Cerezyme

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Imiglucerase 212 U (biological product from recombinant CHO cells)
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Imiglucerase 212 U (biological product from recombinant CHO cells)
Dosage:
40 U/mL
Pharmaceutical form:
Powder for infusion
Composition:
Active: Imiglucerase 212 U (biological product from recombinant CHO cells) Excipient: Citric acid monohydrate Mannitol Nitrogen Polysorbate 80 Sodium citrate dihydrate
Units in package:
Vial, glass, 1 x 400U, 10 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Genzyme Corporation
Product summary:
Package - Contents - Shelf Life: Vial, glass, 1 x 400U - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-6222
Authorization date:
1998-08-12

Data Sheet

Cerezyme - Imiglucerase

DATA SHEET

1. CEREZYME POWDER FOR INFUSION

CEREZYME® Powder for infusion, 40U/mL, 400U/vial

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 400 units* of imiglucerase**.

After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase

per mL (400U/10 mL).

*An Enzyme Unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one

micromole of the synthetic substrate para-nitrophenyl

-D-glucopyranoside (pnpNP-Glc) per

minute at 37

**Imiglucerase is a modified form of human acid

-glucosidase and is produced by

recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell

culture, with mannose modification for targeting macrophages.

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for concentrate for solution for infusion.

Cerezyme is a white to off-white powder.

4. CLINICAL PARTICULARS

4.1

THERAPEUTIC INDICATIONS

Cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for patients

with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3)

Gaucher disease who exhibit clinically significant non-neurological manifestations of the

disease.

The non-neurological manifestations of Gaucher disease include one or more of the following

conditions:

anaemia;

thrombocytopenia;

bone disease;

hepatomegaly or splenomegaly.

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Data Sheet

Cerezyme - Imiglucerase

4.2

DOSE AND METHOD OF ADMINISTRATION

Dose

Dosage should be individualised for each patient. Initial dosages range from 2.5U/kg of body

weight 3 times a week to 60U/kg once every two weeks. 60U/kg every 2 weeks is the dosage

for which most data are available. Disease severity may dictate that treatment be initiated at

a relatively high dose or relatively frequent administration. Dosage adjustments should be

made on an individual basis, and may increase or decrease, based on achievement of

therapeutic goals as assessed by routine comprehensive evaluations of the patient's clinical

manifestations.

Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in

haematological and visceral parameters within 6 months of therapy, and continued use has

either stopped progression of or improved bone disease. Administration of doses as low as 15

U/kg of body weight once every 2 weeks has been shown to improve haematological

parameters and organomegaly, but not bone parameters.

Method of administration

After reconstitution with water for injection and dilution with 0.9% Sodium Chloride

intravenous solution the preparation is administered by intravenous infusion over 1 to 2

hours.

For instruction on reconstitution and dilution of Cerezyme before administration, see section

6.6.

4.3

CONTRAINDICATIONS

There are no known contraindications to the use of Cerezyme. Treatment with Cerezyme

should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to

the product.

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Therapy with Cerezyme should be directed by physicians knowledgeable in the management

of patients with Gaucher disease.

Immunogenicity

Hypersensitivity reactions to Cerezyme may occur. Treatment should be carefully evaluated

if there is significant clinical evidence of hypersensitivity to the product (See section 4.3).

Current data suggest that, during the first year of therapy, IgG antibodies to Cerezyme are

formed in approximately 15% of the treated patients. It appears that patients who will

develop IgG antibody are most likely to do so within 6 months of treatment and will rarely

develop antibodies to Cerezyme after 12 months of therapy. It is suggested that patients be

monitored periodically for IgG antibody formation to imiglucerase during the first year of

treatment.

Patients with antibodies to Cerezyme have a higher risk of hypersensitivity reaction (see

section 4.8). If a patient experiences a reaction suggestive of hypersensitivity, subsequent

testing for imiglucerase antibodies is advised. Anaphylactoid reactions have been reported in

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Data Sheet

Cerezyme - Imiglucerase

less than 1% of the patient population. Further treatment with imiglucerase should be

conducted with caution. Most patients have successfully continued therapy after a reduction

in the rate of infusion and pretreatment with antihistamines and/or corticosteroids.

Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase

(alglucerase) should be treated with caution when administering Cerezyme.

Pulmonary Hypertension

In less than 1% of the patient population, pulmonary hypertension has also been observed

during treatment with Cerezyme. Pulmonary hypertension is a known complication of

Gaucher disease, and has been observed both in patients receiving and not receiving

Cerezyme . No causal relationship with Cerezyme has been established. Patients with

respiratory symptoms should be evaluated for the presence of pulmonary hypertension.

