OTREXUP（氨甲喋呤 methotrexate）注射液被美国食品和药物管理局批准为一周一次注射治疗牛皮癣关节炎及幼年特发性关节炎患者 OTREXUP（甲氨蝶呤 methotrexate）注射液 供皮下注射使用 美国首次批准： 1953 适应症 Otrexup是一种叶酸类似物代谢抑制剂控制矿产为： •重症患者，活动性类风湿关节炎（ RA）和多关节型幼年特发性关节炎（ pJIA ），谁不能耐受或有​​反应不足管理第一线治疗. •严重的，顽固的，在成年人谁没有执行充分反映其他形式的治疗牛皮癣禁用的症状控制 使用限制 Otrexup没有表示对肿瘤性疾病的治疗。 剂量与用法 • Otrexup仅供每周一次皮下注射使用。管理Otrexup在腹部或大腿。 •使用氨甲喋呤的另一个公式tion为需要口服，肌肉注射，静脉注射，动脉内或鞘内给药的患者，剂量每周少于10毫克，剂量超过每周25毫克，高剂量方案，或剂量不足5调整毫克的增量. •起始剂量氨甲喋呤： • RA ：一种口服配方化7.5毫克，每周一次 • pJIA ： 10mg/m2每周一次. •牛皮癣：10到25毫克，每周一次口服，肌内，皮下或静脉内化式. •调整剂量，以逐步实现的成就，最佳响应. 剂型和规格 注射：单剂量自动注射器递送0.4毫升甲氨蝶呤在以下剂量浓度：10毫克，15毫克，20毫克和25毫克。 Otrexup makes subcutaneous delivery of methotrexate easy1 It includes a number of features to help patients feel comfortable and confident in using the device. •For patients with a fear of needles, the needle is hidden both prior to and after the injection •In a study of Otrexup, 98% of patients found Otrexup easy to use1 •A locking safety guard helps protect patients from accidental needle stick injuries •Otrexup is stored at room temperature between 68°F to 77°F (20°C to 25°C)2 OTREXUP Rx Generic Name and Formulations: Methotrexate 10mg/0.4mL, 15mg/0.4mL, 20mg/0.4mL, 25mg/0.4mL; soln for SC inj; preservative-free. Company: Antares Pharma Indications for OTREXUP: Management of adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs. Limitation of use: not for treating neoplastic diseases. Adult Dose for OTREXUP: Administer by SC inj in abdomen or thigh. Initially 7.5mg once weekly using an oral formulation. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Adjust dose gradually. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <10mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <5mg increments. Children's Dose for OTREXUP: <2yrs: not established. Administer by SC inj in abdomen or thigh. ≥2yrs: initially 10mg/m2 once weekly. Switching from oral to Otrexup SC inj: consider differences in bioavailability. Adjust dose gradually. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <10mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <5mg increments. Pharmacological Class: Folic acid antagonist. Contraindications: Alcoholism. Chronic liver disease. Immunodeficiency. Preexisting blood dyscrasias. Pregnancy (Cat.X). Nursing mothers. Warnings/Precautions: Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate-to-severe changes. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Hepatic fibrosis. Steatohepatitis. Active infection. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Maintain adequate hydration. Elderly. Debilitated. Interactions: Avoid live virus vaccines. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics, folic acid antagonists. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine. May be antagonized by folic acid. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation. Adverse Reactions: Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, and “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions, fertility impairment. How Supplied: Single-dose auto-injector—1, 4