Reclast
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures [see Clinical Studies (14.1)].
Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)].
Reclast is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [see Clinical Studies (14.4)].
Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)].
The safety and effectiveness of Reclast for the treatment of osteoporosis is based on clinical data of three years 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.
History
There is currently no drug history available for this drug.
Other Information
Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2 • H2O and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the Reclast solution for infusion is approximately 6.0 – 7.0.
Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.
Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP.
Sources
Reclast Manufacturers
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Novartis Pharmaceuticals Corporation
![Reclast (Zoledronic Acid) Injection, Solution [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Reclast | Novartis Pharmaceuticals Corporation
2.1 Important Administration InstructionsReclast injection must be administered as an intravenous infusion over no less than 15 minutes.
Patients must be appropriately hydrated prior to administration of Reclast [see Warnings and Precautions (5.3)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line. Administration of acetaminophen following Reclast administration may reduce the incidence of acute-phase reaction symptoms. 2.2 Treatment of Osteoporosis in Postmenopausal WomenThe recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
2.3 Prevention of Osteoporosis in Postmenopausal WomenThe recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes.
2.4 Osteoporosis in MenThe recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
2.5 Treatment and Prevention of Glucocorticoid-Induced OsteoporosisThe recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
2.6 Treatment of Paget’s Disease of BoneThe recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.
Re-treatment of Paget’s Disease
After a single treatment with Reclast in Paget’s disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Reclast may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.
2.7 Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose of Reclast, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Reclast dose. Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of Reclast administered intravenously is recommended for patients with creatinine clearance greater than or equal to 35 mL/min. There are no safety or efficacy data to support the adjustment of the Reclast dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than or equal to 35 mL/min [see Contraindications (4), Warnings and Precautions (5.3)]. A routine oral examination should be performed by the prescriber prior to initiation of Reclast treatment [see Warnings and Precautions (5.4)]. 2.8 Calcium and Vitamin D Supplementation Instruct patients being treated for Paget’s disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following Reclast administration [see Warnings and Precautions (5.2)]. Instruct patients being treated for osteoporosis to take supplemental calcium and vitamin D if their dietary intake is inadequate. An average of at least 1200 mg calcium and 800-1000 international units vitamin D daily is recommended. 2.9 Method of AdministrationThe Reclast infusion time must not be less than 15 minutes given over a constant infusion rate.
The i.v. infusion should be followed by a 10 mL normal saline flush of the intravenous line.
Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C–8°C (36°F - 46°F) [see How Supplied/Storage and Handling (16)].
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