Dosage and administration

​

• The recommended dose of Osteotide is 20 µg, to be administered once daily by subcutaneous injection in the thigh or abdomen.

•  The maximum total duration of treatment with Osteotide is 2 years.

•  In addition to Osteotide, patients should receive calcium and vitamin D supplements if dietary intake is inadequate.

• Below is detailed information about how to use Osteotide.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contraindications

Osteotide is contraindicated in the following patients:

• Hypersensitivity to Teriparatide or any of the excipients of this product

• Pre-existing hypercalcemia

• Severe renal impairment

• Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget's disease of the bone)

• Unexplained elevations of alkaline phosphates

• Prior external beam or implant radiation therapy to the skeleton

• Patients with skeletal malignancies or bone metastases

 

Warnings and precautions

• The 2 years duration of treatment should not be exceeded.

• Teriparatide has not been studied in pediatric populations.

• The pediatric patients have an increased baseline risk for osteosarcoma and therefore Osteotide should not be used in pediatric patients or young adults with open epiphyses.

 

Storage and stability

• Osteotide needs to be stored under refrigeration at 2 - 8°C. However, it should not be frozen.

• Osteotide is stable for 2 years from the date of manufacture.

​

​