HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BONSITY safely and effectively. See full prescribing information for BONSITY. BONSITY (teriparatide injection), for subcutaneous use Initial U.S. Approval: 1987 WARNING: POTENTIAL RISK OF OSTEOSARCOMASee full prescribing information for complete boxed warning.�In rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor. (5.1, 13.1) �Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe BONSITY only for patients for whom potential benefits outweigh potential risk. (5.1) �BONSITY should not be prescribed for patients at increased baseline risk for osteosarcoma (e.g., those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton). (5.1) ---------------------------INDICATIONS ANDUSAGE-------------------------�BONSITY is a parathyroid hormone analog (PTH 1- 34) indicated for: �Treatment of postmenopausal women with osteoporosis at high risk for fracture (1.1) �Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture (1.2) �Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture (1.3) -----------------------DOSAGE ANDADMINISTRATION---------------------��Recommended dose is 20 mcg subcutaneously once a day (2.1, 2.2, 2.3) �Administer as a subcutaneous injection into the thigh or abdominal wall (2.4) �Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur (2.4) �Use of the drug for more than 2 years during a patient's lifetime is not recommended (2.5) ---------------------DOSAGE FORMS AND STRENGTHS--------------------�Injection: 620 mcg/2.48 mL (250 mcg/mL) in single-patient-use pen containing 28 daily doses of 20 mcg (3) -----------------------------CONTRAINDICATIONS-----------------------------��Patients with hypersensitivity to teriparatide or to any of its excipients (4) ----------------------WARNINGS AND PRECAUTIONS-----------------------��Patients with Paget's disease of bone, pediatric and young adult patients with open epiphyses, and patients with prior external beam or implant radiation involving the skeleton: Should not be treated with BONSITY (5.1, 8.4) �Treatment duration: Use of BONSITY for more than 2 years during a patient's lifetime is not recommended (5.2) �Patients with bone metastases, history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders: Should not be treated with BONSITY (5.3, 5.4, 5.5) �Laboratory alterations: BONSITY may increase serum calcium, urinary calcium, and serum uric acid (5.5, 5.6) �Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation (5.6) �Orthostatic hypotension: Transient orthostatic hypotension may occur with initial doses of BONSITY (5.7) -----------------------------ADVERSE REACTIONS------------------------------�Most common adverse reactions (>10%) include: arthralgia, pain, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfenex, Inc., at 1- 833-266-7489 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch -----------------------------DRUG INTERACTIONS-------------------------------Digoxin: Use BONSITY with caution in patients receiving digoxin. Transient hypercalcemia may predispose patients to digitalis toxicity (5.8, 7.1, 12.2) -----------------------USE IN SPECIFICPOPULATIONS----------------------��Pregnancy: Consider discontinuing when pregnancy is recognized (8.1) �Lactation: Breastfeeding is not recommended (8.2) �Pediatric Use: BONSITY should not be used in pediatric and young adult patients with open epiphyses due to increased baseline risk of osteosarcoma (5.1, 8.4) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 10 /201
