Enspryng
Pronunciation: en-spring
Generic name: satralizumab-mwge
Dosage form: prefilled syringe for subcutaneous use
Drug class: Interleukin inhibitors
What is Enspryng?
Enspryng is used to treat neuromyelitis optica spectrum disorder (NMOSD) in aquaporin-4 (AQP4) antibody-positive adults. It is an injection given 1 time every 4 weeks after an initial loading period.
Enspryng is an interleukin-6 (IL-6) receptor antagonist that targets and blocks IL-6 signaling, which plays a key role in regulating immune responses and inflammation and is thought to be associated with NMOSD.
Enspryng gained FDA approval on August 14, 2020. There is no generic or biosimilar.
Side effects
The most common side effects of Enspryng include:
- sore throat, runny nose (nasopharyngitis)
- headache
- rash
- upper respiratory tract infection
- fatigue
- nausea
- extremity pain
- inflammation of the stomach lining (gastritis)
- joint pain.
Serious side effects and warnings
Enspryng may cause serious side effects including:
Infections. Enspryng can increase your risk of serious infections some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection or call them right away if you think you have signs of an infection, with or without a fever, such as:
- chills, feeling tired, muscle aches, cough that will not go away or a sore throat
- skin redness, swelling, tenderness, pain or sores on your body
- diarrhea, belly pain, or feeling sick
- burning when you urinate or urinate more often than usual.
Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take Enspryng.
Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking Enspryng.
All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start Enspryng. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start Enspryng.
Increased liver enzymes. Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking Enspryng. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start Enspryng if your liver enzymes are increased.
Low neutrophil count. Enspryng can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking Enspryng.
Serious allergic reactions. Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction, such as:
- shortness of breath or trouble breathing
- swelling of your lips, face, or tongue
- dizziness or feeling faint
- moderate or severe stomach (abdominal) pain or vomiting
- chest pain.
It is not known if Enspryng is safe and effective in children.
These are not all the possible side effects of Enspryng. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
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Before taking
Do not take Enspryng if you:
- are allergic to satralizumab-mwge or any of the ingredients in Enspryng
- have an active hepatitis B infection
- have active or untreated inactive (latent) TB.
Before you take Enspryng, tell your healthcare provider about all of your medical conditions, including if you:
- have or think you have an infection
- have liver problems
- have ever had hepatitis B or are a carrier of the hepatitis B virus
- have had or have been in contact with someone with tuberculosis
- have had a recent vaccination or are scheduled to receive any vaccination
- are pregnant, think that you might be pregnant, or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known if Enspryng will harm your unborn baby.
Pregnancy Registry: There is a registry for pregnant women who take Enspryng. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Enspryng, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-833-277-9338 to enroll.
Breastfeeding
It is not known if Enspryng passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Enspryng.
Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How do I take Enspryng?
Enspryng is provided as a solution in a single-dose, prefilled syringe of 120 mg/mL of satralizumab-mwge.
See the Instructions for Use provided with the medication guide for complete instructions for the right way to prepare and inject Enspryng.
- Enspryng is given by an injection under the skin (subcutaneously).
- It may be administered into the abdomen (but not within 2 inches of the navel) or upper, outer, thigh.
- Rotate injection sites with each administration. Do not give an injection into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
- If your healthcare provider decides that you or your caregiver can give your injections of Enspryng, you or your caregiver should receive training on the right way to prepare and inject Enspryng.
Always inject all of the medicine in the syringe.
- The first 3 injections (loading period) of Enspryng are taken 1 time every 2 weeks.
- After this, an injection of Enspryng is given every 4 weeks (maintenance period). Keep taking Enspryng 1 time every 4 weeks for as long as your healthcare provider tells you to.
Dosing information
Recommended loading dose (Weeks 0, 2, and 4): Enspryng 120 mg SC
Week 8 and every 4 weeks after: Enspryng 120 mg SC.
What happens if I miss a dose?
If you miss a dose of Enspryng, talk to your healthcare provider about restarting dosing.
Does Enspryng interact with any medications?
Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Storage
Store Enspryng in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.
- Protect from light and do not freeze or use the syringe if it has been frozen.
- Do not shake.
Enspryng, if unopened, can be removed from and returned to the refrigerator, if needed.
- The total combined time out of the refrigerator should not be more than 8 days at a temperature that does not go above 86°F (30°C).
Ingredients
Active ingredient: satralizumab-mwge
Inactive ingredients: L-arginine, L-histidine, poloxamer 188, L-aspartic acid, and Water for Injection.
Available as a 120 mg/mL injection in a single-dose prefilled syringe.
Who makes Enspryng?
Enspryng (satralizumab) is manufactured by Genentech Inc., a subsidiary of the Roche Group with headquarters in South San Francisco, California.
It was developed by Chugai Pharmaceutical, a Japanese subsidiary of Roche.
Enspryng Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Enspryng.
Enspryng (satralizumab-mwge) - Genentech, Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 120 mg/mL |
Popular FAQ
How is Enspryng administered?
Enspryng is given as an injection under the skin (a subcutaneous injection) in the thigh or stomach area to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. Your healthcare provider can teach you how to give these injections at home. Continue reading
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.