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Ceredase

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Ceredase

Ceredase Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ceredase (alglucerase) Injection is a manmade form of the enzyme β-glucocerebrosidase used as an enzyme replacement in people with Type I Gaucher disease. It is not a cure for the condition. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include hot flashes, changes in menstrual periods, headache, back pain, swelling in hands or feet, changes in sense of smell, nausea, diarrhea, upset stomach, fever or chills, or burning, itching, or swelling around the IV needle when the medicine is injected.

Dosage of Ceredase is individualized for each patient. Ceredase may interact with other drugs. Tell your doctor all medications and supplements you use. Ceredase may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This drug may pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Ceredase (alglucerase) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ceredase in Detail - Patient Information: Side Effects

Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive alglucerase after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:

  • mouth sores;
  • warmth, redness, or tingly feeling under your skin;
  • easy bruising or bleeding;
  • extreme weakness or tired feeling;
  • swollen belly, stomach discomfort; or
  • pale skin.

Some of these may be symptoms of your condition and not actual side effects of alglucerase.

Less serious side effects may include:

  • hot flashes;
  • changes in your menstrual periods;
  • headache;
  • back pain;
  • swelling in your hands or feet;
  • changes in your sense of smell;
  • nausea, diarrhea, upset stomach;
  • fever or chills; or
  • any burning, itching, or swelling around the IV needle when the medicine is injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ceredase (Alglucerase Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ceredase FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Experience in over 1000 patients treated with Ceredase® (alglucerase injection) has revealed a small number of adverse events. Some of these events were related to the route of administration including discomfort, pruritus, burning and swelling or sterile abscess at the site of venipuncture. The remaining experiences consisted of slight fever, chills, abdominal discomfort, nausea or vomiting. None of these events were judged to require medical intervention.

Symptoms suggestive of hypersensitivity have been noted in a limited number of patients. Onset of such symptoms has occurred during or shortly after infusions; these symptoms have included pruritus, flushing, urticaria/angioedema (a small number of patients have had upper airway involvement), chest discomfort, respiratory symptoms, nausea and abdominal cramping. Hypotension has been reported to occur during a few of these events. (See WARNINGS.)

Pretreatment with antihistamines and reduced rate of infusion has allowed continued use of Ceredase® (alglucerase injection) in most patients. Additional adverse symptoms which have been reported include: fatigue, vasomotor irritability or hot flash, weakness, headache, light headedness, dysosmia, oral ulcerations, backache and transient peripheral edema, and diarrhea. Menstrual abnormalities and false positive pregnancy tests have previously been reported, but due to the introduction of manufacturing steps designed to reduce the level of hCG in Ceredase® (alglucerase injection) , the likelihood of these occurrences is reduced.

Read the entire FDA prescribing information for Ceredase (Alglucerase Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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