CinnoPar®

Description

CinnoPar^® is a recombinant formulation of endogenous parathyroid hormone (PTH), containing a 34-amino-acid sequence which is identical to the N-terminal portion of this hormone. Each Pen of CinnoPar^® containing 600µg (250 µg /1ml) Teriparatide for subcutaneous injection, produced under EU GMP license.

Indication and Usage

CinnoPar^® is indicated for treatment of glucocorticoid-induced osteoporosis, osteoporosis in men and osteoporosis in postmenopausal women who are at high risk for fractures.

Important safety information

• CinnoPar^® is contraindicated in patients who have hypersensitivity to teriparatide or any component of the formulation.
• Orthostatic hypotension: Teriparatide may cause orthostatic hypotension. Transient orthostatic hypotension usually occurs within 4 hours of dosing and within the first several doses.
• Osteosarcoma: [US Boxed Warning]: In animal studies, teriparatide has been associated with an increase in osteosarcoma; risk was dependent on both dose and duration. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, prior radiation, unexplained elevation of alkaline phosphatase, prior external beam or implant radiation therapy involving the skeleton, or in patients with open epiphyses). Do not use in patients with bone metastases, a history of skeletal metastases, hyperparathyroidism, or preexisting hypercalcemia. Not for use in patients with metabolic bone disease other than osteoporosis.
• Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation.