Agalsidase Beta

Agalsidase Beta is a prescription medication used for the treatment of Fabry Disease.

• Agalsidase Beta is available under the following different brand names: Fabrazyme

Common side effects of Agalsidase Beta include:

• fever
• chills
• cough
• dizziness
• swelling in the hands or feet
• numbness or tingling
• tiredness
• rash
• stuffy nose
• sneezing
• sore throat

Serious side effects of Agalsidase Beta include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• skin rash
• flushing (warmth, redness, or tingly feeling)
• trouble swallowing
• chest discomfort
• lightheadedness
• fever
• headache
• chills
• stuffy nose
• muscle pain
• back pain
• dizziness
• drowsiness
• tiredness
• pale skin
• feeling hot or cold
• itching
• numbness or tingly feeling
• swelling in the hands or feet
• nausea
• vomiting
• tight feeling in the throat
• stomach pain
• diarrhea
• chest pain
• fast or slow heart rate
• shortness of breath

Rare side effects of Agalsidase Beta 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, loss of coordination, feeling 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, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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 for reconstitution

• 5 mg/vial
• 35 mg/vial

Fabry Disease

Adult dosage

• 1 mg/kg IV every two Weeks

Pediatric dosage

• Children aged below 2 years: Safety and efficacy not established
• Children aged 2 years and above: 1 mg/kg IV every two Weeks

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, health care provider, or pharmacist first.

• Agalsidase Beta has severe interactions with the following drug:
  • chloroquine
• Agalsidase Beta has serious interactions with the following drugs:
  • amiodarone
  • gentamicin
• Agalsidase Beta has moderate interactions with the following drug:
  • tobramycin inhaled
• Agalsidase Beta 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 of 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, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Anaphylaxis and hypersensitivity reactions
  • In clinical trials and postmarketing safety experience, anaphylactic or severe hypersensitivity reactions reported
  • Higher incidences of hypersensitivity reactions were observed in adults with persistent anti-Fabrazyme antibodies and with high antibody titer compared to that in antibody-negative adults
  • Consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions
  • Consider risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies
  • No marketed tests for antibodies; if testing is warranted, contact Genzyme Corporation at 1-800-745-4447
  • Patients who have had a positive skin test or have tested positive for Fabrazyme-specific IgE antibody have been rechallenged using a rechallenge protocol
  • Rechallenge under direct supervision of qualified personnel, with appropriate medical support measures readily available
• Infusion-associated reactions
  • Infusion-associated reactions, some severe, reported
  • Incidence was higher in patients positive for anti-Fabrazyme antibodies compared with those who were negative
  • Severe infusion-associated reactions included chills, vomiting, hypotension, and paresthesia
  • Other infusion-associated reactions included pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, urticaria, bradycardia, and somnolence
  • Ensure appropriate medical support measures are readily available during administration
  • Closely monitor with history infusion-associated reactions
  • Advanced Fabry disease may compromise cardiac function, which may potentially increase the risk of severe complications from infusion-associated reactions; closely monitor with compromised cardiac function

Pregnancy and Lactation

• Registry available and monitors drug effects on pregnant women and their offspring
• For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500
• Encourage patients to enroll in the registry
• Available data from postmarketing case reports and case series with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of agalsidase Beta in either human or animal milk, the effects of the drug on the breastfed infant, or on milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drug or from an underlying maternal condition
  • Encourage lactating women to enroll in the registry