Aldurazyme

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Laronidase 0.58 mg/mL (rch)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Laronidase 0.58 mg/mL (rch)

Dosage:

500 U/5mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Laronidase 0.58 mg/mL (rch) Excipient: Dibasic sodium phosphate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

BioMarin Pharmaceutical Inc

Therapeutic indications:

ALDURAZYME is indicated as long-term enzyme replacement therapy in patients with Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type 1 clear glass vial, Closure: chlorobutyl rubber stopper and al seal with a plastic cap - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2016-06-30

Patient Information leaflet

ALDURAZYME®
1
ALDURAZYME®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ALDURAZYME?
ALDURAZYME contains the active ingredient laronidase. ALDURAZYME is
used as enzyme replacement therapy in
Mucopolysaccharidosis I (MPS I) storage disorder, a disease in which
the level of α-L-iduronidase is absent or lower than normal.
For more information, see Section 1. Why am I using ALDURAZYME?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALDURAZYME?
Do not use if you have ever had an allergic reaction to laronidase or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS
(PARTICULARLY BREATHING PROBLEMS), TAKE ANY OTHER MEDICINES, OR
ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ALDURAZYME?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ALDURAZYME and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE ALDURAZYME?
•
ALDURAZYME will be given to you directly into the vein (intravenously)
by a trained health care professional in a hospital or a
clinic
•
The recommended dosage for ALDURAZYME is 100 U/kg (0.58 mg/kg) of body
weight once every week
More instructions can be found in Section 4. How do I use ALDURAZYME?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALDURAZYME?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
ALDURAZYME
•
Have any tests when your treating physician says to
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how ALDURAZYME affects
you
DRINKING ALCOHOL
•
Tell your doctor if you drink alcohol
LOOKING AFTER
YOUR MEDICINE
•
ALDURAZYME will be stored in the hospital or clinic pha

Summary of Product characteristics

aldurazyme-ccdsv7-dsv4-15feb23 NEW ZEALAND DATA SHEET – ALDURAZYME® (LARONIDASE-
RCH CONCENTRATE FOR SOLUTION FOR INFUSION)
1
NAME OF THE MEDICINE
Laronidase -rch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The extractable volume of 5.0 mL from each vial provides 2.9 mg (500
U) laronidase, 43.9 mg
sodium chloride, 63.5 mg monobasic sodium phosphate monohydrate, 10.7
mg dibasic sodium
phosphate heptahydrate, and 0.05 mg polysorbate 80. Aldurazyme does
not contain
preservatives; vials are for single use only. See section 6.1 LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
Aldurazyme is intended for intravenous infusion. It is supplied as a
sterile, nonpyrogenic,
colourless to pale yellow, clear to slightly opalescent solution that
must be diluted prior to
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aldurazyme is indicated as long-term enzyme replacement therapy in
patients with
Mucopolysaccharidosis I (MPS I;
α
-L-iduronidase deficiency) to treat the non-neurological
manifestations of the disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Aldurazyme treatment should be supervised by a physician experienced
in the management of
patients with MPS I or other inherited metabolic diseases.
Administration of Aldurazyme
should be carried out in an appropriate clinical setting where
resuscitation equipment to manage
clinical emergencies would be readily available.
aldurazyme-ccdsv7-dsv4-15feb23
The recommended dosage regimen of Aldurazyme is 100 U/kg (0.58 mg/kg)
of actual body
weight administered once weekly as an intravenous infusion.
Pretreatment with antipyretics and/or antihistamines is recommended 60
minutes prior to the
start of the infusion. In the Phase 3 studies, all patients were
pretreated prior to each infusion
with age-appropriate dosages of antihistamines and antipyretics, such
as diphenhydramine or
hydroxyzine and paracetamol or ibuprofen, respectively (see section
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE, General).
The total volume of the infusion is determined by the patient’s
actual