ایمیگلوسراز
Imiglucerase (Cerezyme)
ایمیگلوسراز

نام ژنریک

Imiglucerase

شکل دارویی

اشكال دارويي:


Injection, powder for reconstitution: 200 , 400 U

موارد مصرف

موارد و مقدار مصرف


درمان بيماري گوشه تيپ يك در اطفال و بزرگسالان


دوز: دارو به صورت انفوزيون وريدي در عرض يك تا دو ساعت تجويز مي‌شود. دوز اوليه دارو مي‌تواند به صورت u/kg 5/2 سه بار در هفته يا u/kg 60 هر دو هفته يك بار باشد.


طريقه دوم مصرف يعني u/kg 60 در بيشتر مطالعات با اين دارو استفاده شده است،‌ هرچند بسته به شدت بيماري دوز اوليه دارو مي‌تواند بالاتر باشد يا تجويز دارو در فواصل كوتاهتر صورت گيرد. تنظيم دوز بايد بر مبناي پاسخ بيمار صورت گيرد.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد احتياط: در 15% بيماران مصرف كننده دارو، طي يك سال اول مصرف آنتي‌بادي بر ضد دارو تشكيل مي‌شود، در اين بيماران احتمال واكنش‌هاي حساسيتي به دنبال مصرف دارو بيشتر است.


در كمتر از يك درصد بيماران افزايش فشارخون ريوي و پنوموني گزارش شده است.

موارد قابل توجه

-

تداخل دارویی

عوارض جانبي


اسهال، لرز، سرگيجه، تب، سردرد، استفراغ، راش، درد شكم، تورم اندامهاي تحتاني، احساس خستگي.

مکانیزم اثر

عوارض جانبي


اسهال، لرز، سرگيجه، تب، سردرد، استفراغ، راش، درد شكم، تورم اندامهاي تحتاني، احساس خستگي.

فارماكوكینتیك

فارماكوكينتيك


جذب: دارو به صورت وريدي تجويز مي‌شود.


پخش: حجم توزيع دارو l/kg 15/0-09/0 است.


دفع: دارو به صورت كليوي دفع مي‌شود. نيمه‌ عمر دفع دارو 4/10-6/3 دقيقه است و بعد از نيم ساعت از انفوزيون به غلظت پايدار خود مي‌رسد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آنزيم.


طبقه‌بندي درماني: آنالوگ نوتركيب انساني بتا گلوكو سربروسيداز.


طبقه‌بندي مصرف در بارداري: مشخص نيست.


نام‌هاي تجاري: Cerezyme


ملاحظات اختصاصي


1- دارو بهتر است تحت نظر پزشك تجويز شود. براي تجويز دارو بايد به بيمار آموزش كافي داده شود.


2- موقع تهيه ويال حاوي دارو را به آرامي بين دو دست بچرخانيد ولي آن را تكان ندهيد.


3- تا رسيدن به اثر كامل درماني بعد از مصرف اين دارو چندين ماه زمان لازم است.


4- داده‌هاي آزمايشگاهي مانند سطح آنتي‌بادي ايمنوگلوبين‌ها ممكن است جهت مانيتورينگ دارو استفاده شود.


نكات قابل توصيه به بيمار


1- اين دارو باعث سرگيجه مي‌شود. رانندگي و كار با ماشين‌آلاتي كه نياز به هوشياري بالا دارند با احتياط صورت گيرد.


2- در صورت فراموش كردن يك دوز، حتماً با پزشك خود مشورت كرده و دوز بعدي را طبق دستور پزشك مصرف كنيد.


3- در صورت بروز هرگونه ذرات يا تغيير رنگ ويال حاوي دارو را مصرف
نكنيد.


مصرف در شيردهي: ترشح دارو در شير مشخص نيست، مصرف دارو با احتياط صورت گيرد.

Imiglucerase (Cerezyme)

Cerezyme®
(imiglucerase) Injection

DRUG DESCRIPTION

Cerezyme® (imiglucerase for injection) is an analogue of the human enzyme β-glucocerebrosidase, produced by recombinant DNA technology. β-Glucocerebrosidase (β-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 3.2.1.45) is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide.

