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ZINBRYTA (daclizumab) injection

2016-06-21 08:14:42 来源: 作者: 【大中小】浏览:279次评论:0条

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 life-threatening events, liver failure, and autoimmune hepatitis. Obtain transaminase and bilirubin levels before initiation of ZINBRYTA. Monitor and eva luate 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, non-infectious 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).

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 monthly (2.1)
For subcutaneous use only (2.1)
Train patients in the proper technique for self-administration (2.2)
Conduct laboratory tests at baseline and at periodic intervals to monitor for early signs of potentially serious adverse reactions (2.3, 2.4).

DOSAGE FORMS AND STRENGTHS

Injection: 150 mg/mL solution in a single-dose prefilled syringe (3)
CONTRAINDICATIONS

Pre-existing hepatic disease or hepatic impairment, including ALT or AST at least 2 times the ULN (4)
History of autoimmune hepatitis or other autoimmune condition involving the liver (4)
History of hypersensitivity to daclizumab or any other component of the formulation (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Risk of anaphylaxis and angioedema. Discontinue and do not re-start ZINBRYTA if anaphylaxis or other allergic reactions occur (5.4)
Infections: Increased risk of infections. If serious infection develops, consider withholding ZINBRYTA until infection resolves (5.5)
Depression and Suicide: Advise patients to immediately report symptoms of depression and/or suicidal ideation to their health care provider. Consider discontinuation if severe depression and/or suicidal ideation occur (5.6)

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5% and ≥2% higher incidence than comparator) reported for ZINBRYTA were nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis, eczema and lymphadenopathy compared with AVONEX; and upper respiratory tract infection, depression, rash, pharyngitis, and increased alanine aminotransferase (ALT) compared with placebo (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Hepatotoxic Drugs: eva luate potential for increased risk of hepatotoxicity with concomitant use (7.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: HEPATIC INJURY INCLUDING AUTOIMMUNE HEPATITIS AND OTHER IMMUNE-MEDIATED DISORDERS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

2.2 Important Administration Instructions

2.3 Assessment Prior to Initiating ZINBRYTA

2.4 Laboratory Testing and Monitoring to Assess Safety after Initiating ZINBRYTA

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Injury

5.2 Immune-Mediated Disorders

5.3 ZINBRYTA REMS Program

5.4 Acute Hypersensitivity

5.5 Infections

5.6 Depression and Suicide

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

7 DRUG INTERACTIONS

7.1 Hepatotoxic Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

16.3 Instructions for Disposal

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dosage of ZINBRYTA is 150 milligrams injected subcutaneously once monthly [see Dosage and Administration (2.3, 2.4)].

Instruct patients to inject a missed dose as soon as possible but no more than two weeks late. After two weeks, skip the missed dose and take the next dose on schedule. Administer only one dose at a time.

2.2 Important Administration Instructions

ZINBRYTA is for subcutaneous use only.

Train patients in the proper technique for self-administering subcutaneous injections using the prefilled syringe.

Thirty minutes prior to injection, remove ZINBRYTA from the refrigerator to allow the drug to warm to room temperature. Do not use external heat sources such as hot water to warm ZINBRYTA. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature [see How Supplied/Storage and Handling (16.2)].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZINBRYTA is a colorless to slightly yellow, clear to slightly opalescent solution. Do not use ZINBRYTA if it is cloudy or there are visible particles.

Sites for injection include the thigh, abdomen, and back of the upper arm.

Use each prefilled syringe one time and then place in a sharps disposal container for disposal according to community guidelines [see How Supplied/Storage and Handling (16.3)].

2.3 Assessment Prior to Initiating ZINBRYTA

Hepatic Assessment

Prior to initiating ZINBRYTA, obtain and eva luate the following:

Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) and total bilirubin levels. Initiation of ZINBRYTA is contraindicated in patients with pre-existing hepatic disease o

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