Patients who have undergone a splenectomy have an increased risk of pulmonary

hypertension. Cerezyme therapy reduces the requirement for splenectomy in most cases and

early treatment with Cerezyme has been associated with a reduced risk of pulmonary

hypertension. Routine evaluation to detect the presence of pulmonary hypertension after

diagnosis of Gaucher disease and over time is recommended. Patients diagnosed with

pulmonary hypertension, in particular, should receive adequate doses of Cerezyme to ensure

control of underlying Gaucher disease as well as be evaluated for the need of additional

pulmonary hypertension specific treatments.

Neurologic Symptoms

There is insufficient evidence that the use of imiglucerase improves neurologic symptoms in

patients with Type 2 or Type 3 Gaucher disease.

4.5

INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION

Interactions between Cerezyme and other medicinal products have not been studied. Other

forms of interactions such as with food are unlikely.

4.6

FERTILITY, PREGNANCY AND LACTATION

Fertility

Studies have not been conducted to assess the potential effects of Cerezyme on impairment of

fertility in animals or humans.

Pregnancy

Category B2

Animal reproduction studies have not been conducted with Cerezyme.

It is not known whether Cerezyme can cause foetal harm when administered to a pregnant

woman, or can affect reproductive capacity. Cerezyme should be given to a pregnant woman

only if clearly needed and after a careful risk / benefit analysis has been conducted for both

the mother and foetus.

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Data Sheet

Cerezyme - Imiglucerase

Patients who have Gaucher disease and become pregnant may experience a period of

increased disease activity during pregnancy and the puerperium. This includes an increased

risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage and an increased need

for transfusion. Both pregnancy and lactation are known to stress maternal calcium

homeostasis and to accelerate bone turnover. This may contribute to skeletal disease burden

in Gaucher disease.

Animal studies are insufficient with respect to assessing the effects of Cerezyme on human

pregnancy, embryonal / foetal development, parturition and postnatal development. It is not

known whether Cerezyme passes via the placenta to the developing foetus. No clinical trial

data on exposed pregnancies are available for Cerezyme. From extensive post marketing

experience, however, safety information on the use of Cerezyme in over 150 pregnancies is

available. These data suggest that Cerezyme may be used to better control progression of

underlying Gaucher disease in pregnancy.

Among over 150 Cerezyme exposed pregnancies, the nature and prevalence of major

congenital malformation and foetal death were not different from the occurrences expected in

the general population. The available post marketing data show that Cerezyme treatment in

pregnant patients has, in the majority of cases, led to uncomplicated pregnancies and birth of

healthy infants.

In pregnant Gaucher patients and those intending to become pregnant, a risk/benefit treatment

assessment is required for each pregnancy. Treatment naïve women should be advised to

consider commencing therapy prior to conception in order to attain optimal health. In women

receiving Cerezyme treatment, continuation throughout pregnancy should be considered.

Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is

necessary for the individualisation of dose according to the patient’s needs and therapeutic

response.

Caution should be exercised when prescribing to pregnant women.

Lactation

It is not known whether Cerezyme is excreted in human milk. However, the enzyme is likely

to be digested in the child’s gastrointestinal tract. Caution should therefore be exercised when

Cerezyme is administered to a nursing woman. There are no animal studies on the effects of

imiglucerase on lactation or the potential for excretion of imiglucerase in milk.

4.7

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Cerezyme is presumed to be safe and unlikely to produce an effect on ability to drive or use

machines.

4.8

UNDESIRABLE EFFECTS

Experience in patients treated with Cerezyme has revealed that approximately 13.8% of

patients experienced adverse events which were judged to be related to Cerezyme

administration and which occurred with an increase in frequency. Some of the adverse

events were related to the route of administration. These include discomfort, pruritus,

burning, swelling or sterile abscess at the site of venipuncture. Each of these events were

found to occur in <1% of the total patient population.

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Data Sheet

Cerezyme - Imiglucerase

Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of patients.

Onset of such symptoms has occurred during or shortly after infusions; these symptoms

include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnoea, coughing,

cyanosis and hypotension (see section 4.4). Anaphylactoid reactions have also been reported

(see section 4.4). Each of these events were found to occur in < 1.5% of the total patient

population. Pre-treatment with antihistamines and / or corticosteroids and reduced rate of

infusion has allowed continued use of Cerezyme in most patients.

Additional adverse reactions that have been reported in approximately 6.2% of patients

treated with Cerezyme include nausea, abdominal pain, vomiting, diarrhoea, rash, fatigue,

headache, fever, dizziness, chills, backache and tachycardia. Each of these events were found

to occur in < 1.5% of the total patient population.

