Inebilizumab-cdon (Intravenous)

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

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor monitors your progress closely while you are using this medicine to ensure it is working correctly. Blood and urine tests may be required to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for at least 6 months after your last dose. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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

This medicine can temporarily reduce the number of white blood cells and antibodies in your blood, increasing your risk of getting an infection. If possible, avoid contact with people who have infections. Contact your doctor immediately if you believe you are developing an infection or if you have a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause hepatitis B virus reactivation. Contact your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown 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). Contact your doctor immediately if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding others, or weakness in your legs.

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

Do not receive any live vaccines (immunizations) while being treated with inebilizumab-cdon injection. You should have completed any necessary vaccinations at least 4 weeks before starting treatment with this medicine. Consult your doctor before getting any vaccines.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the effects of inebilizumab-cdon injection in children. Safety and effectiveness have not been established.

Geriatric

Studies have not been done to determine how age affects the effects of inebilizumab-cdon injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions have been chosen based on their potential importance and may not be all-inclusive.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Active Hepatitis B infection
• Active or untreated inactive (latent) Tuberculosis—This medicine should not be given to patients with these conditions.

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

• Weak immune system—Use with caution. It may worsen side effects and increase the risk of infections.

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

In the U.S.

• Uplizna

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Inebilizumab

Find detailed information on biosimilars for this medication.

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.