Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase
AssigneeBaxalta Incorporated
InventorsRichard Schiff, Heinz Leibl, Gregory I. Frost
Life of this patent
Estimating the term…
Abstract
Provided are combinations, compositions and kits containing a immune globulin (IG) composition and a soluble hyaluronidase composition formulated for subcutaneous administration. Such products can be used in methods of treating IG-treatable diseases or conditions. Also provided are methods for subcutaneous administration of immune globulin whereby the dosing regimen is substantially the same as for intravenous administration of the same dosage for treatment of the same IG-treatable disease or condition.
Claims94
A method for treating an IG-treatable disease or condition in a subject, comprising:
- subcutaneously administering to the subject a soluble hyaluronidase and an immune globulin (IG) for treating the disease or condition, wherein:
- administration of the IG is effected such that the amount administered and frequency of administration is substantially the same as for IV (intravenous) administration of the same amount via IV for the same disease or condition;
- and
- administration of the soluble hyaluronidase is effected such that the amount of soluble hyaluronidase is sufficient to render the administered IG therapeutically effective.
A combination of compositions, comprising:
- a first composition comprising IG formulated for subcutaneous single dosage administration in an amount for treatment of an IG-treatable disease or condition no more than once per month;
- and
- a second composition comprising a soluble hyalurondiase formulated for single dosage administration in combination with the IG for the treatment no more than once per month.
A combination of compositions, comprising:
- a first composition comprising IG formulated for subcutaneous administration at a protein concentration of the IG in the composition that is less than 16% w/v IG;
- and
- a second composition comprising a soluble hyaluronidase formulated in combination with the IG in an amount sufficient to render the composition of IG therapeutically effective.
A composition, comprising immune globulin (IG) and a soluble hyaluronidase wherein:
- the composition is formulated for subcutaneous administration;
- the amount of IG in the composition is substantially the same as the amount when administered intravenously at the same dosing regime;
- and
- the amount of hyaluronidase in the composition is sufficient to render the composition therapeutically effective.
A composition, comprising immune globulin (IG) and a hyaluronidase, wherein:
- the composition is formulated for subcutaneous administration;
- the protein concentration of the IG in the composition is less than 16% w/v IG;
- and
- the amount of hyaluronidase in the composition is sufficient to render the composition therapeutically effective.
Dependencies are inferred from the claim text.