英文药名: Thalomid(Thalidomide) 中文药名: 反应停,沙立度胺,酞咪呱啶酮胶囊 规格：50mg, 100mg。 药品名称 通用名称：沙利度胺 英文名：Thalidomide 其它中文名：反应停、沙立度胺、酞胺哌酮、酞胺哌啶酮、酞谷酰亚胺、酞咪哌啶酮 其它英文名：Contergan、Distaval、Kevadon、Pantosediv、Sedalis、Softenon、Talimol 药理毒理 本品作用机制推测有免疫抑制、免疫调节作用，通过稳定溶酶体膜，抑制中性粒细胞趋化性，产生抗炎作用。尚有抗前列腺素、组胺及5－羟色胺作用等。 适应症　　 为一种镇静剂，对于各型麻风反应如发热、结节红斑、神经痛、关节痛、淋巴结肿大，有一定疗效，对结核样型的麻风反应疗效稍差。对麻风本病无治疗作用，可与抗麻风药同用以减少反应。 近年发现本品有免疫抑制作用，可用于骨髓移植。 用法用量　　 口服,一日0.1g-0.2g,分4次给药.重症可增至一日0.3-0.4g,反应得到控制即逐渐减量.病程长者也可较长期给药,每日或隔日口服25-50mg. 或遵医嘱。 禁用 1.孕妇及哺乳期妇女禁用。 2.儿童禁用。 3.对本品过敏者禁用。 4.驾驶员、机器操纵者禁用。 不良反应 口鼻黏膜干燥，头昏，倦怠，嗑睡，恶心，腹痛，便秘，面部浮肿，面部红斑、过敏反应及多发性神经炎等。 药物相互作用 能增强其他中枢抑制剂，尤其是巴比妥类药的作用。 Important Safety Information THALOMID® (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. The effectiveness of THALOMID® is based on response rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival. THALOMID® (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID® (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID® (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Important Safety Information THALOMID® (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. The effectiveness of THALOMID® is based on response rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival. THALOMID® (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID® (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID® (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.   WARNINGS: 1. SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects. Because of this toxicity and in an effort to make the chance of fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called the "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.®)." Under this restricted distribution program, only prescribers and pharmacists registered with the program are allowed to prescribe and dispense the product. In addition, patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S.® program in order to receive product. 2. VENOUS THROMBOEMBOLIC EVENTS The use of THALOMID® (thalidomide) in multiple myeloma results in an increased risk of venous thromboembolic events, such as deep venous thrombosis and pulmonary embolus. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In one controlled trial, the rate of venous thromboembolic events was 22.5% in patients receiving thalidomide in combination with dexamethasone compared to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Preliminary data suggest that patients who are appropriate candidates may benefit from concurrent prophylactic anticoagulation or aspirin treatment. ADDITIONAL WARNINGS: Birth Defects: THALOMID® (thalidomide) can cause severe birth defects in humans. Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential, even if he has had a successful vasectomy. The risk to the fetus from semen of male patients taking thalidomide is unknown. Patients taking THALOMID® (thalidomide) should not share their drug with others or donate blood. Male patients taking THALOMID® (thalidomide) should not donate sperm. Drowsiness and Somnolence: THALOMID® (thalidomide) frequently causes drowsiness and somnolence. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice. Peripheral Neuropathy: THALOMID® (thalidomide) is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Dizziness and Orthostatic Hypotension: Patients should also be advised that THALOMID® (thalidomide) may cause dizziness and orthostatic hypotension and that, therefore, they should sit upright for a few minutes prior to standing up from a recumbent position. Neutropenia: Decreased white blood cell counts, including neutropenia, have been reported in association with clinical use of THALOMID® (thalidomide). Treatment should not be initiated with an absolute neutrophil count (ANC) of <750/mm3. Increased HIV Viral Load: In a randomized, placebo controlled trial of thalidomide in an HIV-seropositive patient population, plasma HIV RNA levels were found to increase (median change = 0.42 log10 copies HIV RNA/mL, p =0.04 compared to placebo). A similar trend was observed in a second, unpublished study conducted in patients who were HIV-seropositive. The clinical significance of this increase is unknown. PRECAUTIONS: Hypersensitivity: THALOMID® (thalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components. Bradycardia: Bradycardia in association with THALOMID® (thalidomide) use has been reported. Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which may be fatal, have been reported. Seizures: Although not reported from pre-marketing clinical trials, seizures, including grand mal convulsions, have been reported during post-approval use of THALOMID® (thalidomide) in clinical practice. Patients with a history of seizures or risk factors for the development of seizures should be monitored closely. Nursing Mothers: It is not known whether THALOMID® (thalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother. ADVERSE REACTIONS: Multiple Myeloma The most frequently reported serious adverse events in multiple myeloma patients (occurring in 20% of patients treated with THALOMID® (thalidomide)/dexamethasone compared with dexamethasone alone) were: fatigue (79% vs 71%), hemoglobin (decreased) (78% vs 86%), hyperglycemia (73% vs 79%), hypocalcemia (72% vs 59%), constipation (55% vs 28%), sensory neuropathy (54% vs 28%), hyponatremia (43% vs 48%), muscle weakness (40% vs 37%), creatinine (35% vs 42%), leukocytes (decreased) (35% vs 29%), bone pain (30% vs 36%), neutrophils (decreased) (31% vs 24%), confusion (28% vs 12%), edema (57% vs 46%), dyspnea (42% vs 31%), thrombosis/embolism (23% vs 5%), anxiety/agitation (26% vs 14%), tremor (26% vs 6%), alkaline phosphatase (increased) (27% vs 28%), and rash/desquamation (30% vs 18%). Other serious reported adverse events in multiple myeloma controlled clinical trials (THALOMID® (thalidomide)/dexamethasone vs. dexamethasone alone) were: hypokalemia (23% vs 23%), insomnia (23% vs 47%), depression (22% vs 24%), neuropathy-motor (22% vs 16%), fever (24% vs 20%), weight loss (23% vs 21%), weight gain (22% vs 13%), platelets (decreased) (24% vs 33%), anorexia (28% vs 25%), nausea (28% vs 23%), pain-other (25% vs 26%), headache (20% vs 23%), dry skin (21% vs 11%), and SGOT (increased) (25% vs 24%). Erythema Nodosum Leprosum Common adverse events reported in THALOMID® (thalidomide) treated patients in controlled clinical trials in ENL: somnolence (38%), rash (21%), headache (13%), asthenia (8%), malaise (8%), pain (8%), vertigo (8%), pruritus (8%), and impotence (8%). DOSAGE AND ADMINISTRATION: THALOMID® (thalidomide) must only be administered in compliance with all of the terms outlined in the S.T.E.P.S.® program. THALOMID® (thalidomide) may only be prescribed by prescribers and dispensed by pharmacists registered with the S.T.E.P.S.® program. Patients taking THALOMID® (thalidomide) should not share the drug. Male patients taking THALOMID® (thalidomide) should not donate sperm. Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS. Thalidomide,THALIDOMIDE Celgene Europe Ltd This medicine is a white, oblong capsule imprinted with "logo" and "CELGENE 50 mg". Generic Name: thalidomide Strength: 50 mg THALOMID 200 MG CAPSULE This medicine is a blue, oblong capsule imprinted with "logo" and "CELGENE 200mg". THALOMID 150 MG CAPSULE This medicine is a blue, oblong capsule imprinted with "Celgene/ 150mg" and "logo". THALOMID 100 MG CAPSULE This medicine is a tan, oblong capsule imprinted with "logo" and "CELGENE 100mg".