Cerezyme® (imiglucerase) is produced by recombinant DNA technology using mammalian cell culture (Chinese hamster ovary). Purified imiglucerase is a monomeric glycoprotein of 497 amino acids, containing 4 N-linked glycosylation sites (Mr = 60,430). Imiglucerase differs from placental glucocerebrosidase by one amino acid at position 495, where histidine is substituted for arginine. The oligosaccharide chains at the glycosylation sites have been modified to terminate in mannose sugars. The modified carbohydrate structures on imiglucerase are somewhat different from those on placental gluco-cerebrosidase. These mannose-terminated oligosaccharide chains of imiglucerase are specifically recognized by endocytic carbohydrate receptors on macrophages, the cells that accumulate lipid in Gaucher disease.

Cerezyme® (imiglucerase) is supplied as a sterile, non-pyrogenic, white to off-white lyophilized product. The quantitative composition of the lyophilized drug is provided in the following table:

Ingredient 200 Unit Vial 400 Unit Vial
Imiglucerase (total amount)* 212 units 424 units
Mannitol 170 mg 340 mg
Sodium Citrates 70 mg 140 mg
(Trisodium Citrate) (52 mg) (104 mg)
(Disodium Hydrogen Citrate) (18 mg) (36 mg)
Polysorbate 80, NF 0.53 mg 1.06 mg
Citric Acid and/or Sodium Hydroxide may have been added at the time of manufacture to adjust pH.

*This provides a respective withdrawal dose of 200 and 400 units of imiglucerase. An enzyme unit (U) is defined as the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per minute at 37°C. The product is stored at 2-8°C (36-46°F). After reconstitution with Sterile Water for Injection, USP, the imiglucerase concentration is 40 U/mL (see DOSAGE AND ADMINISTRATION for final concentrations and volumes). Reconstituted solutions have a pH of approximately 6.1.

What are the possible side effects of imiglucerase (Cerezyme)?

Symptoms of allergic reactions including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives; itching; flushing; and dizziness or fainting, have occurred with the use of imiglucerase. Approximately 15% of patients treated with imiglucerase develop antibodies to imiglucerase. Approximately 46% of patients with detectable antibodies have experienced an allergic reaction. Emergency medical attention may be required if an allergic reaction is experienced.

Talk to your doctor if you experience any of the following less serious side...

Read All Potential Side Effects and See Pictures of Cerezyme »

What are the precautions when taking imiglucerase (Cerezyme)?

Before using imiglucerase, tell your doctor or pharmacist if you are allergic to it; or to alglucerase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: antibodies to alglucerase.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Cerezyme »

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  1. anemia
  2. thrombocytopenia
  3. bone disease
  4. hepatomegaly or splenomegaly

DOSAGE AND ADMINISTRATION

Cerezyme® (imiglucerase for injection) is administered by intravenous infusion over 1-2 hours. Dosage should be individualized to each patient. Initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the dosage for which the 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.

Cerezyme® (imiglucerase) should be stored at 2-8°C (36-46°F). After reconstitution, Cerezyme® (imiglucerase) should be inspected visually before use. Because this is a protein solution, slight flocculation (described as thin translucent fibers) occurs occasionally after dilution. The diluted solution may be filtered through an in-line low protein-binding 0.2 μm filter during administration. Any vials exhibiting opaque particles or discoloration should not be used. DO NOT USE Cerezyme® (imiglucerase) after the expiration date on the vial.

On the day of use, after the correct amount of Cerezyme® (imiglucerase) to be administered to the patient has been determined, the appropriate number of vials are each reconstituted with Sterile Water for Injection, USP. 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 40 U/mL 40 U/mL
Withdrawal volume 5.0 mL 10.0 mL
Units of enzyme within final volume 200 units 400 units

A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit vial) is withdrawn from each vial. The appropriate amount of Cerezyme® (imiglucerase) for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 – 200 mL. Cerezyme® (imiglucerase) is administered by intravenous infusion over 1-2 hours. Aseptic techniques should be used when diluting the dose. Since Cerezyme® (imiglucerase) does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use. Cerezyme® (imiglucerase) , after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2-8°C. Cerezyme® (imiglucerase) , when diluted, has been shown to be stable for up to 24 hours when stored at 2-8°C.

