BONSITY

The pharmacokinetic parameters of teriparatide following single subcutaneous administration of BONSITY in patients with osteoporosis are shown in Table 2. Table 2. Pharmacokinetic Parameters of Teriparatide Following Administration of a Single Dose, 20 mcg, of BONSITY Mean ± S.D. n Arithmetic mean ± S.D.; T max (hour) T max = median (minimum, maximum) 0.25 (0.12, 1.08) 83 C max (pg/mL) 109.5 ± 62.8 83 AUC 0-t (pg∙hr/mL) 134.8 ± 79.7 83 AUC 0-inf (pg∙hr/mL) 149.8 ± 68.1 72 t 1/2 (hour) 0.79 ± 0.3...

14.1 Treatment of Osteoporosis in Postmenopausal Women The safety and efficacy of once-daily teriparatide, median exposure of 19 months, were examined in a double-blind, multicenter, placebo-controlled clinical study of 1637 postmenopausal women with osteoporosis. In this study 541 postmenopausal women were treated with 20 mcg teriparatide subcutaneously once daily. All women received 1000 mg of calcium and at least 400 IU of vitamin D per day. Baseline and endpoint spinal radiographs were evaluated using the semiquantitative scoring. Ninety percent of the women in the study had 1 or more radi...

Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in p...

BONSITY is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] . Patients with hypersensitivity to teriparatide or to any of its excipients ( 4 )

Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.1 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developin...

7 DRUG INTERACTIONS Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.5 , 7.1 ) 7.1 Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when BONSITY is used in patients receiving dig...