ALDURAZYME (LARONIDASE)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Laronidase

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

Laronidase

Units in package:

5ml mL

Manufactured by:

GENZYME CORPORATION

Patient Information leaflet

Not Applicable

Summary of Product characteristics

MAL/ALD/0121/USPI1219
1
WARNING: RISK OF ANAPHYLAXIS.
•
LIFE-THREATENING ANAPHYLACTIC REACTIONS HAVE BEEN OBSERVED IN SOME
PATIENTS
DURING ALDURAZYME
® INFUSIONS.
•
APPROPRIATE
MEDICAL
SUPPORT
SHOULD
BE
READILY
AVAILABLE
WHEN
ALDURAZYME IS ADMINISTERED
(see section Anaphylaxis and Hypersensitivity
Reactions)
•
PATIENTS WITH COMPROMISED RESPIRATORY FUNCTION OR ACUTE RESPIRATORY
DISEASE
MAY BE AT RISK OF SERIOUS ACUTE EXACERBATION OF THEIR RESPIRATORY
COMPROMISE
DUE TO INFUSION REACTIONS AND REQUIRE ADDITIONAL MONITORING
(see section
Acute
Respiratory
Complications
Associated
with
Administration
,
Risk
of
Acute
Cardiorespiratory Failure)
ALDURAZYME
® (LARONIDASE)
Injection for Intravenous use Only
INDICATIONS AND USAGE
ALDURAZYME (laronidase) is indicated for patients with Hurler and
Hurler-Scheie forms
of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie
form who have
moderate to severe symptoms. The risks and benefits of treating mildly
affected patients
with the Scheie form have not been established.
ALDURAZYME has been shown to improve pulmonary function and walking
capacity.
ALDURAZYME has not been evaluated for effects on the central nervous
system
manifestations of the disorder.
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSE
The recommended dosage regimen of ALDURAZYME is 0.58 mg/kg of body
weight
administered once-weekly as an intravenous infusion. Pretreatment is
recommended 60
minutes prior to the start of the infusion and may include
antihistamines, antipyretics or
both (see section Warnings and Precautions).
Each vial of ALDURAZYME provides 2.9 milligrams (mg) of laronidase in
5.0 milliliters
(mL) of solution and is intended for single use only. Do not use the
vial more than one
time. The concentrated solution for infusion must be diluted with 0.9%
Sodium Chloride
Injection, USP, to a final volume of 100 mL or 250 mL, using aseptic
techniques. The final
volume of the infusion is determined by the patient’s body weight.
Patients with a body
weight of 20 kg or less should receive a to