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Agalsidase

Latest prescription information about Agalsidase. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Agalsidase
Pronunciation : aye-GAL-sih-dace
Therapeutic Classification : Endocrine and Metabolic Agents
Trade Name(s): 
India- Galazyme, Gastica plus, Leno.
International- Fabrazyme.
Why it is prescribed (Indications) : 
This medication is a glycoprotein, prescribed for Fabry disease (due to alpha-galactosidase A deficiency). It provides the enzyme alpha-galactosidase A to the body.
When it is not to be taken (Contraindications): 
Hypersensitivity.

Pregnancy Category :

A B C D X
Category B : Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Dosage & When it is to be taken : 
The recommended dosage is 1.0 mg/kg body weight infused every 2 weeks as an IV infusion.
How it should be taken : 
It comes as a solution for injection to be administered by a healthcare provider into the vein.
Warnings and Precautions : 
* Caution should be exercised in patients with history of heart or lung problems, any allergy, who are taking other medications, children, during pregnancy and breastfeeding.
* It may cause dizziness, do not drive a car or operate machinery while taking this medication.
Side Effects : 
Most Common - Chills, fever, feeling hot or cold, difficulty in breathing, nausea, flushing, headache, vomiting, tingling, fatigue, itching, pain in extremity, high blood pressure, chest pain, throat tightness, abdominal pain, dizziness, fast heart rate, nasal congestion, diarrhea, muscle pain, back pain, pallor, slow heart rate, hives, low blood pressure, face swelling, rash, and drowsiness.
Infections - Upper respiratory tract infection and fungal infection.
Central Nervous System - Anxiety and depression.
Respiratory - Cough, difficulty in breathing and wheezing.
Other Precautions : 
* Avoid excess dosage.
Storage Conditions : 
Store it in refrigerator (2°-8°C). Do not freeze it.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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