Relatively low toxicity, combined with the extended time course of response, allows small dosage adjustments to be made occasionally to avoid discarding partially used bottles. Thus, the dosage administered in individual infusions may be slightly increased or decreased to utilize fully each vial as long as the monthly administered dosage remains substantially unaltered.

HOW SUPPLIED

Cerezyme® (imiglucerase for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as follows:

200 Units per Vial NDC 58468-1983-1
400 Units per Vial NDC 58468-4663-1

Store at 2-8°C (36-46°F).

Cerezyme® (imiglucerase for injection) is manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 ,USA. Certain manufacturing operations may have been performed by other firms. (4/05). FDA revision date: 3/3/2005

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Since the approval of Cerezyme® (imiglucerase for injection) in May 1994, Genzyme has maintained a worldwide post-marketing database of spontaneously reported adverse events and adverse events discussed in the medical literature. The percentage of events for each reported adverse reaction term has been calculated using the number of patients from these sources as the denominator for total patient exposure to Cerezyme® (imiglucerase) since 1994. Actual patient exposure is difficult to obtain due to the voluntary nature of the database and the continuous accrual and loss of patients over that span of time. The actual number of patients exposed to Cerezyme® (imiglucerase) since 1994 is likely to be greater than estimated from these voluntary sources and, therefore, the percentages calculated for the frequencies of adverse reactions are most likely greater than the actual incidences.

Experience in patients treated with Cerezyme® (imiglucerase) has revealed that approximately 13.8% of patients experienced adverse events which were judged to be related to Cerezyme® (imiglucerase) 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 was found to occur in < 1% of the total patient population.

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, dyspnea, coughing, cyanosis, and hypotension. Anaphylactoid reaction has also been reported (see WARNINGS). Each of these events was found to occur in <1.5% of the total patient population. Pre-treatment with antihistamines and/or corticosteroids and reduced rate of infusion have allowed continued use of Cerezyme® (imiglucerase) in most patients. Additional adverse reactions that have been reported in approximately 6.5% of patients treated with Cerezyme® (imiglucerase) include: nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Each of these events was found to occur in <1.5% of the total patient population.

Incidence rates cannot be calculated from the spontaneously reported adverse events in the post-marketing database. From this database, the most commonly reported adverse events in children (defined as ages 2 – 12 years) included dyspnea, fever, nausea, flushing, vomiting, and coughing, whereas in adolescents (>12 – 16 years) and in adults (>16 years) the most commonly reported events included headache, pruritis, and rash.

In addition to the adverse reactions that have been observed in patients treated with Cerezyme® (imiglucerase) , transient peripheral edema has been reported for this therapeutic class of drug.

Read the Cerezyme (imiglucerase) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme® (imiglucerase for injection) during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to Cerezyme® (imiglucerase) after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity. Patients with antibody to Cerezyme® (imiglucerase) have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.

Treatment with Cerezyme® (imiglucerase) should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product.

Anaphylactoid reaction has been reported in 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 rate of infusion and pretreatment with antihistamines and/or corticosteroids.

PRECAUTIONS

General

In less than 1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with Cerezyme® (imiglucerase for injection). Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving Cerezyme® (imiglucerase) . No causal relationship with Cerezyme® (imiglucerase) has been established. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.

Therapy with Cerezyme® (imiglucerase) should be directed by physicians knowledgeable in the management of patients with Gaucher disease.

Caution may be advisable in administration of Cerezyme® (imiglucerase) to patients previously treated with Ceredase® (alglucerase injection) and who have developed antibody to Ceredase® or who have exhibited symptoms of hypersensitivity to Ceredase®.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted in either animals or humans to assess the potential effects of Cerezyme® (imiglucerase for injection) on carcinogenesis, mutagenesis, or impairment of fertility.

