Pronunciation:

sat-ra-LIZ-ue-mab

Brand Names:

• Enspryng

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Satralizumab-mwge 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 satralizumab-mwge injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of satralizumab-mwge injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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 taking 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 or
• Neutropenia (low number of white blood cells)—Use with caution. This medicine may decrease your body’s ability to fight infection.

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

This medicine is given as a shot under your skin in the thighs or stomach. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

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

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are red, bruised, tender, hard, or not intact, or areas with moles or scars.

Remove the prefilled syringe from the refrigerator before using. Allow 30 minutes for the medicine to warm up to room temperature outside of the carton. Do not warm it in any other way.

Check the liquid in the prefilled syringe. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake. Do not use the prefilled syringe if it has been damaged or broken.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage forms (prefilled syringe):
  • For neuromyelitis optic spectrum disorder:
    • Adults—At first, 120 milligrams (mg) injected under the skin once every 2 weeks for the first three injections (loading dose). Then, 120 mg is given once every 4 weeks (maintenance dose).
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep it in its original container. Do not use it if it has been frozen, even if it has been thawed. Protect from light. You may also store this medicine at room temperature for up to 8 days.

Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

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 satralizumab-mwge injection. You should have completed any needed immunizations at least 4 weeks for live or live-attenuated vaccines and at least 2 weeks for non-live (inactivated) vaccines before starting treatment with this medicine. Check with your doctor before having any vaccines.

Satralizumab-mwge injection may cause serious allergic reactions, including anaphylaxis. Check with your doctor right away if you have a rash, hives, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

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 immediately if any of the following side effects occur:

More common

Black, tarry stools

body aches or pain

burning feeling in the chest or stomach

chills

cough

dark urine

depression

difficulty in moving

dryness or soreness of the throat

ear congestion

falls

fever

headache

hoarseness

indigestion

joint pain

light-colored stools

loss of voice

lower back or side pain

muscle pain or stiffness

nausea and vomiting

painful or difficult urination

pain, redness, swelling, tenderness, or warmth on the skin

pale skin

skin rash, hives, itching

sneezing

sore throat

stomach upset

stuffy or runny nose

tenderness in the stomach area

tender, swollen glands in the neck

trouble breathing or swallowing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

upper right stomach pain

weight gain

yellow eyes and skin

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth 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.