What is Bonviva?
Bonviva is a medicine that contains the active substance ibandronic acid. It is found in the form of white oblong 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 post-menopausal women at risk of bone fractures. Although the efficacy of the drug in reducing the risk of vertebral (column) fractures has been demonstrated by some studies, its efficacy remains to be established regarding the risk of fracture of the neck of the femur.
The medicine can only be obtained with a prescription.
How is Bonviva used?
Bonviva can be administered either by mouth as a tablet or as an intravenous injection. In the first case, the dose is one tablet per month. The tablet should always be taken after a night of fasting, an hour before taking any type of food or drink, except water, and with a glass of natural water. During the hour that the tablet is taken, the patient must not remain lying down. For the injection, the dose is 3 mg once every three months.
Patients treated with Bonviva must 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 new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to fracture. Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone decrease. Ibandronic acid, the active ingredient in Bonviva, is a bisphosphonate. Inhibits the action of osteoclasts, the body's cells responsible for the decomposition of bone tissue, thus reducing bone loss.
What studies have been carried out on Bonviva?
Bonviva has been studied in three main studies in women with osteoporosis. In the first study, Bonviva 2.5 mg tablets once a day were compared with placebo (a dummy treatment) in about 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. Studies have examined the change in bone density in the spine and in the 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, daily Bonviva 2.5 mg tablet therapy reduced the risk of vertebral fractures by 62% compared to placebo.
The other two studies showed that monthly 150 mg tablets and injections are more effective than 2.5 mg daily tablets in increasing bone density in the spine and hip. Over two years, the bone density of the spine increased by 7% with monthly tablets and 6% with injections, compared with 5% with daily tablets. The bone density of the hip is increased by 4% with the monthly tablets and by 3% with the injections, against 2% with the daily tablets.
What is the risk associated with Bonviva?
The most common side effects (seen in between 1 and 10 patients in 100) are gastritis (inflammation of the stomach), diarrhea, abdominal pain, dyspepsia (indigestion)), nausea, flu-like symptoms, tiredness, musculoskeletal pain (muscle pain and to the bones), arthralgia (joint pain), myalgia (muscle pain) and musculoskeletal stiffness. In the case of the injection, constipation, headache and back pain are also observed in 1-10 patients out of 100. For the full list of side effects reported with Bonviva, see the package leaflet.
Bonviva must not be used in people who may be hypersensitive (allergic) to ibandronic acid or to any of the excipients.
It should not be given to hypocalcemic people (with low blood calcium levels).
Treatment with Bonviva may be related to osteonecrosis of the jaw (collapse of bone in the jaw).
It is necessary to be careful in administering the medicine in the case of 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 Bonviva be given marketing authorization.
More information on Bonviva
On 23 February 2004, the European Commission granted a marketing authorization valid for Bonviva, valid throughout the European Union, to Roche Registration Limited. The marketing authorization was renewed on 23 February 2009.
The full version of the EPAR of Bonviva can be found here.
Last update of this summary: 02-2009.
