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Prescribing Information

For Patients & Caregivers
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For Patients & Caregivers



INDICATION AND IMPORTANT SAFETY INFORMATION


INDICATION AND IMPORTANT SAFETY INFORMATION

 

 

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
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%).

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


 

 


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