cause infusion-related reactions. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine can temporarily lower the number of white blood cells and antibodies in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause hepatitis B virus reactivation. Check with your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.

You will need to have a skin test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Do not have any live vaccines (immunizations) while you are being treated with inebilizumab-cdon injection. You should have completed any needed immunizations at least 4 weeks before starting treatment with this medicine. Check with your doctor before having any vaccines.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bloody or cloudy urine

chills

cough

difficult, burning, or painful urination

dizziness

facial swelling

fever

frequent urge to urinate

headache

lower back or side pain

muscle aches

nausea

pale skin

skin rash

sore throat

stuffy or runny nose

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back or joint pain

difficulty in moving

muscle stiffness

Incidence not known

Pain, itching, burning, swelling, or redness at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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