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.

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.

Pharmacokinetics ⬆ ⬇

Absorption: Extensively absorbed after SUBQ administration.

Distribution: Unknown.

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

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

Time/Action Profile ⬆ ⬇

(effects on serum calcium concentrations)

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

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Paget's disease of the bone or other metabolic bone disease;
Unexplained ↑ alkaline phosphatase;
Bone metastases or skeletal malignancy;
Prior external beam or implant radiation therapy involving the skeleton;
Hereditary disorders predisposing to osteosarcoma;
Hypercalcemia;
Primary hyperparathyroidism;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Active or recent urolithiasis;
Autoimmune disease, renal failure, or concurrent use of warfarin or systemic corticosteroids (↑ risk of calciphylaxis);
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: orthostatic hypotension

F and E: calciphylaxis, hypercalcemia

MS: OSTEOSARCOMA, muscle spasms

Interactions ⬆ ⬇

Drug-drug:

Transient hypercalcemia may ↑ the risk of digoxin toxicity.
Concurrent use of warfarin or systemic corticosteroids may ↑ risk of calciphylaxis.

Route/Dosage ⬆ ⬇

SC (Adults ): 20 mcg once daily.

Availability ⬆ ⬇

(Generic available)

Solution for injection (prefilled pens): 600 mcg/2.4 mL (delivers 28 daily doses of 20 mcg) (Forteo); 620 mcg/2.48 mL (delivers 28 daily doses of 20 mcg) (Bonsity)

Assessment ⬆ ⬇

Assess patient for bone mineral density before and periodically during therapy.

Lab Test Considerations:

↑serum calcium and ↓ serum phosphorus. Maximum effect is within 4–6 hr. By 16 hr postdose, serum calcium has returned to near baseline. If hypercalcemia persists, discontinue teriparatide and evaluate cause of hypercalcemia.
- May asymptomatically ↑ serum uric acid concentrations.

Implementation ⬆ ⬇

Use of teriparatide for >2 yr during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture.
SC: Administer SUBQ into thigh or abdominal wall once daily. May be administered at any time of day without regard to food. Solution should be clear and colorless. Do not use if solid particles appear or if solution is cloudy or colored. Store pen in the refrigerator; do not freeze or use if it has been frozen. Minimize time out of refrigerator; use immediately and return to refrigerator. Forteo and Bonsity pens can be used for up to 28 days after the first injection. After the 28-day use period, discard the pens, even if they still contains some unused solution.

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 reread them each time prescription is refilled. 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.
OB: Advise female patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
Emphasize the importance of follow-up tests for bone mineral density.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