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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Teriparatide
Generic Name
Teriparatide
Active Ingredient
TeriparatideCategory
Parathyroid Hormone Analog [EPC]
Variants
6
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 250 ug/mL | INJECTION | SUBCUTANEOUS | 0548-2311 |
| 250 ug/mL | INJECTION, SOLUTION | SUBCUTANEOUS | 60505-6188 |
| 250 ug/mL | INJECTION, SOLUTION | SUBCUTANEOUS |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Teriparatide, you must consult a qualified healthcare professional.
| 250 ug/mL | INJECTION, SOLUTION | SUBCUTANEOUS | 66993-495 |
| 250 ug/mL | INJECTION, SOLUTION | SUBCUTANEOUS | 66993-989 |
| 250 ug/mL | INJECTION, SOLUTION | SUBCUTANEOUS | 0093-1106 |
Detailed information about Teriparatide
Teriparatide is a recombinant human parathyroid hormone (PTH 1-34) and a potent anabolic agent used to treat osteoporosis in patients at high risk for fractures. It belongs to the parathyroid hormone analog [EPC] class and works by stimulating new bone formation through osteoblast activation.
The standard, FDA-approved dosage for teriparatide in adults is 20 mcg administered once daily. This dosage applies across all primary indications, including postmenopausal osteoporosis, male osteoporosis, and glucocorticoid-induced osteoporosis. Clinical trials have demonstrated that 20 mcg provides the optimal balance between increasing bone mineral density and minimizing the risk of side effects like hypercalcemia (high blood calcium). Increasing the dose beyond 20 mcg does not typically result in better outcomes but does increase the risk of toxicity. Your healthcare provider will likely limit the total lifetime duration of teriparatide use to 2 years, although recent guidelines suggest that in some very high-risk cases, a second course or extended use might be considered by a specialist.
Teriparatide is not approved for use in pediatric patients. Its use is strictly contraindicated in children and adolescents whose epiphyses (growth plates) have not yet closed. This is due to a theoretical increased risk of osteosarcoma (a type of bone cancer) in populations with high bone turnover, such as growing children. If a child or adolescent requires treatment for severe bone fragility, alternative therapies must be discussed with a pediatric endocrinologist.
No dosage adjustment is required for patients with mild to moderate renal impairment. However, teriparatide should be used with extreme caution in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or those on dialysis, as these patients have a higher risk of developing hypercalcemia and secondary hyperparathyroidism. Monitoring of serum calcium and phosphorus is mandatory in this population.
Teriparatide has not been specifically studied in patients with hepatic (liver) impairment. However, since the drug is cleared through non-specific proteolysis and not through hepatic enzyme metabolism, it is generally believed that no dose adjustment is necessary for patients with liver disease.
No dosage adjustments are necessary based on age alone. Clinical trials included a significant number of patients over the age of 75, and no overall differences in safety or effectiveness were observed between these patients and younger adults. However, elderly patients may be more susceptible to orthostatic hypotension (a drop in blood pressure when standing up), so caution is advised during the first few doses.
Teriparatide must be administered as a subcutaneous injection once daily. Follow these specific steps provided by healthcare professionals:
If you miss a dose of teriparatide, take it as soon as you remember on that same day. However, if you do not remember until the following day, skip the missed dose and resume your regular schedule. Do not take two doses on the same day to make up for a missed one. Frequent missed doses can reduce the effectiveness of the treatment in building bone density.
Signs of a teriparatide overdose may include delayed hypercalcemia (high calcium), which can manifest as nausea, vomiting, dizziness, and headache. Acute overdose may also cause orthostatic hypotension (fainting or lightheadedness upon standing). If an overdose is suspected, contact your healthcare provider or local poison control center immediately. In a clinical setting, treatment involves monitoring serum calcium and providing supportive care, such as hydration.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop treatment without medical guidance. Always ensure you have a sufficient supply of needles and a proper sharps disposal container.
