Taiy Chemical
Teriparatide Acetate
Synonym Teriparatide Acetate
Species Human
Protein Accession P04177
Purity Greater than 95%
Endotoxin Level Less than 0.1 EU per μg of the protein
Biological Activity The activity was measured by its ability to bind with immobilized PTH1R in a functional ELISA.
Expression System E. coli
Fusion Tag None
Predicted Molecular Mass 4224 Da
Formulation Lyophilized from a 0.2 μm filtered solution of PBS, pH 7.4
Reconstitution Reconstitute in water to a concentration of 0.1-1.0 mg/ml
Storage & Stability Store lyophilized protein at -20°C to -70°C. Store reconstituted protein at 2-8°C for one week or in aliquots at -20°C to -70°C for long-term storage.
FAQ
What is Teriparatide Acetate, and how does it work in the body?\n\nTeriparatide Acetate is a synthetic form of parathyroid hormone used in the treatment of certain types of osteoporosis. Osteoporosis is a condition characterized by weakened bones, which increases the risk of fractures. It primarily affects postmenopausal women, men with hormonal imbalances, and individuals on glucocorticoid therapy. Teriparatide Acetate works by mimicking the activity of the natural human parathyroid hormone. This hormone plays a critical role in calcium and phosphate metabolism in bones and kidneys. In healthy physiology, parathyroid hormone regulates calcium levels in the blood, influences the absorption and utilization of calcium, and affects bone remodeling. When administered as a medication, Teriparatide Acetate stimulates osteoblasts—cells responsible for new bone formation. It promotes bone growth by encouraging the laying down of bone matrix and enhancing the absorption of calcium. Unlike many other osteoporosis treatments that primarily inhibit bone resorption (the breakdown of bone by cells called osteoclasts), Teriparatide Acetate's ability to promote new bone growth makes it unique. This dual action results in an increase in bone mineral density (BMD), which is a crucial factor in reducing the risk of fractures. By increasing bone strength and density, Teriparatide Acetate effectively reduces the likelihood of fractures, particularly in the spine and hip areas which are often the most susceptible in osteoporotic patients. In some clinical studies, patients who took Teriparatide Acetate were seen to have up to a 65% decrease in vertebral fractures and a nearly 53% decrease in non-vertebral fractures. This significant reduction highlights the drug's effectiveness and its potential to improve the quality of life in individuals with severe osteoporosis. It is important to note, however, that Teriparatide Acetate is typically prescribed for individuals at high risk for fractures and is generally recommended for use over a limited duration, often up to two years, as extended use carries potential risks that need to be thoroughly assessed by healthcare providers.\n\nWho can benefit the most from using Teriparatide Acetate?\n\nTeriparatide Acetate is principally beneficial for individuals who have been diagnosed with osteoporosis and are at a high risk of fractures. This medication is particularly useful for postmenopausal women, as they are among the largest demographic with increased osteoporosis risk due to the significant drop in estrogen levels after menopause. Estrogen is a hormone that helps to maintain bone density, and its reduction accelerates bone loss, making women more susceptible to osteoporosis. Similarly, men suffering from osteoporosis due to primary or hypogonadal osteoporosis—conditions characterized by low bone density linked to hormonal imbalances—can also benefit significantly from systemic treatment with Teriparatide Acetate. Another group who may gain from this medication are individuals with osteoporosis induced by long-term glucocorticoid therapy. Glucocorticoids, or steroid drugs, are often prescribed to reduce inflammation in chronic illnesses such as rheumatoid arthritis or asthma. However, their prolonged use can lead to decreased bone mass and an increase in fracture risk. Teriparatide Acetate can play a vital role in counteracting this side effect by promoting new bone formation and improving bone strength. Those who have not responded well to other osteoporosis treatments or are unable to take other medications due to contraindications can also consider Teriparatide Acetate a viable option. Furthermore, patients who have already experienced osteoporotic fractures can significantly benefit from Teriparatide Acetate to prevent further fractures and deteriorations in bone health. The drug's ability to both build new bone and improve bone architecture makes it particularly well-suited to individuals with severe, established osteoporosis where the risk of breaking bones is exceedingly high. This dual-action is crucial where the enhancement of bone strength is needed swiftly to prevent further injury. For patients who have already sustained fractures, this drug offers a chance to rebuild bone density and mitigate further risks. However, it's crucial for potential candidates to consult their healthcare provider to discuss their specific condition, risk factors, and the suitability of Teriparatide Acetate as part of their osteoporosis management plan.\n\nAre there any side effects associated with taking Teriparatide Acetate?