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Prolia vs Tymlos
Introduction
For patients with osteoporosis or other bone-weakening conditions, certain drugs that help in maintaining bone density and reducing the risk of fractures can be a vital part of their treatment. Prolia and Tymlos are two such medications prescribed for these conditions. They each have different mechanisms but both contribute to the improvement of skeletal health in patients with bone disease. Prolia is a monoclonal antibody which works by binding to RANKL, a protein essential for the formation, function and survival of osteoclasts - cells responsible for breaking down bones. By inhibiting RANKL, it reduces bone resorption thus increasing bone density. Tymlos on the other hand is a parathyroid hormone related protein analog which stimulates new bone formation by increasing osteoblastic activity – cells responsible for forming new bones.
Prolia vs Tymlos Side By Side
| Attribute | Prolia | Tymlos |
|---|---|---|
| Brand Name | Prolia | Tymlos |
| Contraindications | Should not be taken if receiving chemotherapy or radiation therapy due to increased risk of osteonecrosis of the jaw (ONJ). | Not recommended for patients with a history of hypercalcemia or other metabolic bone diseases. |
| Cost | $1,300 for one injection (60 mg/1 ml), approximately $7/day | $3,900 for a package containing two pens (80 mcg/40 doses each), about $65/day |
| Generic Name | Denosumab | Abaloparatide |
| Most Serious Side Effect | Osteonecrosis of the jaw, severe allergic reactions, hypocalcemia | Dizziness or lightheadedness indicating a drop in blood pressure, severe nausea and vomiting, rapid heartbeat or palpitations |
| Severe Drug Interactions | Not specified in the article, but it's important to avoid any medication that could exacerbate low calcium levels or interact with denosumab's mechanism of action. | Not specified in the article, but caution is advised with drugs affecting electrolyte balance or those that could interact with abaloparatide's mechanism. |
| Typical Dose | 60mg injection every six months | 80 mcg subcutaneously once daily |
What is Prolia?
Denosumab (the generic name for Prolia) was the first drug of its class known as RANK Ligand inhibitors, which marked a significant advancement in osteoporosis treatment. Denosumab was first approved by the FDA in 2010. Prolia works by binding to and inhibiting RANK ligand, a protein essential for the formation, function and survival of osteoclasts – cells that break down bone – thereby increasing bone strength and density. It is prescribed for treating postmenopausal women with osteoporosis who are at high risk of fractures.
Abaloparatide (the generic name for Tymlos), on the other hand, belongs to a different class called parathyroid hormone-related protein analogs. Approved by the FDA in 2017, it functions differently than Prolia: it stimulates new bone growth rather than just slowing resorption or breakdown of existing bones.
Both medications have their usage based on individual patient's needs yet tend to have relatively fewer side effects compared to other classes such as bisphosphonates used in this condition.
What conditions is Prolia approved to treat?
Prolia is approved for the treatment of different forms of bone loss:
- Postmenopausal osteoporosis (in women at high risk for fracture)
- Bone loss in men with prostate cancer receiving androgen deprivation therapy
- Bone loss in women undergoing breast cancer adjuvant aromatase inhibitor therapy
On the other hand, Tymlos is approved specifically to treat postmenopausal women with osteoporosis at a high risk for fracture. Its use offers increased bone mass and reduced incidents of vertebral and nonvertebral fractures.
How does Prolia help with these illnesses?
Prolia works to manage osteoporosis by decreasing the action of cells that break down bone, called osteoclasts. It does this via a substance known as RANK ligand, which typically stimulates the formation and activity of osteoclasts. By blocking RANK ligand, Prolia lessens the breakdown of bones and thus allows for an increase in bone mass and strength over time.
Bone is a living tissue that constantly undergoes remodeling with old bone being broken down by osteoclasts and new bone formed by cells called osteoblasts. In individuals with osteoporosis, there is an imbalance in this process leading to more bone loss than gain resulting in weaker bones susceptible to fracture.
Therefore, by inhibiting the activities of osteoclasts, Prolia can help limit the negative effects of excessive bone loss seen in patients with conditions like postmenopausal women at high risk for fracture or patients who have failed or are intolerant to other available therapy for osteoporosis. This helps these individuals manage their condition better thereby improving their quality of life.
What is Tymlos?
Tymlos, the brand name for abaloparatide, is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP) approved by the FDA in 2017. It works to stimulate bone formation and increase bone mass and strength. This differs from Prolia's mechanism of action which inhibits osteoclasts, the cells responsible for bone resorption.
The specific focus on promoting new bone growth gives Tymlos an advantage in treating severe cases of osteoporosis where significant loss of bone density has already occurred. Its side effect profile is also different from that of drugs like Prolia - while common side effects include nausea and dizziness, it doesn't carry as high a risk for conditions such as atypical fractures or jaw necrosis associated with long-term use of some other osteoporosis medications. However, because Tymlos is relatively new compared to established treatments like Prolia, more research may be needed to fully understand its long-term effects.
What conditions is Tymlos approved to treat?
Tymlos is an FDA-approved medication that has been specifically designed for the treatment of:
- Postmenopausal women with osteoporosis at high risk for fracture, defined as history of osteoporotic fracture, or multiple risk factors for fracture.
- Increase in bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture.
How does Tymlos help with these illnesses?
Tymlos, like Prolia, is a medication used to treat osteoporosis but works in a distinct way. It's an anabolic agent that stimulates the production of new bone by activating the parathyroid hormone receptor, which leads to increased bone mass and improved bone strength. This action can significantly reduce the risk of fractures - making it especially beneficial for postmenopausal women at high risk or those who have failed other therapies. While both Tymlos and Prolia are effective treatments for osteoporosis, Tymlos operates in a more proactive manner compared to Prolia's function as a RANK ligand inhibitor that slows down the rate of existing bone breakdown. Therefore, Tymlos might be preferable if the goal is not only to prevent further loss but actively build new bone.
How effective are both Prolia and Tymlos?
Both denosumab (Prolia) and abaloparatide (Tymlos) have been recognized as effective treatments for osteoporosis, with their FDA approvals being only 7 years apart. Each drug has a distinct mechanism of action: while Prolia is a human monoclonal antibody that inhibits the development and activity of osteoclasts, Tymlos is a parathyroid hormone related protein analog which stimulates new bone formation.
The effectiveness of Prolia and Tymlos in treating postmenopausal women with osteoporosis at high risk for fracture was directly studied in separate randomized clinical trials. They both demonstrated significant reductions in vertebral, non-vertebral, and hip fractures compared to placebo. However, it's important to note that these two drugs haven't been directly compared against each other in clinical trials.
A 2010 review reported on the efficacy of Prolia starting from six months after treatment initiation; its side effect profile includes hypocalcemia, serious infections requiring hospitalization including endocarditis and cellulitis or skin rash. The same study highlighted that Prolia has become one of the most widely used drugs worldwide amongst those suffering from osteoporosis due to its biannual dosing regimen making it more convenient than daily medications.
A 2016 review indicated that Tymlos appears more effective than placebo in reducing fractures among post-menopausal women with osteoporosis; however data confirming its long-term safety remains limited given its recent approval by the FDA. As such it may be considered as an alternative option for patients who cannot use antiresorptive agents due to contraindications or intolerance but do need rapid increases in bone mass.
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At what dose is Prolia typically prescribed?
The dosage for Prolia is one 60mg injection every six months. It's given under the skin in your upper arm, upper thigh, or abdomen by a healthcare provider. On the other hand, Tymlos is administered daily. The recommended dose of Tymlos is 80 micrograms subcutaneously once daily. In both cases, proper calcium and vitamin D intake should be maintained throughout treatment to prevent hypocalcemia. Dosage adjustments are not typically needed but may be considered based on individual patient response or side effects. Always consult with a healthcare professional before making any changes to medication dosages.
At what dose is Tymlos typically prescribed?
