Adult Dosing

Treatment of osteoporosis in postmenopausal women

• 3 mg IV over 15-30 sec; q3 months
• Patients receiving IV ibandronate for osteoporosis must receive supplemental calcium and vitamin D regardless of dietary intake

Reduction of bone damage in bone metastases in breast cancer (Not FDA approved)

• 6 mg IV q3-4 weeks

Treatment of hypercalcemia of malignancy (Not FDA approved)

• 2-4 mg IV as a single infusion (dose dependent on severity of hypercalcemia)

Pediatric Dosing

• Safety and effectiveness in pediatric patients <18 years of age has not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Osteoporosis in postmenopausal women
• Reduction of bone damage in bone metastases in breast cancer (Not FDA approved)
• Treatment of hypercalcemia of malignancy (Not FDA approved)

Note:

• Patient on bisphosphonate therapy should periodically re-evaluate the need for continued therapy
• Consider discontinuation after 3-5 yrs of use in patients at low-risk for fracture; periodically assess risk for fracture in patients who discontinue therapy

• Hypersensitivity to any of the ingredients of the product
• Uncorrected hypocalcemia
• Renal impairment: CrCl <30 ml/min

• N/A

Renal Dose Adjustment (Based on CrCl)

• >30 mL/min: No adjustment indicated
• <30 mL/min: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Ibandronate must only be administered intravenously. It may cause a transient decrease in serum calcium values
• Prior to initiating therapy effectively treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism. Treat with supplemental calcium and vitamin D
• Therapy can be associated with renal toxicity manifested as deterioration in renal function or renal failure
• Monitor serum creatinine prior to initiating the therapy. Do not administer in patients with severe renal impairment
• Therapy may cause osteonecrosis of the jaw
• Ibandronate therapy may lead to bone, joint, or muscle pain. Suspend therapy in such conditions
• Feasible chances of increased risk for atypical subtrochanteric and diaphyseal femur fractures has been reported; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment >5 years
• Cases of hypersensitivity, anaphylaxis, including fatalities has been reported, immediately discontinue the therapy and initiate appropriate treatment
• Therapy can cause renal impairement as bisphosphonate is associated with renal toxicity, hence not recommended in severe renal impairment (CrCl <30 mL/min)

Cautions: Use cautiously in

• Renal impairment
• Invasive dental procedure

Pregnancy Category:C

Breastfeeding: Safety Unknown; is excreted in breast milk of lactating rats. Manufacturer advises caution.

• CV: Hypertension, insomnia, depression
• EENT: Uveitis, scleritis, jaw osteonecrosis
• CNS: Headache, dizziness, fatigue
• GI: Abdominal pain, dyspepsia, nausea, constipation, diarrhea, gastritis
• RESP: URI
• METABOLIC: Hypocalcemia
• GU: Acute renal failure, UTI
• MUSC: Severe musculoskeletal pain, back pain, myalgia
• MISC: Anaphylaxis, atypical femur fracture, arthralgia, influenza, influenza like symptoms, rash, extremity pain

• Biphosphonate; inhibits resorption of bone by inhibiting ostoclast activity
• Metabolism: not metabolized; CYP450: None
• Renally excreted (50-60% unchanged); minimal in feces
• Half life: 4.6-25.5 hrs

US Trade Name(s)

• Boniva

US Availability

ibandronate (generic)

• INJ: 1 mg/mL (3 mL)

Boniva

• INJ: 1 mg/mL (3 mL)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Bondronat
• Bonviva

UK Availability

Bondronat

• INJ: 1 mg/mL (2, 6 mL)

Boniva

• INJ: 1 mg/mL (3 mL)

Australian Trade Name(s)

• Bondronat

Australian Availability

Bondronat

• INJ: 1 mg/mL (6 mL)

[Outline]

Endocrine/Metabolic

Bisphosphonates

Bone Resorption Inhibitor, Hypocalcemic Agent

Pricing data from www.DrugStore.com in U.S.A.

• Boniva 3 MG/3ML SOLN [Syringe] (GENENTECH)
  3 3ml = $473.97
  9 3ml = $1340.03

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.