Agalsidase Alfa | Anti Fabry Disease

  • Generic Name/Brand Name: Agalsidase Alfa/Replagal
  • Indications: Agalsidase Alfa is a new and special drug indicated for Fabry disease and glycogen accumulation disease (type I, type II)
  • Dosage Form: Injection
  • Specification: 3.5 mg (3.5 mL)/vial

Agalsidase Alfa Application Scope

Agalsidase Alfa is used for the treatment of Fabry disease (α-galactosidase A deficiency), as a new and special drug and a long-term enzyme replacement therapy. It is suitable for adults, children, and adolescents. The safety and efficacy for children aged 0–6 years have not been established.

 

agalsidase alfa
agalsidase alfa

 

Agalsidase Alfa Characteristics

  • Ingredients: Concentrated solution for injection
  • Properties: Treats α-galactosidase A deficiency
  • Specification: 3.5 mg (3.5 mL)/vial
  • Packaging Specification: Each box contains 1, 4, or 10 vials of 3.5 mL.
  • Storage: 2°C to 8°C (36°F to 46°F). Do not freeze. Avoid light.
  • Expiry Date: 24months
  • Executive Standard: JX20200106
  • Approval Number: SJ20200021
  • Date of Revision: According to the latest drug insert.
  • Manufacturer: Shire Human Genetic Therapies AB

Guidelines For The Use Of Agalsidase Alfa

Dosage and Administration: 0.2 mg/kg body weight, administered once every two weeks by intravenous infusion over a duration of more than 40 minutes.

Adverse Reactions: Common adverse reactions include infusion-related reactions (e.g., fever, chills), headache, nausea, abdominal pain, and fatigue. In some cases, allergic reactions may occur.

Medication Limitations

Contraindications: Agalsidase is contraindicated in patients with hypersensitivity to Agalsidase or any of its excipients.

Precautions: During infusion, patient response should be closely monitored.Caution is required when used in patients with heart disease.Consideration should be given to slowing down or stopping the infusion if serious infusion-related reactions occur.

Agalsidase Alfa Interactions

Interactions of Agalsidase with other drugs have not been determined. Before starting treatment, inform your doctor of all medications you are using.

Note: If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYueMed. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.

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