For Patients & Caregivers

Patient monitoring prior to and during ENSPRYNG treatment

Assessments prior to the first dose of ENSPRYNG3

  • Infection assessment: Identify and resolve any active infection before starting ENSPRYNG
  • Hepatitis B virus screening: ENSPRYNG should not be initiated in patients with active HBV
  • Tuberculosis screening: Evaluate for active tuberculosis and test for latent infection
  • Liver transaminase screening: Liver transaminases and serum bilirubin should be assessed prior to initiation of treatment
  • Vaccination: 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 for non-live vaccines

Patient monitoring during ENSPRYNG treatment3

  • Liver transaminases: Monitor alanine ALT and AST levels every 4 weeks for the first 3 months of treatment, followed by every 3 months for 1 year, and thereafter as clinically necessary
  • Neutrophil counts: Monitor neutrophils 4 to 8 weeks after initiation of therapy and thereafter at regular clinically determined intervals

Monitoring schedule: patient’s first year on ENSPRYNG3

WEEKS

0*

4

8

12

16

20

24

28

32

36

40

44

48

52

ALT and AST†

  

✓

✓

✓

    

✓

    

✓

    

✓

  

Neutrophils

  

✓

                      

*Time of first administration.
†Liver transaminases should be assessed prior to initiation of ENSPRYNG.
ALT=alanine aminotransferase; AST=aspartate transaminase; HBV=hepatitis B virus.

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Treatment Initiation Guide

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Dose Management3

If ALT or AST levels exceed 5x the ULN, discontinue ENSPRYNG as follows:

  • if any bilirubin elevation is detected: discontinue ENSPRYNG; reinitiation is not recommended
  • if bilirubin is normal: when ALT or AST return to normal and a benefit-risk assessment is performed, restart treatment per schedule below
    • Upon restarting treatment, closely monitor liver parameters. Discontinue and do not restart ENSPRYNG if ALT, AST, or bilirubin rise above the ULN
Clinical Trial Experience3
  • SAkuraStar: ALT and AST levels rose above the ULN in 43% and 25% of patients taking ENSPRYNG, respectively, vs 13% and 9% with placebo
  • SAkuraSky: ALT and AST levels rose above the ULN in 8% and 8% of patients taking ENSPRYNG, respectively, vs 12% and 19% with placebo
  • SAkuraStar and SAkuraSky: 3% of patients in ENSPRYNG group experienced ALT or AST elevations over 3X the ULN (vs none in placebo group)‡

Last Dose Administered 

Recommended Dosage for Restart of Treatment After Liver Transaminase Elevation

<12 weeks

Restart at a dosage of 120 mg by SC every 4 weeks.

12 weeks or longer

Restart at a dose of 120 mg by SC at Weeks 0,§ 2, and 4, followed by a dosage of 120 mg every 4 weeks.

‡These elevations were not associated with increases in total bilirubin. One patient in SAkuraSky had ALT levels rise above 5X the ULN, which was observed 4 weeks after initiation of therapy, normalizing 78 days after discontinuation of ENSPRYNG.
§“0 weeks” refers to time of the first administration after the missed dose. ULN=upper limit of normal.

Dose management3
  • If neutrophil count is below 1.0 x 109/L and confirmed by repeat testing, ENSPRYNG should be interrupted
  • Resume treatment once neutrophil count is >1.0 X 109/L
Clinical trial experience3
  • SAkuraStar: 10% of patients taking ENSPRYNG had neutrophils below 1 x 109/L vs 9% with placebo
  • SAkuraSky: 15% of patients taking ENSPRYNG had neutrophils below 1 x 109/L vs 4% with placebo#

There was one patient in SAkuraStar treated with ENSPRYNG with neutrophil counts < 0.5 x 109/L.
#One patient in SAkuraSky discontinued ENSPRYNG because of neutropenia.
ULN=upper limit of normal.

 

If a dose is missed for any reason other than increase in liver enzymes, refer to the table below3

Time since last dose

Recommended dosage for delayed or missed doses

<8 weeks during the maintenance period or missed a loading dose

Administer 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 first maintenance dose 4 weeks later

 

8 weeks to <12 weeks

 120 mg by SC injection at 0** and 2 weeks, followed by 120 mg every 4 weeks

≥12 weeks

 120 mg by SC 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. SC=subcutaneous.

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Important Safety Information & Indication

Indication

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

Contraindications

ENSPRYNG is contraindicated in patients with a known hypersensitivity to satralizumab or any of the inactive ingredients, an active hepatitis B infection, or 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. The most common infections reported in a randomized clinical trial of patients treated with ENSPRYNG who were not on other chronic immunosuppressant therapies, and that occurred more often than in patients receiving placebo, were nasopharyngitis (12%) and cellulitis (10%). The most common infections in patients who were on an additional concurrent immunosuppressant, and that occurred more often than in patients receiving placebo, were nasopharyngitis (31%), upper respiratory infection (19%), and pharyngitis (12%). Delay ENSPRYNG administration in patients with an active infection, including localized infections, until the infection is resolved.

Hepatitis B Virus (HBV) Reactivation
Risk of HBV reactivation has been observed with other immunosuppressant therapies. Patients with chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment with ENSPRYNG. Do not administer ENSPRYNG to patients with active hepatitis. For patients who are chronic carriers of HBV [HBsAg+] or are negative for HBsAg and positive for HB core antibody [HBcAb+], consult liver disease experts before starting and during treatment with ENSPRYNG.

Tuberculosis
Tuberculosis has occurred in patients treated with other IL-6 receptor antagonists. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating ENSPRYNG. Consider anti-tuberculosis therapy prior to initiation of ENSPRYNG in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment. Patients should be monitored for the development of signs and symptoms of tuberculosis with ENSPRYNG, even if initial tuberculosis testing is negative.

Vaccinations
Live or live-attenuated vaccines should not be given concurrently with ENSPRYNG because clinical safety has not been established. 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.

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 IL-6 receptor antagonists.

Use in Specific Populations

Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENSPRYNG during pregnancy. Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-277-9338.

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 ENSPRYNG at doses up to 50 mg/kg/week. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Lactation
No information is available on the presence of ENSPRYNG in human milk, the effects of ENSPRYNG on the breastfed infant, or the effects of ENSPRYNG on milk production. ENSPRYNG was excreted in the milk of lactating monkeys administered ENSPRYNG 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.

Geriatric Use
Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. However, population pharmacokinetic analyses in patients with NMOSD did not show that age affected the pharmacokinetics of ENSPRYNG. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Most Common Adverse Reactions
The most common adverse reactions (≥15% in either trial) were nasopharyngitis (31%), headache (27%), upper respiratory tract infection (19%), rash (17%), arthralgia (17%), extremity pain (15%), gastritis (15%), fatigue (15%), and nausea (15%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.

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