teriparatide

REMS

Treatment of osteoporosis in postmenopausal women at high risk for fractures.
To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fractures.
Treatment of osteoporosis in men and women with glucocorticoid-induced osteoporosis at high risk for fractures.
Most useful for those have failed or are intolerant to other osteoporosis therapies.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Paget's disease of the bone or other metabolic bone disease;
Unexplained ↑ alkaline phosphatase;
Pedi: Safety and efficacy not established;
Previous radiation therapy, history of bone metastases, or skeletal malignancy;
Pre-existing hypercalcemia;
OB: Pregnancy or lactation.

Use Cautiously in:

Active or recent urolithiasis.

Adv. Reactions/Side Effects ⬆ ⬇

CV: orthostatic hypotension

MS: muscle spasms

Interactions ⬆ ⬇

Drug-drug:

Transient hypercalcemia may ↑ the risk of digoxin toxicity.

Availability ⬆ ⬇

Solution for subcutaneous injection (prefilled pens): 600 mcg/2.4 mL (delivers 28 daily doses of 20 mcg)

Route/Dosage ⬆ ⬇

SC (Adults ): 20 mcg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Regulates calcium and phosphate metabolism in bone and kidney by binding to specific cell receptors; stimulates osteoblastic activity.
Increases serum calcium and decreases serum phosphorus.

Therapeutic effects:

Increased bone mineral density with reduced risk of fractures.

Classifications ⬆ ⬇

Therapeutic Classification: hormones

Pharmacologic Classification: parathyroid hormones (rDNA origin)

Pharmacokinetics ⬆ ⬇

Absorption: Extensively absorbed after subcut administration.

Distribution: Unknown.

Metabolism/Excretion: Metabolized by the liver; metabolites renally excreted.

Half-Life: 1 hr (after subcut use).

Time/Action Profile ⬆ ⬇

(effects on serum calcium)

ROUTE	ONSET	PEAK	DURATION
Subcut	2 hr	4–6 hr	16–24 hr

Patient/Family Teaching ⬆ ⬇

Advise patient to administer medication at same time each day. Administer missed doses as soon as remembered that day. Do not take more than one injection/day.
Instruct patient on proper administration technique and disposal of needles. Patient should read Medication Guide and User Manual before starting therapy and re-read them each time prescription is refilled. User manual can be found at www.forteo.com/control/pen_user_manual. Caution patient to throw pen away after 28-day use period and not to share their pen with other patients.
Discuss the importance of other treatments for osteoporosis (supplemental calcium and/or vitamin D, weight-bearing exercise, modification of behavioral factors such as smoking and/or alcohol consumption).
May cause orthostatic hypotension during first several doses. Caution patient to administer medication in a lying or sitting position. If light-headedness or palpitations occur, lie down until symptoms resolve. Notify health care professional if symptoms persist or worsen.
Instruct patient to notify health care professional if persistent symptoms of hypercalcemia (nausea, vomiting, constipation, lethargy, muscle weakness) occur.
Emphasize the importance of follow-up tests for bone mineral density.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0002- Eli Lilly and Company
- 0002-8400- Forteo
  - 0002-8400-01- 1 SYRINGE in 1 CARTON (0002-8400-01) > 2.4 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-8400- Forteo
  - 0002-8400-99- 1 SYRINGE in 1 CARTON (0002-8400-99) > 2.4 mL in 1 SYRINGE

47781- Alvogen, Inc.
- 47781-652- teriparatide
  - 47781-652-89- 1 SYRINGE in 1 CARTON (47781-652-89) > 2.48 mL in 1 SYRINGE

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Indications ⬇