In addition to the adverse reactions that have been observed in patients treated with

Cerezyme, transient peripheral oedema has been reported for this therapeutic class of drug.

A completed post-marketing clinical study conducted in Japan (protocol 8-98) investigated

the use of Cerezyme in patients with neuronopathic Gaucher disease. During this study, one

Type 3 Gaucher patient experienced an adverse event of nail disorder which was considered

potentially related to Cerezyme therapy. No additional adverse events were reported that

were related to Cerezyme.

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions using the following website

link: https://nzphvc.otago.ac.nz/reporting/

4.9

OVERDOSE

Experience with doses up to 240 U/kg every two weeks have been reported. At that dose

there have been no reports of obvious toxicity.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES

5.1

PHARMACODYNAMIC PROPERTIES

Mechanism of action

Imiglucerase is a recombinant, macrophage-targeted, variant of human

-glucocerebrosidase,

purified from Chinese Hamster Ovary cells. It catalyses the hydrolysis of the glycolipid,

glucocerebroside, to glucose and ceramide following the normal degradation pathway for

membrane lipids.

Glucocerebroside is primarily derived from haematopoietic cell turnover. Gaucher disease is

characterised by a functional deficiency in

-glucocerebrosidase enzymatic activity and the

resultant accumulation of lipid glucocerebroside in tissue macrophages, which become

engorged and are termed Gaucher cells.

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Data Sheet

Cerezyme - Imiglucerase

Gaucher cells are typically found in liver, spleen and bone marrow and occasionally, as well,

in lung, kidney and intestine. Secondary haematological sequelae include severe anaemia

and thrombocytopenia in addition to the characteristic progressive hepatosplenomegaly. The

skeletal complications are a common, and frequently the most debilitating and disabling,

feature of Gaucher disease. Possible skeletal complications are osteonecrosis, osteopenia

with secondary pathological fractures, remodelling failure, osteosclerosis and bone crises.

Pharmacodynamic effects

Imiglucerase replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus

correcting initial pathophysiology and preventing secondary pathology. Cerezyme reduces

spleen and liver size, improves or normalises thrombocytopenia and anaemia, improves or

normalises bone mineral density and bone marrow burden, and reduces or eliminates bone

pain and bone crises. Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide

accumulation in macrophages and response to treatment.

The rate and extent of response to Cerezyme treatment is dose-dependent. Generally,

improvements in organ systems with a faster turnover rate, such as the haematological, can be

noted far more rapidly than in those with a slower turnover, such as the bone.

Clinical efficacy and safety

After the completion of the pivotal clinical trial, at 6 months, patients continued to be

followed for an extended study period of 26 to 29 months. In addition, a separate dosing

schedule comparison study was conducted. The tables below describe the design features and

results of these studies.

CLINICAL TRIAL INFORMATION SUMMARY

Protocol #

RC91-0110 – Pivotal

Trial

RC92-501 – Extension to

Pivotal Trial

RC92-301

Investigators

1. Barton, NW;

2. Grabowski, GA

1. Barton, NW;

2. Pastores, G

Zimran, A

Publications

Grabowski GA, Barton NW, Pastores G, Dambrosia

JM, Banerjee TK, McKee M, et al. Enzyme therapy

in Type 1 Gaucher Disease: Comparative efficacy of

mannose-terminated glucocerebrosidase from

natural and recombinant sources.

Ann Intern Med

1995; 122:33-9

Zimran A, Elstein D,

Levy-Lahad E, Zevin

S, Hadas-Halpern I,

Bar-Ziv Y, et al.

Replacement therapy

with imiglucerase for

Type 1 Gaucher

Disease.

Lancet

1995; 345: 1479-80.

Location of

Study

Mt. Sinai School of Medicine in New York, NY.

Nat’l Inst. of Neurolog. Disorders and Strokes in

Bethesda, MD

Shaare-Zedek

Medical Centre,

Jerusalem, Israel

Dates

Jan. 1992 - Sept. 1992

July 1992 - May 1994

Not reported

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Data Sheet

Cerezyme - Imiglucerase

Study Design

CONT, DB, RAND,

parallel

CONT, DB, RAND,

parallel

CONT, RAND,

matched pair

Treatment

CDASE or CZYME

60 U/kg IV q other wk

60 U/kg IV q other wk

A: 15 U/kg IV q

other wk

B: 2.5 U/kg IV

3x/wk

# Entered

30 (15 CDASE;

15 CZYME)

30 (15 CDASE;

15 CZYME)

10 (5 in each group)

# Completed

30* (29 CZYME)

