Forteo Teriparatide 250 ug/mL Injection, Solution, 1 syringe
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Parathyroid Hormone Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Palopegteriparatide is used for the treatment of hypoparathyrodism in adults. Palopegteriparatide is in a class of medications called parathyroid agents. It works by increasing the amount of parathyroid hormone to maintain appropriate calcium levels in the body.
Read the full MedlinePlus article ↗- Most osteoporosis drugs work by slowing down the cells that break bone down. Teriparatide works the opposite way — it actually stimulates your body to build new bone. It's a lab-ma...
- What exactly is teriparatide and how is it different from other osteoporosis medications?
- You'll use a prefilled pen device to inject it just under the skin — into your thigh or abdomen — once a day. Your pharmacist or nurse will walk you through the first time. For the...
- How do I give myself the injection and are there things I need to know before I start?
Patient education
Supplement & herbal interactions
Teriparatide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.41 mg / 1 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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45.4 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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3.0 mg / 1 mL
UNII GGO4Y809LO
Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
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0.1 mg / 1 mL
UNII NVG71ZZ7P0
A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1,841.000 | $4,418.40 / 2.4 ml |
| Medicaid paysCMS SDUD · 12 mo | $1,799.94 | $4,319.87 / 2.4 ml |
| Medicare drug plans payPart D · Q2 2026 | $1,842.86 | $4,422.88 / 2.4 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Teriparatide 250 ug/mL 00093-1106-16 | Teva | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| Teriparatide 250 ug/mL 00548-2311-00 | Amphastar | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| teriparatide 250 ug/mL 47781-0652-89 | Alvogen, | 1 syringe | $494.805 | — | Availability likely | save 73% |
| Bonsity 250 ug/mL 47781-0852-89 | Alvogen | 1 syringe | $494.805 | — | Availability likely | save 73% |
| Teriparatide 250 ug/mL 60505-6188-00 | Apotex | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| Teriparatide 250 ug/mL 66993-0495-28 | Prasco | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| Teriparatide 250 ug/mL 66993-0989-28 | Prasco | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| Teriparatide 250 ug/mL 68001-0693-76 | BluePoint | 1 syringe | $494.805 | AP | Availability likely | save 73% |
| Forteo 250 ug/mLthis 00002-8400-01 | Eli | 1 syringe | $1,841.000 | AP | Availability likely | — |
| Forteo 250 ug/mL 00002-9678-01 | Eli | 1 syringe | $1,841.000 | AP | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00002-8400-01 You're viewing this | 1 SYRINGE in 1 CARTON (0002-8400-01) / 2.4 mL in 1 SYRINGE | 2008-10-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE FORTEO is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. FORTEO is a parathyroid hormone analog, (PTH 1-34), indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 ) Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 ) Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage is 20 mcg subcutaneously once a day ( 2.1 ) Consider supplemental calcium and Vitamin D based on individual patient needs ( 2.1 ) Administer as a subcutaneous injection into the thigh or abdominal region ( 2.2 ) Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur ( 2.2 ) Use of FORTEO for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture ( 2.3 )
2.1Recommended Dosage The recommended dosage is 20 mcg per dose given subcutaneously once a day. Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.
2.2Administration Instructions Administer FORTEO as a subcutaneous injection into the thigh or abdominal region. FORTEO is not approved for intravenous or intramuscular use. FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions ( 5.5 )] .
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (FORTEO is a clear and colorless liquid). Do not use if solid particles appear or if the solution is cloudy or colored. Patients and/or caregivers who administer FORTEO should receive appropriate training and instruction on the proper use of the FORTEO prefilled delivery device (pen) from a qualified health professional.
Discard the delivery device 28 days after first use.
2.3Recommended Treatment Duration Use of FORTEO for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture [see Warnings and Precautions ( 5.2 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 560 mcg/2.24 mL (250 mcg/mL) clear, colorless solution in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg. Injection: 560 mcg/2.24 mL (250 mcg/mL) in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS FORTEO is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.2 )] . Patients with severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone analogs, including FORTEO. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with FORTEO, initiate supportive care, and monitor until signs and symptoms resolve. Discontinue FORTEO permanently in patients with a severe hypersensitivity reaction to FORTEO.
