美国FDA批准一月1次的口服伊班膦酸钠片上市

美国FDA批准罗氏公司和葛兰素史克公司一月1次的口服伊班膦酸钠（ibandronate sodium，Boniva）150mg片上市用于治疗绝经后妇女的骨质疏松症。本品是首个和迄今唯一用于绝经后妇女骨质疏松症的一月1次药品。
本品是治疗慢性病中迄今第一个上市一月1次1片的口服片。患者一年只要服用12片，而目前以双磷酸盐药物治疗，每周共需服用52片。本品批准意义重大，它向患者提供了有效且服用方便的产品。
3年多的研究显示，一日1次的伊班膦酸钠（2.5mg）获准用于治疗和预防骨质疏松症可显著减少绝经后骨质疏松妇女脊椎新骨折的发生率和增加绝经后无骨质疏松妇女的骨矿物质密度（BMD）。
一月1次口服伊班膦酸钠（150mg）片的批准是基于对1 602例绝经后骨质疏松妇女国际多中心随机双盲研究。结果显示，治疗一年后本品一月1次给药增加腰脊柱和其它骨骼部位的BMD至少可与小剂量一日1次给药相当。

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.

【原产地英文商品名】:BONIVA 150mg/tab 3tabs/box
【原产地英文药品名】:IBANDRONATE SODIUM
【中文参考商品译名】:BONIVA 150毫克/片 3片/盒
【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