Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
AssigneeEagle Pharmaceuticals, Inc.
InventorsSrikanth Sundaram, Scott L. Tarriff
Life of this patent
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Abstract
Methods of treating bendamustine responsive conditions in patients having fluid and/or sodium intake restrictions are disclosed. The methods include identifying patients having such restrictions and in need of bendamustine, and then administering thereto a bendamustine-containing composition in a volume of about 120 ml or less intravenously over a period of about 15 minutes or less. The smaller volumes and reduced sodium load as compared to currently known methods of treatment minimize cardiac and/or renal stress in patients having diseases such as congestive heart failure or renal disease.
Claims30
A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising
- a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake;
- b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing:
- i) from about 0.05 to about 12.5 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof;
- ii) a solubilizer comprising polyethylene glycol and propylene glycol, the polyethylene glycol being present in an amount of from about 0.3 to about to 45% volume and the propylene glycol being present in an amount of from about 0.03 to about 5% volume;
- and, optionally
- iii) a parenterally acceptable diluent
- over a substantially continuous period of less than or equal to about 30 minutes.
A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising
- a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake;
- b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing:
- Ingredient
- Concentration Range (mg/ml)
- Bendamustine HCl
- 0.05 to 1.6
- Solubilizer 1 propylene glycol
- 0.3 to 6.5
- Solubilizer 2 PEG 400
- 3.3 to 65
- Monothioglycerol
- 0.02 to 0.35
- NaOH
- 0.0 to 0.01
- and, optionally a parenterally acceptable diluent, over a substantially continuous period of less than or equal to about 30 minutes.
A method of treating a bendamustine-responsive condition in a subject requiring restricted fluid and/or sodium intake, comprising
- a) identifying a subject in need of bendamustine therapy and having a physiological condition requiring restricted fluid and/or sodium intake;
- b) parenterally administering to said subject a volume of about 100 ml or less of a liquid composition containing:
- Ingredient
- Concentration Range (mg/ml)
- Bendamustine HCl
- 1.1 to 12.5
- Solubilizer 1 propylene glycol
- 4.5 to 51
- Solubilizer 2 PEG 400
- 45 to 500
- Monothioglycerol
- 0.2 to 2.5
- NaOH
- 0.0 to 0.04
- and, optionally a parenterally acceptable diluent, over a substantially continuous period of less than or equal to about 30 minutes.
Dependencies are inferred from the claim text.