Zoledronic Acid (Reclast)

ZOLEDRONIC ACID (Reclast) Zoledronic acid is a bisphosphonate prescribed to prevent or treat osteoporosis or Paget's disease. Unlike other common bisphosphonates that are taken by mouth, Reclast bypasses the stomach because it is an infusion into the bloodstream. 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

Rheumatic Indications and Dosing Zoledronic Acid is Indicated for

  1. Treatment and prevention of postmenopausal osteoporosis
  2. Treatment to increase bone mass in men with osteoporosis
  3. Treatment and prevention of glucocorticoid-induced osteoporosis
  4. Treatment of Paget's disease of bone in men and women

Dosing

  1. Intravenous zoledronic acid for treatment of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, and treatment and prevention of glucocorticoid-induced osteoporosis is 5mg per 100mL once every 12 months
  2. Intravenous zoledronic acid is given for the prevention of osteoporosis as 5mg once every 2 years.
  3. In patients with osteoporosis, the current recommended daily intake of calcium is 1200 mg in divided doses and vitamin D 800 IU to 1000 IU daily.
  4. The recommended dose is a 5 mg infusion for the treatment of Paget’s disease of bone.

Contraindications

  1. Creatinine clearance < 35 mL per minute
  2. Known hypersensitivity to zoledronic acid
  3. Hypocalcemia
  4. Acute renal impairment

Warnings and Precautions

  1. Zoledronic acid should not be prescribed if the patient is receiving Zometa® since both drugs contain zoledronic acid.
  2. Low calcium must be treated before zoledronic acid therapy is prescribed, as hypocalcemia may worsen during treatment. Adequate supplementation with calcium and Vitamin D is also necessary.
  3. Use with caution in patients with chronic renal insufficiency and patients on diuretics. Creatinine clearance should be calculated based on actual body weight before each dose. A single dose should not exceed 5 mg and duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment, advanced age or dehydration
  4. Osteonecrosis of the jaw has been reported and a dental examination should be performed in patients with other significant risk factors to include poor dental hygiene, cancer, and chemotherapy, radiotherapy, history of dental infections or hematologic problems.
  5. Bronchoconstriction in aspirin-sensitive patients has been reported with use of bisphosphonates, although no clear guidance can be provided regarding treatment in patients with asthma.
  6. Atypical femur fractures have occurred in patients receiving treatment with bisphosphonates, and those on long-term therapy are at an increased risk. Patients with thigh or groin pain with a history of receiving bisphosphonates should be evaluated to rule out a femur fracture.
  7. Zoledronic acid should not be used during pregnancy. Women of childbearing age should be advised to avoid becoming pregnant while on zoledronic acid, as it may cause fetal harm when administered to pregnant women.
  8. Severe bone, joint, and muscle pain may occur while on zoledronic acid. Future doses should be withheld if severe symptoms occur.

Adverse Reactions

  1. Common side effects may include flu-like symptoms, headache, nausea, vomiting, diarrhea, joint, bone, or muscle pain. If any of these symptoms or others persists then they should be discussed with the prescribing provider.
  2. Serious side effects should be immediately reported to your health care provider. These side effects would include:
    • Low calcium levels in your blood that can be associated with numbness, tingling or muscle spasms.
    • Kidney problems with abnormal blood tests or symptoms.
    • Jaw pain or delayed healing of teeth after dental work.
    • Severe muscle, bone or joint pain.
    • Unusual thigh-bone pain or fractures.

Pre-infusion Checklist

  1. No potential for present or future pregnancy/breastfeeding.
  2. CrCl >35 mL per minute.
  3. On calcium/ Vitamin D 1200mg/800IU daily, in divided doses.
  4. Renal panel within 2-4 weeks pre-infusion and 10-14 days post ordered.
  5. Caution should be used if patient is on a loop diuretic.
  6. Calcium levels should be closely monitored for hypocalcemia.
  7. No extensive dental procedures planned
  8. Caution should be used in patients with aspirin sensitive asthma
  9. Tylenol ordered before and after first dose to prevent acute phase reaction.
  10. Patient ordered to drink two glasses of water 2 hours before infusion.
  11. Patient has not already had Zometa within one year.
  12. Discussion with patients who may be considering conceiving in the future and/or breastfeeding should be had prior to initiating.
  13. Informed verbal consent with a teaching sheet given

Medication Preparation

  1. Zoledronic acid comes as 5mg in a 100mL ready-to-infuse solution
  2. Zoledronic acid should be stored at 25 °C and is stable for 24 hours at 2 °C-8 °C after opening.

Medication Administration

  1. Zoledronic acid should be infused intravenously over no less than 15 minutes at a constant rate.
  2. Solution should NOT come into contact with any calcium or other divalent-cation containing solutions.
  3. Flush I.V. line with 10 mL NS flush following infusion. Infuse in a line separate from other medications.
  4. Patients must be appropriately hydrated prior to treatment. Acetaminophen after administration may reduce the incidence of acute reaction (eg, arthralgia, fever, flu-like symptoms, myalgia).
  5. Monitor patient post-infusion as per the Infusion Clinic standard operating procedure and once stable remove the IV.

Additional Patient Information

  1. Adequate calcium and vitamin D supplementation is important in patients with osteoporosis. The current recommended daily intake of calcium is 1200 mg in divided doses and vitamin D 800 IU to 1000 IU daily, and all patients should be instructed on the important of maintaining serum calcium levels.
  2. Patient should eat and drink normally on the day of treatment. This includes drinking at least 2 glasses of fluid such as water within a few hours prior to the infusion.
  3. Patient should tell their doctor if they are taking any new medications, including an antibiotic, a diuretic or “water pill”, or a non-steroidal anti-inflammatory medicine (NSAIDS).
  4. Notify their dentists, surgeon, and other healthcare providers of ibandronate therapy and have regular routine dental examinations and cleanings.
  5. Undergo periodic bone density testing to assess response to therapy
  6. Adhere to routine lab monitoring (Calcium, Vitamin D, Creatinine)

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