Product Information
TPT 20 (Teriparatide Injection I.P.) is a sterile, clear, colorless solution intended for subcutaneous administration. Each pre-filled syringe delivers 600 mcg of Teriparatide, a bioactive fragment of human parathyroid hormone, which plays a crucial role in calcium and phosphate metabolism.
Teriparatide functions as an anabolic (bone-building) agent by stimulating osteoblast activity, leading to increased bone formation. Clinical studies have demonstrated its efficacy in enhancing bone mineral density and reducing the incidence of vertebral and non-vertebral fractures in individuals with osteoporosis.
Indications
TPT 20 is indicated for:
- Treatment of Osteoporosis in Postmenopausal Women: To increase bone mass and reduce the risk of fractures.
- Treatment of Primary or Hypogonadal Osteoporosis in Men: To increase bone mass in men at high risk for fracture.
- Glucocorticoid-Induced Osteoporosis: For men and women at high risk for fracture receiving systemic glucocorticoid therapy.
Composition
Each pre-filled syringe contains:
- Active Ingredient: Teriparatide (rDNA origin) 600 mcg in 2.4 mL solution (250 mcg/mL).
- Excipients: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injection.
Dosage and Administration
- Recommended Dose: 20 mcg administered once daily via subcutaneous injection into the thigh or abdominal wall.
- Treatment Duration: The cumulative use of Teriparatide for more than 2 years during a patient’s lifetime is not recommended.
- Administration: Patients should be trained on proper injection techniques. Inspect the solution visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particles.
Precautions
- Hypercalcemia: Monitor serum calcium levels; use with caution in patients with pre-existing hypercalcemia.
- Urolithiasis: Use cautiously in patients with active or recent urolithiasis due to the potential for exacerbation.
- Orthostatic Hypotension: Transient orthostatic hypotension may occur; advise patients to sit or lie down if symptoms occur after injection.
- Osteosarcoma Risk: Avoid use in patients with increased baseline risk for osteosarcoma, including those with Paget’s disease, unexplained elevations of alkaline phosphatase, or prior radiation therapy involving the skeleton.
- Hypersensitivity Reactions: Contraindicated in patients with known hypersensitivity to Teriparatide or any component of the formulation.
- Pregnancy and Lactation: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when administered to nursing mothers.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Do not freeze.
- Protect from light; keep the pre-filled syringe in the original carton until use.
- After the first use, discard the pre-filled syringe after 28 days, even if it still contains some unused solution.
Note
- Monitoring: Regular monitoring of serum calcium levels is recommended, especially during the initial phase of therapy.
- Adverse Reactions: Common side effects include nausea, joint pain, dizziness, and injection site reactions. Serious adverse reactions may include hypercalcemia and orthostatic hypotension.