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Last Updated: March 29, 2024

Claims for Patent: 8,119,134


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Summary for Patent: 8,119,134
Title:Method for extending pregnancy in patients exhibiting at least one symptom of preeclampsia and eclampsia
Abstract: A composition is provided to prevent, limit the effects of, delay the onset of, or treat one or more of the causes, symptoms or complications of gestational hypertension, preeclampsia, eclampsia and/or intrauterine growth restriction. The composition comprises a therapeutically effective amount of an antibody that reacts immunologically with or binds digoxin and has a high dose of digoxin binding capacity as the active ingredient. There is also provided a method of preventing, limiting the effects of, delaying the onset of, or treating a cause, symptom or complication of gestational hypertension, preeclampsia, eclampsia or intrauterine growth restriction, comprising the step of administering to a mammal a composition comprising a therapeutically effective amount of an antibody that reacts immunologically with or binds digoxin and has a high dose of digoxin binding capacity.
Inventor(s): Adair; Charles David (Signal Mountain, TN)
Assignee: Glenveigh Pharmaceuticals, LLC (Chattanooga, TN)
Application Number:12/849,651
Patent Claims:1. A method of extending pregnancy in a gravid human patient by reducing endogenous inhibition of Na+, K+ ATPase activity in a cell of the gravid human patient exhibiting at least one symptom of gestational hypertension, preeclampsia, eclampsia, or intrauterine growth restriction comprising administration of a dosage of digoxin antibody to the gravid human patient, wherein the dosage is effective to reduce endogenous inhibition of Na+, K+ ATPase activity and extend pregnancy in the patient.

2. The method of claim 1, wherein the patient exhibits proteinuria levels greater than 300 mg over an interval of 24 hours prior to administration.

3. The method of claim 2, comprising administration of subsequent doses of digoxin antibody at least until the levels of proteinuria in the gravid human patient decrease after administration.

4. The method of claim 1, wherein the at least one symptom includes hypertension greater than 140 mm Hg systolic or 90 mm Hg diastolic and proteinuria greater than 300 mg per 24 hours.

5. The method of claim 1, wherein the at least one symptom includes hypertension greater than 160 mm Hg systolic or 110 mm Hg diastolic and proteinuria greater than 500 mg per 24 hours.

6. The method of claim 1, wherein the at least one symptom includes hypertension greater than 140 mm Hg systolic or 90 mm Hg diastolic and proteinuria greater than 1+ on two random urine dipstick samples collected at least 4 hours apart.

7. The method of claim 1, wherein the at least one symptom includes hypertension greater than 160 mm Hg systolic or 110 mm Hg diastolic and proteinuria greater than 3+ on two random urine dipstick samples collected at least 4 hours apart.

8. The method of claim 1, wherein the dosage is administered over a period of six hours or less.

9. The method of claim 8 comprising administration of subsequent dosages of digoxin immune Fab.

10. The method of claim 1, wherein the method further comprises administering a therapeutically effective amount of corticosteroid.

11. The method of claim 1, wherein the method further comprises administering a therapeutically effective amount of an antihypertensive drug.

12. The method of claim 11, wherein the antihypertensive drug is labetalol, altenolol, nifedipine, 1-methyldopa or hydralazine.

13. The method of claim 1, wherein the method further comprises administering a therapeutically effective amount of magnesium sulfate or phenytoin.

14. The method of claim 1, wherein the digoxin immune Fab is ovine digoxin immune Fab.

15. A method of extending pregnancy in a gravid human patient by increasing Na+, K+ ATPase activity in a cell of the gravid human patient exhibiting endogenous inhibition of Na+, K+ ATPase, comprising administration of a dosage of digoxin antibody to the gravid human patient, wherein the dosage is effective to increase Na+, K+ ATPase activity and extend pregnancy in the human patient.

16. The method of claim 15, wherein the patient exhibits proteinuria levels greater than 300 mg over an interval of 24 hours prior to administration.

17. The method of claim 16, comprising administration of subsequent doses of digoxin antibody at least until the levels of proteinuria in the gravid human patient decrease after administration.

18. The method of claim 15, wherein the at least one symptom includes hypertension greater than 140 mm Hg systolic or 90 mm Hg diastolic and proteinuria greater than 300 mg per 24 hours.

19. The method of claim 15, wherein the at least one symptom includes hypertension greater than 160 mm Hg systolic or 110 mm Hg diastolic and proteinuria greater than 500 mg per 24 hours.

20. The method of claim 15, wherein the at least one symptom includes hypertension greater than 140 mm Hg systolic or 90 mm Hg diastolic and proteinuria greater than 1+ on two random urine dipstick samples collected at least 4 hours apart.

21. The method of claim 15, wherein the at least one symptom includes hypertension greater than 160 mm Hg systolic or 110 mm Hg diastolic and proteinuria greater than 3+ on two random urine dipstick samples collected at least 4 hours apart.

22. The method of claim 15, wherein the dosage is administered over a period of six hours or less.

23. The method of claim 22, comprising administration of subsequent dosages of digoxin immune Fab.

24. The method of claim 15, wherein the method further comprises administering a therapeutically effective amount of corticosteroid.

25. The method of claim 15, wherein the method further comprises administering a therapeutically effective amount of an antihypertensive drug.

26. The method of claim 25, wherein the antihypertensive drug is labetalol, altenolol, nifedipine, 1-methyldopa or hydralazine.

27. The method of claim 15, wherein the method further comprises administering a therapeutically effective amount of magnesium sulfate or phenytoin.

28. The method of claim 15, wherein the digoxin immune Fab is ovine digoxin immune Fab.

Details for Patent 8,119,134

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Wellcome Foundation Limited Wellcome Research Laboratories DIGIBIND digoxin immune fab (ovine) For Injection 103141 04/22/1986 ⤷  Try a Trial 2022-07-25
Btg International Inc. DIGIFAB digoxin immune fab (ovine) For Injection 103910 08/31/2001 ⤷  Try a Trial 2022-07-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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