Methods of Administering Pirfenidone Therapy

1 . A method of administering pirfenidone therapy to a patient in need thereof, comprising administering an effective amount of pirfenidone, and avoiding grapefruit juice.

2 . The method of claim 1 wherein the patient suffers from a disease selected from idiopathic pulmonary fibrosis, pulmonary fibrosis, idiopathic interstitial pneumonia, autoimmune lung diseases, benign prostate hypertrophy, coronary or myocardial infarction, atrial fibrillation, cerebral infarction, myocardiac fibrosis, musculoskeletal fibrosis, post-surgical adhesions, liver cirrhosis, renal fibrotic disease, fibrotic vascular disease, scleroderma, Hermansky-Pudlak syndrome, neurofibromatosis, Alzheimer's disease, diabetic retinopathy, or skin lesions, lymph node fibrosis associated with HIV, chronic obstructive pulmonary disease (COPD), inflammatory pulmonary fibrosis, rheumatoid arthritis; rheumatoid spondylitis; osteoarthritis; gout, other arthritic conditions; sepsis; septic shock; endotoxic shock; gram-negative sepsis; toxic shock syndrome; myofacial pain syndrome (MPS); Shigellosis; asthma; adult respiratory distress syndrome; inflammatory bowel disease; Crohn's disease; psoriasis; eczema; ulcerative colitis; glomerular nephritis; scleroderma; chronic thyroiditis; Grave's disease; Ormond's disease; autoimmune gastritis; myasthenia gravis; autoimmune hemolytic anemia; autoimmune neutropenia; thrombocytopenia; pancreatic fibrosis; chronic active hepatitis including hepatic fibrosis; acute or chronic renal disease; renal fibrosis; diabetic nephropathy; irritable bowel syndrome; pyresis; restenosis; cerebral malaria; stroke or ischemic injury; neural trauma; Alzheimer's disease; Huntington's disease; Parkinson's disease; acute or chronic pain; allergies, including allergic rhinitis or allergic conjunctivitis; cardiac hypertrophy, chronic heart failure; acute coronary syndrome; cachexia; malaria; leprosy; leishmaniasis; Lyme disease; Reiter's syndrome; acute synoviitis; muscle degeneration, bursitis; tendonitis; tenosynovitis; herniated, ruptured, or prolapsed intervertebral disk syndrome; osteopetrosis; thrombosis; silicosis; pulmonary sarcosis; bone resorption diseases, such as osteoporosis or multiple myeloma-related bone disorders; cancer, including but not limited to metastatic breast carcinoma, colorectal carcinoma, malignant melanoma, gastric cancer, or non-small cell lung cancer; graft-versus-host reaction; or auto-immune diseases, such as multiple sclerosis, lupus or fibromyalgia; AIDS or other viral diseases such as Herpes Zoster, Herpes Simplex I or II, influenza virus, Severe Acute Respiratory Syndrome (SARS) or cytomegalovirus; or diabetes mellitus, proliferative disorders (including both benign or malignant hyperplasias), acute myelogenous leukemia, chronic myelogenous leukemia, Kaposi's sarcoma, metastatic melanoma, multiple myeloma, breast cancer, including metastatic breast carcinoma; colorectal, carcinoma; malignant melanoma; gastric cancer; non-small cell lung cancer (NSCLC); bone metastases; pain disorders including neuromuscular pain, headache, cancer pain, dental pain, or arthritis pain; angiogenic disorders including solid tumor angiogenesis, ocular neovascularization, or infantile hemangioma; conditions associated with the cyclooxygenase or lipoxygenase signaling pathways, including conditions associated with prostaglandin endoperoxide synthase-2 (including edema, fever, analgesia, or pain); organ hypoxia; thrombin-induced platelet aggregation; or protozoal diseases.

3 . The method of claim 1 wherein the pirfenidone is administered at a total daily dosage of at least 1800 mg.

4 . The method of claim 2 wherein the pirfenidone is administered at a total daily dosage of at least 1800 mg.

5 . The method of claim 1 wherein the pirfenidone is administered at a total daily dosage of about 2400 mg or 2403 mg.

6 . The method of claim 2 wherein the pirfenidone is administered at a total daily dosage of about 2400 mg or 2403 mg.

7 . The method of claim 3 wherein the pirfenidone is administered to the patient three times per day, with food.

8 . The method of claim 4 wherein the pirfenidone is administered to the patient three times per day, with food.

9 . A method of administering pirfenidone therapy to a patient with idiopathic pulmonary fibrosis, comprising administering an effective amount of pirfenidone, and avoiding grapefruit juice.

10 . The method of claim 9 wherein the pirfenidone is administered at a total daily dosage of at least 1800 mg.

11 . The method of claim 9 wherein the pirfenidone is administered at a total daily dosage of about 2400 mg or 2403 mg.

12 . The method of claim 10 wherein the pirfenidone is administered to the patient three times per day, with food.

13 . The method of claim 11 wherein the pirfenidone is administered to the patient three times per day, with food.