Ibandronate (Boniva) Injection

Ibandronate is a bisphosphonate prescribed to prevent or treat osteoporosis in women after menopause. Bone is a living tissue constantly being remodeled. Bisphosphonates specifically act on bone cells (osteoclasts) to inhibit bone resorption and turnover activity and reduce progressive bone loss and risk for fracture.

Online Resources from Manufacturer

  1. Patient Medication Guide
  2. Full Prescribing Information
  3. Financial Resources: Genentech Access to Care Foundation or call 888-587-9438

Indication and Dosing Ibandronate Injection is Indicated for

  • Treatment of osteoporosis in postmenopausal women

Dosing

  1. Intravenous ibandronate dosage is 3 mg once every 3 months. This is administered intravenously over 15-30 seconds.
  2. Calcium and Vitamin D supplements are also recommended while receiving intravenous ibandronate, and can be obtained over-the-counter as well as from food rich in these nutrients.

Contraindications

  1. Known hypersensitivity to ibandronate or excipients
  2. Uncorrected hypocalcemia
  3. Creatinine clearance <30 mL/min

Warning and Precautions

  1. Hypocalcemia: Must be corrected before initiating ibandronate. Hypocalcemia may worsen, especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D.
  2. Anaphylaxis has been reported
  3. Caution with renal impairment (do not administer in patients with creatinine clearance less than 30 mL/min)
  4. Tissue damage with inappropriate drug administration can occur
  5. Severe bone, joint and/or muscle pain may occur.
  6. Pregnancy
  7. Osteonecrosis of the jaw (ONJ) has been reported with ibandronate – monitor for symptoms.
  8. Atypical femoral fractures have been reported. Evaluate patients with thigh or groin pain for femoral fracture.

Adverse Reactions

  1. Common side effects include flu-like symptoms, heartburn, and abdominal pain, or diarrhea, headache, and bone/joint, or muscle pain. The most frequently reported adverse reactions (>5%) are arthralgia, back pain and abdominal pain. If any of these or other symptoms persist, patient should be discussing with the prescribing provider.
  2. Serious side effects should be immediately reported to the patient's provider. Concerning side effects include worsening heartburn, difficulty swallowing, chest discomfort, pain with swallowing, swollen or painful gums, loose teeth, jaw symptoms, poor healing after dental procedures, aching pain in groin, hips or thighs or unexpected broken bone in the hip or femur. Allergic reactions are uncommon. The skin could be irritated near the site of infusion.
  3. Advise patient to seek emergency care with any signs or symptoms of life threatening reactions. These may include wheezing, chest tightness, itching, and cough, swelling of face, tongue or throat.

Pre-infusion Checklist

  1. Check to ensure that a creatinine clearance has been performed within two weeks of the infusion, and that creatinine clearance is greater than 30 mL per minute.
  2. Calcium level must be within normal range.

Medication Preparation

  1. Ibandronate injection must be administered by a healthcare professional.
  2. Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F)
  3. Remove prefilled syringe of ibandronate sodium injection, 3 mg/3 mL single-use, clear glass prefilled syringe and attach provided 25-gauge, ¾ inch butterfly needle, and attach plastic tubing to barrel.
  4. 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.
  5. Administer only with the enclosed needle.

Medication Administration and Monitoring

  1. Establish intravenous access. Avoid intra-arterial or paravenous administration.
  2. Do not mix with calcium-containing solutions or other intravenously administered drugs.
  3. Administer in a 15 to 30 second IV bolus using the prefilled syringe which contains 1mg/ml (3 mg total) of ibandronate.
  4. Discard any unused portion.
  5. Prefilled syringes are for single use only.
  6. Recommend monitoring of serum creatinine, serum calcium, phosphorus and magnesium, signs and symptoms of hypocalcemia, especially in patients predisposed to hypocalcemia (severe renal impairment, thyroid/parathyroid surgery, malabsorption syndromes, hypoparathyroidism); flu-like symptoms; routine oral exam (prior to treatment); dental exam if risk factors for ONJ; monitor for signs/symptoms of hypersensitivity

Note: If a dose is missed, reschedule injection administration as soon as possible. Schedule subsequent injections every 3 months from the date of last injection

Updated January 2017 - ARHP Practice Committee

DISCLAIMER:The information contained in this biologic reference guide is offered solely for purposes of providing health care professionals with a quick and initial reference. Before prescribing or administering any drug contained in this biologic reference guide, health professionals should read the manufacturer’s complete prescribing information in order to be informed of the various clinical considerations to be taken into account. The American College of Rheumatology is providing this information as a benefit and service in furtherance of its educational mission. By providing this information, ACR is not endorsing or recommending any of the listed companies or any of their drugs or other products. The information contained in the biologic reference guides reflect the conclusions of the individual companies and not those of the ACR which specifically disclaims any responsibility or liability for the use of such information and/or for the performance of any of the drugs listed in this biologic reference guide.

© 2017 American College of Rheumatology