ELELYSO- taliglucerase alfa injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TALIGLUCERASE ALFA (UNII: 0R4NLX88O4) (TALIGLUCERASE ALFA - UNII:0R4NLX88O4)

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

TALIGLUCERASE ALFA

Composition:

TALIGLUCERASE ALFA 200 U in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. None. Risk Summary The limited available data on ELELYSO use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] . In animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (RHD), there was no evidence of embryo-fetal toxicity [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women with Type 1 Gaucher disease have an increased risk of spontaneous abortion if diseas

Product summary:

ELELYSO (taliglucerase alfa) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial. Each vial of ELELYSO contains 200 units of taliglucerase alfa. Each carton contains one vial (NDC 0069-0106-01). Refrigerate ELELYSO at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ELELYSO- TALIGLUCERASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
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
Dosage and Administration, Pretreatment to Reduce Risk of Subsequent
Hypersensitivity
Reactions (2.1)
5/2023
Dosage and Administration, Administration Instructions (2.5)
8/2022
Warnings and Precautions, Hypersensitivity Reactions Including
Anaphylaxis (5.1)
5/2023
INDICATIONS AND USAGE
ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme
indicated for the treatment of
patients 4 years and older with a confirmed diagnosis of Type 1
Gaucher disease (1).
DOSAGE AND ADMINISTRATION
Recommended Dosage in Patients 4 Years and Older (2.2):
•
•
Preparation and Administration (2.3,2.4,2.5):
•
•
DOSAGE FORMS AND STRENGTHS
For injection: 200 units lyophilized powder in a single-dose vial for
reconstitution (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, 6.2).
ADVERSE REACTIONS
The most common adverse reactions are:
•
•
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: 5/2023
®
Treatment-naïve: 60 units/kg administered every other week as a 60-
to 120-minute intravenous
infusion.
Patients switching from imiglucerase: Initiate ELELYSO intravenous
treatment (60- to 120-minute
infusion) with the same units/kg imiglucerase dosage and subsequently
administer ELELYSO every
other week. D