Bonviva - ibandronic acid

What is Bonviva?

Bonviva is a medicine that contains the active substance ibandronic acid. It comes in the form of oblong white tablets (150 mg) and a solution for injection (3 mg).

What is Bonviva used for?

Bonviva is indicated for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women at risk of bone fractures. some studies, its effectiveness with regard to the risk of fracture of the femoral neck remains to be established.
The medicine can only be obtained with a prescription.

How is Bonviva used?

Bonviva can be administered either by mouth as a tablet or by intravenous injection. In the first case, the dose is one tablet per month. The tablet should always be taken after an overnight fast, one hour before any food or drink, except water, and with a glass of plain water. During the hour following tablet-taking, the patient should not lie down. For injection, the dose is 3 mg once every three months.
Patients treated with Bonviva should supplement their diet with vitamin D and calcium if food intake is insufficient. Bonviva is not recommended for patients with severe kidney problems.

How does Bonviva work?

Osteoporosis arises when enough new bone is not produced to replace what is naturally consumed. Bones become progressively thinner and more fragile and more prone to fracture. Osteoporosis is more common in women after menopause, when the levels of the female hormone estrogen. Ibandronic acid, the active substance in Bonviva, is a bisphosphonate. It inhibits the action of osteoclasts, the body's cells responsible for breaking down bone tissue, thus reducing bone loss.

How has Bonviva been studied?

Bonviva has been studied in three main studies involving women with osteoporosis. In the first study, Bonviva 2.5 mg tablets once daily was compared with placebo (a dummy treatment) in approximately 3,000 women and the number of fractures reported by patients over three years was observed.
In the other two studies, monthly 150 mg tablets (in 1,609 patients) and injections (in 1,395 patients) were compared with 2.5 mg daily tablets. The studies looked at the change in bone density in the spine and hip over two years.
It is noted that the 2.5 mg daily tablets used in the studies are no longer authorized.

What benefit has Bonviva shown during the studies?

In the first study, Bonviva 2.5 mg tablet daily therapy reduced the risk of vertebral fractures by 62% compared with placebo.
The other two studies showed that the 150 mg monthly tablets and injections were more effective than the 2.5 mg daily tablets in increasing bone density in the spine and hip. Over two years, bone density in the spine increased 7% with monthly tablets and 6% with injections, compared with 5% with daily tablets. Hip bone density increased by 4%. with monthly tablets and 3% with injections, against 2% with daily tablets.

What is the risk associated with Bonviva?

The most common side effects (seen in 1 to 10 patients in 100) are gastritis (stomach inflammation), diarrhea, abdominal pain, dyspepsia (indigestion), nausea, flu-like symptoms, fatigue, musculoskeletal pain (pain in the muscles and bone), arthralgia (joint pain), myalgia (muscle pain) and musculoskeletal stiffness. Constipation, headache and back pain are also seen in 1 to 10 out of 100 patients with the injection. For the full list of side effects reported with Bonviva, see the package leaflet.
Bonviva must not be used in people who are hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
It must not be given to hypocalcemic people (with low blood levels of calcium).
Treatment with Bonviva may be linked to osteonecrosis of the jaw (collapse of bone in the jaw).
Caution should be exercised in administering the medicinal product to patients with ongoing dental treatment.

Why has Bonviva been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva's benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women with an increased risk of fractures. The Committee recommended that it be given marketing authorization. marketed for Bonviva.

Learn more about Bonviva

On 23 February 2004, the European Commission granted Roche Registration Limited a "Marketing Authorization" for Bonviva, valid throughout the European Union. The "Marketing Authorization" was renewed on 23 February 2009.
For the full version of Bonviva's EPAR click here.

Last update of this summary: 02-2009.

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