\n\nLike any medication, Teriparatide Acetate is associated with potential side effects, though not everyone will experience them. It’s crucial for patients and healthcare providers to weigh the benefits of treatment against any potential risks. The most common side effects observed with Teriparatide Acetate use include nausea, leg cramps, dizziness, and injection site reactions such as pain, redness, bruising, or swelling. These side effects are generally mild and may resolve as the body adjusts to the medication. However, some users might experience more systemic effects such as headache, increased sweating, or a feeling of weakness or fatigue. A more concerning but rare side effect is the potential for causing excessively high levels of calcium in the blood, a condition known as hypercalcemia. Symptoms of hypercalcemia may include confusion, muscle weakness, or abdominal pain. If any of these occur, the patient should seek medical consultation promptly, as adjustments to their treatment might be necessary. Teriparatide Acetate has also been associated with orthostatic hypotension—the sudden drop in blood pressure when standing up from sitting or lying down—which can lead to dizziness or lightheadedness. It is advisable for patients to rise slowly from sitting or lying positions to minimize this risk. In animal studies, particularly studies involving rats, there has been a noted incidence of an increase in bone tumors, specifically osteosarcoma, with long-term use of Teriparatide Acetate. While these results have not been directly observed in humans, it is a significant consideration for healthcare providers when prescribing the medication, and it is why the drug is generally not used for more than two years consecutively. Patients with certain pre-existing conditions like Paget’s disease, unexplained elevations of alkaline phosphatase, or a history of bone cancer or radiation therapy involving bones should not use Teriparatide Acetate. Understanding these side effects is critical, and it is important that individuals taking the medication communicate any new or persistent symptoms to their healthcare provider for appropriate management, ensuring the ongoing suitability of the treatment.\n\nHow long should a patient use Teriparatide Acetate?\n\nThe duration of treatment with Teriparatide Acetate is generally capped at a maximum of two years over a patient's lifetime. This limitation is guided by both the results of clinical efficacy trials and safety concerns drawn from extended biological studies. Unlike other osteoporosis treatments that might be taken indefinitely, Teriparatide Acetate builds new bone significantly over a relatively short period. Most of the benefits of Teriparatide Acetate in increasing bone mineral density and reducing fracture risk are accrued during this two-year period. After two years, alternative osteoporosis treatments, such as bisphosphonates, are often considered to help maintain the gains achieved with Teriparatide Acetate. These subsequent treatments can continue the prevention of bone resorption, thereby maintaining the density improvements gained from the bone-forming phase offered by Teriparatide Acetate. Importantly, the finite duration of use is also influenced by safety considerations. In preclinical studies, particularly those using rodent models, longer durations of high-dose Teriparatide Acetate raised concerns regarding the risk of developing osteosarcoma, a type of bone cancer. Although this has never been proven in humans, healthcare providers monitor these possibilities closely and continually weigh the benefits against potential risks. Thus, to mitigate any potential long-term risks, the two-year limit is generally adhered to. It's crucial for patients to maintain regular follow-ups with their healthcare provider to reassess bone health, evaluate treatment efficacy, and decide on the best subsequent therapy post-Teriparatide Acetate treatment. Every Osteoporosis management plan is personalized, factoring in the patient's bone density response, overall health, and risk factors throughout the course of treatment. For some patients, the therapeutic strategy may shift to other osteoporosis medications, lifestyle changes, dietary adjustments, or a combination of these to ensure optimal management of bone health. Additionally, during and after treatment with Teriparatide Acetate, patients are often recommended to maintain an adequate intake of calcium and vitamin D in their diets to support overall skeletal health and maximize the treatment benefits.\n\nWhat precautions should patients take while using Teriparatide Acetate?\n\nPatients prescribed Teriparatide Acetate should adhere to several precautions to ensure safety and maximize the treatment’s efficacy. Firstly, it’s essential to follow dosing instructions carefully, typically involving subcutaneous injections once daily into the thigh or abdominal area. Proper administration technique helps to avoid complications and ensures that the medication is absorbed correctly. Prior to beginning treatment, patients should inform their healthcare provider of their full medical history, particularly any bone disorders other than osteoporosis, such as Paget’s disease, a history of bone cancers, or metabolic bone conditions such as renal osteodystrophy. These conditions could potentially contraindicate Teriparatide Acetate use. Owing to the potential risk of hypercalcemia, patients should regularly monitor their blood calcium levels, especially if they experience symptoms such as confusion, nausea, vomiting, or frequent urination, which might indicate elevated calcium levels. During treatment, maintaining hydration is important, as it can help mitigate potential side effects such as dizziness or hypotension when changing positions. This is particularly relevant because Teriparatide Acetate can, in some patients, cause a drop in blood pressure. Patients should rise slowly from sitting or lying positions to prevent dizziness or falls. Although there is no specific diet required while on Teriparatide Acetate, maintaining a diet sufficient in calcium and Vitamin D is advisable, as these nutrients are essential for bone health and will complement the action of the medication. Any supplements should, however, be taken under the advice of a healthcare provider to avoid excessive intake. Given that Teriparatide Acetate is associated with potential tumor risks seen in animal studies and theoretical risks in humans, ongoing monitoring by healthcare professionals is critical. Patients should have regular consultations to evaluate their response to treatment, bone density improvements, and adjust therapy as necessary. Finally, an important precaution involves ensuring that injection sites are rotated daily to prevent local irritation and help distribute the drug's absorption consistently. Properly disposing of needles and syringes is also crucial for safety and hygiene, and patients should use a sharps container for disposal. Adherence to these precautions can help ensure that the benefits of Teriparatide Acetate are realized while minimizing any potential risks or side effects associated with treatment.