Teriparatide is generally well-tolerated, but like all medications, it can cause side effects. The most commonly reported side effects (occurring in more than 10% of patients) include:
Teriparatide is a potent medication that significantly alters bone metabolism. It is essential that patients are screened for underlying conditions that might be exacerbated by parathyroid hormone analogs. Before starting treatment, you must inform your healthcare provider of any history of kidney stones, bone cancer, or radiation therapy. Because the medication requires daily self-injection and refrigeration, patients must be capable of managing this regimen or have a caregiver who can assist. Regular follow-up appointments are necessary to monitor bone density and blood chemistry.
As of late 2020, the FDA has removed the boxed warning regarding osteosarcoma for teriparatide. The warning was originally implemented because high doses of teriparatide caused bone tumors in laboratory rats. Extensive human data collected since 2002 has not demonstrated a similar risk in humans. However, the drug remains contraindicated in patients who are at an inherently higher baseline risk for osteosarcoma, such as those with Paget’s disease or those who have had radiation to the bones.
There are no absolute 'never-use' drug-drug contraindications for teriparatide in the same way there are for some other classes of drugs. However, it is strictly contraindicated in patients with certain medical conditions (like Paget's disease or bone cancer) rather than specific drug combinations. That said, using teriparatide with other parathyroid hormone analogs (like abaloparatide) is not recommended, as the cumulative effects on calcium and bone metabolism have not been studied and could lead to severe hypercalcemia.
There are several conditions where teriparatide must NEVER be used because the risks significantly outweigh any potential benefits:
Teriparatide is classified as FDA Pregnancy Category C (under the older system). There are no adequate and well-controlled studies of teriparatide in pregnant women. Animal studies have shown some evidence of fetal harm at very high doses. Because teriparatide affects calcium metabolism and bone development, it could theoretically interfere with the skeletal development of the fetus. Osteoporosis is rare in pregnant women, and if it occurs (e.g., pregnancy-associated osteoporosis), alternative treatments are usually sought. Teriparatide is not recommended for use during pregnancy. Women of childbearing potential should discuss effective contraception with their doctor while on this medication.
It is not known whether teriparatide is excreted in human milk. Because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants (including effects on their developing bones), a decision should be made whether to discontinue nursing or discontinue the drug. In most clinical scenarios, teriparatide is not recommended for women who are breastfeeding.
Teriparatide is a recombinant human parathyroid hormone (1-34) [rhPTH(1-34)]. It acts as an agonist at the PTH1 Receptor (PTH1R). This receptor is a G protein-coupled receptor located on osteoblasts and osteocytes. When teriparatide is administered intermittently (once daily), it triggers the following molecular events:
Common questions about Teriparatide
Teriparatide is primarily used to treat osteoporosis in postmenopausal women and men who are at a high risk for bone fractures. It is also indicated for people who have developed osteoporosis as a result of long-term steroid use (glucocorticoid-induced osteoporosis). Unlike other bone medications that prevent bone loss, teriparatide is an anabolic agent, meaning it helps the body build new, stronger bone. This makes it particularly useful for patients who have already suffered a fracture or who have failed other treatments. Your healthcare provider will determine if you meet the 'high-risk' criteria for this medication.
The most common side effects reported by patients taking teriparatide include nausea, joint pain, and leg cramps. Some people also experience dizziness or a feeling of lightheadedness shortly after the injection, which is often due to a temporary drop in blood pressure. These symptoms are generally mild and tend to go away as your body becomes accustomed to the medication. If nausea or dizziness is severe, it is important to sit or lie down and contact your healthcare provider. Most side effects occur within the first few weeks of starting the treatment.
There is no known direct drug interaction between alcohol and teriparatide. However, alcohol can increase the risk of dizziness and loss of balance, which are also potential side effects of teriparatide. Since the primary goal of taking teriparatide is to prevent falls and fractures, excessive alcohol consumption is discouraged as it can increase your risk of falling. Additionally, chronic heavy alcohol use can interfere with bone health and the effectiveness of osteoporosis treatments. It is best to discuss your alcohol consumption habits with your doctor.
Teriparatide is generally not recommended for use during pregnancy. It is classified as Category C, meaning animal studies have shown potential harm to the fetus, but there are no adequate studies in humans. Because teriparatide significantly affects calcium and bone metabolism, it could potentially interfere with the development of the baby's skeleton. Osteoporosis is rare in women of childbearing age, but if you are pregnant or planning to become pregnant, you must discuss alternative options with your healthcare provider. Breastfeeding is also typically avoided while using this medication.
