ZINBRYTA PEN - daclizumab injection, solution ZINBRYTA- daclizumab injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Daclizumab (UNII: CUJ2MVI71Y) (Daclizumab - UNII:CUJ2MVI71Y)

제공처:

Abbvie

INN (국제 이름):

Daclizumab

구성:

Daclizumab 150 mg in 1 mL

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

ZINBRYTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. ZINBRYTA is contraindicated in patients with: - Pre-existing hepatic disease or hepatic impairment, including ALT or AST at least 2 times the ULN, because ZINBRYTA could exacerbate existing liver dysfunction [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)] . - A history of autoimmune hepatitis or other autoimmune condition involving the liver [see Warnings and Precautions (5.1)]. - A history of hypersensitivity to daclizumab or any other components of the formulation. Use in such patients may result in anaphylaxis or life-threatening multi-organ hypersensitivity [see Warnings and Precautions (5.4)] . Risk Summary There are no adequate data on the developmental risk associated with use of ZINBRYTA in

제품 요약:

ZINBRYTA injection is a sterile, colorless to slightly yellow, clear to slightly opalescent solution for subcutaneous injection. ZINBRYTA is provided in a 29 gauge, 0.5 inch staked (pre-affixed) needle syringe with a rubber plunger stopper and rigid needle shield that are not made with natural rubber latex. Two presentations are provided for ZINBRYTA injection, a single-dose prefilled autoinjector and a single-dose prefilled syringe. ZINBRYTA PEN Single-Dose Prefilled Autoinjector The ZINBRYTA PEN is available in a carton containing a single-dose prefilled disposable autoinjector, which contains a syringe providing 1 mL of 150 mg/mL of daclizumab. The NDC is 0074-0034-01. ZINBRYTA Single-Dose Prefilled Syringe The ZINBRYTA prefilled syringe is available in a carton containing a single-dose prefilled disposable syringe providing 1 mL of 150 mg/mL of daclizumab. The NDC is 0074-0033-01. Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Dispose in a sharps container or other hard plastic or metal sealable container. Always follow local regulations for disposal.

승인 상태:

Biologic Licensing Application

환자 정보 전단

ZINBRYTA- DACLIZUMAB INJECTION, SOLUTION
Abbvie
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration Issued: 08/2017
Medication Guide
ZINBRYTA® (zin-bry-tuh)
(daclizumab)
injection, for subcutaneous use
What is the most important information I should know about ZINBRYTA?
ZINBRYTA can cause serious side effects, including:
•
Liver problems. ZINBRYTA may cause serious liver problems (including
autoimmune-related
liver problems) that may lead to death. Your healthcare provider
should do blood tests to check
your liver before you start using ZINBRYTA, every month while you are
using ZINBRYTA, and
monthly for 6 months after you stop using ZINBRYTA. Your healthcare
provider should check
your test results before your next dose.
Call your healthcare provider right away if you have any of the
following symptoms of liver
problems:
•
nausea or vomiting
•
stomach pain
•
unusual tiredness
•
not wanting to eat
•
yellowing of the skin or whites of your eyes
•
dark urine
•
Immune system problems. Some people using ZINBRYTA develop
immune-mediated disorders
(a condition where the body's immune system attacks healthy cells in
their body) and other
immune system problems.
Call your healthcare provider right away if you have any of the
following symptoms:
•
skin reactions such as rash or skin irritation
•
tender, painful, or swollen lymph nodes
•
symptoms of low red blood cell counts, which can include looking very
pale, feeling more
tired than usual, dark urine, shortness of breath, yellowing of the
skin or whites of your
eyes
•
intestinal problems (colitis). Symptoms can include fever, stomach
pain, blood in your
stools, or diarrhea that does not go away
•
any new and unexplained symptoms affecting any part of your body
Because of the risk of serious liver problems (including
autoimmune-related liver problems) and other
immune system problems, ZINBRYTA is only available through a
restricted program called the
ZINBRYTA Risk Evaluation and Mitigation (REMS) Program.
�

제품 특성 요약

ZINBRYTA PEN - DACLIZUMAB INJECTION, SOLUTION
ZINBRYTA- DACLIZUMAB INJECTION, SOLUTION
ABBVIE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZINBRYTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZINBRYTA.
ZINBRYTA (DACLIZUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2016
WARNING: HEPATIC INJURY INCLUDING AUTOIMMUNE HEPATITIS AND OTHER
IMMUNE-
MEDIATED DISORDERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
HEPATIC INJURY INCLUDING AUTOIMMUNE HEPATITIS
ZINBRYTA CAN CAUSE SEVERE LIVER INJURY, INCLUDING AUTOIMMUNE HEPATITIS
AND LIVER FAILURE. FATAL CASES
HAVE OCCURRED. OBTAIN TRANSAMINASE AND BILIRUBIN LEVELS BEFORE
INITIATION OF ZINBRYTA. MONITOR AND
EVALUATE TRANSAMINASE AND BILIRUBIN LEVELS MONTHLY AND UP TO 6 MONTHS
AFTER THE LAST DOSE (2.3, 2.4, 5.1).
ZINBRYTA IS CONTRAINDICATED IN PATIENTS WITH PRE-EXISTING HEPATIC
DISEASE OR HEPATIC IMPAIRMENT (4,
5.1).
OTHER IMMUNE-MEDIATED DISORDERS
IMMUNE-MEDIATED DISORDERS INCLUDING SKIN REACTIONS, LYMPHADENOPATHY,
IMMUNE-MEDIATED COLITIS,
AND OTHER IMMUNE-MEDIATED DISORDERS CAN OCCUR WITH ZINBRYTA (5.2).
THESE CONDITIONS MAY REQUIRE TREATMENT WITH SYSTEMIC CORTICOSTEROIDS
OR IMMUNOSUPPRESSIVE
MEDICATION (5.1, 5.2).
ZINBRYTA IS AVAILABLE ONLY THROUGH A RESTRICTED DISTRIBUTION PROGRAM
CALLED THE ZINBRYTA REMS
PROGRAM (5.3).
RECENT MAJOR CHANGES
Boxed Warning
08/2017
Warnings and Precautions, Hepatic Injury (5.1)
08/2017
Warnings and Precautions, Immune-Mediated Disorders (5.2)
08/2017
Warnings and Precautions, Infections (5.5)
08/2017
INDICATIONS AND USAGE
ZINBRYTA is an interleukin-2 receptor blocking antibody indicated for
the treatment of adult patients with relapsing forms
of multiple sclerosis (MS). Because of its safety profile, the use of
ZINBRYTA should generally be reserved for patients
who have had an inadequate response to two or more drugs indicated for
the treatment of MS. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage: 150 milligrams once mont