Ibandronicdosage

3 mg every 3 months administered intravenously over a period of 15 to 30 seconds Dosing Instructions: Only administer intravenously by a health care professional. Do not mix with calcium-containing solutions or other intravenously administered drugs. Do not administer more frequently than once every 3 months. Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate.

2.1 Important

Administration Instructions Ibandronate sodium Injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage. Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment. Visually inspect the liquid in the prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration. Administer only with the enclosed needle. Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Prefilled syringes are for single-dose only.

2.2 Dosage Information

The recommended dose of ibandronate sodium 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.

2.3 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 ibandronate sodium injection.

2.4 Calcium and

Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate..

2.5 Dosing After

Missed Dose If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, ibandronate sodium injection should be scheduled every 3 months from the date of the last injection.

2.6 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).