部分中文Boniva处方资料（仅供参考） FDA已批准Boniva（ibandronate sodium）注射剂。该药是治疗绝经后妇女骨质疏松症的第一种静脉注射剂。 Boniva是首个每季度用药一次的绝经后妇女骨质疏松症治疗药，它属于最常用于治疗该病的双磷酸化合物类药物。在专业保健人员的指导下，患者每三个月用药一次。 Boniva为那些不便使用口服药物治疗的患者带来了福音。此外，该药需要在专业保健人员的指导下使用，这使临床医生更容易了解患者对药物的适应性。Boniva注射剂将于今年年初上市。 FDA在2005年3月批准了每月用药一次的Boniva（150毫克），它已于2005年4月上市。 2～3个月给药一次的抗骨质疏松药物Boniva Roche公司于7月8日宣布，Boniva（ibandronate）的新的Ⅲ 期临床试验结果表明每2～3个月静脉注射Boniva可有效控制绝经期骨质疏松症。这一新的给药方式无疑会给患者带来更大的方便和提供更大的安全性。 二种剂量研究（每2个月2mg或每3个月3mg）在增加脊椎骨密度（BMD）方面与 2.5mg·d-1的剂量效果相当。美国FDA在2003年5月曾批准该药每天一次的给药剂量。 每月一次口服该药治疗骨质疏松的补充新药申请（sNDA）已于2004年5月递交给了FDA，目前正在审核中。 所进行的临床试验是一项为期2年的国际多中心试验，主要是比较FDA批准的每日口服剂量 (2.5mg，qd）与静脉给药（2mg／2个月和3mg／3个月）对绝经期骨质疏松的有效性和安全性。 该试验目前已进入第2年。Boniva原被批准每日一次，每次2.5mg用于预防绝经期骨质疏松症。该药可增加骨密度和减少脊椎骨折的发生。 Boniva不适用于不能站立或坐直达60min的患者、对膦酸盐类化合物有过敏反应的患者，和未经治疗的低钙血症患者。 同其他二膦酸盐类药物一样，Boniva可造成上胃肠道紊乱，如吞咽困难，食管炎，食管或胃溃疡等。 BONIVA® (ibandronate sodium)INJECTION Boniva Injection 3mg/3ml Medication  FDA approval for Boniva Injection—the first intravenous (IV) medication indicated for the treatment of postmenopausal osteoporosis. The product is a member of the bisphosphonate class, which is the most frequently prescribed medicine for osteoporosis. Boniva Injection, administered as a 15-to 30-second IV injection, will provide an alternative for patients who have difficulty with oral bisphosphonate dosing requirements. Furthermore, because the product will be administered once every 3 months by health care professionals, clinicians will have a greater awareness of patient compliance with therapy. Boniva Injection 3 mg/3 mL will be available in boxes containing one single- use, clear glass prefilled syringe, along with 1 needle and an alcohol swab. BONIVA INJECTION Rx Generic Name and Formulations: Ibandronate (as monosodium monohydrate) 3mg/3mL; soln for IV inj. Company: Roche Laboratories Select therapeutic use: Bone disorders Indications for BONIVA INJECTION: Treatment of postmenopausal osteoporosis. Limitations of use: optimal duration of use has not been determined. For patients at low-risk for fracture: consider drug discontinuation after 3–5yrs. Limitations Of use: Optimal duration of use has not been determined. For patients at low-risk for fracture: consider drug discontinuation after 3–5yrs. Adult: Must be given by healthcare professional. Give as IV bolus inj over 15–30secs. 3mg every 3 months; if dose is missed, give as soon as possible, then every 3 months from the date of last inj. Children: Not established. Contraindications: Hypocalcemia. Tabs: Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 60mins. Warnings/Precautions: Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <30mL/min): not recommended. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Ensure adequate Vit. D and calcium intake. Reevaluate periodically. Inj: check renal function before each dose. Pregnancy (Cat.C). Nursing mothers. Interactions: Calcium, aluminum, magnesium, other divalent cations reduce absorption (separate dosing). Caution with aspirin, NSAIDs, other GI irritants. May interfere with bone-imaging agents. Concomitant nephrotoxic agents; monitor for renal toxicity. See Also: BONIVA Pharmacological Class: Bisphosphonate. Adverse Reactions: Back pain, dyspepsia, pain in extremity, diarrhea, headache, myalgia; musculoskeletal pain (may be severe), dysphagia, esophagitis, esophageal or gastric ulcer, jaw osteonecrosis, atypical femur fractures. Inj: inj site reactions, flu-like syndrome, anaphylaxis. How Supplied: Tabs 150mg—3; Prefilled syringe (5mL)—1 (w. supplies) Boniva Injection (Ibandronate) • Administered over 15 to 30 seconds with an IV bolus injection • Intravenous administration eliminates the need for pre- and post-dose fasting and activity restrictions • Each BONIVA Injection kit contains a pre-filled syringe, butterfly needle, and two alcohol swabs • No reconstitution or refrigeration is necessary (store kit between 59°F and 86°F) • Patients with uncorrected hypocalcemia should not receive BONIVA Injection • Patients must receive supplemental calcium and vitamin D • Patients who receive BONIVA Injection should have serum creatinine measured prior to each dose • Patients with severe renal impairment (creatinine clearance <30 mL/min) should not receive BONIVA Injection BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women. Important Safety Information for BONIVA Injection BONIVA Injection is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to BONIVA Injection or any of its excipients. BONIVA Injection, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values. Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D. BONIVA Injection must be administered intravenously only by a healthcare professional. Patients who receive BONIVA Injection should have serum creatinine measured prior to each dose. BONIVA Injection should not be administered to patients with severe renal impairment (serum creatinine >2.3mg/dL or creatinine clearance <30 mL/min). Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures who received intravenous bisphosphonates. In a one-year study comparing BONIVA Injection 3 mg quarterly and BONIVA Tablets 2.5mg daily, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events (>5.0%), regardless of causality, were arthralgia (9.6% BONIVA Injection vs 8.6% BONIVA Tablets 2.5 mg), back pain (7.0% vs 7.5%), hypertension (5.3% vs 7.1%), abdominal pain (5.1% vs 5.6%), influenza (4.7% vs 8.0%) and nasopharyngitis (3.4% vs 6.0%). In some patients acute phase reaction-like events (10% BONIVA Injection vs 4% BONIVA Tablets) have been reported within 3 days of an IV dose and lasting for 7 days or less, most commonly after the first injection. In most cases, no specific treatment was required and symptoms subsided within 24-48 hours. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=13109 ---------------------------------------------------------------- 产地国家：美国 原产地英文商品名： BONIVA 3mg/3ml/SYRINGE/KIT 原产地英文药品名： IBANDRONATE SODIUM 中文参考商品译名： BONIVA 3毫克/3毫升/注射器/套 中文参考药品译名： 伊班膦酸钠  生产厂家英文名： ROCHE 生产厂家中文参考译名： 罗氏