Generic Name and Formulations:
Agalsidase beta 5mg, 35mg; per vial; pwd for IV infusion after reconstitution; preservative-free.
Sanofi Genzyme Company
Indications for FABRAZYME:
Adults and Children:
<8yrs: not recommended. ≥8yrs: Pretreat with antipyretic and antihistamine. Give by IV infusion. 1mg/kg infused every 2 weeks. Initial infusion rate should be ≤0.25mg/min; if tolerated, may increase infusion rate in increments of 0.05–0.08mg/min with each subsequent infusion. <30kg: max rate should remain at 0.25mg/min. ≥30kg: administration duration should not be less than 1.5hrs. Slow rate in the event of infusion reactions. Rechallenge (see literature): initially should be a low dose and infusion rate (eg, 0.5mg/kg at 0.01mg/min); once tolerated, may increase dose to 1mg/kg, titrate rate slowly upwards (doubled every 30 minutes up to max 0.25mg/min).
Have appropriate medical support measures available if anaphylaxis or severe allergic reactions develop. Compromised cardiac function; monitor closely. Consider testing for IgE antibodies in patients who experienced suspected allergic reactions; if positive, may be rechallenged. Pregnancy (Cat.B). Nursing mothers.
Recombinant human alpha-galactosidase A enzyme.
Infusion reactions (chills, fever, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, peripheral edema, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face edema, rash, somnolence; if severe, discontinue immediately), anaphylaxis and allergic reactions (may be fatal; discontinue immediately).
Register pregnant patients at www.fabryregistry.com or call (800) 745-4447.
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- Genetic Counseling Recommended for Advanced Prostate Cancer
- BRCA1/Shieldin Double Mutations May Signal Resistance to PARP Inhibitors
- Higher-Dose Immunoglobulin Replacement Therapy in Chronic Lymphocytic Leukemia
- "Impressive" CNS Responses With Osimertinib Compared With Standard EGFR-TKIs in Patients With CNS Metastases at Baseline
- Study Zeroes in on Cause of Castration-Resistant Prostate Cancer
- Higher Doses of Image-Guided Neoadjuvant Radiation Therapy Found to Be Safe in Locally Advanced NSCLC: Study
- Supply Shortages of Bacillus Calmette-Guérin Found to Spur Drug Rationing in Non-Muscle-Invasive Bladder Cancer
- Study Analyzing Postmarketing Data on Breast Implant Safety Sparks FDA Response
- Epacadostat and Pembrolizumab Combo Active in Relapsed NSCLC
- PD-1 Inhibitor Cemiplimab Shows Antitumor Activity in Relapsed NSCLC