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CEREZYME is a brand name for Imiglucerase, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CEREZYME® (imiglucerase for injection) is indicated for: • long-term enzyme replacement therapy in patients with a confirmed diagnosis of non- neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit non- neurological manifestations of the disease. The non-neurological manifestations of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • 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 non-neurological manifestations.
• The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established. • In situations where Cerezyme will be administered in a home care environment, it is suggested that the health care professional be trained and prepared for the possibility of an allergic-type reaction.
2 Recommended Dose and Dosage Adjustment Dosage should be individualized to each patient. 5 units/kg of body weight 3 times a week up to 60 U/kg administered as frequently as once every two weeks. Titrate the dosage based on clinical manifestations of disease and therapeutic goals for the patient.
Higher doses (up to 120 U/kg every 2 weeks) have been given safely to Type 3 patients. 3 Reconstitution Parenteral Products: Preparation of Solution for Intravenous Infusion: CEREZ YME® (imiglucerase for injection) Page 6 of 34 Internal 1.
2 mL of Sterile Water for Injection, USP, without preservatives. 6 mL for the 400U vial). This results in a final concentration of 40 U/mL for each 400 U vial. 0 mL 40 U/mL 2. Gently swirl each vial to mix the solution.
Important:
Avoid excessive agitation during the reconstitution. 3. Bubbles may be present in the solution following reconstitution. Let the solution sit for several minutes to allow any bubbles to dissipate and the lyophilized product to be thoroughly dissolved.
4. The reconstituted preparation results in a clear solution. Inspect vials visually for particulate matter or discolouration before further dilution. Vials exhibiting opaque particles or discolouration should not be used. Because this is a protein solution, slight flocculation (described as thin translucent fibers) occurs occasionally after dilution.
Dilution 1. The total volume following dilution may vary from 100-200mL. The amount of Normal Saline within the range used for dilution does not affect the amount of Cerezyme administered to the patient. 2. 9% Sodium Chloride Injection, USP (Normal Saline) to a total volume of 100-200mL.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognize the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 2:
Dosage Forms, Strengths, Composition and Packaging Cerezyme is intended for intravenous infusion. It is supplied as a sterile, non-pyrogenic, white to off- white lyophilized powder. The total sodium citrate composition is made up of trisodium citrate and disodium hydrogen citrate in a ratio of 26:9.
3. Cerezyme is preservative-free. Cerezyme is supplied in Type I glass vials capped with a 20 mm plastic cap and a flip-off aluminum crimp seal. Cerezyme is supplied in a 20 mL vial containing 400U (red label) of imiglucerase. Individual cartons are available in shrink-wrapped bundles of 100, 108 and 120 vials.
7 WARNINGS AND PRECAUTIONS General Hypersensitivity reactions, including anaphylaxis and anaphylactic shock have been reported. Onset of such symptoms has occurred during or shortly after infusions; these symptoms include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, transient hypertension and hypotension.
Treatment with Cerezyme should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product. Consider using pre-medication in patients with Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Lyophilized powder for reconstitution 400 Units mannitol, nitrogen, polysorbate 80, sodium citrates (disodium hydrogen citrate and trisodium citrate) CEREZ YME® (imiglucerase for injection) Page 8 of 34 Internal prior history of hypersensitivity with CEREZYME®.
03/2025 Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................. 2 RECENT MAJOR LABEL CHANGES............................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ...................................................................................................
4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................
Imiglucerase is contraindicated in patients who are severely hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. CEREZ YME® (imiglucerase for injection) Page 5 of 34 Internal
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3. When more than 10 vials of Cerezyme are required, the drug itself prior to dilution yields a volume of 100 mL. The upper range (200mL) for total volume offers the flexibility for ensuring dilution of the drug in these instances. 4.
Discard any unused portion remaining in the vials. Since Cerezyme does not contain any antibacterial preservatives, it must be reconstituted and diluted immediately prior to administration (see 11 STORAGE, STABILITY AND DISPOSAL). 4 Administration Cerezyme is administered by intravenous infusion over 1-2 hours.