Age: Mean

32.7 years old

32.7 years old

32.2 years old

Age: Range

12-69

12-69

18-46

Average

Weight

62.4 kg

62.4 kg

58.4 kg

17/13

17/13

Duration

6 months

26-29 months

1.5 to 2 years

Efficacy

Results

Stat. Sign Improvement from baseline for all 1"

endpoints; Sign

in haematologic parameters; sign

in hepatomegaly/splenomegaly;

cachexia;

improvements in skeleton and disease markers

hepatomegaly;

improvement in

haematology

parameters

and disease markers;

possible minimal

improvement in

skeletal

manifestations

Safety Results

185 non-serious AEs;

0 serious AEs

385 non-serious AEs;

0 serious AEs

35 non-serious AEs;

0 serious AEs. Most

frequent events were

pain and nausea

Most frequent events were pain, ecchymosis,

epistaxis, pharyngitis, diarrhoea, rash, fever,

headache, rhinitis, dizziness, menorrhagia, pruritus

CONT = controlled; RAND = randomised; DB = double blinded; CDASE = Ceredase; CZYME =

Cerezyme

; AE = adverse event. *All patients were converted to Cerezyme

by the end of the trial.

CLINICAL EFFECTS ON HAEMATOLOGY AND ORGAN WEIGHTS

(% change compared to baseline)

Report

Number

Parameter

Haemoglobin

Platelet

Liver

Spleen

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Data Sheet

Cerezyme - Imiglucerase

RC91-110

Mean

-11%

-35%

p-value

p < 0.001

p = 0.001

p < 0.001

p < 0.001

Response

1.0 g/dL

Response rate

13/15 87%

9/15 60%

8/15 53%

15/15 100%

RC92-501

Mean

- 21%

- 54.7%

Response

1.0 g/dL

Response rate

12/15 80%

11/15 73%

14/15 93%

14/15 93%

RC92-301

Mean

12.5%

- 19%

- 42.5%

Response

1.0 g/dL

Response rate

7/10 70%

5/10 50%

7/10 70%

9/10 90%

In an International Collaborative Gaucher Group (ICGG) Gaucher Registry analysis of a

large cohort of patients (n=528) with Gaucher disease type 1, a time- and dose-dependent

effect for Cerezyme was observed for haematological and visceral parameters (platelet count,

haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60

U/kg body weight once every 2 weeks. Patients treated with 60 U/kg body weight every 2

weeks showed a faster improvement and a greater maximum treatment effect as compared to

patients receiving the lower doses.

(Grabowski et al, 2009)

Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy

X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral

density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but

not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al,

2007).

Evaluation of treatment efficacy data captured from the International Collaborative Gaucher

Group Registry (ICGG/Gaucher Registry), published literature, and from a Japanese post-

marketing study show evidence of improvement in non-neurological manifestations

(anaemia, thrombocytopenia, bone disease, hepatomegaly, and splenomegaly) for Type 3

patients, similar to that observed in Type 1 patients.

5.2

PHARMACOKINETIC PROPERTIES

During 1 hour intravenous infusions of 4 doses (7.5, 15, 30 and 60 U/kg) of Cerezyme, steady

state enzymatic activity was achieved within 30 minutes. Following infusion, plasma

enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes. Plasma

clearance ranged from 9.8 to 20.3 mL/min/kg (mean

S.D., 14.5

4.0 mL/min/kg). The

volume of distribution corrected for weight ranged from 0.09 to 0.15 L/kg (mean

S.D., 0.12

0.02 L/kg). These variables do not appear to be influenced by dose or duration of infusion,

however, only 1 or 2 patients were studied at each dose level and infusion rate.

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Data Sheet

Cerezyme - Imiglucerase

5.3

PRECLINICAL SAFETY DATA

Studies have not been conducted to assess the potential effects of CEREZYME on

carcinogenesis, or impairment of fertility in animals or human. No evidence of mutagenic

activity was seen in the bacterial gene mutation (AMES) tests, however, assays for

chromosomal aberrations have not been carried out.

6. PHARMACEUTICAL PARTICULARS

6.1

LIST OF EXCIPIENTS

Mannitol,

Sodium citrate dihydrate,

Citric acid monohydrate,

Polysorbate 80.

6.2

INCOMPATIBILITIES

In the absence of compatibility studies, Cerezyme must not be mixed with other medicinal

products.

6.3

SHELF LIFE

Unopened vial:

2 years

Diluted solution:

Cerezyme, after reconstitution, has been shown to be stable for up to 12 hours when stored at

room temperature (25

C) and at 2

C. Cerezyme, when diluted, has been shown to be

stable for up to 24 hours when stored at 2

C. After reconstitution, promptly dilute vials

and do not store for subsequent use.

