Source: FDA, National Drug Code (US) Revision Year: 2020
FORTEO (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.
The molecular formula of teriparatide is C181H291N55O51S2 and molecular weight is 4117.8 daltons.
Its amino acid sequence is shown below:
Teriparatide is manufactured using a strain of Escherichia coli modified by recombinant DNA technology.
FORTEO is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg of teriparatide (as a free base), 0.41 mg of glacial acetic acid, 0.1 mg of sodium acetate (anhydrous), 45.4 mg of mannitol, 3 mg of Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 4.
Each prefilled delivery device (pen) delivers 20 mcg of teriparatide per dose for up to 28 days.
| Dosage Forms and Strengths |
|---|
|
Injection: 620 mcg/2.48 mL (250 mcg/mL) clear, colorless solution in a single-patient-use prefilled delivery device (pen) containing 28 daily doses of 20 mcg. |
| How Supplied |
|---|
|
FORTEO (teriparatide injection) is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size:
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA, www.forteo.com |
| Drug | Countries | |
|---|---|---|
| FORTEO | Australia, Brazil, Canada, Hong Kong, Israel, Japan, New Zealand, Singapore, United States, South Africa |
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