(ter i PAR a tide)
- Parathyroid Hormone (1-34)
- Recombinant Human Parathyroid Hormone (1-34)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Forteo: 600 mcg/2.4 mL (2.4 mL) [contains metacresol]
Brand Names: U.S.
- Parathyroid Hormone Analog
Teriparatide is a recombinant formulation of endogenous parathyroid hormone (PTH), containing a 34-amino-acid sequence which is identical to the N-terminal portion of this hormone. The pharmacologic activity of teriparatide, which is similar to the physiologic activity of PTH, includes stimulating osteoblast function, increasing gastrointestinal calcium absorption, and increasing renal tubular reabsorption of calcium. Treatment with teriparatide results in increased bone mineral density, bone mass, and strength. In postmenopausal women, teriparatide has been shown to decrease osteoporosis-related fractures.
Vd: ~0.12 L/kg
Hepatic (nonspecific proteolysis)
Urine (as metabolites)
Time to Peak
Serum: ~30 minutes
IV: 5 minutes; SubQ: ~1 hour
Special Populations: Renal Function Impairment
In patients with severe renal impairment (CrCl less than 30 mL/min), the AUC and half-life increased 73% and 77%, respectively. Maximum serum concentration was not increased.
Special Populations: Gender
Systemic exposure is approximately 20% to 30% lower in men.
Use: Labeled Indications
Glucocorticoid-induced osteoporosis: Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to prednisone 5 mg or more) at high risk for fracture.
Osteoporosis in men: To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.
Osteoporosis in postmenopausal women: Treatment of postmenopausal women with osteoporosis who are at high risk for fracture.
Hypersensitivity to teriparatide or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Preexisting hypercalcemia; severe renal impairment; metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’s disease of the bone); unexplained elevations of alkaline phosphatase; prior external beam or implant radiation therapy involving the skeleton; bone metastases or history of skeletal malignancies; pregnancy; breast-feeding mothers; pediatric patients or young adults with open epiphysis
Osteoporosis (men, postmenopausal women, glucocorticoid induced): Adults: SubQ: 20 mcg once daily; Note: Initial administration should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis.
Dosage adjustment in renal impairment: No dosage adjustment necessary. Use in severe renal impairment is contraindicated in the Canadian labeling.
Dosage adjustment in hepatic impairment: There is no dosage adjustment provided in the manufacturer’s labeling (has not been studied).
Inject subcutaneously into the thigh or abdominal wall. Administer without regard to meals or time of day. May administer dose immediately following removal from the refrigerator. Initial administration should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis. Each teriparatide delivery device can be used for up to 28 days after the first injection. Note: The 3 mL prefilled pen (Canadian availability; not available in US) must be primed prior to each dose.
Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Women and men should consume:
Calcium: 1,000 mg/day (men: 50 to 70 years) or 1,200 mg/day (women ≥51 years and men ≥71 years) (IOM, 2011; NOF [Cosman 2014])
Vitamin D: 800 to 1,000 int. units/day (men and women ≥50 years) (NOF [Cosman 2014]). Recommended Dietary Allowance (RDA): 600 int. units/day (men and women ≤70 years) or 800 int. units/day (men and women ≥71 years) (IOM, 2011).
Store refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze (discard if freezing occurs). Protect from light. Discard pen 28 days after first injection, even if it still contains some unused solution. Do not use if solution is cloudy, colored, or contains solid particles.
There are no known significant interactions.
Transiently increases serum calcium; maximal effect 4 to 6 hours postdose; generally returns to baseline ~16 hours postdose
>10%: Endocrine & metabolic: Hypercalcemia (transient increases noted 4 to 6 hours postdose [women 11%; men 6%])
1% to 10%:
Cardiovascular: Orthostatic hypotension (5%; transient), angina pectoris (3%), syncope (3%)
Central nervous system: Dizziness (8%), headache (8%), insomnia (5%), anxiety (4%), depression (4%), vertigo (4%)
Endocrine & metabolic: Hyperuricemia (3%)
Gastrointestinal: Nausea (9% to 14%), gastritis (7%), dyspepsia (5%), vomiting (3%)
Immunologic: Antibody development (3% of women in long-term treatment; hypersensitivity reactions or decreased efficacy were not associated in preclinical trials)
Infection: Herpes zoster (3%)
Neuromuscular & skeletal: Arthralgia (10%), weakness (9%), leg cramps (3%)
Respiratory: Rhinitis (10%), pharyngitis (6%), dyspnea (4% to 6%), pneumonia (3% to 6%)
<1% (Limited to important or life-threatening): Allergic reactions, anaphylaxis, angioedema, chest pain, dyspnea (acute), facial edema, hypercalcemia (>13 mg/dL), injection site reactions (bruising, pain, swelling), mouth edema, muscle spasm, osteosarcoma, urticaria
Concerns related to adverse effects:
• Orthostatic hypotension: May cause orthostatic hypotension. Transient orthostatic hypotension usually occurs within 4 hours of dosing and within the first several doses.
• Osteosarcoma: [US Boxed Warning]: In animal studies, teriparatide has been associated with an increase in osteosarcoma; risk was dependent on both dose and duration. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, prior radiation, unexplained elevation of alkaline phosphatase, prior external beam or implant radiation therapy involving the skeleton, or in patients with open epiphyses). Do not use in patients with bone metastases, a history of skeletal metastases, hyperparathyroidism, or preexisting hypercalcemia. Not for use in patients with metabolic bone disease other than osteoporosis. A voluntary patient registry has been established to collect information regarding osteosarcoma; patients are encouraged to enroll. Registry information may be obtained at www.forteoregistry.rti.org or by calling 866-382-6813.
• Renal impairment: Use in severe renal impairment is contraindicated in the Canadian labeling.
• Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Multiple-dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC, 2012).
• Appropriate use: Use of teriparatide for longer than 2 years is not recommended.
• Appropriate use: Glucocorticoid-induced osteoporosis: For use in men and women at high risk of fracture, which is defined as a history of osteoporotic fracture or multiple risk factors for fracture. May also be used in patients who have failed or are intolerant to other available osteoporosis therapy.
• Appropriate use: Osteoporosis in men: For use in men at high risk for fracture, which is defined as a history of osteoporotic fracture or multiple risk factors for fracture. May also be used in men who have failed or are intolerant to previous osteoporosis therapy.
• Appropriate use: Postmenopausal osteoporosis: For use in women at high risk for fracture, which is defined as a history of osteoporotic fracture or multiple risk factors for fracture. May also be used in women who have failed or are intolerant of previous osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide reduces the risk of vertebral and nonvertebral fractures.
Orthostatic hypotension; urinary calcium (patients with suspected active urolithiasis or preexisting hypercalciuria); bone mineral density (BMD) should be evaluated 1 to 2 years after initiating therapy and every 2 years thereafter (NOF [Cosman 2014]); annual measurements of height and weight, assessment of chronic back pain; serum calcium and 25(OH)D; consider measuring biochemical markers of bone turnover
Pregnancy Risk Factor
Adverse events were observed in animal studies; the effect on human fetal development has not been studied. Teriparatide is not indicated for use in pregnant or premenopausal women.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience arthralgia or dyspepsia. Have patient report immediately to prescriber angina, tachycardia, severe dizziness, syncope, considerable headache, blurred vision, depression, insomnia, intolerable asthenia, dyspnea, severe nausea, or considerable constipation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about teriparatide
- Other brands: Forteo