RECLAST

Pharmacokinetic data in patients with osteoporosis and Paget's disease of bone are not available. Distribution: Single or multiple (every 28 days) 5-minute or 15-minute infusions of 2, 4, 8, or 16 mg zoledronic acid were given to 64 patients with cancer and bone metastases. The post-infusion decline of zoledronic acid concentrations in plasma was consistent with a triphasic process showing a rapid decrease from peak concentrations at end-of-infusion to less than 1% of C max 24 hours post infusio...

14.1 Treatment of Postmenopausal Osteoporosis

Study 1The efficacy and safety of Reclast in the treatment of postmenopausal osteoporosis was demonstrated in Study 1, a randomized, double-blind, placebo-controlled, multinational study of 7736 women aged 65 to 89 years (mean age of 73) with either: a femoral neck BMD T-score less than or equal to -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score less than or equal to -2.5 with or without evidence of an existing vertebral fracture(s). Women were stratified into two groups: Stratum I: no con...

The following clinically significant adverse drug reactions are described elsewhere in the labeling:

• Drugs with Same Active Ingredient [see Warnings and Precautions ( 5.1 )]
• Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.2 )]
• Renal Impairment [see Warnings and Precautions ( 5.3 )]
• Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )]
• Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.5 )]
• Musculoskeletal Pain [see Warning...

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 reacti...

• Products Containing Same Active Ingredient: Patients receiving Zometa should not receive Reclast ( 5.1 )
• Hypocalcemia may worsen during treatment . Patients must be adequately supplemented with calcium and vitamin D ( 5.2 )
• Renal Impairment: A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration. Monitor c...

7 DRUG INTERACTIONS No in vivo drug interaction studies have been performed for Reclast. In vitro and ex vivo studies showed low affinity of zoledronic acid for the cellular components of human blood. In vitro mean zoledronic acid protein binding in human plasma ranged from 28% at 200 ng/mL to 53% at 50 ng/mL. In vivo studies showed that zoledronic acid is not metabolized, and is excreted into the...