ALTERING PHARMACOKINETICS OF PIRFENIDONE THERAPY
First Claim
1. A method of administering pirfenidone to a human patient in need thereof comprising(a) orally administering to the patient (1) food and (2) a pharmaceutical composition comprising pirfenidone, at a total daily dose of 2403 mg pirfenidone, wherein the ratio of the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (Cmax(fed)) to the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to said patient under fasted conditions (Cmax(fasted)) is about 0.35 to about 0.7 and(b) advising the patient that taking pirfenidone with food reduces the incidence of adverse events, other than nausea.
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Accused Products
Abstract
The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy.
32 Citations
20 Claims
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1. A method of administering pirfenidone to a human patient in need thereof comprising
(a) orally administering to the patient (1) food and (2) a pharmaceutical composition comprising pirfenidone, at a total daily dose of 2403 mg pirfenidone, wherein the ratio of the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (Cmax(fed)) to the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to said patient under fasted conditions (Cmax(fasted)) is about 0.35 to about 0.7 and (b) advising the patient that taking pirfenidone with food reduces the incidence of adverse events, other than nausea.
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2. (canceled)
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6. (canceled)
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8. (canceled)
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10. A method of providing pirfenidone therapy to a human patient in need thereof comprising
(a) orally administering pirfenidone, at a total daily dose of 2403 mg, with food to reduce the of adverse events, and (b) advising the patient that the mean maximum plasma concentration of pirfenidone when administered under fed conditions (Cmax(fed)) is lower than the mean maximum plasma concentration of pirfenidone when administered under fasted conditions (Cmax(fasted)), wherein the ratio of Cmax(fed): - Cmax(fasted) is about 0.35 to about 0.7.
- View Dependent Claims (11, 12, 13, 15)
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14. (canceled)
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16. (canceled)
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17. A method of administering pirfenidone to a human patient in need thereof comprising
(a) orally administering to the patient (1) food and (2) a pharmaceutical composition comprising pirfenidone, at a total daily dose of 2400 mg pirfenidone, wherein the ratio of the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (Cmax(fed)) to the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to said patient under fasted conditions (Cmax(fasted)) is about 0.35 to about 0.7 and (b) advising the patient that taking pirfenidone with food reduces incidence of adverse events, other than nausea.
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18. A method of providing pirfenidone therapy to a human patient in need thereof comprising
(a) orally administering pirfenidone, at a total daily dose of 2400 mg, with Food to reduce the incidence of adverse events, and (b) advising the patient that the mean maximum plasma concentration of pirfenidone when administered under fed conditions (Cmax(fed)) is lower than the mean maximum plasma concentration of pirfenidone when administered under fasted conditions (Cmax(fasted)), wherein the ratio of Cmax(fed): - Cmax(fasted) is about 0.35 to about 0.7.
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19. A method of providing pirfenidone therapy to a human patient in need thereof comprising
(a) orally administering pirfenidone, at a total daily dose of 2400 mg or 2403 mg, with food to reduce the incidence of adverse events, other than nausea and (b) advising the patient that administering pirfenidone under fed conditions results in reduced mean maximum plasma concentration of pirfenidone (Cmax) compared to fasted conditions, wherein the ratio of Cmax under fed conditions divided by Cmax under fasted conditions is about 0.35 to about 0.7.
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20. A method of providing pirfenidone therapy to a human patient in need thereof comprising
(a) orally administering pirfenidone with food to reduce the incidence of dizziness, somnolence, or headaches and (b) advising the patient that administering pirfenidone under fed conditions results in reduced mean maximum plasma concentration of pirfenidone (Cmax) compared to fasted conditions, wherein the ratio of Cmax under fed conditions divided by Cmax under fasted conditions is about 0.35 to about 0.7.
Specification