ENSPRYNG- satralizumab injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SATRALIZUMAB (UNII: YB18NF020M) (SATRALIZUMAB - UNII:YB18NF020M)

Available from:

Genentech Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ENSPRYNG is contraindicated in patients with: - A known hypersensitivity to satralizumab or any of the inactive ingredients [see Warnings and Precautions (5.4)] - Active Hepatitis B infection [see Warnings and Precautions (5.1)] - Active or untreated latent tuberculosis [see Warnings and Precautions (5.1)] 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. Risk Summary 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,

Product summary:

ENSPRYNG (satralizumab-mwge) injection is available as a sterile, preservative-free, clear, colorless to slightly yellow solution in single-dose prefilled syringe (PFS) with needle safety device. ENSPRYNG PFS is not made with natural rubber latex. Each ENSPRYNG carton contains one single-dose 120 mg/mL prefilled syringe (NDC 50242-007-01).

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Genentech Inc.
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This Medication Guide has been approved by the U.S.
Food and Drug Administration
Issued: 3/2022
MEDICATION GUIDE
ENSPRYNG® (en-spryng)
(satralizumab-mwge)
injection, for subcutaneous use
What is the most important information I should know about ENSPRYNG?
ENSPRYNG may cause serious side effects including:
1.
Infections. ENSPRYNG can increase your risk of serious infections some
of which can be life-
threatening. Talk to your healthcare provider if you are being treated
for an infection or call them
right away if you think you have signs of an infection, with or
without a fever, such as:
•
chills, feeling tired, muscle aches, cough that will not go away or a
sore throat
•
skin redness, swelling, tenderness, pain or sores on your body
•
diarrhea, belly pain, or feeling sick
•
burning when you urinate or urinating more often than usual
Your healthcare provider will check if you have an infection and treat
it if needed before you start
or continue to take ENSPRYNG.
•
Your healthcare provider should test you for hepatitis and
tuberculosis (TB) before you start
taking ENSPRYNG.
•
All required vaccinations should be completed before starting
ENSPRYNG. People using
ENSPRYNG should not be given 'live' or 'live-attenuated' vaccines.
'Live' or 'live-attenuated'
vaccines should be given at least 4 weeks before you start ENSPRYNG.
Your healthcare provider
may recommend that you get a 'non-live' (inactivated) vaccine, such as
some of the seasonal flu
vaccines. If you plan to get a 'non-live' (inactivated) vaccine, it
should be given, whenever
possible, at least 2 weeks before you start ENSPRYNG.
2.
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 how
often you will need to
have these blood tests. Make sure you get all of your follow-up blood
tests as ordered by your
healthcare provider. Your healthcare provider will tell you if you
need to wait to start EN

Summary of Product characteristics

ENSPRYNG- SATRALIZUMAB INJECTION, SOLUTION
GENENTECH INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENSPRYNG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENSPRYNG.
ENSPRYNG (SATRALIZUMAB-MWGE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for
the treatment of neuromyelitis optica
spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4
(AQP4) antibody positive. (1)
DOSAGE AND ADMINISTRATION
Hepatitis B virus, tuberculosis, and liver transaminase screening is
required before the first dose. (2.1)
Prior to every use, determine if there is an active infection. (2.2)
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. (2.2)
See Full Prescribing Information for important preparation and
administration instructions. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 120 mg/mL in a single-dose prefilled syringe (3)
CONTRAINDICATIONS
Known hypersensitivity to satralizumab or any of the inactive
ingredients (4)
Active Hepatitis B infection (4)
Active or untreated latent tuberculosis (4)
WARNINGS AND PRECAUTIONS
Infections: 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. (5.1)
Elevated Liver Enzymes: Monitor ALT and AST levels during treatment;
interruption of ENSPRYNG may
be required. (5.2)
Decreased Neutrophil Counts: Monitor neutrophils during treatment.
(5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence at least 15%) are
nasopharyngitis, headache, upper
respiratory tract infection, gastritis, rash, arthralgia, extremity
pain, fatigue, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GENENTECH AT
1-888-835-2555 OR FDA