API

TERIPARATIDE

Drug classification

Hormones (parathyroid hormone analog).

Dosage form

SOLUTION;SUBCUTANEOUS

API strength per dosage

0.75MG/3ML (0.25MG/ML)

Dose

The recommended dose of teriparatide (Forteo) for adults is 20 micrograms administered subcutaneously once daily. Pediatric use is not recommended. For patients with severe renal impairment, consider potential risks and benefits, as safety and efficacy in this group have not been established.

Mechanism of action

Teriparatide, a recombinant form of parathyroid hormone (PTH), binds to the PTH1 receptor on osteoblasts, stimulating bone formation by increasing osteoblastic activity and calcium absorption, and decreasing osteoblastic apoptosis, leading to increased bone mineral density and strength.

Indications

Osteoporosis in postmenopausal women at high risk for fracture, increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis.

Side effects

Nausea, dizziness, leg cramps, injection site pain, orthostatic hypotension, increased serum calcium, osteosarcoma risk (in animal studies), headache, joint pain, increased uric acid levels.

Pregnancy category

Category C

Precautions

Monitor serum calcium levels, risk of osteosarcoma, avoid in patients with bone metastases or skeletal malignancies, contraindicated in Paget's disease, caution in severe renal impairment, not recommended for more than 2 years of treatment, potential orthostatic hypotension, caution in patients with urolithiasis or pre-existing hypercalcemia.

Contraindications

Hypersensitivity to teriparatide or its components, pre-existing hypercalcemia, severe renal impairment, metabolic bone diseases other than osteoporosis, skeletal malignancies, bone metastases, prior radiation therapy involving the skeleton.