Imiglucerase

Imiglucerase is an enzyme indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly, and splenomegaly.

• Imiglucerase is available under the following different brand names: Cerezyme

Common side effects of imiglucerase include:

• injection site reactions (discomfort, burning, itching, swelling, or open wound or sore)
• nausea
• vomiting
• abdominal pain
• diarrhea
• fatigue
• headache
• dizziness
• rash

Serious side effects of imiglucerase include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• itching
• light-headedness
• sweating
• chest pain
• cough
• flushing (warmth, redness, or tingly feeling)
• fever
• chills
• cough with yellow or green mucus
• stabbing chest pain
• wheezing
• shortness of breath
• worsening or no improvement in the Gaucher disease symptoms

Rare side effects of imiglucerase include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder of reconstitution

• 400 units/vial

Gaucher disease

Adult dosage

• 2.5 units/kg IV 3 times per week OR 30-60 units/kg IV every 2 weeks initially
• May initiate at a higher dose/frequency based on disease severity.

Pediatric dosage

• Children aged younger than 2 years: Safety and efficacy not established
• Children aged older than 2 years: 2.5 units/kg IV 3 times per week OR 30-60 units/kg IV every 2 weeks initially
• May initiate at a higher dose/frequency based on disease severity

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Imiglucerase has severe interactions with no other drugs.
• Imiglucerase has serious interactions with no other drugs.
• Imiglucerase has moderate interactions with the following drug:
  • miglustat
• Imiglucerase has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed in the manufacturer's label

Effects of drug abuse

None

Short-Term Effects

• See “What Are Side Effects Associated with Using Imiglucerase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Imiglucerase?”

Cautions

• Antibodies to imiglucerase that may lead to infusion reactions are reported in up to 15% of patients within 6 months from the onset of therapy; antibody formation is rare after 12 months of therapy
• Most patients with infusion reactions can continue treatment if pretreated with antihistamines and/or corticosteroids and infused at a lower rate

Pregnancy and Lactation

• Published observational studies and case reports with use in pregnant women have not identified a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• No animal reproduction studies have been conducted
• Pregnancy exposure registry
  • Monitors pregnancy outcomes in women during pregnancy
  • Encourage pregnant women exposed to drugs to contact the Gaucher patient registry at 1-800-745-4447, extension 15500, or visit www.registrynxt.com
  • Disease-associated maternal and/or embryo-fetal risk
  • Pregnancy may exacerbate existing type 1 Gaucher disease symptoms or result in new disease manifestations
  • Untreated symptomatic type 1 Gaucher disease may lead to complications during pregnancy, including hepatosplenomegaly, which can interfere with the normal growth of pregnancy, and thrombocytopenia, which can lead to excessive bleeding
• Lactation
  • Available published literature suggests a small amount of imiglucerase is present in breast milk immediately following an infusion
  • Published case reports and postmarketing reports of breastfed infants have not reported adverse effects owing to Cerezyme exposure
  • There are no data available on the effects of milk production