Tymlos therapy usually begins with a dosage of 80 mcg administered once daily via subcutaneous injection in the thigh or abdomen, typically at any time that falls within convenience for the patient. The dose is not increased but remains consistent throughout treatment duration. It's important to note that Tymlos should be used for up to only two years due to its anabolic effect on bone formation and remodeling. Furthermore, after two years of Tymlos treatment, osteoporosis therapy should continue with an antiresorptive drug like bisphosphonates as per individual therapeutic response and medical advice.
What are the most common side effects for Prolia?
When comparing Prolia to Tymlos, some of the common side effects include:
- Fatigue (general weakness and tiredness)
- Back pain
- Hypocalcemia (low levels of calcium in your blood)
- Dyspnea (shortness of breath)
- Nausea
- Headache
- Diarrhea
- Pain in extremities (pain in arms or legs) for Prolia.
On the other hand, for Tymlos, you may experience:
- Hypercalciuria (high levels of calcium in urine)
- Dizziness
- Nausea
- Headache
- Palpitations
- Fatigue
- Upper abdominal pain
- Vertigo.
It's important to note that not everyone who takes these medications will experience all or any of these side effects; they are simply possibilities based on past reports from patients.
Are there any potential serious side effects for Prolia?
When comparing Prolia to Tymlos, it's important to note that while both medications are used for osteoporosis treatment, they may have different side effects.
For Prolia, severe potential side effects include:
- Signs of a serious allergic reaction such as difficulty breathing or swallowing; swelling of the face, lips, tongue or throat; rash, itching or hives on the skin.
- Hypocalcemia (low levels of calcium in your blood), symptoms can include spasms, twitches or cramps in your muscles; numbness and tingling in fingers and toes
- Skin problems such as dryness , peeling , redness , cracking blisters rashes etc.
- Bone loss in the jaw (Osteonecrosis), which could involve jaw pain, swollen gums and loosening teeth.
For Tymlos patients might experience:
- Dizziness and fast heartbeat: A person might feel light-headed or faint when they get up too quickly from a lying position.
- Increased amount of calcium in your blood: Symptoms such as nausea , vomiting , constipation etc
- Hypercalciuria (too much calcium in urine)
It is always recommended to discuss with healthcare providers before starting any medication.
What are the most common side effects for Tymlos?
When considering Tymlos, some side effects you might encounter include:
- Increased heart rate
- Nausea or vomiting
- Fatigue and dizziness
- Headache
- Abdominal pain
- Vertigo (sensation of spinning)
- Orthostatic hypotension (drop in blood pressure upon standing up) The medication can also cause an increase in urine output. On rare occasions, it may induce a skin rash or itchiness. If you are taking Tymlos for bone health, be aware that joint pain could be experienced too.
Are there any potential serious side effects for Tymlos?
While Tymlos is generally considered safe, it can cause adverse effects in some individuals. These may be signs of a serious reaction to the medication:
- An allergic response such as hives, itching, difficulty breathing or swallowing, swelling of your face or throat
- Dizziness or lightheadedness (which could indicate a drop in blood pressure)
- Severe nausea and vomiting
- Rapid heartbeat or palpitations
- Unusually high levels of calcium in the bloodstream. Symptoms might include frequent urination, constipation, confusion or memory problems.
If you notice any of these symptoms after starting Tymlos treatment, seek medical attention promptly.
Contraindications for Prolia and Tymlos?
Both Prolia and Tymlos, like most osteoporosis medications, may cause certain side effects. If you notice any unusual bone pain or experience a fracture after starting these treatments, please seek immediate medical attention.
Prolia should not be taken if you are receiving chemotherapy or radiation therapy as it can increase the risk of developing osteonecrosis of the jaw (ONJ). Similarly, Tymlos is not recommended for patients with a history of hypercalcemia or other metabolic bone diseases. Always inform your physician about all the medications and treatments you are currently undergoing; stopping bisphosphonate therapy will require a period of at least 5 weeks to prevent dangerous interactions with Prolia and Tymlos.
For both drugs, some common side effects include back pain, joint pain and headaches. However, Tymlos might also cause dizziness or increased heart rate shortly after injection so it's advised to sit or lie down until symptoms subside.
How much do Prolia and Tymlos cost?