( 5.1 ) Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.2 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification.
( 5.3 ) Risk of Urolithiasis : Consider the risk/benefit in patients with active or recent urolithiasis because of risk of exacerbation ( 5.4 ) Orthostatic Hypotension : Transient orthostatic hypotension may occur with initial doses of FORTEO ( 5.5 )
5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported in patients treated with parathyroid hormone (PTH) analogs, including FORTEO [ see Adverse Reactions ( 6.2 ) ]. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with FORTEO, initiate appropriate supportive care, and monitor until signs and symptoms resolve. Discontinue FORTEO permanently in patients with a severe hypersensitivity reaction to FORTEO.
FORTEO is contraindicated in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO [ see Contraindications ( 4 ) ].
5.2Osteosarcoma An increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide. Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.2 ), and Nonclinical Toxicology ( 13.1 )] .
Avoid FORTEO use in patients with (these patients are at increased baseline risk of osteosarcoma): Open epiphyses (pediatric and young adult patients) (FORTEO is not approved in pediatric patients) [see Use in Specific Populations ( 8.4 )] . Metabolic bone diseases other than osteoporosis, including Paget's disease of the bone. Bone metastases or a history of skeletal malignancies.
Prior external beam or implant radiation therapy involving the skeleton. Hereditary disorders predisposing to osteosarcoma.
5.3Hypercalcemia and Cutaneous Calcification Hypercalcemia FORTEO has not been studied in patients with pre-existing hypercalcemia. FORTEO may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia [see Adverse Reactions ( 6.1 , 6.2 )] . Avoid FORTEO in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.
Risk of Cutaneous Calcification Including Calciphylaxis Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying auto-immune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue FORTEO in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.
5.4Risk of Urolithiasis In clinical trials, the frequency of urolithiasis was similar in patients treated wi…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] Osteosarcoma [ see Warnings and Precautions ( 5.2 ) ] Hypercalcemia and Cutaneous Calcification [ see Warnings and Precautions ( 5.3 ) ] Risk of Urolithiasis [ see Warnings and Precautions ( 5.4 ) ] Orthostatic Hypotension [ see Warnings and Precautions ( 5.5 ) ] Risk of Digoxin Toxicity [ see Warnings and Precautions ( 5.6 ) ] Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Men with Primary or Hypogonadal Osteoporosis and Postmenopausal Women with Osteoporosis The safety of FORTEO in the treatment of osteoporosis in men and postmenopausal women was assessed in two randomized, double-blind, placebo-controlled trials of 1382 patients (21% men, 79% women) aged 28 to 86 years (mean 67 years) [see Clinical Studies ( 14.1 , 14.2 )] .
The median durations of the trials were 11 months for men and 19 months for women, with 691 patients exposed to FORTEO and 691 patients to placebo. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day. The incidence of all-cause mortality was 1% in the FORTEO group and 1% in the placebo group.
The incidence of serious adverse events was 16% in the FORTEO group and 19% in the placebo group. Early discontinuation due to adverse events occurred in 7% in the FORTEO group and 6% in the placebo group. Table 1 lists adverse events from these two trials that occurred in ≥2% of FORTEO-treated and more frequently than placebo-treated patients.
