Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- 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 Monkeypox 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
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh or stomach area. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the 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, broken, tender, hard, or not intact, or areas with moles or scars.
This medicine comes in 2 forms: a prefilled autoinjector and a prefilled syringe.
Allow 30 minutes for the prefilled autoinjector or prefilled syringe to warm up to room temperature. Do not warm it in any other way (eg, microwave, hot water, sunlight).
Check the liquid in the prefilled autoinjector or 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 it if it has been frozen, cracked, or damaged, or if it has been dropped.
To use the prefilled autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Hold the autoinjector and pull the cap straight off. Do not touch the green needle shield. Do not put the cap back on.
- Place the autoinjector against your skin. Push firmly and hold it down against your skin. You will hear the first "click" when the injection starts. The green plunger will move down in the viewing window. It will take up to 15 seconds for the green plunger to move all the way down. You will hear a second "click" when the injection is done.
- Lift the autoinjector straight up form the skin. The green needle shield will lock into place, covering the needle.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Hold the barrel of the syringe. With your other hand, pull the needle cap straight off. Do not take the needle cap off until you are ready to inject. Do put the cap back on. Do not touch the needle.
- Gently pinch the skin. Use a quick, dart-like motion to insert the needle at a 45 to 90 degree angle. Slowly push the plunger all the way down until it touches the activation guards.
- Slowly release the plunger. The needle will be covered by the needle shield.
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 (Weeks 0, 2, and 4) 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.
- For neuromyelitis optic spectrum disorder:
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 carton. Protect from light. You may also store this medicine at room temperature for up to 8 days. Throw the medicine away if it has been left out of the refrigerator for more than 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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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 serious infections. Check with your doctor right away if you have chest tightness, stomach pain, fever, itching, pain or redness of the skin, indigestion, nausea, vomiting, chills, confusion, dizziness, fast heartbeat, bone pain, diarrhea, loss of appetite, weakness, bleeding in the eye, blurred vision, trouble breathing, sneezing, or cough.
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, which can be life-threatening and require immediate medical attention. 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
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
- difficulty in moving
- discouragement
- dryness or soreness of the throat
- ear congestion
- falls
- feeling sad or empty
- fever
- headache
- hoarseness
- indigestion
- irritability
- joint pain
- lack of appetite
- light-colored stools
- loss of interest or pleasure
- 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
- trouble concentrating
- trouble sleeping
- 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.
DRG-20502481
