Adjunctive therapy with 25-hydroxyvitamin D and articles therefor
AssigneeEirgen Pharma Ltd.
InventorsP. Martin Petkovich, Joel Z. Melnick, Jay A. White, Samir P. Tabash, Charles W. Bishop, Susan Peers, Stephen A. Strugnell
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Abstract
Methods, compositions, and kits for adjunctive therapy using 25-hydroxyvitamin D are disclosed. The 25-hydroxyvitamin D may be administered with an agent that increases the risk of hypocalcemia, such as cinacalcet or a salt thereof, and/or an anticancer agent. The adjunctive therapy is effective to treat and prevent iatrogenic hypocalcemia and/or secondary hyperparathyroidism, as well as delay cancer progression and the time to a post-treatment skeletal related event.
Claims24
A method of treating a patient treated with an agent that increases the risk of hypocalcemia, comprising administering to said patient an effective amount of 25-hydroxyvitamin D to effectively and safely restore blood 25-hydroxyvitamin D levels to a range of 50 ng/mL to 100 ng/mL and to maintain blood 25-hydroxyvitamin D levels at such optimal levels.
A method of treating a patient treated with an agent that increases the risk of hypocalcemia comprising cinacalcet or a salt thereof, comprising administering to said patient an effective amount of 25-hydroxyvitamin D3 to effectively and safely restore blood 25-hydroxyvitamin D levels to in a range of 50 ng/mL to 100 ng/mL and to maintain blood 25-hydroxyvitamin D levels at such optimal levels.
A method of treating a patient treated with an agent that increases the risk of hypocalcemia comprising cinacalcet or a salt thereof at a dose of less than 360 mg daily, optionally in a range of about 20 mg to about 25 mg once daily, comprising administering to said patient an effective amount of 25-hydroxyvitamin D3 by modified release to effectively and safely restore or maintain blood 25-hydroxyvitamin D levels to in a range of 50 ng/mL to 100 ng/mL and restore or maintain the patient's serum calcium level to in a range of about 8.3 mg/dL to about 11.6 mg/dL, corrected for serum albumin.
A method of treating a patient treated with an agent that increases the risk of hypocalcemia, comprising administering to said patient an effective amount of 25-hydroxyvitamin D to effectively and safely restore blood 25-hydroxyvitamin D levels to at least 30 ng/mL and to maintain blood 25-hydroxyvitamin D levels at such optimal levels,
- wherein
- the agent that increases the risk of hypocalcemia comprises an antiresorptive agent comprising one or more in the group of zoledronic acid, alendronate, risedronate, ibandronate, etidronate, pamidronate, raloxifene, estrogen, and denosumab.
A method of treating a patient treated with an agent that increases the risk of hypocalcemia, comprising administering to said patient an effective amount of 25-hydroxyvitamin D to effectively and safely restore blood 25-hydroxyvitamin D levels to at least 30 ng/mL and to maintain blood 25-hydroxyvitamin D levels at such optimal levels,
- wherein
- the agent that increases the risk of hypocalcemia comprises cinacalcet or a salt thereof;
- and
- the patient is treated with an amount of cinacalcet or salt thereof in an amount of less than 360 mg daily.
Dependencies are inferred from the claim text.