Table 1: Percentage of Patients with Adverse Events Reported by at Least 2% of FORTEO-Treated Patients and in More FORTEO-Treated Patients than Placebo-Treated Patients from the Two Principal Osteoporosis Trials in Women and Men Adverse Events are Shown Without Attribution of Causality FORTEO N=691 Placebo N=691 Event Classification (%) (%) Body as a Whole Pain 21.3
20.5Headache 7.5
7.4Asthenia 8.7
6.8Neck pain 3.0
2.7Cardiovascular Hypertension 7.1
6.8Angina pectoris 2.5
1.6Syncope 2.6
1.4Digestive System Nausea 8.5
6.7Constipation 5.4
4.5Diarrhea 5.1
4.6Dyspepsia 5.2
4.1Vomiting 3.0
2.3Gastrointestinal disorder 2.3
2.0Tooth disorder 2.0
1.3Musculoskeletal Arthralgia 10.1
8.4Leg cramps 2.6
1.3Nervous System Dizziness 8.0
5.4Depression 4.1
2.7Insomnia 4.3
3.6Vertigo 3.8
2.7Respiratory System Rhinitis 9.6
8.8Cough increased 6.4
5.5Pharyngitis 5.5
4.8Dyspnea 3.6
2.6Pneumonia 3.9
3.3Skin and Appendages Rash 4.9
4.5Sweating 2.2
1.7Laboratory Findings Serum Calcium — FORTEO transiently increased serum calcium, with the maximal effect observed at approximately 4 to 6 hours post-dose. Serum calcium measured at least 16 hours post-dose was not different from pretreatment levels. In clinical trials, the frequency of at least 1 episode of transient hypercalcemia in the 4 to 6 hours after FORTEO administration was 11% of women and 6% of men treated with FORTEO compared to 2% of women and 0% of the men treated with placebo.
The percentage of patients treated with FORTEO whose transient hypercalcemia was verified on consecutive measurements was 3% of women and 1% of men. Urinary Calcium — FORTEO increased urinary calcium excretion, but the frequency of hypercalciuria in clinical trials was similar for patients treated with FORTEO and placebo [see Clinical Pharmacology ( 12.2 )] . Serum Uric Acid — FORTEO increased serum uric acid concentrations.
In clinical…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Digoxin: Transient hypercalcemia may predispose patients to digitalis toxicity ( 5.6 , 7.1 )
7.1Digoxin Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. FORTEO may transiently increase serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin [see Warnings and Precaution ( 5.6 ) and Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Consider discontinuing when pregnancy is recognized ( 8.1 ) Lactation: Breastfeeding is not recommended ( 8.2 ) Pediatric Use: Safety and effectiveness not established. Avoid use due to increased baseline risk of osteosarcoma ( 5.2 , 8.4 )
8.1Pregnancy Risk Summary There are no available data on FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing FORTEO when pregnancy is recognized. In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m 2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m 2 ).
At subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. In a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose.
Mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.
8.2Lactation Risk Summary It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Avoid FORTEO use in women who are breastfeeding.
8.4Pediatric Use The safety and effectiveness of FORTEO have not been established in pediatric patients. Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see Warnings and Precautions ( 5.2 )] .
8.5Geriatric Use Of the patients who received FORTEO in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. Of the patients who received FORTEO in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. Of the 214 patients who received FORTEO in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older.
No overall differences in safety or effectiveness of FORTEO have been observed between patients 65 years of age and older and younger adult patients.
8.6Hepatic Impairment No studies have been performed in patients with hepatic impairment [see Clinical Pharmacology ( 12.3 )] .
8.7Renal Impairment In 5 patients with severe renal impairment (CrCl<30 mL/minute), the AUC and T 1/2 of teriparatide were increased by 73% and 77%, respectively. Maximum serum concentration of teriparatide was not increased. It is unknown whether FORTEO alters the underlying metabolic bone disease seen in chronic renal impairment [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing FORTEO when pregnancy is recognized. In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m 2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m 2 ).
At subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. In a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose.
Mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of FORTEO have not been established in pediatric patients. Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see Warnings and Precautions ( 5.2 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the patients who received FORTEO in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. Of the patients who received FORTEO in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. Of the 214 patients who received FORTEO in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older.
No overall differences in safety or effectiveness of FORTEO have been observed between patients 65 years of age and older and younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the FORTEO prefilled delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported.
Additional signs, symptoms, and complications of FORTEO overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache. Overdose Management — There is no specific antidote for a FORTEO overdosage. Treatment of suspected overdosage should include discontinuation of FORTEO, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors.
Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure.
Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength.
By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.
12.2Pharmacodynamics Pharmacodynamics in Men with Primary or Hypogonadal Osteoporosis and Postmenopausal Women with Osteoporosis Effects on Mineral Metabolism — Teriparatide affects calcium and phosphorus metabolism in a pattern consistent with the known actions of endogenous PTH (e.g., increases serum calcium and decreases serum phosphorus). Serum Calcium Concentrations — When teriparatide 20 mcg was administered once daily, the serum calcium concentration increased transiently, beginning approximately 2 hours after dosing and reaching a maximum concentration between 4 and 6 hours (median increase, 0.4 mg/dL).
The serum calcium concentration began to decline approximately 6 hours after dosing and returned to baseline by 16 to 24 hours after each dose. In a clinical study of postmenopausal women with osteoporosis, the median peak serum calcium concentration measured 4 to 6 hours after dosing with FORTEO (20 mcg subcutaneous once daily) was 9.68 mg/dL at 12 months. The peak serum calcium remained below 11 mg/dL in >99% of women at each visit.
Sustained hypercalcemia was not observed. In this study, 11.1% of women treated with FORTEO had at least 1 serum calcium value above the upper limit of normal (ULN) (10.6 mg/dL) compared with 1.5% of women treated with placebo. The percentage of women treated with FORTEO whose serum calcium was above the ULN on consecutive 4- to 6-hour post-dose measurements was 3% compared with 0.2% of women treated with placebo.
In these women, calcium supplements and/or FORTEO doses were reduced. The timing of these dose reductions was at the discretion of the investigator. FORTEO dose adjustments were made at varying intervals after the first observation of increased serum calcium (median 21 weeks).
During these intervals, there was no evidence of progressive increases in serum calcium. In a clinical study of men with either primary or hypogonadal osteoporosis, the effects on serum calcium were similar to those observed in postmenopausal women. The median peak serum calcium concentration measured 4 to 6 hours after dosing with FORTEO was 9.44 mg/dL at 12 months.
The peak serum calcium remained below 11 mg/dL in 98% of men at each visit. Sustained hypercalcemia was not observed. In this study, 6% of men treated with FORTEO daily had at least 1 serum calcium value above the ULN (10.6 mg/dL) compared with none of the men treated with placebo.
The percentage of men treated with FORTEO wh…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors.
Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Teriparatide is not expected to accumulate in bone or other tissues. The skeletal effects of teriparatide depend upon the pattern of systemic exposure.
Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, teriparatide improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of teriparatide manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength.
By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied FORTEO (teriparatide injection) is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size: 560 mcg/2.24 mL (250 mcg/mL) [intended to deliver 28 daily doses of 20 mcg] NDC 0002-9678-01 (MS8400).
16.2Storage and Handling Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. When using FORTEO, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator.
Do not freeze. Do not use FORTEO if it has been frozen. Throw away the device 28 days after first use.
16.1How Supplied FORTEO (teriparatide injection) is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size: 560 mcg/2.24 mL (250 mcg/mL) [intended to deliver 28 daily doses of 20 mcg] NDC 0002-9678-01 (MS8400).
📦 Storage and Handling ▾
16.2Storage and Handling Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. When using FORTEO, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator.
Do not freeze. Do not use FORTEO if it has been frozen. Throw away the device 28 days after first use.
📋 Description ▾
11 DESCRIPTION FORTEO (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C 181 H 291 N 55 O 51 S 2 and molecular weight is 4117.8 daltons.
Its amino acid sequence is shown below: Teriparatide is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. FORTEO is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with volume to allow delivery of 2.24 mL.
Each mL contains 250 mcg of teriparatide (as a free base), 0.41 mg of glacial acetic acid, 0.1 mg of sodium acetate (anhydrous), 45.4 mg of mannitol, 3 mg of Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 4. Each prefilled delivery device (pen) delivers 20 mcg of teriparatide per dose for up to 28 days.
