Drug ID: 1d00000035
Drug Name: Agalsidase
Generic Names: Galazyme | Gastica plus | Leno | Fabrazyme | Replagal
Category: Endocrine and Metabolic Agents
Legal Status: Non Opioid Prescription only drug
Indication for Mother: 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.
Recommended Dose: The recommended dosage is 1.0 mg/kg body weight infused every 2 weeks as an IV infusion.
Recommended In: Agalsidase is glycoprotein. This is used to treat Fabry disease which is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A, in the body. This enzyme is necessary for the body.
Directions For Use: It comes as a solution for injection to be administered by a healthcare provider into the vein.
Storage: Store it in refrigerator (2°-8°C). Do not freeze it.
Dosage Forms: Intravenous injection
Side Effects: Most Common - Chills, fever, feeling hot or cold, difficulty in breathing, nausea, swelling of the face, mouth, and throat, 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.
In Case of Overdose: There have been no reports of overdose with agalsidase beta. In clinical trials, patients received doses up to 3 mg/kg body weight.
Avoid If: 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.
Drug Interaction: No drug interaction studies were performed.