Taliglucerase alfa

Taliglucerase alfa
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Dosage

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.

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

DOSAGE FORMS AND STRENGTHS

• For injection: lyophilized powder for reconstitution; 200 units/vial.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Taliglucerase alfa in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Taliglucerase alfa in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Taliglucerase alfa in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Taliglucerase alfa in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Taliglucerase alfa in pediatric patients.

Contraindications

• None

Warnings

Hypersensitivity Reactions Including Anaphylaxis

• Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with ELELYSO. In clinical trials, 2 of 72 (2.8%) patients treated with ELELYSO experienced signs and symptoms consistent with anaphylaxis. Signs and symptoms of these patients included urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions occurred during ELELYSO infusion.

• In clinical trials with ELELYSO, 21 of 72 (29%) patients experienced hypersensitivity reactions, including anaphylaxis. Signs and symptoms of hypersensitivity reactions included pruritus, angioedema, flushing, erythema, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions have occurred up to 3 hours after the start of infusion.

• Due to the potential for anaphylaxis, appropriate medical support should be readily available when ELELYSO is administered. Observe patients closely for an appropriate period of time after administration of ELELYSO, taking into account the time to onset of anaphylaxis seen in clinical trials. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. If anaphylaxis occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated.

• Management of hypersensitivity reactions should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of antihistamines, antipyretics, and/or corticosteroids for mild reactions. Pretreatment with antihistamines and/or corticosteroids may prevent subsequent hypersensitivity reactions. Patients were not routinely premedicated prior to infusion of ELELYSO during clinical studies. If severe hypersensitivity reactions occur, immediately stop the infusion of ELELYSO and initiate appropriate treatment.

• Consider the risks and benefits of re-administering ELELYSO in patients who have experienced a severe reaction associated with ELELYSO. Caution should be exercised upon rechallenge, and appropriate medical support should be readily available.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Taliglucerase alfa in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Taliglucerase alfa in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Taliglucerase alfa in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Taliglucerase alfa during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Taliglucerase alfa with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Taliglucerase alfa with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Taliglucerase alfa with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Taliglucerase alfa with respect to specific gender populations.

Race

There is no FDA guidance on the use of Taliglucerase alfa with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Taliglucerase alfa in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Taliglucerase alfa in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Taliglucerase alfa in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Taliglucerase alfa in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Taliglucerase alfa in the drug label.

• Description

IV Compatibility

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):

• Total dose in units = Patient's weight (kg) × dose (units/kg)

• Total number of vials = Total dose in units divided by 200 units/vial

• 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; the solution should be clear and colorless. Do not use if the solution is discolored or if foreign particulate matter is present.

Withdraw the calculated dose of drug from the appropriate number of vials and dilute with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL.

• For pediatric patients, a final volume of 100 to 120 mL should be used.

• For adult patients, a final volume of 130 to 150 mL may be used. However, if the volume of reconstituted product alone is equal to or greater than 130 to 150 mL, then the final volume should not exceed 200 mL.

• Mix gently. DO NOT SHAKE. Since this is a protein solution, slight flocculation (described as translucent fibers) occurs occasionally after dilution.

Overdosage

There is limited information regarding Chronic Overdose of Taliglucerase alfa in the drug label.

Pharmacology

There is limited information regarding Taliglucerase alfa Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Taliglucerase alfa Mechanism of Action in the drug label.

Structure

There is limited information regarding Taliglucerase alfa Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Taliglucerase alfa in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Taliglucerase alfa in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Taliglucerase alfa in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Taliglucerase alfa in the drug label.

How Supplied

Storage

There is limited information regarding Taliglucerase alfa Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Taliglucerase alfa in the drug label.

Precautions with Alcohol

• Alcohol-Taliglucerase alfa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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