6.4

SPECIAL PRECAUTIONS FOR STORAGE

The lyophilised product is stored between 2

For storage condition after dilution of Cerezyme, see section 6.3.

6.5

NATURE AND CONTENTS OF CONTAINER

Cerezyme is supplied in clear glass 20 mL vials. The closure consists of a siliconised butyl

rubber stopper with a tamper-proof flip-top cap.

6.6

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

Each vial is for single use only.

To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain

an overfill of 0.3 mL.

Preparation and Administration Instructions: Use Aseptic Techniques

The lyophilised powder has to be reconstituted with water for injection, diluted with 0.9%

Sodium Chloride intravenous solution and then administered by intravenous infusion. It is

recommended that the diluted solution be filtered through an in-line low protein-binding

0.2μm filter during administration.

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Data Sheet

Cerezyme - Imiglucerase

Determine the number of vials to be reconstituted based on the individual patient’s

dosage regimen and remove the vials from the refrigerator.

Occasionally, small dosage adjustments may be made to avoid discarding partially

used vials. Dosages may be rounded to the nearest full vial as long as the monthly

administered dosage remains substantially unaltered.

Reconstitute each vial with water for injection. The final concentrations and

administration volumes are provided in the following table:

200 Unit Vial*

400 Unit Vial

Sterile water for reconstitution

5.1 mL

10.2 mL

Final volume of reconstituted product

5.3 mL

10.6 mL

Concentration after reconstitution

40U/mL

40U/mL

Withdrawal volume

5.0 mL

10.0 mL

Units of enzyme within final volume

200 Units

400 Units

*200 Unit presentation is not available in New Zealand.

Avoid forceful impact of water for injection on the powder and, by mixing gently,

avoid foaming of the solution. The pH of the reconstituted solution is approximately

6.1.

Before further dilution, visually inspect the reconstituted solution in each vial for

foreign particles and discolouration. Do not use vials exhibiting foreign particles or

discolouration. Do not use Cerezyme after the expiration date on the vial.

Cerezyme contains no preservatives or antimicrobial agent. Use once and discard

any residue. Any unused reconstituted solution must be discarded appropriately.

The reconstituted solution contains 40 units imiglucerase per mL. The reconstituted

volume allows accurate withdrawal of a nominal volume of 5.0 mL for the 200 Unit

vial (10.0 mL for the 400 Unit vial).

Withdraw the reconstituted solution from each of the reconstituted vials and dilute

with 0.9% Sodium Chloride intravenous solution to a total volume of 100 to 200 mL.

Mix the infusion solution gently. Being a protein solution, slight flocculation

(described as thin translucent fibres) occurs occasionally after dilution. The diluted

solution may be filtered through an in-line low protein-binding 0.2 μm filter during

administration.

It is recommended that the diluted solution be administered within 3 hours. The product

diluted in 0.9% Sodium Chloride intravenous solution will retain chemical stability if stored

for up to 24 hours between 2

and 8

C, protected from light, but microbial safety will depend

on the reconstitution and dilution having been performed aseptically.

7. MEDICINE SCHEDULE

Prescription Only Medicine

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Data Sheet

Cerezyme - Imiglucerase

8. SPONSOR

NEW ZEALAND

sanofi-aventis new zealand limited

Level 8, 56 Cawley Street

Ellerslie

Auckland

New Zealand

Toll Free Number: 0800 283 684

Email: medinfo.australia@sanofi.com

9. DATE OF FIRST APPROVAL

25 May 1999

10. DATE OF REVISION OF THE TEXT

31 May 2018

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

General

Reformatted section headings/sub-headings and changed order of

information for sections in line with Medsafe DS format

Minor editorial changes were made for better readability.

Amended the therapeutic indications to include Type 3 Gaucher

disease

Amended the dose and method of administration to include additional

information on positive clinical effect (e.g. bone) per dose level

Amended the special warnings and precautions for use to make the

information on effect to bone disease be aligned with the section 4.2

Amended the undesirable effects to include additional information

from post-marketing clinical study conducted in Japan.

Amended to include NZ specific reporting information.

Amended the pharmacodynamics effects to include:

detailed description on clinical effect of Cerezyme,

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Data Sheet

Cerezyme - Imiglucerase

additional information on dose-dependent clinical response

aligning with the section 4.2,

positive clinical outcome for Type 1 and 3 Gaucher disease

based on ICGG Registry, published literature, and post-

marketing study.

cere-ccdsv4-dsv1-31may18

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