For the brand name versions of these drugs:
- The price for one injection of Prolia (60 mg/1 ml) is about $1,300. As this medication is administered biannually, it works out to approximately $7/day.
- A package containing two Tymlos pens (80 mcg/40 doses each) averages around $3,900. Considering that one pen lasts 30 days with once-daily injections, this drug costs about $65/day.
Thus, if you are considering cost alone, brand-name Prolia is less expensive on a per-day treatment basis than Tymlos. However, please note that cost should not be the primary consideration in determining which of these osteoporosis treatments is right for you.
As of now there are no generic versions available for either denosumab (Prolia's active ingredient) or abaloparatide (Tymlos' active ingredient). Costs can vary significantly depending on insurance coverage and any assistance programs you may qualify for.
Popularity of Prolia and Tymlos
Denosumab, available under the brand name Prolia, is an osteoporosis medication that was prescribed to approximately 2.5 million people in the US in 2020. This drug accounted for nearly 15% of all prescriptions for osteoporosis treatment. Denosumab works by inhibiting a protein essential to the function of bone-destroying cells, and it has been steadily increasing in prevalence as a treatment option since its approval.
Abaloparatide, sold under the brand name Tymlos, is another medication used to treat osteoporosis but it primarily focuses on promoting new bone formation rather than preventing bone loss. In comparison to denosumab, abaloparatide was prescribed noticeably less frequently with records indicating just over half a million prescriptions filled in 2020 across America. Despite this difference in prescription rates though, both medications are approved for similar use cases and have proven effective at reducing fracture risk related to osteoporosis.
Conclusion
Both Prolia (denosumab) and Tymlos (abaloparatide) are commonly used for the treatment of osteoporosis in postmenopausal women at a high risk of fractures. They have been shown through numerous clinical studies to be more effective than placebo treatments in increasing bone density and reducing the risk of fractures. Both drugs have different mechanisms of action, with Prolia working by inhibiting RANKL, a protein essential for the formation, function and survival of cells that break down bone, while Tymlos works as an analog of human parathyroid hormone related peptide (PTHrP), stimulating new bone growth.
In terms of administration, Prolia is given as an injection under the skin every six months by healthcare professionals whereas Tymlos is self-administered daily subcutaneously. This difference can influence patient preferences depending on their comfort level with self-injection or their ability to visit a clinic biannually.
Both medications come at significant cost but also offer saving programs; however generic forms are not currently available which may impact out-of-pocket costs. The adjustment period varies among patients due to factors like age and overall health conditions.
The side effect profile differs between both drugs - common side effects include back pain for Prolia users and dizziness or fast heartbeat with Tymlos. For both medications it's crucial that any persistent adverse reactions should prompt immediate contact with a medical professional.
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Refrences
- Dore, R. K. (2011, August). The RANKL Pathway and Denosumab. Rheumatic Disease Clinics of North America. Elsevier BV.http://doi.org/10.1016/j.rdc.2011.07.004
- on behalf of the Austrian Society for Bone and Mineral Research (AuSBMR), Peter Dimai, H., Pietschmann, P., Resch, H., Preisinger, E., Fahrleitner-Pammer, A., … Klaushofer, K. (2010, December). Österreichischer Leitfaden zur medikamentösen Therapie der postmenopausalen Osteoporose: Addendum 2010. Wiener Medizinische Wochenschrift. Springer Science and Business Media LLC.http://doi.org/10.1007/s10354-010-0840-z
- Sleeman, A., & Clements, J. N. (2019, January 17). Abaloparatide: A new pharmacological option for osteoporosis. American Journal of Health-System Pharmacy. Oxford University Press (OUP).http://doi.org/10.1093/ajhp/zxy022
- Moen, M. D., & Keam, S. J. (2011, January). Denosumab. Drugs & Aging. Springer Science and Business Media LLC.http://doi.org/10.2165/11203300-000000000-00000
- Boyce, E. G., Mai, Y., & Pham, C. (2017, December 14). Abaloparatide: Review of a Next-Generation Parathyroid Hormone Agonist. Annals of Pharmacotherapy. SAGE Publications.http://doi.org/10.1177/1060028017748649