US RE49,967 E1
Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase
Richard Schiff, Eastsound, WA (US); and Heinz Leibl, Pechtoldsdorf (AT)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on May 27, 2021, as Appl. No. 17/332,776.
Application 17/332,776 is a reissue of application No. 12/381,844, filed on Mar. 16, 2009, granted, now 10,301,376, issued on May 28, 2019.
Claims priority of provisional application 61/069,841, filed on Mar. 17, 2008.
Int. Cl. C07K 16/06 (2006.01); A61K 39/395 (2006.01); C12N 9/26 (2006.01); A61K 38/00 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/06 (2013.01) [A61K 39/39516 (2013.01); C12N 9/2408 (2013.01); A61K 38/00 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/21 (2013.01); Y02A 50/30 (2018.01)] 78 Claims
 
[ 56. A method for treating an immune globulin (IG)-treatable disease or condition in a subject, comprising:
subcutaneously administering a hyaluronidase composition comprising a soluble hyaluronidase at one or more sites on the subject;
after administering the hyaluronidase composition, subcutaneously administering an IG composition comprising IG for treating the disease or condition at the one or more sites on the subject, wherein:
the IG is from human plasma,
the IG composition has a protein concentration of from about 5 to about 25% w/v IG,
the subject is administered an IG dosage of from about 100 mg per kg body weight (mg/kg BW) to about 2 g/kg BW, and
the subject is administered a soluble hyaluronidase dosage at a ratio of from about 10 to about 500 Units hyaluronidase per gram of the administered IG;
wherein the hyaluronidase composition and the IG composition are subcutaneously administered to the subject no more frequently than once every three weeks. ]