The maximum recommended infusion rate is 1 unit/kg/minute. 2 μm filter during administration. The vials are single use only. All unused portions must be discarded. 5 Missed Dose It is important to have the infusion on a regular basis to avoid the accumulation of glucocerebroside.
The total dose administered each month should remain substantially unchanged. If you have missed a dose, please contact your doctor. CEREZ YME® (imiglucerase for injection) Page 7 of 34 Internal
1 Dosing Considerations;7 WARNINGS AND PRECAUTIONS ; and 8 ADVERSE REACTIONS). If a severe hypersensitivity reaction occurs, stop administration of CEREZYME® and initiate appropriate medical treatment. The risks and benefits of re-administering CEREZYME® following a severe hypersensitivity or anaphylactic reaction should be considered.
Caution is advisable in administration of CEREZYME® to patients previously treated with placental- derived ß-glucocerebrosidase (alglucerase injection) and who have developed antibody or who have exhibited symptoms of hypersensitivity to placental-derived ß-glucocerebrosidase (alglucerase injection).
, anaphylactic reactions) to this drug or to any ingredient in the formulation or component of the container (see 2 CONTRAINDICATIONS). Patients should be closely monitored during the Cerezyme infusion. , anaphylactic reactions) occurs during or after infusions, Cerezyme infusion should be discontinued immediately and appropriate medical treatment should be initiated.
, eczema, pruritis, flushing, rash, etc) to the active ingredient or excipients in the drug product. Pre-treatment with antihistamines and/or corticosteroids and reduction in the rate of infusion has allowed continued use of Cerezyme in most patients.
Anaphylactoid reaction has been reported in less than 1% of the patient population. Further treatment with Cerezyme should be conducted with caution. Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids.
, anaphylaxis) occurs, discontinue Cerezyme and immediately initiate appropriate medical treatment, including use of epinephrine. Consider the risks and benefits of readministering Cerezyme to individual patients following a severe reaction.
If the decision is made to readminister the product, consider reducing the rate of infusion and pretreat with antihistamines and/or corticosteroids and monitor patients for the occurrence of new signs and symptoms of a severe hypersensitivity reaction.
Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur. Data from clinical trials, using a screening enzyme-linked immunosorbent assay (ELISA) followed by a confirmatory radioimmunoprecipitation assay, suggest that approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy.
Patients who developed IgG antibody largely did so within 6 months of treatment and rarely developed antibodies to Cerezyme after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies CEREZ YME® (imiglucerase for injection) Page 9 of 34 Internal experienced symptoms of hypersensitivity.
It is recommended that patients suspected of a decreased response to treatment be monitored periodically for the formation of IgG antibody to imiglucerase. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions.
Patients who have developed antibodies or symptoms of hypersensitivity to placental-derived ß-glucocerebrosidase (alglucerase) should be treated with caution when Cerezyme (imiglucerase) is administered. However, not all patients with symptoms of hypersensitivity have detectable IgG antibodies.
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1 Special Populations .......................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
3 Pediatrics ................................................................................................... 4 Geriatrics ................................................................................................... 13 8 ADVERSE REACTIONS ................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other CEREZ YME® (imiglucerase for injection) Page 3 of 34 Internal Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions........................................................................ 15 9 DRUG INTERACTIONS................................................................................................ 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
18 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action.................................................................................. 2 Pharmacodynamics ....................................................................................
3 Pharmacokinetics ....................................................................................... 19 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 20 PART II: SCIENTIFIC INFORMATION ......................................................................................
20 13 PHARMACEUTICAL INFORMATION............................................................................ 20 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 23 15 MICROBIOLOGY ........................................................................................................ 27 16 NON-CLINICAL TOXICOLOGY .....................................................................................
27 PATIENT MEDICATION INFORMATION ................................................................................. 29 CEREZ YME® (imiglucerase for injection) Page 4 of 34 Internal PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS CEREZYME® (imiglucerase for injection) is indicated for: • long-term enzyme replacement therapy in patients with a confirmed diagnosis of non- neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit non- neurological manifestations of the disease.
1 Pediatrics Pediatrics (2 - 16 years of age): Based on the data submitted and […]