Each device contains additional volume to allow troubleshooting of the device 2 times. Teriparatide Amino Acid Sequence
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide and the User Manual) before starting FORTEO and each time the prescription is renewed. Failure to follow the instructions may result in inaccurate dosing. Hypersensitivity Reactions Advise patients that serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, can occur with FORTEO.
Advise patients to discontinue FORTEO and promptly seek medical attention if signs or symptoms of hypersensitivity reactions occur [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. Osteosarcoma Patients should be made aware that in rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor). Although cases of osteosarcoma have been reported in patients using FORTEO no increased risk of osteosarcoma was observed in adult humans treated with FORTEO [see Warnings and Precautions ( 5.2 )] .
Hypercalcemia Instruct patients taking FORTEO to contact a health care provider if they develop persistent symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, muscle weakness) [see Warnings and Precautions ( 5.3 )] . Orthostatic Hypotension When initiating FORTEO treatment, instruct patients to be prepared to immediately sit or lie down during or after administration in case they feel lightheaded or have palpitations after the injection. Instruct patients to sit or lie down until the symptoms resolve.
If symptoms persist or worsen, instruct patients to consult a healthcare provider before continuing treatment [see Warnings and Precautions ( 5.5 )] . Other Osteoporosis Treatment Modalities Patients should be informed regarding the roles of supplemental calcium and/or vitamin D. Use of the Prefilled Delivery Device (Pen) Instruct patients and caregivers who administer FORTEO on how to properly use the delivery device (refer to User Manual) , to properly dispose of needles, and not to share their prefilled delivery device with other patients.
Instruct patients and caregivers who administer FORTEO that the contents of the delivery device should not be transferred to a syringe. Inform patients that each FORTEO delivery device can be used up to 28 days after first use. After the 28-day use period, instruct patients to discard the FORTEO delivery device, even if it still contains some unused solution.
Instruct patients not to use FORTEO after the expiration date printed on the delivery device and packaging. Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA www.forteo.com Pat.: www.lilly.com/patents Copyright © 2002, 2026, Eli Lilly and Company. All rights reserved.
FOR-0007-USPI-20260803
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2026 MEDICATION GUIDE FORTEO ® (for-TAY-o) teriparatide injection for subcutaneous use Read this Medication Guide before you start using FORTEO and each time you get a refill.
There may be new information. Also, read the User Manual that comes with the FORTEO delivery device (pen) for information on how to use the device to inject your medicine the right way. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about FORTEO? FORTEO may cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis. Stop using FORTEO and get medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, lips, mouth, or tongue breathing problems fainting, dizziness, feeling lightheaded (low blood pressure) fast heartbeat itching rash hives Possible bone cancer.
During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that FORTEO increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using FORTEO beyond 2 years.
What is FORTEO? FORTEO is a prescription medicine used to: treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis. increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.
It is not known if FORTEO is safe and effective in children. FORTEO should not be used in children and young adults whose bones are still growing. Who should not use FORTEO?
Do not use FORTEO if you: have had a severe allergic reaction to teriparatide or any of the ingredients in FORTEO. Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of the ingredients in FORTEO.
What should I tell my healthcare provider before using FORTEO? Before you use FORTEO, tell your healthcare provider about all of your medical conditions, including if you: have a certain bone disease called Paget's disease or other bone disease. have bone cancer or have had a history of bone cancer. are a young adult whose bones are still growing. have had radiation therapy. are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones. have or have had too much calcium in your blood (hypercalcemia). have or have had a skin condition with painful sores or wounds caused by too much calcium. have or have had kidney stones. take medicines that contain digoxin. are pregnant or plan to become pregnant.
It is not known if FORTEO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if FORTEO passes into your breastmilk. You should not breastfeed while taking FORTEO.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use FORTEO? Read the detailed Instructions for Use (User Manual) included with your FORTEO delivery device. Use FORTEO exactly as your healthcare provider tells you to.
Your healthcare provider wi…