Agalsidase Alfa

Agalsidase alfa has an orphan designation used to treat Fabry disease.

Agalsidase alfa is available under the following different brand names: Replagal.

Dosages of Agalsidase Alfa:

Dosage Forms and Strengths

Injectable Solution

• 1 mg/mL

Dosage Considerations – Should be Given as Follows:

Fabry Disease (Orphan)

• 0.2 mg/kg intravenous (IV) infusion every 2 weeks over 40 minutes
• Antihistamines and corticosteroids may alleviate infusion-related reactions

Common side effects of agalsidase_alfa include:

• Flushing
• Headache
• Infusion reactions
• Fever
• Chills
• Abdominal pain
• Acne
• Weakness/lethargy
• Chest pain/tightness
• Diarrhea
• Dizziness
• Indigestion/heartburn
• Eczema
• Skin redness and other skin problems
• Fluid retention (edema)
• Fatigue
• Gastrointestinal problems
• High blood pressure (hypertension)
• Muscle pain
• Nausea
• Vomiting
• Nerve pain
• Other pain
• Sore throat
• Throat irritation

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, 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 alfa has no listed severe interactions with other drugs.
• Serious interactions of agalsidase alfa include:
  • amiodarone
  • chloroquine
  • gentamicin
• Agalsidase Alfa has no listed moderate interactions with other drugs.
• Agalsidase Alfa has no listed mild interactions with other drugs.

Warnings

• This medication contains agalsidase alfa. Do not take Replagal if you are allergic to agalsidase alfa or any ingredients contained in this drug.

Black Box Warnings

• Contraindicated in children aged under 6 years; in nonclinical studies in young juvenile mice, administration of a single oral dose caused deaths owing to dehydration
• Avoid use in children 6 years to under18 years
• Safety and effectiveness have not been established in children aged under 18 years

Contraindications

• Hypersensitivity
• Concurrent use of chloroquine, amiodarone, benoquin or gentamicin (drugs that inhibit intracellular alpha-galactosidase activity)

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Agalsidase Alfa?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Agalsidase Alfa?"

Cautions

• No information available

Pregnancy and Lactation

• There are no clinical data regarding the use of agalsidase alfa during pregnancy. Animal studies indicate it is safe for use. Consult your doctor.
• It is not known whether agalsidase alfa is distributed in breast milk. Use caution while breastfeeding.