# US 10,441,631 B2 · Therapeutic agent for amniotic fluid embolism

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- Number: US 10,441,631 B2
- Document ID: US10441631B2
- Status: Granted
- Kind: B2
- Application number: 14/771,090
- Filed: 2014-02-28
- Published: 2016-01-14
- Granted: 2019-10-15
- Earliest claimed: 2013-02-28
- Assignees: CSL Behring GmbH
- Applicants: Csl Behring GmbH
- Inventors: Naohiro Kanayama; Tomoaki Ikeda; Madoka Furuhashi
- Web page: https://patentgrep.com/patent/US10441631B2

## CPC

- A61K 38/1709: {from mammals}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 38/57: from animals; from humans {(A61K38/553, A61K38/556 take precedence)}
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to a therapeutic agent for amniotic fluid embolism (AFE). Furthermore, the present invention relates to a therapeutic agent for AFE comprising a C1-inhibitor, particularly a human plasma-derived C1-inhibitor.

## Claims

### Claim 1

A method for the treatment of amniotic fluid embolism comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition including human plasma-derived C1 esterase inhibitor to treat amniotic fluid embolism,
wherein the pharmaceutical composition comprises human plasma-derived C1 esterase inhibitor in a concentration higher than that present in normal human plasma,
wherein the human plasma-derived C1 esterase inhibitor is administered as the sole active compound.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered intravenously or subcutaneously.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered in a dose of 1 to 1000 units per kg body weight.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered in a single dose as an injection or as an infusion.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered within 2 hours after the onset of clinically potential amniotic fluid embolism.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered in a dose of 5 to 500 units per kg body weight.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered in two doses, each as an injection or as an infusion.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered in multiple doses, each as an injection or as an infusion.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered as a long term infusion or application.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered within 1 hour after the onset of clinically potential amniotic fluid embolism.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered within 30 minutes after the onset of clinically potential amniotic fluid embolism.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered directly after the onset of clinically potential amniotic fluid embolism.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition includes human plasma-derived C1 esterase inhibitor in a concentration at least 50 times higher than that present in normal human plasma.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered intravenously.

### Claim 15 (depends on 14)

The method according to claim 14, wherein the human plasma-derived C1 esterase inhibitor is administered in a dose of 10 to 200 units per kg body weight.

### Claim 16

A method for treatment of amniotic fluid embolism comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition including human plasma derived C1 esterase inhibitor to treat amniotic fluid embolism,
wherein the pharmaceutical composition comprises human plasma derived C1 esterase inhibitor in a concentration higher than that present in normal human plasma, and
wherein the human plasma derived C1 esterase inhibitor is administered within 3 hours after the onset of clinically potential amniotic fluid embolism,
wherein the human plasma derived C1 esterase inhibitor is administered as the sole active compound.

### Claim 17

A method for treatment of amniotic fluid embolism comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition including recombinant human C1 esterase inhibitor to treat amniotic fluid embolism,
wherein the pharmaceutical composition comprises recombinant human C1 esterase inhibitor in a concentration higher than that present in normal human plasma,
wherein the recombinant human C1 esterase inhibitor is administered as the sole active compound.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the recombinant human C1 esterase inhibitor is administered within 3 hours after the onset of clinically potential amniotic fluid embolism.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the human plasma-derived C1 esterase inhibitor is administered as a monotherapy.

### Claim 20 (depends on 16)

The method according to claim 16, wherein the human plasma-derived C1 esterase inhibitor is administered as a monotherapy.

### Claim 21 (depends on 17)

The method according to claim 17, wherein the recombinant human C1 esterase inhibitor is administered as a monotherapy.
