Cuvitru Immune Globulin Approved
September 13, 2016 - The U.S. Food and Drug Administration (FDA) approved Cuvitru [Immune Globulin Subcutaneous (Human)] 20% Solution, a new immune globulin formulation manufactured by Shire. Cuvitru 20% Solution treats primary immunodeficiency disorders including congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies, common variable immunodeficiency and several others. Indicated for patients who are at least two years old, it is given subcutaneously through a portable infusion pump. Depending on the patient’s response, dosing can be as often as once a day; but some patients need only a few doses a week and others can be treated as infrequently as once every other week. When a dosing pattern is established, it should continue on a regular schedule, but adjustments in the amount of drug for each infusion are common. Cuvitru will be dispensed as 200mg/mL in single-use 5mL, 10mL, 20mL and 40mL vials. All immune globulins have a boxed warning that cautions they have the potential to cause blood clots and that advises patients to drink adequate fluids before each dose. It further recommends that the lowest effective amount be given over the minimum practical infusion time. Shire plans to release Cuvitru on the U.S. market within the next few weeks. It will be available through limited distribution specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.