BONIVA Injection is indicated for:

Treatment of Postmenopausal Osteoporosis:

• BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Do not administer more frequently than once every 3 months. 

Boniva is contraindicated in patients with hypocalcemia.

Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including ibandronate injection. Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment.

While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. 

Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area.These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure.

Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute).

Cases of anaphylaxis, including fatal events, have been reported in patients treated with BONIVA Injection.

BONIVA Injection may cause a decrease in serum calcium values.Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting ibandronate injection therapy.

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking BONIVA and other bisphosphonates. The time to onset of symptoms varied from one day to several months after starting the drug.

BONIVA is not indicated for use in women of reproductive potential.

There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. Ibandronate is present in rat milk.

GoToSource

• Use in patients under 18 years of age. GoToSource

• Paget’s disease. GoToSource

• Elevated calcium in the blood (hypercalcemia). GoToSource

• Management of cancers that have metastasized to the bone. GoToSource

• Osteoporosis in men. GoToSource

• Pre-menopausal women. GoToSource

• Calcific uraemic arteriolopathy. GoToSource

• Osteogenesis imperfecta. GoToSource

• Spinal giant cell tumors. GoToSource

• Use to slow the progression of calcific aortic stenosis. GoToSource

• Adjuvant therapy of breast cancer. GoToSource

• Complex regional pain syndrome type I. GoToSource

• Idiopathic hyperphosphatasia. GoToSource

Atrial fibrillation (heart rhythm disorder). GoToSource

Severe bone, joint and muscle (musculoskeletal) pain. GoToSource

Osteonecrosis of the jaw. GoToSource

Esophageal cancer. GoToSource

Esophagitis, esophageal ulcers and esophageal erosions. GoToSource

Femur fractures. GoToSource

Inflammatory ocular events including scleritis (inflammation of the white part of the eye) and uveitis (inflammation inside the eye). GoToSource 

Maxillary sinusitis and oro-antral fistula. GoToSource

Macula-papular rashes and toxic epidermal necrolysis (severe drug reactions). GoToSource 

Hypocalcemia (low blood calcium level). GoToSource

Lawsuits filed for osteonecrosis of the jaw and atypical (subtrochanteric or femoral shaft) fractures.