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 详细处方信息以本药内容附件PDF文件（2010112118574615.pdf）的“原文Priscribing Information”为准
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部分中文处方资料（仅供参考）

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。

Boniva
Generic Name: ibandronate (eye BAN dro nate)
Brand Names: Boniva
What is Boniva?
Boniva (ibandronate) is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation

and breakdown in the body. Ibandronate slows bone loss while increasing bone mass, which may prevent bone fractures.
Boniva is used to treat or prevent osteoporosis in women after menopause.
Boniva may also be used for other purposes not listed in this medication guide.
Important information about Boniva
Do not take a Boniva tablet if you cannot sit upright or stand for at least one full hour. Boniva can cause serious problems in the

stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 60 minutes after

taking this medication.
Take the Boniva tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other

medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Boniva tablet.
For at least the first 60 minutes after taking a Boniva tablet, do not lie down or recline; do not eat or drink anything other than

plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to Boniva have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms

of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery

involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with

chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders,

anemia (low red blood cells), and pre-existing dental problems.
Boniva is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin

supplements. Follow your diet, medication, and exercise routines very closely.
Before using Boniva
You should not use Boniva if you are allergic to ibandronate, or if you have severe kidney disease, low blood levels of calcium

(hypocalcemia), or a problem with your esophagus (the tube that connects your mouth and stomach).
Do not take a Boniva tablet if you cannot sit upright or stand for at least one full hour. Boniva can cause serious problems in the

stomach or esophagus. You will need to stay upright for at least 60 minutes after taking this medication.
To make sure you can safely take Boniva, tell your doctor if you have any of these other conditions:
• a vitamin D deficiency;
• kidney disease;
• an ulcer in your stomach or esophagus; or
• trouble swallowing.
Some people using medicines similar to Boniva have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms

of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery

involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or

steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells),

and dental surgery or pre-existing dental problems.
FDA pregnancy category C. It is not known whether Boniva will harm an unborn baby. Tell your doctor if you are pregnant or plan to

become pregnant while using this medication. It is not known whether ibandronate passes into breast milk or if it could harm a

nursing baby. Do not use Boniva without telling your doctor if you are breast-feeding a baby.
How should I use Boniva?
Use Boniva exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the

directions on your prescription label.
Boniva tablets are taken either once each day or once each month. Boniva intravenous solution is given as an injection into one of

your veins once every three (3) months. A healthcare provider will give you this injection. Boniva tablets can be taken at home.
Take the Boniva tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other

medicine. If you take a Boniva tablet only once a month, take it on the same day each month and always first thing in the morning.
Take each Boniva tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a Boniva

tablet. Do not crush, chew, or suck the tablet. Swallow the tablet whole.
After taking a Boniva tablet, carefully follow these instructions:
• Do not lie down or recline for at least 60 minutes after taking the tablet.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes after taking Boniva. It

may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for

your other medicines.
To be sure this medication is helping your condition, your bone mineral density will need to be tested often. Visit your doctor

regularly.
Boniva is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin

supplements. Follow your diet, medication, and exercise routines very closely.
Store Boniva tablets at room temperature away from moisture and heat.
What happens if I miss a dose?
If you take Boniva tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the

day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.
If you take Boniva tablets once a month: If you forget to take Boniva on your scheduled day, take it first thing in the morning on

the day after you remember the missed dose. Then return to your regular monthly schedule on your chosen dose day. If your next

scheduled dose is less than 7 days away, wait until then to take the medicine and skip the missed dose. Do not take two (2) tablets

in one week.
If you receive Boniva injections every 3 months: Call your doctor for instructions if you miss an appointment for your injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local

poison control center or emergency room right away. Do not make yourself vomit and do not lie down.
Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your

face, seizure (convulsions), irritability, and unusual thoughts or behavior.
What should I avoid while taking Boniva?
Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes before or after taking a Boniva

tablet. Avoid milk and other dairy products for at least 60 minutes after taking Boniva (except in the case of overdose as stated

above). Do not lie down for at least 1 hour (60 minutes) after you take a tablet.
Boniva side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Boniva: hives; difficulty breathing; swelling

of your face, lips, tongue, or throat. Stop using Boniva and call your doctor at once if you have any of these serious side

effects:
• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe joint, bone, or muscle pain; or
• jaw pain, numbness, or swelling.
Less serious Boniva side effects may include:
• back pain, headache;
• redness or swelling of your eyes;
• diarrhea;
• flu symptoms;
• redness or swelling where the medicine was injected;
• nausea or upset stomach; or
• pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may

report side effects to FDA at 1-800-FDA-1088.
See also: Boniva side effects (in more detail)
What other drugs will affect Boniva?
Tell your doctor about all other medicines you use, especially aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such

as:
• celecoxib (Celebrex);
• diclofenac (Voltaren);
• diflunisal (Dolobid);
• ibuprofen (Motrin, Advil);
• indomethacin (Indocin);
• ketoprofen (Orudis)
• ketorolac (Toradol);
• naproxen (Aleve, Naprosyn); or
• piroxicam (Feldene), and others.
This list is not complete and other drugs may interact with Boniva. Tell your doctor about all medications you use. This includes

prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
• Your pharmacist can provide more information about Boniva.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use

this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-

date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum

information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not

warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information

does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to

assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a

supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a

warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe,

effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered

with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses,

directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs

you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件（2010112118574615.pdf）的“原文Priscribing Information”为准
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