FORTEO Teriparatide Application Scope

FORTEO is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture (to reduce the risk of vertebral and nonvertebral fractures). Men with primary or hypogonadal osteoporosis at high risk for fracture (to increase bone mass). Adult men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

FORTEO Teriparatide Characteristics

Ingredients: Teriparatide (PTH 1-34) with excipients (acetic acid, mannitol, metacresol, etc.)
Properties: Clear, colorless, isotonic solution
Packaging Specification: Pre-filled disposable pen delivering 20 mcg per dose, total content 600 mcg/2.4 mL; provides 28 doses
Storage: Store refrigerated at 2–8°C (36–46°F). Do not freeze
Expiry Date: Discard 28 days after first use, even if the pen is not empty
Executive Standard: According to the approved prescribing information in each market (e.g., US FDA labeling)
Approval Number: US FDA NDA 021318.
Date of Revision: September 2021 (FDA Prescribing Information); Patient Information revised June 2025
Manufacturer:Eli Lilly and Company

Guidelines for the Use of FORTEO Teriparatide

Dosage and Administration:
- Recommended Dose: 20 mcg once daily
- Administration: Subcutaneous injection in the thigh or abdomen. Do not administer intravenously. Use a new needle for each injection
- Missed Dose: If a dose is missed, administer it as soon as possible on the same day. Do not take more than one dose on the same day.
Adverse Reactions:
- Common Adverse Reactions: Arthralgia, pain, nausea, dizziness, headache, fatigue, depression
- Serious Adverse Reactions:
  - Osteosarcoma (observed in rats; not confirmed in humans, but risk in susceptible populations cannot be excluded).
  - Hypercalcemia and risk of calciphylaxis or calcifying uremic arteriolopathy.
  - Orthostatic hypotension (especially after initial doses).
  - Nephrolithiasis (use with caution in patients with history of kidney stones).
  - Hypersensitivity reactions including angioedema and anaphylaxis.
Contraindications: Hypersensitivity to teriparatide or to any excipients.
Precautions:
- Avoid use in patients at increased risk for osteosarcoma: Paget’s disease of bone, prior skeletal radiation therapy, bone malignancy, genetic predisposition, open epiphyses.
- Not recommended in patients with pre-existing hypercalcemia or primary hyperparathyroidism.
- Use with caution in patients with active or recent urolithiasis or hypercalciuria.
- Use with caution in severe renal impairment.
- Not recommended during pregnancy or breastfeeding.

FORTEO Interactions

Use with caution in patients receiving digoxin, as transient increases in serum calcium may predispose to digitalis toxicity.
Transient hypercalcemia may interfere with laboratory tests measuring serum calcium if blood is drawn within 4–6 hours after administration.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.