IP Library › Granted Patent US 12,295,934
Granted Patent B2
US 12,295,934 · App. 18/370,926 · Granted May 13, 2025

Treating iron deficiency with ferric carboxymaltose

Inventors: Tobias Sidelmann Christensen (Roskilde, DK); Philip Schaffalitzky De Muckadell (Virum, DK); Lars Lykke Thomsen (Holte, DK); Claes Christian Strom (Rungsted, DK)
Assignee: PHARMACOSMOS HOLDING A/S
A61K31/295A61P7/06
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Quick Facts
Patent No.
US 12,295,934
App. No.
18/370,926
Granted
May 13, 2025
Kind
B2
Abstract

The present invention relates to the field of treating iron deficiency with IV iron carbohydrate complexes such ferric carboxymaltose, monitoring or identifying subjects to determine their eligibility for being administered said IV iron carbohydrate complexes, and combining said IV iron carbohydrate complexes with additional drugs in order to mitigate or reduce side effects induced by said IV iron carbohydrate complexes.

Claims (77)

1. A method of reducing severity of side effects associated with hypophosphatemia in connection with repeated treatment of iron deficiency with ferric carboxymaltose to a subject in need thereof, said method comprising,

administering a dose of ferric carboxymaltose to said subject;

determining that said subject needs a further dose of ferric carboxymaltose;

prior to administering the further dose of ferric carboxymaltose, measuring said subject's serum phosphate levels, and if said subject has hypophosphatemia, treating the hypophosphatemia as medically indicated prior to administering the further dose of ferric carboxymaltose; and

administering the further dose of ferric carboxymaltose to said subject.

2. The method of claim 1 , wherein said subject has symptomatic hypophosphatemia.

3. The method of claim 1 , wherein said side effects comprise reduced muscle function.

4. The method of claim 1 , wherein said side effects comprise increased bone turnover.

5. The method of claim 1 , wherein said side effects comprise osteomalacia.

6. The method of claim 1 , wherein said side effects comprise fractures of the bone.

7. The method of claim 1 , wherein said side effects comprise bone pain.

8. The method of claim 1 , wherein said side effects comprise fatigue.

9. The method of claim 1 , wherein said subject has inflammatory bowel disease.

10. The method of claim 1 , wherein said subject has vitamin D deficiency.

11. The method of claim 1 , wherein said subject has iron deficiency anemia.

12. The method of claim 11 , wherein said subject has intolerance to oral iron or has had unsatisfactory response to oral iron.

13. The method of claim 11 , wherein said subject has lost or impaired kidney function.

14. The method of claim 1 , wherein said subject has heart failure.

15. The method of claim 1 , wherein the subject has abnormal uterine bleeding.

16. The method of claim 1 , wherein measuring said subject's serum phosphate levels comprises measuring the serum phosphate levels in a biological sample obtained from said subject, wherein said subject has hypophosphatemia if their serum phosphate is:

i. <2.5 mg/dL; or

ii. <2 mg/dL.

iii. <1 mg/dL.

17. The method of claim 1 , wherein the medically indicated treatment comprises a phosphate selected from glucose- 1 -phosphate, calcium phosphate, potassium phosphate, or sodium phosphate.

18. The method of claim 17 , wherein the phosphate is administered to said subject orally or intravenously (IV).

19. The method of claim 16 , wherein the medically indicated treatment comprises a vitamin D selected from calcitriol, alfacalcidol, cholecalciferol or ergocalciferol.

20. The method of claim 1 , wherein the side effects are side effects associated with the further dose of ferric carboxymaltose.

21. The method of claim 1 , wherein the time between the dose and the further dose is not more than 3 months.

22. The method of claim 1 , wherein the further dose of ferric carboxymaltose is part of a repeat course of treatment following a first course of treatment.

23. The method of claim 22 , wherein the side effects are side effects associated with the repeat course of treatment.

24. The method of claim 22 , wherein the first course of treatment administered to said subject is administered as a single-dose treatment.

25. The method of claim 22 , wherein the repeat course of treatment administered to said subject is administered as a single-dose treatment.

26. The method of claim 22 , wherein the first course of treatment with ferric carboxymaltose comprises:

a. a dose of ferric carboxymaltose containing 750 mg of elemental iron and a further dose of ferric carboxymaltose containing 750 mg of elemental iron; or

b. a dose of ferric carboxymaltose containing 1000 mg of elemental iron and a further dose of ferric carboxymaltose containing 500 mg to 1000 mg of elemental iron.

27. The method of claim 22 , wherein the repeat course of treatment with ferric carboxymaltose contains 500 mg to 1000 mg elemental iron.

