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Teriparatide (including biosimilars available in Canada): Drug information

Teriparatide (including biosimilars available in Canada): Drug information
(For additional information see "Teriparatide (including biosimilars available in Canada): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Forteo
Brand Names: Canada
  • Forteo;
  • TEVA-Teriparatide
Pharmacologic Category
  • Parathyroid Hormone Analog
Dosing: Adult

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.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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)

Medication Guide and/or Vaccine Information Statement (VIS)

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.

Administration: Adult

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.

Use: Labeled Indications

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.

Medication Safety Issues
Sound-alike/look-alike issues:

Forteo may be confused with Forfivo XL

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

There are no known significant interactions.

Pregnancy Considerations

Adverse events were observed in animal reproduction studies; consider discontinuing treatment once pregnancy is recognized.

Breastfeeding Considerations

It is not known if teriparatide is present in breast milk.

The manufacturer recommends avoiding use in patients who are breastfeeding.

Dietary Considerations

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).

Monitoring Parameters

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).

Mechanism of Action

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.

Pharmacokinetics

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).

Pharmacokinetics: Additional Considerations

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.

Gender: Systemic exposure is approximately 20% to 30% lower in males.

Pricing: US

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

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Forsteo (AT, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, KR, LT, LU, LV, MT, NL, NO, PL, PT, RO, RU, SE, SI, SK, TR);
  • Forteo (AE, AR, AU, BB, BH, BR, CL, CO, HK, HR, JP, KW, LB, LK, MX, MY, NZ, PE, PH, PY, QA, SA, SG, TH, TW, VE);
  • Forteo Colter (CR, DO, GT, HN, NI, PA, SV);
  • Human PTH (JP);
  • Mega PTH (TH);
  • Movymia (AT, BE, CZ, DE, DK, EE, ES, FR, HR, HU, IE, LT, LV, NL, PT, SK);
  • Osteofortil (AR);
  • Teribone (JP, KR);
  • Terrosa (AT, BE, CZ, DE, DK, EE, ES, HR, HU, LT, LV, NL, PT, SK)


For country abbreviations used in Lexicomp (show table)
  1. Body JJ, Gaich GA, Scheele WH, et al. A Randomized Double-blind Trial to Compare the Efficacy of Teriparatide [Recombinant Human Parathyroid Hormone (1-34)] With Alendronate in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2002;87(10):4528-4535. [PubMed 12364430]
  2. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2017;69(8):1521-1537. doi:10.1002/art.40137 [PubMed 28585373]
  3. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis–2020 update. Endocr Pract. 2020;26(suppl 1):1-46. doi:10.4158/GL-2020-0524SUPPL [PubMed 27643923]
  4. Centers for Disease Control and Prevention (CDC). CDC clinical reminder: insulin pens must never be used for more than one person. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed January 9, 2012.
  5. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-2381. doi:10.1007/s00198-014-2794-2 [PubMed 25182228]
  6. Eastell R, Rosen CJ, Black DM, Cheung AM, Murad MH, Shoback D. Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1595-1622. doi:10.1210/jc.2019-00221 [PubMed 30907953]
  7. Forteo (teriparatide) [prescribing information]. Indianapolis, IN: Lilly USA LLC; September 2021.
  8. Forteo (teriparatide) [product monograph]. Toronto, Ontario, Canada: Eli Lilly Canada Inc; August 2021.
  9. Geusens P, Marin F, Kendler DL, et al. Effects of teriparatide compared with risedronate on the risk of fractures in subgroups of postmenopausal women with severe osteoporosis: the VERO Trial. J Bone Miner Res. 2018;33(5):783-794. doi:10.1002/jbmr.3384 [PubMed 29329484]
  10. IOM (Institute of Medicine). Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press; 2011.
  11. Licata AA. Osteoporosis, teriparatide, and dosing of calcium and vitamin D. N Engl J Med. 2005;352(18):1930-1931. doi:10.1056/NEJM200505053521822 [PubMed 15872215]
  12. Miller PD, Hattersley G, Riis BJ, et al; ACTIVE Study Investigators. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136 [PubMed 27533157]
  13. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Postmenopausal Women With Osteoporosis. N Engl J Med. 2001;344(19):1434-1441. [PubMed 11346808]
  14. North American Menopause Society. Management of osteoporosis in postmenopausal women: the 2021 position statement of the North American Menopause Society. Menopause. 2021;28(9):973-997. doi:10.1097/GME.0000000000001831 [PubMed 34448749]
  15. Osnuvo (teriparatide) [product monograph]. Blainville, Quebec, Canada: AVIR Pharma Inc; March 2022.
  16. Reeve J. Recombinant Human Parathyroid Hormone. BMJ. 2002;324(7335):435-436. [PubMed 11859030]
  17. Rosen HN, Drezner MK. Overview of the management of osteoporosis in postmenopausal women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 4, 2021.
  18. Saag KG, Shane E, Boonen S, et al. Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis. N Engl J Med. 2007;357(20):2028-2039. [PubMed 18003959]
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