"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
VELAGLUCERASE ALPHA - INJECTION
COMMON BRAND NAME(S): VPRIV
USES: Velaglucerase is used to treat a certain rare genetic problem (Gaucher disease). Velaglucerase replaces a certain natural substance (an enzyme called glucocerebrosidase) that is missing in people with Gaucher disease.
This medication improves blood, bone, liver, and spleen problems caused by Gaucher disease. Velaglucerase does not correct the genetic problem, and treatment must be continued for life.
HOW TO USE: This medication is given slowly, usually over 1 hour, into a vein as directed by your doctor, usually every 2 weeks. Your dose and how often it is given depends on your weight, medical condition, and response to treatment.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. It may contain a few white particles. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Velaglucerase may infrequently cause side effects (such as headache, dizziness, fainting, weakness/tiredness, nausea, high fever) while it is being given. Your doctor may decide to temporarily stop or slow down the medication infusion if this happens. Tell your healthcare professional right away if you have any of these symptoms during your treatment. Your doctor may direct you to take other medications (such as antihistamines, drugs for fever, or corticosteroids such as prednisone) before your treatment to prevent these reactions from happening again.
Tell your doctor if your condition persists or worsens. Blood, liver, and spleen problems usually improve in the first year of treatment. It may take 2 to 3 years of treatment to see the full benefit to your bones.
Additional VPRIV Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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