UPLIZNA- inebilizumab injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

INEBILIZUMAB (UNII: 74T7185BMM) (INEBILIZUMAB - UNII:74T7185BMM)

متاح من:

Viela Bio, Inc.

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. UPLIZNA is contraindicated in patients with: - A history of a life-threatening infusion reaction to UPLIZNA [see Warnings and Precautions ( 5.1 )] - Active hepatitis B infection [see Warnings and Precautions ( 5.2 )] - Active or untreated latent tuberculosis [see Warnings and Precautions ( 5.2 )] Risk Summary UPLIZNA is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with the use of UPLIZNA in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. B-cell levels in infants following maternal exposure to UPLIZNA have not been studied in clinical trials. The potential duration of B-cell depletion in such infan

ملخص المنتج:

UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as:

الوضع إذن:

Biologic Licensing Application

نشرة المعلومات

UPLIZNA- INEBILIZUMAB INJECTION
Viela Bio, Inc.
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Medication Guide
UPLIZNA® (up-liz’-nah)
(inebilizumab-cdon)
injection, for intravenous use
What is the most important information I should know about UPLIZNA?
UPLIZNA may cause serious side effects, including:
Infusion reactions. UPLIZNA can cause infusion reactions that can be
serious or
may cause you to be hospitalized. You will be monitored during your
infusion
and for at least 1 hour after each infusion of UPLIZNA for signs and
symptoms
of an infusion reaction. Tell your healthcare provider right away if
you get any of
these symptoms:
•
headache
•
nausea
•
sleepiness
•
shortness
of breath
•
fever
•
muscle
aches
•
rash
If you develop an infusion reaction, your healthcare provider may need
to stop or
slow down the rate of your infusion and treat your symptoms.
Infections. Infections can happen during treatment with UPLIZNA. Tell
your
healthcare provider right away if you have an infection or get any of
these
symptoms:
•
painful and frequent urination
•
nasal congestion, runny nose,
sore throat, fever, chills,
cough, body aches
•
UPLIZNA taken before or after other medicines that weaken the immune
system may increase your risk of getting infections.
•
Hepatitis B virus (HBV) reactivation. Before starting treatment with
UPLIZNA, your healthcare provider will do blood tests to check for
hepatitis B viral infection. If you have ever had hepatitis B virus
infection,
the hepatitis B virus may become active again during or after
treatment
with UPLIZNA. Hepatitis B virus becoming active again (called
reactivation) may cause serious liver problems, including liver
failure or
death. Your healthcare provider will monitor you if you are at risk
for
hepatitis B virus reactivation during treatment and after you stop
receiving
UPLIZNA.
•
Progressive Multifocal Leukoencephalopathy (PML). PML may happen
with UPLIZNA. PML is a rare brain infection that leads to death or
severe
disability. Symptoms of PML may get worse over days to weeks. Call
y

خصائص المنتج

UPLIZNA- INEBILIZUMAB INJECTION
VIELA BIO, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UPLIZNA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR UPLIZNA .
UPLIZNA (INEBILIZUMAB-CDON) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
UPLIZNA is a CD19-directed cytolytic antibody 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, quantitative serum immunoglobulins, and
tuberculosis screening is required before the first dose (2.1)
Prior to every infusion:
Determine if there is an active infection (2.2, 5.2)
Premedicate with a corticosteroid, an antihistamine, and an
antipyretic (2.2, 5.1)
UPLIZNA must be diluted in 250 mL of 0.9% Sodium Chloride Injection,
USP prior to administration (2.3, 2.4)
UPLIZNA is administered as an intravenous infusion titrated to
completion, approximately 90 minutes. The
recommended dose is:
Initial dose: 300 mg intravenous infusion followed two weeks later by
a second 300 mg intravenous infusion
Subsequent doses (starting 6 months from the first infusion): single
300 mg intravenous infusion every 6
months (2.3)
Monitor patients closely during the infusion and for at least one hour
after completion of the infusion (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial (3)
CONTRAINDICATIONS
Previous life-threatening reaction to infusion of UPLIZNA (4)
Active hepatitis B infection (4)
Active or untreated latent tuberculosis (4)
WARNINGS AND PRECAUTIONS
Infusion reactions: Administer premedications prior to infusion (2.2)
Management recommendations for infusion
reactions depend on the type and severity of the reaction. Permanently
discontinue UPLIZNA if a life-threatening or
disabling infusion reaction occurs (5.1)
Infections: Delay UPLIZNA administration in patients with an active
infectio