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.
Stimulates new bone growth by binding to specific high-affinity cell-surface receptors
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
• 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
Use cautiously in:
• urolithiasis, hypotension
• concurrent use of cardiac glycosides
• pregnant or breastfeeding patients.
• 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.
CNS: dizziness, headache, insomnia, depression, vertigo, asthenia
CV: hypertension, angina, syncope
EENT: rhinitis, pharyngitis
GI: nausea, vomiting, diarrhea, dyspepsia, anorexia
Musculoskeletal: joint pain, cramps
Respiratory: cough, dyspnea, pneumonia
Skin: rash, sweating
Drug-drug. Digoxin: increased digoxin toxicity
Drug-diagnostic tests. Calcium: increased level
• Monitor respiratory and neurologic status and assess patient's mood.
• Monitor bone mineral density tests and calcium level.
• 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.
Pharmacologic: parathyroid hormones
Time/action profile (effects on serum calcium)
|Subcut||2 hr||4–6 hr||16–24 hr|
Adverse Reactions/Side Effects
- orthostatic hypotension
- muscle spasms
Drug-Drug interactionTransient hypercalcemia may ↑ the risk of digoxin toxicity.
- 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 DiagnosesRisk for injury (Indications)
- 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.
- 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.
- Increased bone mineral density with reduced risk of fractures.