Forteo

teriparatide (recombinant)

Forsteo, Forteo

Pharmacologic class: Biosynthetic fragment of human parathyroid hormone

Therapeutic class: Parathyroid hormone

Pregnancy risk category C

FDA Box Warning

In male and female rats, drug increased incidence of osteosarcoma (malignant bone tumor). Because of uncertain relevance of this finding to humans, use drug only in patients for whom potential benefits outweigh potential risk. Don't administer to patient at increased baseline risk for osteosarcoma.

Action

Stimulates new bone growth by binding to specific high-affinity cell-surface receptors

Availability

Injection: Multidose prefilled delivery device (pen) with 28 daily doses of 20 mcg/dose (600 mcg/2.4 ml)

Indications and dosages

Osteoporosis in patients at high risk for bone fracture

Adults: 20 mcg/day subcutaneously for up to 2 years

Contraindications

• Hypersensitivity to drug

• Conditions that increase osteosarcoma risk (such as Paget's disease, unexplained alkaline phosphatase elevation, open epiphyses, skeletal radiation therapy)

• Bone cancer metastases or history of bone cancer

• Metabolic bone disease other than osteoporosis

• Hypercalcemia

Precautions

Use cautiously in:

• urolithiasis, hypotension

• concurrent use of cardiac glycosides

• pregnant or breastfeeding patients.

Administration

• Inject subcutaneously into thigh or abdominal wall, with patient lying down.

• Know that prefilled injection pen delivers 20 mcg of drug per actuation and may be reused for up to 28 days after first injection. Discard pen in protected container after 28 days, even if it's not empty.

Adverse reactions

CNS: dizziness, headache, insomnia, depression, vertigo, asthenia

CV: hypertension, angina, syncope

EENT: rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, dyspepsia, anorexia

Metabolic: hyperuricemia

Musculoskeletal: joint pain, cramps

Respiratory: cough, dyspnea, pneumonia

Skin: rash, sweating

Other: pain

Interactions

Drug-drug. Digoxin: increased digoxin toxicity

Drug-diagnostic tests. Calcium: increased level

Patient monitoring

• Monitor respiratory and neurologic status and assess patient's mood.

• Monitor bone mineral density tests and calcium level.

Patient teaching

• Instruct patient to promptly report such adverse reactions as cough and difficulty breathing.

• Tell patient that prefilled injection pen delivers 20 mcg of drug per actuation. Inform him that he may reuse it for up to 28 days after first injection, and should then discard it in appropriate receptacle, even if it's not empty.

• Advise patient to establish effective bedtime routine to minimize insomnia.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects strength and balance.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

teriparatide

(ter-i-par-a-tide) ,

Forteo

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: parathyroid hormones
Pregnancy Category: C

Indications

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.

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 subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Metabolized by the liver; metabolites renally excreted.
Half-life: 1 hr (after subcut use).

Time/action profile (effects on serum calcium)

ROUTEONSETPEAKDURATION
Subcut2 hr4–6 hr16–24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Paget's disease of the bone or other metabolic bone disease; Unexplained ↑ alkaline phosphatase; Pediatric: Safety and efficacy not established; Previous radiation therapy, history of bone metastases, or skeletal malignancy; Pre-existing hypercalcemia; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Active or recent urolithiasis.

Adverse Reactions/Side Effects

Cardiovascular

  • orthostatic hypotension

Musculoskeletal

  • muscle spasms

Interactions

Drug-Drug interaction

Transient hypercalcemia may ↑ the risk of digoxin toxicity.

Route/Dosage

Subcutaneous (Adults) 20 mcg once daily.

Availability

Pre-filled pen delivery device (FORTEO pen): delivers 20 mcg/day

Nursing implications

Nursing assessment

  • Assess patient for bone mineral density before and periodically during therapy.
  • Lab Test Considerations: Effects ↑ serum calcium and ↓ serum phosphorus. Maximum effect is within 4–6 hr. By 16–hr post-dose, serum calcium has returned to near baseline. If hypercalcemia persists, discontinue teriperatide and evaluate cause of hypercalcemia.
    • May asymptomatically ↑ serum uric acid concentrations.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Use of teriparatide should not continue more than 2 yr.
  • Subcutaneous: Administer subcut 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 pen can be used for up to 28 days after the first injection. After the 28-day use period, discard the Forteo pen, even if it 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 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.

Evaluation/Desired Outcomes

  • Increased bone mineral density with reduced risk of fractures.

Forteo

(fôr-tā′ō)
A trademark for the drug teriparatide.
References in periodicals archive ?
Coupled with the vast clinical experience with the marketed PTH injection (Forteo by Lilly), the Company initiated a dose-ranging, placebo-controlled, Phase 2 study in June 2019.
For the fourth quarter of 2018, worldwide revenue for Forteo was $437.1 million, a 15 percent decrease compared with the fourth quarter of 2017.
For the second quarter of 2019, worldwide Forteo revenue decreased 17 percent compared with the second quarter of 2018, to $360.8 million.
Human PTH is a known anabolic treatment currently available as a daily subcutaneous injection, Forteo with a known effect on bone formation biomarkers and bone mineral density.
The first anabolic drug to be approved by the FDA for osteoporosis, teriparatide (Forteo, Lilly), increases BMD while lowering the risk of fractures.
This includes use of teriparatide (Forteo) or abaloparatide (Tymlos) for periods of up to 2 years in patients with a history of severe or multiple fractures.
Uni-PTH, a biosimilar of Forteo (Teriparatide), which is used to treat osteoporosis has come to the last stage of China Food and Drug Administration ('CFDA') approval.
Forteo sales were up 21% in the quarter to $513.2 million.
Two of these peptide hormone medications are abaloparatide (brand name Tymlos) and teriparatide (brand name Forteo).