28. The method of claim 22 , further comprising delaying administration of the repeat course of treatment to a subject exhibiting low serum phosphate levels following the first course of treatment, in order to allow said subject's phosphate levels to normalize prior to the repeat course of treatment.

29. The method of claim 22 , wherein the time between the first course of treatment and the repeat course of treatment is not more than 3 months.

30. The method of claim 22 , wherein the first course of treatment and the repeat course of treatment are received by the subject within 3 months.

31. A method of reducing severity of side effects associated with hypophosphatemia in connection with repeated treatment of iron deficiency with ferric carboxymaltose to a subject in need thereof, said method comprising,

administering a dose of ferric carboxymaltose to said subject;

determining that said subject needs a further dose of ferric carboxymaltose;

prior to administering the further dose of ferric carboxymaltose, first treating said subject with a medically indicated treatment for hypophosphatemia, then measuring said subject's serum phosphate levels; and

administering the further dose of ferric carboxymaltose to said subject.

32. The method of claim 31 , wherein said subject has symptomatic hypophosphatemia.

33. The method of claim 31 , wherein said side effects comprise reduced muscle function.

34. The method of claim 31 , wherein said side effects comprise increased bone turnover.

35. The method of claim 31 , wherein said side effects comprise osteomalacia.

36. The method of claim 31 , wherein said side effects comprise fractures of the bone.

37. The method of claim 31 , wherein said side effects comprise bone pain.

38. The method of claim 31 , wherein said side effects comprise fatigue.

39. The method of claim 31 , wherein said subject has inflammatory bowel disease.

40. The method of claim 31 , wherein said subject has vitamin D deficiency.

41. The method of claim 31 , wherein said subject has iron deficiency anemia.

42. The method of claim 41 , wherein said subject has intolerance to oral iron or has had unsatisfactory response to oral iron.

43. The method of claim 41 , wherein said subject has lost or impaired kidney function.

44. The method of claim 31 , wherein said subject has heart failure.

45. The method of claim 31 , wherein the subject has abnormal uterine bleeding.

46. The method of claim 31 , wherein measuring said subject's serum phosphate levels comprises measuring the serum phosphate levels in a biological sample obtained from said subject, wherein said subject is only administered the further dose of ferric carboxymaltose if their serum phosphate is:

i. ≥2.5 mg/dL; or

ii. ≥2 mg/dL.

47. The method of claim 31 , wherein the medically indicated treatment comprises a phosphate selected from glucose- 1 -phosphate, calcium phosphate, potassium phosphate, or sodium phosphate.

48. The method of claim 47 , wherein the phosphate is administered to said subject orally or intravenously (IV).

49. The method of claim 31 , wherein the medically indicated treatment comprises a vitamin D selected from calcitriol, alfacalcidol, cholecalciferol or ergocalciferol.

50. The method of claim 31 , wherein the side effects are side effects associated with the further dose of ferric carboxymaltose.

51. The method of claim 31 , wherein the time between the dose and the further dose is not more than 3 months.

52. The method of claim 31 , wherein the further dose of ferric carboxymaltose is part of a repeat course of treatment following a first course of treatment.

53. The method of claim 52 , wherein the side effects are side effects associated with the repeat course of treatment.

54. The method of claim 52 , wherein the first course of treatment administered to said subject is administered as a single-dose treatment.

55. The method of claim 52 , wherein the repeat course of treatment administered to said subject is administered as a single-dose treatment.

56. The method of claim 52 , wherein the first course of treatment with ferric carboxymaltose comprises:

a. a dose of ferric carboxymaltose containing 750 mg of elemental iron and a further dose of ferric carboxymaltose containing 750 mg of elemental iron; or

b. a dose of ferric carboxymaltose containing 1000 mg of elemental iron and a further dose of ferric carboxymaltose containing 500 mg to 1000 mg of elemental iron.

57. The method of claim 52 , wherein the repeat course of treatment with ferric carboxymaltose contains 500 mg to 1000 mg elemental iron.

58. The method of claim 52 , further comprising delaying administration of the repeat course of treatment to a subject exhibiting low serum phosphate levels following the first course of treatment, in order to allow said subject's phosphate levels to normalize prior to the repeat course of treatment.

59. The method of claim 52 , wherein the time between the first course of treatment and the repeat course of treatment is not more than 3 months.

60. The method of claim 52 , wherein the first course of treatment and the repeat course of treatment are received by the subject within 3 months.

Priority Claims (2)
EP 18203223 · Oct 29, 2018 · regional
EP 18203818 · Oct 31, 2018 · regional
Continuity (4)
Division 17187992 · Mar 1, 2021
Division 16822911 · Mar 18, 2020
Division PCTEP2019079528 · Oct 29, 2019
Related Publication 20240058295A1 · Feb 22, 2024
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