Long-acting growth hormone treatment

1. A method of treating growth hormone deficiency in human children, the method comprising:

a step of administering to human children patients in need thereof a long-acting growth hormone formulation in a bracketed dosing regimen in which a range of patients' weights is allocated a particular dose of drug, which weight range is referred to as a “weight bracket”;

wherein dosage increases occur in a step-wise manner and wherein a bracketed dosage regimen has between 3 and 20 weight brackets;

wherein the dose a patient receives measured in mg hGH equivalents per week is the same for all patients within that weight bracket;

wherein the dose of one weight falling into each particular weight bracket corresponds to 0.24 mg/kg/week;

wherein patients of the same bracket having a lower weight receive a dose that is higher than said dose of the fixed dosage regimen and patient of the same bracket having a higher weight receive a dose that is lower than said dose of the fixed dosage regimen, wherein the dose received by a patient with the lowest weight within a bracket is 15-22% higher than the dose received by a patient with the highest weight within a bracket; and

wherein if a patient's weight exceeds the weight of a particular weight bracket the dose is increased to the dose of the next weight bracket, which dose of growth hormone equivalents in two neighboring brackets increases by at least 10%;

wherein the long-acting growth hormone formulation comprises a compound of formula IV:

wherein D is an hGH moiety having the amino acid sequence of SEQ ID NO: 1 connected to the rest of the molecule through an amine functional group; and p1, p2, p3 and p4 are independently selected from 200-250.

2. The method of claim 1 ;

wherein the long-acting growth hormone formulation is a lyophilized formulation that is reconstituted prior to administration.

3. The method of claim 1 ;

wherein the long-acting growth hormone formulation is a liquid formulation.

4. The method of claim 1 ;

wherein the long-acting growth hormone formulation is administered via a prefilled syringe.

5. The method of claim 1 ;

wherein the long-acting growth hormone formulation is administered via a pen injector.

6. The method of claim 1 ;

wherein the long-acting growth hormone formulation is contained in a dual chamber cartridge.

7. The method of claim 6 ;

wherein the dual chamber cartridge is utilized with a syringe to administer the long-acting growth hormone formulation.

8. The method of claim 6 ;

wherein the dual chamber cartridge is utilized with a pen device or electronic injector to administer the long-acting growth hormone formulation.

9. The method of claim 1 ;

wherein all increases between neighboring brackets are by a constant percentage value.

10. The method of claim 1 ;

wherein the bracketed dosage regimen comprises 3 to 15 brackets.

11. The method of claim 1 ;

wherein doses of the long-acting growth hormone formulation are administered to a patient with a time period of at least two days between two consecutive doses.

12. The method of claim 1 ;

wherein the bracketed dosing regimen of the long-acting growth hormone formulation is continued for a time period of at least 6 months.

13. The method of claim 1 ;

wherein doses of the long-acting growth hormone formulation are administered to a patient with a time period of seven days between two consecutive doses.

14. The method of claim 1 ;

wherein the dose of growth hormone equivalents in two neighboring brackets increases from 15 to 40%.

15. The method of claim 1 ;

wherein the dose of growth hormone equivalents in two neighboring brackets increases from 18 to 30%.

16. The method of claim 1 ;

wherein the bracketed dosage regimen has between 6 and 14 weight brackets.

17. The method of claim 1 ;

wherein the growth hormone deficiency is treated for a time period of at least 24 months.

18. The method of claim 1 , wherein the bracketed dosage regime has 12 brackets.

19. The method of claim 1 , wherein the bracketed dosage regime is supplied from nine unit dosages.

20. The method of claim 1 , wherein the weight brackets and their respective dosages comprise:

Weight

Dose

bracket

Mg/

(kg)

week

11.5-

3

13.9

14-

3.6

16.4

16.5-

4.3

19.9

20-

5.2

23.9

24-

6.3

28.9

29-

7.6

34.9

35-

9.1

41.9

42-

11

50.9