FDA已批准Boniva（ibandronate sodium）注射剂。罗氏和GSK称，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。

• 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.

BONIVA

Boniva Information

Boniva is a popular medicine that is also generically called Ibandronate. This product belongs to a wide class of drugs that are known bisphosphonates. Such medicines are able to alter the natural bone formation and breakdown cycle of the patient’s organism. A treatment with this drug is known to effectively increase bone mass and to slow bone loss, thus preventing bone fractures.

Boniva Indications

Boniva is a popular drug that is generally prescribed to post menopausal female patients, in the treatment or in the prevention of osteoporosis. However, this drug could also serve some other purposes that have not been listed in this guide. Ask your personal health care provider for more information.

Boniva Warnings

Patients who are unable of standing or sitting upright for at least one hour should not be allowed to start a treatment with this medicine. Intake of Boniva could trigger severe esophagus or stomach disorders. After using a dose of this medicine, a patient should stand for at least one hour.

Some patients who have followed a treatment with this medicine have developed jaw osteonecrosis (jaw bone loss). This medical disorder’s symptoms are known to include jaw swelling, pain, numbness, gum infection, loss of teeth, or slow healing after gums surgery or injury. Patients who are suffering from cancer or who have recently followed a steroid, radiation or chemotherapy treatment are more prone to developing this condition. A treatment with Boniva should be accompanied by exercise, special diet, and an intake of vitamin or calcium supplements. Ask your doctor for more information.

Patients who are suffering from known allergic reactions to any of this medicine’s components must not start taking Boniva. Before you start a treatment with this drug you should inform your personal health care specialist if you are allergic to any dyes, foods, preservatives or other substances (this includes other medicines). Some medical conditions are known to harmfully interact with a treatment with this drug, preventing the patient from taking Boniva. Alert your personal physician if you are suffering from any of the following disorders, as you might not be allowed to take this drug or you might have to be given a lower dose of it:

• hypocalcaemia (abnormally low blood calcium levels);
• kidney disorder;
• vitamin D deficiency;
• stomach ulcer or esophagus disorders.

Boniva is a category C FDA pregnancy drug. Therefore, a treatment with this medicine during pregnancy could harm a growing fetus. If you are pregnant, or if you think you will become pregnant soon you should not start taking this product (ask your doctor for more information). It has not been clearly determined whether this drug’s components are able to pass into the patient’s breast milk or not. If you are currently nursing an infant, you should ask your personal health care specialist if it is safe to start a treatment with this product.

Boniva Intake Guidelines

Ask your personal health care provider to tell you exactly how you should take your doses of Boniva. Do not deviate from any of his or her instructions. If you have further questions regarding your treatment with this medicine you should ask a nurse or a pharmacist for more information. Consult the medicine’s label for further professional advice. A dose of Boniva should be taken in early in the morning, on an empty stomach. Wait an hour before you eat, drink or take other drugs. A dose of this medicine should be accompanied by a glass of plain water (avoid drinking mineral water). Avoid crushing, sucking or chewing a pill of Boniva: try to swallow it as a whole.

The intravenous form of Boniva is regularly administered as an injection in a vein by an authorized health care provider in a medical setting (such as a clinic or a hospital). In order to see if your treatment with this medicine is working properly, you will probably have to undergo several medical exams, to test your bone mineral density. Avoid missing any of your doctor’s appointments. Store this product in a place that is far from the reach of both pets and children. Do not keep it in the bathroom or near the kitchen sink. Store it in a cool any dry place, away from direct sunlight.

Boniva Dosage

Ask your personal health care provider to tell you the exact dose of Boniva that you should take in, in order to get the best results from your treatment with it. A tablet of this medicine is generally taken in either daily or monthly.

Boniva Overdose

If you suspect that you might be suffering from an overdose with this medicine you should seek medical care as soon as possible. You should alert your personal physician at once. You should drink a full glass of milk. Avoid lying down or vomiting. An overdose with this product should trigger heartburn, nausea, diarrhea, abdominal pain, muscle cramps, tingling, numbness, tight facial muscles, irritability, seizure (convulsions), and unusual behavior or thoughts.

Boniva Missed Dose

If you happen to miss one of your doses of Boniva you should call your personal health care specialist as soon as possible and ask him or her for further instructions.

Boniva Side Effects

Alert your personal physician if you experience anything unusual while using Boniva.

Boniva Drug Reactions

During your treatment with Boniva it is important to avoid using any antacids, or drugs (this includes supplements) that are known to contain magnesium, aluminum, iron or any other substances (especially minerals) that interfere with how the organism absorbs Boniva’s ingredients.

【原产地英文商品名】:BONIVA 3mg/3ml 1SYRINGE 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/套
【中文参考药品译名】：伊班膦酸钠
【生产厂家中文参考译名】：罗氏
【生产厂家英文名】:ROCHE