ENSPRYNG® (satralizumab-mwge) injection

Gafacom April 03, 2023

ENSPRYNG® (satralizumab-mwge) injection

Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive.

ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose prefilled syringe. Each syringe delivers 1 mL of solution containing 120 mg of satralizumab-mwge, L-arginine (26.1 mg), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), L-aspartic acid (pH adjustment), and Water for Injection, USP.



INDICATIONS AND USAGE

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

Mechanism of Action

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.

DOSAGE AND ADMINISTRATION

Hepatitis B Virus Screening: 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. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with ENSPRYNG.

Tuberculosis Screening: Prior to initiating ENSPRYNG, evaluate for active tuberculosis and test for latent infection. For patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating treatment with ENSPRYNG.

Liver Transaminase Screening: Liver transaminases and serum bilirubin should be assessed prior to initiation of treatment with ENSPRYNG.

Caution should be exercised when considering initiation of ENSPRYNG treatment in patients whose aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are greater than 1.5 times the upper limit of normal (ULN).

Vaccinations: Because vaccination with live-attenuated or live vaccines is not recommended during treatment with ENSPRYNG, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ENSPRYNG for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ENSPRYNG for non-live vaccines.

Recommended Dosage

For subcutaneous use only.

Prior to every use of ENSPRYNG, advise patients to consult with their healthcare professional (HCP) if they suspect an active infection, including localized infections. In case of active infection, delay use of ENSPRYNG until the infection is resolved.

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.

Missed Dose

If a dose of ENSPRYNG is missed for any reason other than increases in liver enzymes,  administer as described in Table 1.

Table 1 Recommended Dosage for Delayed or Missed Doses

Last Dose AdministeredRecommended Dosage for Delayed or Missed Doses
Less than 8 weeks during the maintenance period or missed a loading doseAdminister 120 mg by subcutaneous injection as soon as possible, and do not wait until the next planned dose.  
Maintenance period:  After the delayed or missed dose is administered, reset the dose schedule to every 4 weeks.  
Loading period: If the second loading dose is delayed or missed, administer as soon as possible and administer the 3rd and final loading dose 2 weeks later. If the third loading dose is delayed or missed, administer as soon as possible and administer the 1st maintenance dose 4 weeks later.
8 weeks to less than 12 weeks120 mg by subcutaneous injection at 0* and 2 weeks, followed by 120 mg every 4 weeks.
12 weeks or longer120 mg by subcutaneous injection at 0*, 2, and 4 weeks followed by 120 mg every 4 weeks.

* “0 weeks” refers to time of the first administration after the missed dose.

Important Administration Instructions

  • ENSPRYNG is intended for patient self-administration by subcutaneous injection under the guidance of a health care professional (HCP). After proper training in subcutaneous injection technique, a patient may self-inject ENSPRYNG or the patient’s caregiver may administer ENSPRYNG, if the HCP determines that it is appropriate. See ENSPRYNG “Instructions for Use” (IFU) for more detailed instructions on the preparation and administration of ENSPRYNG.
  • Patients or caregivers should seek immediate medical attention if the patient develops symptoms of a serious allergic reaction and should not administer further doses until evaluated by a HCP.
  • Prior to use, remove the prefilled syringe from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes. Do not warm ENSPRYNG in any other way.
  • Inspect visually for particulate matter and discoloration prior to administration. ENSPRYNG solution should be clear and colorless to slightly yellow. Do not use ENSPRYNG if the solution is cloudy, discolored, or contains particles, or if any part of the prefilled syringe appears to be damaged.
  • Instruct patients to inject the full amount in the syringe (1 mL), which provides 120 mg of ENSPRYNG, according to the directions provided in the IFU.
  • Administer ENSPRYNG by subcutaneous injection in the abdomen or thigh. Rotate injection sites with each administration. Do not give injection into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

CONTRAINDICATIONS

ENSPRYNG is contraindicated in patients with:

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

WARNINGS AND PRECAUTIONS

Infections: An increased risk of infections, including serious and potentially fatal infections, has been observed in patients treated with IL-6 receptor antagonists, including ENSPRYNG.

Delay ENSPRYNG administration in patients with an active infection, including localized infections, until the infection is resolved.

Elevated Liver Enzymes: Mild and moderate elevations of liver enzymes have been observed in patients treated with ENSPRYNG at a higher incidence than in patients receiving placebo.

ALT and AST levels should be monitored every 4 weeks for the first 3 months of treatment, followed by every 3 months for one year, and thereafter, as clinically indicated.

Decreased Neutrophil Counts: Decreases in neutrophil counts were observed in patients treated with ENSPRYNG at a higher incidence than placebo.

Neutrophil counts should be monitored 4 to 8 weeks after initiation of therapy, and thereafter at regular clinically determined intervals.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin-6 receptor antagonists.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In an animal reproduction study, no adverse effects on maternal animals or fetal development were observed in pregnant monkeys and their offspring, with administration of satralizumab-mwge at doses up to 50 mg/kg/week.

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to ENSPRYNG in utero.

Lactation: No information is available on the presence of satralizumab-mwge in human milk, the effects of the satralizumab-mwge on the breastfed infant, or the effects of the satralizumab-mwge on milk production. Satralizumab-mwge was excreted in the milk of lactating monkeys administered satralizumab-mwge throughout pregnancy. Human IgG is excreted in human milk and the potential for absorption in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENSPRYNG and any potential adverse effects on the breastfed infant from ENSPRYNG or from the underlying  maternal condition.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

KEYWORDS

  • satralizumab uses
  • enspryng indications
  • satralizumab mechanism of action
  • enspryng dosing
  • enspryng side effects
  • satralizumab myasthenia gravis
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