البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
Daclizumab (UNII: CUJ2MVI71Y) (Daclizumab - UNII:CUJ2MVI71Y)
Abbvie
Daclizumab
Daclizumab 150 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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
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.
Biologic Licensing Application
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. اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة