Note: Assess serum calcium prior to initiation; avoid use in patients with preexisting hypercalcemia or hypercalcemic disorder. Correct vitamin D deficiency (eg, to a 25-hydroxyvitamin D level ≥20 ng/mL [≥50 nmol/L]) prior to initiating therapy and ensure adequate calcium and vitamin D intake during therapy; however, use caution to avoid hypercalcemia (ES [Eastell 2019]; Licata 2005; NAMS 2021; Rosen 2021; manufacturer’s labeling).
Osteoporosis, glucocorticoid induced (alternative agent): Note: Alternative agent if bisphosphonate therapy is not appropriate. Avoid use in women who are pregnant, who plan on becoming pregnant, or who are not using effective birth control (ACR [Buckley 2017]).
SUBQ: 20 mcg once daily.
Osteoporosis, fracture risk reduction (males and postmenopausal females):
Note: For use as initial therapy in patients with very high fracture risk, including those with a T-score less than –3, a T-score less than –2.5 with fragility fracture history, or severe or multiple prior vertebral fractures. May also be used as an alternative agent in patients with high fracture risk in whom first-line therapies are ineffective or cannot be used (AACE/ACE [Camacho 2020]; ES [Eastell 2019]). Prior to use, evaluate and treat any potential causes of secondary osteoporosis (eg, severe vitamin D deficiency) (NOF [Cosman 2014]).
SUBQ: 20 mcg once daily.
Duration of therapy: Duration of teriparatide therapy should generally not exceed 2 years due to limited data with use beyond this; fracture reduction efficacy has been demonstrated over a period of 18 to 24 months (Geusens 2018; Neer 2001; manufacturer’s labeling).
Discontinuation/interruption of therapy: Following a course of teriparatide, switch to antiresorptive therapy (eg, with a bisphosphonate or denosumab) to maintain bone density gains (ES [Eastell 2019]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Forteo: 600 mcg/2.4 mL (2.4 mL) [contains metacresol]
Generic: 620 mcg/2.48 mL (2.48 mL)
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Forteo: 750 mcg/3 mL (3 mL) [contains metacresol]
Generic: 600 mcg/2.4 mL (2.4 mL)
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf#page=16, must be dispensed with this medication.
SUBQ: Initial administration should occur under circumstances in which the patient may sit or lie down, in the event of orthostasis.
Inject into the thigh or abdominal wall. Administer without regard to meals or time of day. May administer dose immediately following removal from the refrigerator. Each teriparatide delivery device can be used for up to 28 days after the first injection. Note: The 3 mL prefilled pen [Canadian product] must be primed prior to each dose.
Osteoporosis: Treatment of osteoporosis in postmenopausal females who are at high risk for fracture (defined as history of osteoporotic fracture or multiple risk factors for fracture); treatment to increase bone mass in males with primary or hypogonadal osteoporosis who are high risk for fracture; treatment of males and females with glucocorticoid-induced osteoporosis associated with chronic systemic glucocorticoids with a prednisone dosage of ≥5 mg/day (or equivalent) at a high risk for fracture. May also be used in patients who have failed or are intolerant to other available osteoporosis therapy.
Limitations of use: Cumulative lifetime duration of teriparatide beyond 2 years should only be considered if a patient remains at or has returned to having a high risk of fracture.
Note: In Canada, Osnuvo is approved as a biosimilar to Forteo.
Forteo may be confused with Forfivo XL
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Endocrine & metabolic: Hypercalcemia (females: 11%; males: 6%; transient increases noted 4 to 6 hours postdose)
Gastrointestinal: Nausea (9% to 14%)
1% to 10%:
Cardiovascular: Angina pectoris (3%), orthostatic hypotension (5%; transient), syncope (3%)
Endocrine & metabolic: Hyperuricemia (3%)
Gastrointestinal: Dyspepsia (5%), gastritis (7%), 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%)
Nervous system: Anxiety (4%), depression (4%), dizziness (8%), headache (8%), insomnia (5%), vertigo (4%)
Neuromuscular & skeletal: Arthralgia (10%), asthenia (9%), lower limb cramp (3%)
Respiratory: Dyspnea (4% to 6%; including acute dyspnea), pharyngitis (6%), pneumonia (3% to 6%), rhinitis (10%)
Postmarketing:
Cardiovascular: Chest pain, facial edema
Dermatologic: Cutaneous calcification (including calciphylaxis and exacerbation of cutaneous calcification), urticaria
Endocrine & metabolic: Hypercalcemia (>13 mg/dL)
Hematologic & oncologic: Osteosarcoma
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, mouth edema
Local: Injection site reaction (including bruising at injection site, pain at injection site, swelling at injection site)
Neuromuscular & skeletal: Muscle spasm
Hypersensitivity (eg, anaphylaxis, angioedema) 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 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; breastfeeding; pediatric patients or young adults with open epiphysis.
