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Overview
Ibandronate (injection) is a {{{drugClass}}} that is FDA approved for the treatment of osteoporosis in postmenopausal women. Common adverse reactions include arthralgia, back pain, and abdominal pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
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.
Important Limitations of Use
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.
DOSAGE
The recommended dose of BONIVA Injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months.
Laboratory Testing and Oral Examination Prior to Administration
Prior to administration of each dose obtain a serum creatinine. Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of BONIVA Injection.
Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.
Dosing After Missed Dose
If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, BONIVA Injection should be scheduled every 3 months from the date of the last injection.
Dosage Modifications in Patients with Renal Impairment
Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute). No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min)
DOSAGE FORMS AND STRENGTHS
BONIVA Injection is supplied as a kit containing:
A 3 mg/3 mL single-use prefilled syringe.
A 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ibandronate (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibandronate (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Ibandronate (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ibandronate (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibandronate (injection) in pediatric patients.
Contraindications
Boniva is contraindicated in patients with the following conditions:
Known hypersensitivity to BONIVA Injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported.
Warnings
Hypocalcemia and Mineral Metabolism
BONIVA Injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting BONIVA Injection therapy.
Adequate intake of calcium and vitamin D is important in all patients. It is recommended that patients receive supplemental calcium and vitamin D if dietary intake is inadequate.
Anaphylactic Reaction
Cases of anaphylaxis, including fatal events, have been reported in patients treated with BONIVA Injection.
Appropriate medical support and monitoring measures should be readily available when BONIVA Injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.
Renal Impairment
Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure. Although no cases of acute renal failure were observed in controlled clinical trials in which intravenous BONIVA was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer BONIVA Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min).
Obtain serum creatinine prior to each BONIVA Injection. After BONIVA Injection, assess renal function, as clinically appropriate, in patients with concomitant diseases or taking medications that have the potential for adverse effects on the kidney. BONIVA Injection should be withheld in patients with renal deterioration.
Tissue Damage Related to Inappropriate Drug Administration
BONIVA Injection must only be administered intravenously. Care must be taken not to administer BONIVA Injection intra-arterially or paravenously as this could lead to tissue damage.
Do not administer BONIVA Injection by any other route of administration. The safety and efficacy of BONIVA Injection following non-intravenous routes of administration have not been established.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including BONIVA 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. Consider a dental examination with appropriate preventive dentistry prior to treatment with bisphosphonates in patients with a history of concomitant risk factors (e.g., cancer, chemotherapy, angiogenesis inhibitors, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy). Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to bisphosphonates.
While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible. For patients who develop 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. The clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Musculoskeletal Pain
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. Most patients had relief of symptoms after stopping the bisphosphonate. A subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Discontinue BONIVA if severe symptoms develop.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. 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. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.
Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.
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. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ibandronate (injection) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ibandronate (injection) in the drug label.
Drug Interactions
There is limited information regarding Ibandronate (injection) Drug Interactions in the drug label.
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