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Cerezyme® (imiglucerase for injection). It is also not known whether Cerezyme® (imiglucerase) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cerezyme® (imiglucerase) should not be administered during pregnancy except when the indication and need are clear and the potential benefit is judged by the physician to substantially justify the risk.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cerezyme® (imiglucerase for injection) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Cerezyme® (imiglucerase for injection) have been established in patients between 2 and 16 years of age. Use of Cerezyme® (imiglucerase) in this age group is supported by evidence from adequate and well-controlled studies of Cerezyme® (imiglucerase) and Ceredase® (alglucerase injection) in adults and pediatric patients, with additional data obtained from the medical literature and from long-term post-marketing experience. Cerezyme® (imiglucerase) has been administered to patients younger than 2 years of age, however the safety and effectiveness in patients younger than 2 have not been established.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Experience with doses up to 240 U/kg every 2 weeks have been reported. At that dose there have been no reports of obvious toxicity.

CONTRAINDICATIONS

There are no known contraindications to the use of Cerezyme® (imiglucerase for injection). Treatment with Cerezyme® (imiglucerase) should be carefully re-evaluated if there is significant clinical evidence of hypersensitivity to the product.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action/Pharmacodynamics

Gaucher disease is characterized by a deficiency of β-glucocerebrosidase activity, resulting in accumulation of glucocerebroside in tissue macrophages which become engorged and are typically found in the liver, spleen, and bone marrow and occasionally in lung, kidney, and intestine. Secondary hematologic sequelae include severe anemia and thrombocytopenia in addition to the characteristic progressive hepatosplenomegaly, skeletal complications, including osteonecrosis and osteopenia with secondary pathological fractures. Cerezyme® (imiglucerase for injection) catalyzes the hydrolysis of glucocerebroside to glucose and ceramide. In clinical trials, Cerezyme® (imiglucerase) improved anemia and thrombocytopenia, reduced spleen and liver size, and decreased cachexia to a degree similar to that observed with Ceredase® (alglucerase injection).

Pharmacokinetics

During one-hour intravenous infusions of four doses (7.5, 15, 30, 60 U/kg) of Cerezyme® (imiglucerase for injection), steady-state enzymatic activity was achieved by 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 (0.12 ± 0.02 L/kg). These variables do not appear to be influenced by dose or duration of infusion. However, only one or two patients were studied at each dose level and infusion rate. The pharmacokinetics of Cerezyme® (imiglucerase) do not appear to be different from placental-derived alglucerase (Ceredase® ).

In patients who developed IgG antibody to Cerezyme® (imiglucerase) , an apparent effect on serum enzyme levels resulted in diminished volume of distribution and clearance and increased elimination half-life compared to patients without antibody (see WARNINGS).

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Cerezyme Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

IMIGLUCERASE - INJECTION

(im-eh-GLUE-ser-aze)

COMMON BRAND NAME(S): Cerezyme

USES: Imiglucerase is used to treat a certain rare genetic problem (Gaucher disease). Imiglucerase replaces a certain natural substance (an enzyme called glucocerebrosidase) that is missing in people with Gaucher disease.

This medication improves blood, bone, liver, and spleen problems caused by Gaucher disease. Imiglucerase does not correct the genetic problem, and treatment must be continued for life.

HOW TO USE: This medication is given slowly into a vein over 1 to 2 hours or as directed by your doctor. Your dose and how often it is given depends on your weight, condition, and response to treatment. Your doctor may direct you to receive it as often as 3 times per week or as little as once every 2 weeks. Follow your doctor's directions carefully.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition persists or worsens. Blood, liver, and spleen problems usually improve in the first year of treatment. It may take 2 to 3 years of treatment to see the full benefit to your bones.

