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Claims for Patent: 7,772,209

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Claims for Patent: 7,772,209

Title:Antifolate combination therapies
Abstract:A method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.
Inventor(s): Niyikiza; Clet (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:11/776,329
Patent Claims: 1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

2. The method of claim 1, wherein the methylmalonic acid lowering agent is vitamin B12.

3. The method of claim 2, wherein the vitamin B12 is administered as an intramuscular injection of about 500 .mu.g to about 1500 .mu.g.

4. The method of claim 2, wherein the vitamin B12 is administered as an intramuscular injection of about 1000 .mu.g.

5. The method of claim 2, 3 or 4, wherein the vitamin B12 administration is repeated about every 6 to about every 12 weeks following the administration of vitamin B12 until the administration of the pemetrexed disodium is discontinued.

6. The method of claim 5 wherein the folic acid is administered 1 to 3 weeks prior to the first administration of the pemetrexed disodium.

7. The method of claim 5 wherein the folic acid is administered from about 1 to about 24 hours prior to administration of the pemetrexed disodium.

8. The method according to any one of claims 1-4, wherein between 0.3 mg to about 5 mg of folic acid is administered orally.

9. The method of claim 8 wherein about 350 .mu.g to about 1000 .mu.g of folic acid is administered.

10. The method of claim 9 wherein 350 .mu.g to 600 .mu.g of folic acid is administered.

11. The method of claim 1 further comprising the administration of cisplatin to the patient.

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises: a) administration of between about 350 .mu.g and about 1000 .mu.g of folic acid prior to the first administration of pemetrexed disodium; b) administration of about 500 .mu.g to about 1500 .mu.g of vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of pemetrexed disodium.

13. The method of claim 12 further comprising the administration of cisplatin to the patient.

14. The method of claim 12, wherein vitamin B12 is administered as an intramuscular injection of about 500 .mu.g to about 1500 .mu.g.

15. The method of claim 14, wherein vitamin B12 is administered as an intramuscular injection of about 1000 .mu.g.

16. The method of claim 15, wherein between 0.3 mg to about 5 mg of folic acid is administered orally.

17. The method of claim 16 wherein about 350 .mu.g to about 1000 .mu.g of folic acid is administered.

18. The method of claim 17 wherein 350 .mu.g to 600 .mu.g of folic acid is administered.

19. The method of claim 18 wherein folic acid is administered 1 to 3 weeks prior to the first administration of the pemetrexed disodium.

20. The method of claim 18 wherein the folic acid is administered from about 1 to about 24 hours prior to administration of the pemetrexed disodium.

21. The method of claim 12, 18, or 19, wherein the vitamin B12 administration is repeated about every 6 to about every 12 weeks following the administration of vitamin B12 until administration of pemetrexed disodium is discontinued.

22. The method of claim 21 further comprising the administration of cisplatin to the patient.
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