\n\nCan Teriparatide Acetate be used in conjunction with other osteoporosis treatments?\n\nTeriparatide Acetate can be a part of a comprehensive osteoporosis treatment regimen, but its simultaneous use with other osteoporosis medications requires careful consideration and professional medical supervision. There is a variety of classes of drugs used to manage osteoporosis, including bisphosphonates, denosumab, selective estrogen receptor modulators (SERMs), and hormone replacement therapies among others, each with its own mechanisms of action aimed primarily at reducing bone resorption or promoting bone formation. Teriparatide Acetate stands out as one of the few treatments that actively promote bone formation. However, concurrent use of Teriparatide Acetate with antiresorptive agents (those that reduce bone turnover, like bisphosphonates) is not usually recommended. This is because the primary mechanism of action of antiresorptive agents is to slow down bone degradation, which might counteract or alter the bone formation efficacy stimulated by Teriparatide Acetate. Clinical studies have yet to demonstrate a clear advantage in combining these therapies, and it could potentially lead to adverse effects or mitigate the desired bone-building properties of Teriparatide Acetate. That said, Teriparatide Acetate is often sequenced with other osteoporosis treatments to maintain bone density gains. After completing a cycle of Teriparatide Acetate (generally two years), transitioning to antiresorptive therapies like bisphosphonates is common practice to sustain the bone mass improvements achieved during Teriparatide Acetate therapy. This strategy can be particularly important for maximizing long-term bone health benefits and minimizing fracture risks after the patient’s bone density has been built with Teriparatide Acetate. In certain specific cases, Teriparatide Acetate might be prescribed along with calcium and vitamin D supplements to ensure adequacy and enhance bone health, but, again, these should be managed under healthcare supervision to avoid complications such as hypercalcemia. It's essential for patients and healthcare providers to customize osteoporosis management plans based on the individual’s health status, response to medication, and specific risk factors. Decision-making regarding the combination or sequential use of osteoporosis treatments should always be driven by careful clinical assessment and the ongoing monitoring of bone health markers. Always consulting with a healthcare provider will ensure the most effective and safe use of Teriparatide Acetate as part of an osteoporosis treatment plan.\n\nIs Teriparatide Acetate safe for long-term use?\n\nTeriparatide Acetate is generally not recommended for long-term use due to safety and efficacy considerations that have been determined through extensive clinical and preclinical studies. The standard duration of treatment with Teriparatide Acetate is capped at two years over a patient’s lifetime. The two-year treatment duration is not only due to significant gains in bone mineral density and fracture risk reduction during that period, but also due to safety concerns that have emerged from long-term studies. Prolonged use beyond two years has not been extensively studied in humans, raising questions about the safety and potential risks that might occur with extended therapy. The major concern regarding long-term use of Teriparatide Acetate comes from preclinical animal studies, where rats subjected to high doses over extended periods developed osteosarcoma, a type of bone cancer. While these findings have not been observed in humans receiving therapeutic doses, such outcomes have informed guidelines and precautions in clinical practice to limit usage duration. Healthcare providers adhere to these guidelines to mitigate any theoretical risks while optimizing patient outcomes. After completing the two-year course of Teriparatide Acetate, patients often transition to other osteoporosis treatments that maintain bone density, such as bisphosphonates. This complementary approach allows for continued management of osteoporosis and helps to preserve the bone health gains achieved with Teriparatide Acetate. While research and clinical debate continue, the consensus currently remains that the two-year limit provides a balance between maximizing therapeutic benefits and minimizing potential risks. Additionally, within this two-year period, rigorous monitoring and assessment are crucial to ensure that the treatment is both effective and safe. Regular follow-up appointments with healthcare providers, comprehensive assessments of bone density, and the evaluation of any emerging symptoms are essential components of responsible Teriparatide Acetate treatment. Patients should always consult with their healthcare providers for personalized medical advice and to discuss any concerns about treatment duration, benefits, and potential risks. This collaborative approach ensures a tailored and effective strategy for managing osteoporosis in the safest way possible.\n
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