Adult Dosing
Prevention and treatment of postmenopausal osteoporosis (Reclast)
- Recommended dose: 5 mg IV qyr over no less than 15 minutes
- Max: 5 mg/dose
Osteoporosis in men (Reclast)
- Recommended dose: 5 mg IV qyr over no less than 15 minutes
- Max: 5 mg/dose
Treatment and prevention of glucocorticoid-induced osteoporosis (Reclast)
- Recommended dose: 5 mg IV qyr over no less than 15 minutes
- Max: 5 mg/dose
Note:
- Hydrate patient prior to administration
- Calcium and vitamin D supplementation recommended if inadequate dietary intake
- Postmenopausal women require 1200 mg calcium and 800-1000 IU vitamin D daily
Paget’s disease of bone (Reclast)
- Recommended dose: 5 mg IV x 1 over no less than 15 minutes
- Max: 5 mg/dose
Note:
- Administer 1500 mg PO elemental calcium daily in divided doses (750 mg bid, or 500 mg tid) and 800 IU vitamin D daily in 2 weeks following zoledronic acid administration
Hypercalcemia of malignancy (Zometa)
- Recommended dose: 4 mg IV x 1 over no less than 15 minutes
Note- Rehydrate patient before administration of therapy
Multiple myeloma and metastatic bone lesions of solid tumors (Zometa)
- Recommended dose: 4 mg IV q3-4 wks no less than 15 minutes
Note- Administer an oral calcium supplement of 500 mg PO and a multiple vitamin containing 400 IU of vitamin D daily
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl) (Multiple myeloma/metastatic bone lesions from solid tumors)
- 50-60 mL/min: 3.5mg IV
- 40-49 mL/min: 3.3mg IV
- 30-39 mL/min: 3mg IV
- <30 mL/min: Contraindicated
Renal Dose Adjustment (Based on CrCl) (Paget's disease or osteoporosis)
35 mL/min: No adjustment required- <35 mL/min: Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
- Patients treated with Zometa should not be treated with Reclast
- Pre-existing hypocalcemia and disturbances of mineral metabolism should be treated prior to initiating zoledronic acid. Monitoring of calcium and mineral levels is required for these patients
- Adequately rehydrate patients with hypercalcemia of malignancy before initiation of therapy. Use cautiously with loop diuretics and nephrotoxic drugs
- Inform patients of the symptoms of hypocalcemia and importance of supplements such as calcium and vitamin D in maintaining serum calcium levels
- When administrating therapy, dose should not exceed 5 mg and duration of infusion should be no less then 15 min. Zoledronic acid is contraindicated in patients with severe renal impairment. Monitor serum creatinine before each dose
- Therapy may cause osteonecrosis of the jaw; especially in cancer patients treated with intravenous bisphosphonates undergoing dental procedures, and few cases in patients with postmenopausal osteoporosis. Physicians should perform a routine oral examination before initiation of therapy
- Consider examination with appropriate preventive dentistry in patients with a history of concomitant risk factors such as cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy. Avoid invasive dental procedures in patients with concomitant risk factors
- Patients receiving therapy have reported atypical low-energy, or low trauma fractures of the femoral shaft. Evaluate patients with thigh or groin pain to rule out a femoral fracture
- Advise patients to avoid becoming pregnant while on zoledronic acid, and advise of the potential harm to the fetus if patient becomes pregnant while on zoledronic acid. Avoid using zoledronic acid during pregnancy.
Cautious: Use cautiously in
- Hypovolemia
- Dehydration
- Concurrent diuretics
- Concurrent nephrotoxic agents
- Mineral metabolism disturbances
- Parathyroid or thyroid surgery
- Hypoparathyroidism
- Malabsorption
- Small intestine excision
- Malignancy
- Recent CA chemotherapy
- Corticosteroid use
- Poor oral hygiene
- Invasive dental procedures
- Asthma, ASA-sensitive
Pregnancy Category:D
Breastfeeding: Safety unknown. No information is available on the use of zoledronic acid during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. However, absorption of zoledronic acid by a breastfed infant is unlikely. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 April 2011). Manufacturer advises zoledronic acid should not use in nursing woman.
US Trade Name(s)
US Availability
zoledronic acid (generic)
- INJ: 4 mg/vial
- INJ: 4 mg/5 mL
- INJ: 5 mg/100 mL
Reclast
Zometa
- INJ: 4 mg/5 mL
- INJ: 4 mg/100 mL
Canadian Trade Name(s)
- Aclasta
- Zometa Concentrate
Canadian Availability
Aclasta
Zometa Concentrate
UK Trade Name(s)
UK Availability
Aclasta
Zometa
Australian Trade Name(s)
Australian Availability
Aclasta
Zometa
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Reclast 5 MG/100ML SOLN [Plas Cont] (NOVARTIS)
100 100ml = $1140.02
300 100ml = $3289.87
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.