Spectrum Pharmaceuticals, Inc.

Acrotech Biopharma Inc.

Bahman Shimiaei

Ramsharan Singh

Pramod Kumar Gupta

Shaofeng Xie

Provided herein are compositions comprising disodium levofolinate. Also provided are processes for preparing compositions comprising disodium levofolinate. Also provided are compositions comprising disodium levofolinate prepared by the processes provided herein. Also provided are methods of treating folic acid deficiency in a subject in need thereof, comprising administering a composition provided herein to the subject. Also provided are methods of treating cancer in a subject in need thereof, comprising administering 5-fluorouracil and a composition provided herein to the subject. Also provided are methods of reducing the immediate toxic effects of methotrexate overdose in a subject in need thereof, comprising administering a composition provided herein to the subject. Also provided are methods of treating cancer in a subject in need thereof, comprising administering high-dose methotrexate and a composition provided herein to the subject. Also provided are methods of treating megaloblastic anemia in a subject in need thereof, comprising administering a composition provided herein to the subject.

Compositions comprising disodium levofolinate

Compositions comprising a calcium salt of L-leucovorin may be prepared that have a higher concentration of L-leucovorin than may be prepared using racemic leucovorin under similar conditions. Thus, some pharmaceutical compositions described herein may comprise a calcium salt of L-leucovorin at a relatively high concentration, such as at least about 15 mg/mL. Such a composition may be a stable aqueous solution, and may have near physiological pH, such as about 6 to about 8. Some pharmaceutical compositions may be substantially free of D-leucovorin, and may contain either: a) no EDTA, or b) less than about 1 mg/ml of EDTA. These compositions may be prepared, for example, by sonicating a mixture comprising the solid calcium salt of L-leucovorin and water. In some compositions, a calcium salt of L-leucovorin may be sufficiently soluble that it does not precipitate when it is injected.

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Laguna Niguel, CA, United States of America

Bahman Shimiaei