Disclaimer

Cerezyme Consumer (continued)

SIDE EFFECTS: Fever, headache, nausea, vomiting, swelling of the hands/feet (edema), or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, flushing, chest pain, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Cerezyme (imiglucerase) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using imiglucerase, tell your doctor or pharmacist if you are allergic to it; or to alglucerase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: antibodies to alglucerase.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Cerezyme Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., IgG antibodies) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised January 2011. Copyright(c) 2011 First Databank, Inc.

Cerezyme Patient Information Including Side Effects

Brand Names: Cerezyme

Generic Name: imiglucerase (Pronunciation: im ih GLUE ker ase)

What is imiglucerase (Cerezyme)?

Imiglucerase is a man-made form of the naturally-occurring protein beta-glucocerebrosidase. A deficiency of beta-glucocerebrosidase is called Gaucher disease.

Imiglucerase is used for the treatment of Type 1 Gaucher disease that results in one or more of the following: anemia (low level of red blood cells), thrombocytopenia (low level of platelets), bone disease, hepatomegaly (enlargement of the liver), or splenomegaly (enlargement of the spleen).

Imiglucerase may also be used for purposes other than those listed here.

What are the possible side effects of imiglucerase (Cerezyme)?

Symptoms of allergic reactions including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives; itching; flushing; and dizziness or fainting, have occurred with the use of imiglucerase. Approximately 15% of patients treated with imiglucerase develop antibodies to imiglucerase. Approximately 46% of patients with detectable antibodies have experienced an allergic reaction. Emergency medical attention may be required if an allergic reaction is experienced.

Talk to your doctor if you experience any of the following less serious side effects:

  • discomfort, burning, itching, swelling, or abscess (open wound or sore) at the injection site;
  • nausea or vomiting;
  • abdominal pain;
  • diarrhea;
  • fatigue;
  • headache;
  • dizziness; or
  • rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Cerezyme (imiglucerase) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about imiglucerase (Cerezyme)?

Symptoms of allergic reactions including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives; itching; flushing; and dizziness or fainting, have occurred with the use of imiglucerase. Approximately 15% of patients treated with imiglucerase develop antibodies to imiglucerase. Approximately 46% of patients with detectable antibodies have experienced an allergic reaction. Emergency medical attention may be required if an allergic reaction is experienced.

Side Effects Centers

Cerezyme Patient Information including How Should I Take

What should I discuss with my health care provider before using imiglucerase (Cerezyme)?

Before using imiglucerase, tell your doctor if you have

  • had an allergic reaction to imiglucerase, alglucerase (Ceredase), or have antibodies to either medication; or
  • breathing problems or pulmonary hypertension.

You may not be able to use imiglucerase, or you may require a dosage adjustment or special monitoring during treatment.

Imiglucerase is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use imiglucerase without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether imiglucerase passes into breast milk. Do not use imiglucerase without first talking to your doctor if you are breast-feeding a baby.

How should I use imiglucerase (Cerezyme)?

Use imiglucerase exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Imiglucerase is given by intravenous (into the vein) injection and will most likely be administered by a healthcare provider.

Your doctor may want you to have blood tests or other medical evaluations during treatment with imiglucerase to monitor progress and side effects.

Your healthcare provider will store imiglucerase as instructed by the manufacturer. If you are storing imiglucerase at home, your healthcare provider will give you instructions regarding how to store the medication.

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Cerezyme Patient Information including If I Miss a Dose

What happens if I miss a dose (Cerezyme)?

Contact your doctor if you miss a dose of imiglucerase.

What happens if I overdose (Cerezyme)?

Contact your doctor, a hospital emergency room, or a poison control center if an overdose is suspected.

Although symptoms of an imiglucerase overdose are not known, an overdose is unlikely to threaten life.

What should I avoid while taking imiglucerase (Cerezyme)?

There are no restrictions on food, beverages, or activity during treatment with imiglucerase.

What other drugs will affect imiglucerase (Cerezyme)?

Imiglucerase is not expected to interact with other medications. Talk to your doctor or pharmacist before taking other prescription or over-the-counter medications, including herbal products, during treatment with imiglucerase.

Where can I get more information?

Your pharmacist has more information about imiglucerase written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.03. Revision date: 12/15/2010.

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