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).

Satralizumab-mwge Resources
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