Fabrazyme ® 5mg (agalsidase beta)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Agalsidase beta

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

A16AB04

Dosage:

5.5mg/5mg vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Agalsidase beta 5.5mg/5mg vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Genzyme Ireland Limited (Fill-finish)

Authorization status:

ACTIVE

Authorization date:

2009-03-10

Patient Information leaflet

Black
Insert is 100% of actual size
5
0
3
1
(07
/1
0
)
DOSAGE FORMS AND STRENGTHS
•
Lyophilized powder for reconstitution with Sterile Water for Injection, USP to yield 5 mg/mL (3).
•
Available as 35 mg or 5 mg single-use vials (3).
CONTRAINDICATIONS
•
None (4).
WARNINGS AND PRECAUTIONS
•
Life-threatening anaphylactic and severe allergic reactions have been observed in some patients during
Fabrazyme infusions. If severe allergic or anaphylactic reactions occur, immediately discontinue administration
of Fabrazyme and provide necessary emergency treatment. Appropriate medical support measures should be
readily available when Fabrazyme is administered because of the potential for severe infusion reactions (5.1).
•
Infusion reactions occurred in approximately 50 to 55% of patients during Fabrazyme administration in clin-
ical trials. Some reactions were severe. In patients experiencing infusion reactions, pretreatment with an
antipyretic and antihistamine is recommended. If an infusion reaction occurs, decreasing the infusion rate,
temporarily stopping the infusion, and/or administrating additional antipyretics, antihistamines, and/or steroids
may ameliorate the symptoms (5.2).
•
If severe infusion reactions occur, immediate discontinuation of the administration of Fabrazyme should be
considered, and appropriate medical treatment should be initiated. Severe reactions are generally managed
with administration of antihistamines, corticosteroids, IV fluids and/or oxygen as clinically indicated (5.2).
•
Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them
to a higher risk of severe complications from infusion reactions, and these patients should be monitored
closely during Fabrazyme administration (5.3).
•
Re-administration of Fabrazyme to patients 

Summary of Product characteristics

1
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FABRAZYME SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FABRAZYME.
FABRAZYME (AGALSIDASE BETA) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
---------------------------INDICATIONS AND
USAGE-----------------------------
Fabrazyme is indicated for use in patients with Fabry disease.
Fabrazyme
reduces globotriaosylceramide (GL-3) deposition in capillary
endothelium of
the kidney and certain other cell types. (1)
---------------------DOSAGE AND
ADMINISTRATION-------------------------

The recommended dosage is 1 mg/kg body weight given every two weeks as
an intravenous infusion. (2.1)

Administer antipyretics prior to infusion. (2.1)

See the full prescribing information for the recommended infusion
rate. (2.1)
---------------------DOSAGE FORMS AND
STRENGTHS------------------------
For injection: 5 mg or 35 mg lyophilized cake or powder in a
single-dose vial
for reconstitution (3)
------------------------------CONTRAINDICATIONS-------------------------------
None. (4)
----------------------WARNINGS AND
PRECAUTIONS--------------------------

Life-threatening anaphylactic and severe allergic reactions have been
observed in some patients during Fabrazyme infusions. If severe
allergic or
anaphylactic reactions occur, immediately discontinue administration
of
Fabrazyme and provide necessary emergency treatment. Appropriate
medical
support measures should be readily available when Fabrazyme is
administered because of the potential for severe infusion-associated
reactions. (5.1)

Infusion-associated reactions occurred in 59% of patients during
Fabrazyme
administration in clinical trials. Some reactions were severe. In
patients
experiencing infusion-associated reactions, pretreatment with an
antipyretic
and antihistamine is recommended. If an infusion-associated reaction
occurs,
decreasing the infusion rate, temporarily stopping the infusion,
and/or
administrating additional