Ibandronate Sodium

IBANDRONATE SODIUM- ibandronate sodium injection, solution
Accord Healthcare Inc.

1 INDICATIONS AND USAGE

1.1 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(14)] .

1.2 Important Limitations of Use

The safety and effectiveness of Ibandronate Sodium 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.

2 DOSAGE AND ADMINISTRATION

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 [see Warnings and Precautions (5.4)] .

  • 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 (5.2)] .
  • 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.

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 [see Warnings and Precautions (5.3)] . 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. [see Warnings and Precautions (5.1)] .

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) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. 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 (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Ibandronate Sodium 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

4 CONTRAINDICATIONS

Ibandronate Sodium is contraindicated in patients with the following conditions:

5 WARNINGS AND PRECAUTIONS

5.1 Hypocalcemia and Mineral Metabolism

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

5.2 Anaphylactic Reaction

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

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.

5.3 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 Ibandronate Sodium was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer Ibandronate Sodium Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Obtain serum creatinine prior to each Ibandronate Sodium Injection. After Ibandronate Sodium 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. Ibandronate Sodium Injection should be withheld in patients with renal deterioration.

5.4 Tissue Damage Related to Inappropriate Drug Administration

Ibandronate Sodium Injection must only be administered intravenously. Care must be taken not to administer Ibandronate Sodium Injection intra-arterially or paravenously as this could lead to tissue damage.

Do not administer Ibandronate Sodium Injection by any other route of administration. The safety and efficacy of Ibandronate Sodium Injection following non-intravenous routes of administration have not been established.

5.5 Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including Ibandronate Sodium 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 [ ]. 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 [ see Adverse Reactions (6.1) ].

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