Definition :
Boniva (ibandronate) belongs to a 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 purposes not listed in this medication guide.
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). Slideshow: View Frightful (But Dead Serious) Drug Side Effects View Frightful (But Dead Serious) Drug Side Effects Do not take an 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.
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 an 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.
a vitamin D deficiency; kidney disease; an ulcer in your stomach or esophagus; or trouble swallowing. In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Boniva, the more likely you are to develop this condition. Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem. FDA pregnancy category C. It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. See also: Pregnancy and breastfeeding warnings (in more detail) 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.
Use Boniva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. 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. The tablets can be taken at home. Take the 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 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 a tablet. Swallow the pill whole.
Do not lie down or recline for at least 60 minutes after taking Boniva. 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. You may not need to take Boniva for longer than 3 to 5 years. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using this medicine. You may need to stop using the medicine for a short time. 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 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 a tablet 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? Do not take any other medicines including vitamins, calcium, or antacids for at least 60 minutes before or after taking a tablet. Avoid milk and other dairy products for at least 60 minutes after taking Boniva (except in the case of overdose as stated above).
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: chest pain, new or worsening heartburn; difficulty or pain when swallowing; pain or burning under the ribs or in the back; severe joint, bone, or muscle pain; new or unusual pain in your thigh or hip; or jaw pain, numbness, or swelling. Common 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. . See also: Side effects (in more detail) What other drugs will affect Boniva? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Boniva, especially: aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others. This list is not complete. Other drugs may interact with ibandronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Definition :
This new treatment option comes in the wake of the Surgeon General's Report elevating osteoporosis to a major public health threat on par with smoking and obesity.1 Forty-four million Americans over 50 years of age, are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.2 To improve persistence, the Surgeon General's Report has recommended, among various measures, simplifying and organizing treatment regimens.1 Developed in response to patient need, once-monthly Boniva was approved based on a supplemental new drug application. Once-monthly oral Boniva is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva. Slideshow: View Frightful (But Dead Serious) Drug Side Effects View Frightful (But Dead Serious) Drug Side Effects Boniva 150 mg once-monthly and Boniva 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly Boniva is expected to be available by prescription in U.S. pharmacies in April. Boniva Clinical Trial Results Daily Boniva (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis. Once-monthly oral Boniva (150 mg) was approved based on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double-blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis. MOBILE showed the following: The monthly dose was at least equivalent to the daily dose in increasing BMD after one year at the lumbar spine and other skeletal sites The mean increase from baseline in lumbar spine BMD was 4.9 percent in the once-monthly group and 3.9 percent in the daily group (p=0.002) The once-monthly group also had consistently higher BMD increases at the other skeletal sites compared to the daily group
Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients. Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).
Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes. Patients who take Boniva are eligible to sign up for MyBONIVA, a patient support program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this unique once-monthly regimen.
Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia),2 placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.2 Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.1
Tags:
bisphosphonates