Concerns related to adverse effects:
• Cutaneous calcification: Serious worsening of previous stable cutaneous calcification or calciphylaxis has been reported; discontinue use if occurs. Patients with underlying autoimmune disease, kidney failure, or concomitantly taking warfarin or systemic corticosteroids are at increased risk.
• Orthostatic hypotension: May cause orthostatic hypotension. Transient orthostatic hypotension usually occurs within 4 hours of dosing and within the first several doses; usually resolved without treatment within a few minutes to a few hours.
• Osteosarcoma: In animal studies, teriparatide has been associated with an increase in osteosarcoma. Human cases have been reported in postmarketing; increased risk has not been seen in observational studies. Avoid use in patients with an increased risk of osteosarcoma (including Paget disease, bone metastases or a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, hereditary disorders predisposing to osteosarcoma, or in patients with open epiphyses).
Disease-related concerns:
• Hypercalcemia: Use with caution in patients with hypercalcemia (not studied); may increase or exacerbate hypercalcemia. Avoid use in patients with known or history of hypercalcemia disorder (eg, primary hyperparathyroidism).
• Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation.
Dosage form specific issues:
• Multiple-dose injection pens: According to the Centers for Disease Control and Prevention, 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).
None known.
There are no known significant interactions.
Adverse events were observed in animal reproduction studies; consider discontinuing treatment once pregnancy is recognized.
It is not known if teriparatide is present in breast milk.
The manufacturer recommends avoiding use in patients who are breastfeeding.
Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Patients should consume:
Calcium: 1,000 mg/day (males: 50 to 70 years of age) or 1,200 mg/day (females ≥51 years of age and males ≥71 years of age) (IOM 2011; NOF [Cosman 2014]). Some clinicians have suggested limiting calcium to ≤1,000 mg/day in patients taking teriparatide (Licata 2005).
Vitamin D: 800 to 1,000 units/day (age ≥50 years) (NOF [Cosman 2014]). Recommended Dietary Allowance (RDA): 600 units/day (age ≤70 years) or 800 units/day (age ≥71 years) (IOM 2011).
Orthostatic hypotension; serum calcium (draw at least 16 hours after teriparatide dose); urinary calcium (patients with suspected active urolithiasis or preexisting hypercalciuria).
Bone mineral density (BMD) should be evaluated at baseline and ~1 to 2 years following initiation of therapy) (AACE/ACE [Camacho 2020]; ES [Eastell 2019]; NOF [Cosman 2014]); may consider monitoring biochemical markers of bone turnover (eg, serum P1NP) at baseline, 3 months, and 6 months to assess treatment response (ES [Eastell 2019]; Miller 2016).
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 females, teriparatide has been shown to decrease osteoporosis-related fractures.
Distribution: Vd: ~0.12 L/kg.
Metabolism: Hepatic (nonspecific proteolysis).
Bioavailability: ~95%.
Half-life elimination: IV: 5 minutes; SubQ: ~1 hour.
Time to peak, serum: ~30 minutes.
Excretion: Urine (as metabolites).
Altered kidney function: 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.
Sex: Systemic exposure is approximately 20% to 30% lower in males.
Solution Pen-injector (Forteo Subcutaneous)
600 mcg/2.4 mL (per mL): $1,983.30
Solution Pen-injector (Teriparatide (Recombinant) Subcutaneous)
620MCG/2.48ML (per mL): $1,197.58
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