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ELELYSO (taliglucerase alfa) for injection

2015-09-18 07:24:11 来源: 作者: 【大中小】浏览:427次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO.

ELELYSO™ (taliglucerase alfa) for injection, for intravenous use
Initial U.S. Approval: 2012
RECENT MAJOR CHANGES

Indications and Usage (1)	8/2014
Dosage and Administration, Recommended Dosage (2.1)	8/2014
Dosage and Administration, Preparation Instructions (2.2)	8/2014
Dosage and Administration, Administration Instructions (2.3)	8/2014
Warnings and Precautions, Hypersensitivity Reactions Including Anaphylaxis (5.1)	8/2014

INDICATIONS AND USAGE

ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease (1).
DOSAGE AND ADMINISTRATION

Treatment-naïve adult and pediatric patients 4 years of age and older: 60 units/kg administered every other week as a 60 to 120 minute intravenous infusion (2.1)
Patients switching from imiglucerase: Begin treatment with ELELYSO at the same unit/kg dose as the patient's previous imiglucerase dose. Physicians can make dosage adjustments based on achievement and maintenance of each patient's therapeutic goals (2.1).

DOSAGE FORMS AND STRENGTHS

For injection: lyophilized powder for reconstitution with diluent, 200 unit single-use vials (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis: Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment. Reduction in the infusion rate and/or pre-medication may prevent subsequent reactions (5.1, 6.3).

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) in clinical studies were pruritus, flushing, headache, arthralgia, pain in extremity, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea and rash (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2014

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

2.2 Preparation Instructions

2.3 Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions Including Anaphylaxis

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

6.3 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Clinical Trials of ELELYSO as Initial Therapy

14.2 Clinical Trial in Patients Switching from Imiglucerase Treatment to ELELYSO

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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

1 INDICATIONS AND USAGE

ELELYSO is indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Treatment-naïve patients: The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.

Patients switching from imiglucerase: Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to ELELYSO. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals [see Clinical Studies (14.2)].

ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.

2.2 Preparation Instructions

Each vial of ELELYSO provides 200 units of taliglucerase alfa and is intended for single use only. Do not use the vial more than one time. The reconstitution and dilution steps must be completed using aseptic technique.

ELELYSO should be reconstituted with Sterile Water for Injection and diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 mL to 200 mL, and delivered by intravenous infusion.

Prepare ELELYSO according to the following steps. Use aseptic technique.

Determine the number of vials to be reconstituted based on the patient's weight and the recommended dose of 60 units/kg, using the following calculations (1–3):

(1): Total dose in units = Patient's weight (kg) × dose (units/kg)
(2): Total number of vials = Total dose in units divided by 200 units/vial
(3): Round up to the next whole vial.

Remove the required number of vials from the refrigerator. Do not leave these vials at room temperature longer than 24 hours prior to reconstitution. Do not heat or microwave these vials.

Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for Injection to yield a reconstituted product volume of 5.3 mL and a withdrawal volume of 5 mL. Upon reconstitution, mix vials gently. DO NOT SHAKE. Prior to further dilution, visually inspect the solution in the vials;