UPLIZNA- inebilizumab injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Horizon Therapeutics USA, 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 infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see   Warnings and Precautions ( 5.2 )]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg/week) to human CD19 transgenic (huCD19 Tg) male and female mice prior to and during mating and continuing in females through gestation day 15 resulted in no adverse effects on embryofetal development; however, there was a marked reduction in B cells in fetal blood and liver at both doses tested. These results demonstrate that inebilizumab-cdon crosses the placenta and depletes B cells in the fetus. Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg) to huCD19 Tg mice every three days throughout organogenesis and lactation resulted in depletion of B cells and persistent reductions in immune function (even following repletion of B cells and lasting into adulthood) in offspring at both doses tested. At the end of the lactation period, plasma inebilizumab-cdon levels in offspring were only slightly lower than those in maternal plasma. A no-effect level for immunotoxicity in the offspring was not identified. Risk Summary There are no data on the presence of inebilizumab-cdon in human milk, the effects on a breastfed infant, or the effects on milk production. Human IgG is excreted in human milk, and the potential for absorption of UPLIZNA to lead to B-cell depletion in the breastfed infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UPLIZNA and any potential adverse effects on the breastfed infant from UPLIZNA or from the underlying maternal condition. Contraception Women of childbearing potential should use contraception while receiving UPLIZNA and for 6 months after the last infusion of UPLIZNA [see Clinical Pharmacology ( 12.3 )] . Safety and effectiveness in pediatric patients have not been established. Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

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

Horizon Therapeutics USA, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued: 7/2021
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

خصائص المنتج

UPLIZNA- INEBILIZUMAB INJECTION
HORIZON THERAPEUTICS USA, INC.
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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