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Ibandronate (Ibandronate Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Postmenopausal Osteoporosis

Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies].

Important Limitations of Use

The safety and effectiveness of Ibandronate Sodium Injection 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 AND ADMINISTRATION

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 [see Warnings and Precautions ].

  • 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 [see Warnings and Precautions].
  • 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 use only.

Dosage Information

The recommended dose of ibandronate sodium injection for the treatment of postmenopausal osteoporosis is 3 mg (ibandronate) 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 [see Warnings and Precautions ]. Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of ibandronate sodium injection.

Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. [see Warnings and Precautions].

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.

Dosage Modifications in Patients with Renal Impairment

Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions and Clinical Pharmacology]. No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min) [see Clinical Pharmacology].

DOSAGE FORMS AND STRENGTHS

Ibandronate Sodium Injection is supplied as a kit containing:

  • a 3 mg per 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.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ibandronate Sodium Injection is supplied in a kit as follows:

NDC Ibandronate Sodium Injection
(1 mg per mL)
Package Factor
25021-827-61 3 mg per 3 mL Single-Use Prefilled Syringe with one needle 1 kit per carton

Each syringe is supplied with a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment.

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]

Sterile, Nonpyrogenic, Preservative-free, DEHP-free.

The container closure is not made with natural rubber latex.

TERUMO and Surflo are registered trademarks of TERUMO CORPORATION.

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