Teriparatide begins working at the cellular level almost immediately after the first dose, stimulating bone-forming cells. However, measurable changes in bone mineral density (BMD) usually take several months to become apparent on a DXA scan. Most clinical studies show significant increases in bone density after 6 to 12 months of daily use. Markers of bone formation in the blood, such as P1NP, can often show that the drug is working within the first 1 to 3 months. It is essential to take the medication consistently every day to achieve these results.
You should not stop taking teriparatide without first consulting your healthcare provider. While there is no 'withdrawal' syndrome, the bone-building benefits of teriparatide begin to reverse quickly once the medication is stopped. To maintain the new bone that has been created, most doctors will prescribe an antiresorptive medication, such as a bisphosphonate or denosumab, to be started immediately after the teriparatide course is finished. Stopping the drug early or without a follow-up plan can put you at an increased risk for fractures. Always follow your doctor's specific transition plan.
If you miss a dose of teriparatide, you should take it as soon as you remember on the same day. If you do not realize you missed the dose until the next day, simply skip the missed dose and take your next scheduled dose at the usual time. Do not take two doses in one day to make up for a missed one. While a single missed dose will not significantly impact your long-term bone health, consistent daily use is required for the medication to be most effective. Try to set a reminder or link the injection to a daily habit to help you remember.
Weight gain is not a commonly reported side effect of teriparatide in clinical trials. Most patients do not experience significant changes in body weight while on this medication. If you notice rapid or unusual weight gain, it is more likely related to other factors, such as lifestyle changes, other medications (like steroids), or an underlying medical condition. However, some patients may experience mild swelling (edema), which could cause a slight change in weight. If you are concerned about weight changes, discuss them with your healthcare provider to identify the cause.
Teriparatide can be taken with many other medications, but there are some important exceptions. You should be especially cautious if you are taking digoxin, as teriparatide can increase the risk of digitalis toxicity due to changes in calcium levels. Diuretics (water pills), especially thiazides, can also interact by raising calcium levels too high. While it is often used sequentially with other osteoporosis drugs like bisphosphonates, taking them at the same time may reduce teriparatide's effectiveness. Always provide your doctor with a complete list of all prescriptions, over-the-counter drugs, and supplements you are taking.
Yes, teriparatide is available as a generic medication and also as a biosimilar in many regions. The brand name version, Forteo, was the first to be approved, but several other manufacturers now produce teriparatide injection pens that are therapeutically equivalent. Generic versions are typically more cost-effective while providing the same bone-building benefits and safety profile. When using a generic or biosimilar, ensure that you receive proper training on how to use the specific injection device provided, as the design of the pen may vary slightly between manufacturers.
Other drugs with the same active ingredient (Teriparatide)
> Warning: Stop taking Teriparatide and call your doctor immediately if you experience any of these symptoms, as they may indicate a serious reaction or toxicity.
The most significant long-term consideration for teriparatide is its effect on bone remodeling. Because it is a potent anabolic agent, there was a historical concern regarding the risk of osteosarcoma (bone cancer). While long-term surveillance data has significantly downplayed this risk in humans, the medication is still generally limited to a 2-year lifetime duration to ensure maximum safety. Additionally, stopping teriparatide without starting an antiresorptive medication (like a bisphosphonate) can lead to a rapid decline in the bone density gains achieved during treatment. Your healthcare provider will plan a 'sequencing' strategy to maintain your bone health after the teriparatide course is complete.
Note on FDA Status: For many years, teriparatide carried a boxed warning regarding the risk of osteosarcoma based on studies in rats. However, in November 2020, the FDA removed the boxed warning for teriparatide (Forteo and its generics/biosimilars). This decision was based on over 15 years of post-marketing surveillance data which did not show an increased risk of osteosarcoma in humans treated with the drug.
Despite the removal of the 'Black Box,' the following precautions remain:
Report any unusual symptoms, especially persistent bone pain or lumps, to your healthcare provider immediately.
