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).
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