Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. Failure to comply may result in legal action.Serotonin syndrome is a drug reaction that is caused by high levels of serotonin in your body. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) with ruxolitinib and danazol for patients with myelofibrosis suffering from anemia.Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) and danazol PO thrice daily (TID) on days 1-56. 0000013477 00000 n If your doctor prescribes a new medication, make sure he or she knows about all the other medications you're taking, especially if you receive prescriptions from more than one doctor.If you and your doctor decide the benefits of combining certain serotonin-level-affecting drugs outweigh the risks, be alert to the possibility of serotonin syndrome.Mayo Clinic does not endorse companies or products. A severe case will be treated in a hospital. 0000016709 00000 n To evaluate the efficacy (best overall response) of ruxolitinib (ruxolitinib phosphate) and danazol in patients with myelofibrosis suffering from anemia.I. Rares : hypertension, des effets thrombotiques ont aussi été observés, incluant thrombose veineuse profonde et thrombose artérielle. This includes prescription drugs, over-the-counter drugs, herbal supplements, and illegal drugs. 0000005317 00000 n 0000013455 00000 n 0000019040 00000 n We use cookies to ensure that we give you the best experience on our website. 0000011740 00000 n Your lungs or kidneys could fail. Tell him the names of all the drugs you take. Serotonin syndrome, which occurs as a result of enhanced serotonin concentration in the central nervous system, is a well-known adverse effect of serotonin-active medications.

0000022148 00000 n 0000011718 00000 n They are used to treat anemia in patients with … Medical experts don't fully understand why normal hormone changes cause PMS in some women and not others. trailer << /Size 173 /Info 99 0 R /Root 105 0 R /Prev 165264 /ID[<2894ce4ed8763460d6103355c749875b> 0000010845 00000 n 0000007348 00000 n Serotonin syndrome is a potentially fatal and largely avoidable adverse drug reaction caused by serotonergic drugs. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression.After completion of study treatment, patients are followed up every 6 months for 2 years.- Histological confirmation of primary myelofibrosis (MF), post polycythemia vera (PV) or post essential thrombocythemia (ET) myelofibrosis (intermediate 1, intermediate II or high risk) requiring medical therapy- Anemia is required for trial entry (defined as hemoglobin < 10g/dL or transfusion dependent [having needed a transfusion anytime in the past 6 months])- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study entry- Serum creatinine =< 1.5 x the upper limit of normal (ULN)- Total bilirubin =< 1.5 x ULN; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be < 1.5mg/dL- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN; higher values (i.e., =< 5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis- Patient able to provide voluntary written informed consent to participate- Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only- Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide, interferon-alpha), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin), hormones (e.g., androgens, danazol) =< 14 days prior to registration; note: patients who are on ruxolitinib may continue on without a 14 day wash out at the treating physician's discretion- Major surgery =< 28 days or radiation =< 6 months prior to registration- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens- Uncontrolled congestive heart failure (New York Heart Association classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass, graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to registration- Participation in any study of an investigational agent (drug, biologic, device) =< 30 days, unless during non-treatment phase- Men or women of childbearing potential who are unwilling to employ adequate contraception- Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness- Active malignancy other than MF, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ or other malignancies that have been stable and off therapy for 5 years- Patient currently taking simvastatin, or lovastatin at a dose greater than 10 mg/day- Men with prostate specific antigen (PSA) > 4 ng/ml or with uncontrolled benign prostatic hypertrophy- Patient received prior combination treatment with ruxolitinib and danazol together; note: previous treatment with ruxolitinib and/or danazol as single agent therapy is allowed- Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration- Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE)- Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan)- Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)

Serotonin syndrome occurs when you take medications that cause high levels of the chemical serotonin to accumulate in your body.Serotonin is a chemical your body produces that's needed for your nerve cells and brain to function. Signs and symptoms of premenstrual syndrome change with hormonal fluctuations and disappear with pregnancy and menopause. 0000010102 00000 n 0000017583 00000 n