To ensure safety and efficacy, your healthcare provider will likely order the following tests:
Teriparatide generally does not interfere with the ability to drive or operate machinery. However, because dizziness or orthostatic hypotension can occur shortly after an injection, patients should wait to see how they feel before engaging in these activities. If you experience dizziness, avoid driving or using heavy equipment until the sensation passes.
There is no direct chemical interaction between alcohol and teriparatide. However, both alcohol and teriparatide can cause dizziness and increase the risk of falls. Since the goal of teriparatide is to prevent fractures, excessive alcohol consumption should be avoided as it can impair balance and further weaken bone structure over time. Discuss your alcohol intake with your doctor to ensure it does not compromise your safety.
Teriparatide is typically used for a period of 18 to 24 months. When the treatment course is finished, the bone-building effect stops. Without follow-up therapy, the new bone created by teriparatide can be rapidly lost. Therefore, healthcare providers almost always transition patients to an antiresorptive agent (such as a bisphosphonate or denosumab) immediately after stopping teriparatide to 'lock in' the bone density gains. Do not stop taking teriparatide early without consulting your doctor, as this may limit the long-term benefits of the therapy.
> Important: Discuss all your medical conditions, especially those involving your kidneys or bones, with your healthcare provider before starting Teriparatide.
For each interaction, the mechanism is usually pharmacodynamic (how the drugs affect the body's systems like calcium regulation) rather than pharmacokinetic (how the body processes the drug). The clinical consequence is usually an increased risk of high calcium or a reduced effect on bone density. Management strategies always involve regular blood work and dose titration of the other medications (like digoxin or diuretics).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially any heart medications or other bone-related supplements.
These are conditions where the healthcare provider must perform a careful risk-benefit analysis:
Patients who have had a severe allergic reaction to abaloparatide (Tymlos) should exercise extreme caution, as both are analogs of parathyroid hormone and share structural similarities. Any history of anaphylaxis to the components of the injection (such as metacresol, which is used as a preservative) is a contraindication.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of cancer or radiation, before prescribing Teriparatide.
As emphasized throughout this guide, teriparatide is strictly contraindicated in pediatric patients. The safety and efficacy have not been established in anyone under the age of 18. The primary concern is the risk of osteosarcoma in bones that are still growing. The drug should only be used in adults with closed growth plates.
In clinical trials, approximately 75% of patients were 65 years of age or older, and 30% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, geriatric patients are at a higher risk for falls and fractures, which is the very condition teriparatide aims to treat. Elderly patients should be monitored closely for orthostatic hypotension during the initiation of therapy to prevent falls. Additionally, since elderly patients are more likely to be on multiple medications (polypharmacy), the risk of interactions with drugs like digoxin or diuretics must be carefully managed.
No studies have been performed in patients with hepatic impairment. However, since the clearance of teriparatide is not dependent on liver enzyme systems (CYP450), hepatic impairment is not expected to significantly alter the drug's levels. No dose adjustment is recommended for patients with liver disease.
> Important: Special populations, particularly the elderly and those with kidney disease, require individualized medical assessment and frequent monitoring while on Teriparatide.
The pharmacodynamic response to teriparatide is characterized by a rapid increase in markers of bone formation (like P1NP) followed by a slower and less pronounced increase in markers of bone resorption (like CTX). This creates the 'anabolic window.' The effect on serum calcium is transient; levels rise slightly, peaking at 4-6 hours post-dose, and return to baseline within 16-24 hours. Teriparatide also increases the renal reabsorption of calcium and increases the excretion of phosphate.
| Parameter | Value |
|---|---|
| Bioavailability | ~95% (Subcutaneous) |
| Protein Binding | Minimal / Not significant |
| Half-life | ~1 hour (SC), ~5 min (IV) |
| Tmax | ~0.5 hours (30 minutes) |
| Metabolism | Non-specific proteolysis (not CYP) |
| Excretion | Renal (as peptide fragments) |
Teriparatide is the first-in-class Parathyroid Hormone Analog [EPC]. It is distinct from other osteoporosis drugs like bisphosphonates (Alendronate), RANK-ligand inhibitors (Denosumab), and Sclerostin inhibitors (Romosozumab). Its closest relative is abaloparatide, which is an analog of parathyroid hormone-related protein (PTHrP).