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Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study.

Martinez-Saguer I, Cicardi M, Suffritti C, Rusicke E, Aygören-Pürsün E, Stoll H, Rossmanith T, Feussner A, Kalina U, Kreuz W - Transfusion (2013)

Bottom Line: Human C1-INH concentrate given intravenously (IV) is effective and safe, but venous access may be difficult.We compared SC and IV administration of human pasteurized C1-INH concentrate with respect to pharmacokinetics, pharmacodynamics, and safety.With a relative bioavailability of 39.7%, SC administration of human pasteurized C1-INH yields potentially clinically relevant and sustained plasma levels of C1-INH and is safe and well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Hemophilia Center Rhine Main GmbH, Mörfelden-Walldorf, Germany.

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Related in: MedlinePlus

Mean clHK over time (pharmacokinetic per-protocol set, n = 6 subjects). Black and gray whiskers show SDs. Median values are indicated with “X.” Horizontal lines show baseline values (before first administration of study drug). () IV; () SC.
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fig04: Mean clHK over time (pharmacokinetic per-protocol set, n = 6 subjects). Black and gray whiskers show SDs. Median values are indicated with “X.” Horizontal lines show baseline values (before first administration of study drug). () IV; () SC.

Mentions: After IV and SC administration of C1-INH concentrate, the percentage of clHK levels decreased for up to 36 hours (Fig. 4). This was more pronounced with IV administration, where the percentage of clHK decreased from a mean of 46.0% at baseline (0 hr) to 37.1% at 36 hours. In contrast, after SC administration, the lowest value was 42.0%, starting from a baseline value of 44.8%. After 36 hours, the clHK levels increased again to attain approximately baseline levels.


Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study.

Martinez-Saguer I, Cicardi M, Suffritti C, Rusicke E, Aygören-Pürsün E, Stoll H, Rossmanith T, Feussner A, Kalina U, Kreuz W - Transfusion (2013)

Mean clHK over time (pharmacokinetic per-protocol set, n = 6 subjects). Black and gray whiskers show SDs. Median values are indicated with “X.” Horizontal lines show baseline values (before first administration of study drug). () IV; () SC.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4215596&req=5

fig04: Mean clHK over time (pharmacokinetic per-protocol set, n = 6 subjects). Black and gray whiskers show SDs. Median values are indicated with “X.” Horizontal lines show baseline values (before first administration of study drug). () IV; () SC.
Mentions: After IV and SC administration of C1-INH concentrate, the percentage of clHK levels decreased for up to 36 hours (Fig. 4). This was more pronounced with IV administration, where the percentage of clHK decreased from a mean of 46.0% at baseline (0 hr) to 37.1% at 36 hours. In contrast, after SC administration, the lowest value was 42.0%, starting from a baseline value of 44.8%. After 36 hours, the clHK levels increased again to attain approximately baseline levels.

Bottom Line: Human C1-INH concentrate given intravenously (IV) is effective and safe, but venous access may be difficult.We compared SC and IV administration of human pasteurized C1-INH concentrate with respect to pharmacokinetics, pharmacodynamics, and safety.With a relative bioavailability of 39.7%, SC administration of human pasteurized C1-INH yields potentially clinically relevant and sustained plasma levels of C1-INH and is safe and well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Hemophilia Center Rhine Main GmbH, Mörfelden-Walldorf, Germany.

Show MeSH
Related in: MedlinePlus