Reclast

RECLAST- zoledronic acid injection, solution
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

1.1 Treatment of Osteoporosis in Postmenopausal Women

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) ].

1.2 Prevention of Osteoporosis in Postmenopausal Women

Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2) ].

1.3 Osteoporosis in Men

Reclast is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3 ) ].

1.4 Glucocorticoid-Induced Osteoporosis

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 [s ee Clinical Studies (14.4) ].

1.5 Paget’s Disease of Bone

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) ].

1.6 Important Limitations of Use

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 reevaluated 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 reevaluated periodically.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Reclast 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 Women

The 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 Women

The recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes.

2.4 Osteoporosis in Men

The 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 Osteoporosis

The 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 Bone

The 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 creatinine clearance 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 Administration

The Reclast infusion time must not be less than 15 minutes given over a constant infusion rate.

The intravenous 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 to 8°C (36°F to 46°F) [see How Supplied/Storage and Handling (16) ].

3 DOSAGE FORMS AND STRENGTHS

5 mg in a 100 mL ready to infuse solution.

4 CONTRAINDICATIONS

Reclast is contraindicated in patients with the following conditions:

  • Hypocalcemia [see Warnings and Precautions (5.2) ]
  • Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3) ].
  • Known hypersensitivity to zoledronic acid or any components of Reclast. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2) ].

5 WARNINGS AND PRECAUTIONS

5.1 Drug Products With Same Active Ingredient

Reclast contains the same active ingredient found in Zometa, used for oncology indications, and a patient being treated with Zometa should not be treated with Reclast.

5.2 Hypocalcemia and Mineral Metabolism

Preexisting hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast. Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended for these patients [see Contraindications (4) ].

Hypocalcemia following Reclast administration is a significant risk in Paget’s disease. All patients should be instructed about the symptoms of hypocalcemia and the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration (2.8), Adverse Reactions (6.1), Patient Counseling Information (17) ].

All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration (2.8), Adverse Reactions (6.1), Patient Counseling Information (17) ].

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