Satralizumab-mwge

What Is Satralizumab-mwge?

Satralizumab-mwge (ENSPRYNG) is an interleukin-6 (IL-6) receptor antagonist.

What are the uses of this medicine?

This medicine is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

How does this medicine work?

The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• A known hypersensitivity to satralizumab or any of the inactive ingredients
• Active Hepatitis B infection
• Active or untreated latent tuberculosis

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Prior to initiating ENSPRYNG, perform Hepatitis B virus (HBV) screening.
• ENSPRYNG is contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests.
• Prior to every use, determine if there is an active infection.
• The recommended loading dosage of ENSPRYNG for the first three administrations is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 120 mg/mL in a single-dose prefilled syringe

This medicine is available in fallowing brand namesː

• ENSPRYNG

What side effects can this medication cause?

Common possible side effects of this medicine include:

• nasopharyngitis
• headache
• upper respiratory tract infection
• gastritis
• rash
• arthralgia
• extremity pain
• fatigue
• nausea

ENSPRYNG may cause serious side effects including:

Infections

• ENSPRYNG can increase your risk of serious infections some of which can be life-threatening.

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 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.

What special precautions should I follow?

• Delay ENSPRYNG administration in patients with an active infection until the infection is resolved.
• Vaccination with live or live-attenuated vaccines is not recommended during treatment.
• Mild and moderate elevations of liver enzymes have been observed in patients treated with ENSPRYNG at a higher incidence than in patients receiving placebo. Monitor ALT and AST levels during treatment; interruption of ENSPRYNG may be required.
• Decreases in neutrophil counts were observed in patients treated with ENSPRYNG at a higher incidence than placebo. Monitor neutrophils during treatment.

What to do in case of emergency/overdose?

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
• Prior to administration, ENSPRYNG, if unopened, can be removed from and returned to the refrigerator, if necessary. The total combined time out of refrigeration should not exceed 8 days at a temperature that does not exceed 30°C (86°F).

• Dailymed label info on Satralizumab-mwge
• FDA Satralizumab-mwge

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