Eladynos (Abaloparatide)
Bone Anabolic Agent for Postmenopausal Osteoporosis
Quick Facts About Eladynos
Key Takeaways
- Eladynos (abaloparatide) is an anabolic bone-forming therapy that stimulates new bone growth and reduces fracture risk in postmenopausal women with osteoporosis.
- It is injected subcutaneously once daily (80 mcg) in the lower abdomen using a pre-filled pen, and treatment must not exceed 18 months.
- Dizziness and increased heart rate may occur within 4 hours of injection — the first dose should be given under medical supervision.
- Store the pen in the refrigerator before first use; once opened, keep at room temperature (up to 25°C) and discard after 30 days.
- After completing Eladynos treatment, transition to an antiresorptive agent (such as a bisphosphonate) to maintain bone density gains.
What Is Eladynos and What Is It Used For?
Eladynos contains the active substance abaloparatide, a synthetic 34-amino acid peptide analogue of parathyroid hormone-related protein (PTHrP). Unlike antiresorptive medications that primarily slow bone breakdown, Eladynos is classified as a bone anabolic agent — it actively promotes the building of new bone tissue. This makes it a particularly important option for patients with severe osteoporosis who have already experienced fractures or who have very low bone density.
Osteoporosis is a systemic skeletal disorder characterised by reduced bone mineral density (BMD) and deterioration of bone microarchitecture, leading to increased bone fragility and susceptibility to fractures. The condition is especially prevalent among postmenopausal women due to the decline in oestrogen levels, which normally plays a protective role in maintaining bone density. The World Health Organization (WHO) estimates that osteoporosis affects approximately 200 million women worldwide, and the lifetime risk of an osteoporotic fracture in women aged 50 years or older ranges from 40% to 50%.
Abaloparatide works by selectively activating the parathyroid hormone type 1 receptor (PTH1R), specifically engaging its RG conformation. This selective activation preferentially stimulates osteoblast-mediated bone formation over osteoclast-mediated bone resorption. The clinical result is a net increase in bone mass, improved bone quality, and enhanced bone strength. In the pivotal ACTIVE clinical trial (Abaloparatide Comparator Trial In Vertebral Endpoints), abaloparatide reduced the risk of new vertebral fractures by 86% compared to placebo over 18 months and demonstrated significant reductions in non-vertebral fractures as well.
Eladynos is approved for the treatment of osteoporosis in postmenopausal women who are at increased risk of fracture. The European Medicines Agency (EMA) granted marketing authorisation in 2022 following review of comprehensive clinical data. In clinical practice, it is typically reserved for patients at high or very high fracture risk, including those with prior fragility fractures, very low T-scores on bone densitometry, or those who have not responded adequately to other osteoporosis therapies.
What Should You Know Before Taking Eladynos?
Contraindications
There are several important situations in which Eladynos must not be used. Understanding these contraindications is essential for patient safety and optimal treatment outcomes. Your healthcare provider will perform a thorough assessment before prescribing this medication to ensure it is appropriate for you.
- Are allergic to abaloparatide or any of the other ingredients (phenol, sodium acetate trihydrate, acetic acid, water for injections)
- Are pregnant or breastfeeding
- Are of childbearing potential (still able to become pregnant)
- Have high blood calcium levels (hypercalcaemia)
- Have severe kidney impairment
- Have unexplained elevated alkaline phosphatase levels
- Have received radiation therapy affecting the skeleton
- Have ever been diagnosed with bone cancer or other cancers that have spread to bone
The contraindication regarding bone cancer and prior skeletal radiation is particularly important. Bone anabolic agents stimulate osteoblast activity, and there is a theoretical concern that this could promote the growth of existing bone malignancies. This contraindication is based on precautionary principles rather than specific clinical events observed with abaloparatide in humans, but it remains an absolute contraindication that must be respected.
Warnings and Precautions
Before and during treatment with Eladynos, several important precautions should be discussed with your healthcare provider. These warnings help ensure the safest possible use of the medication and guide clinical decision-making.
Orthostatic hypotension and dizziness: One of the most clinically significant considerations with Eladynos is the risk of postural hypotension (a drop in blood pressure upon standing). Some patients experience dizziness or increased heart rate within 4 hours of the injection. For this reason, the first injection (or first few injections) should be administered under the supervision of a healthcare professional who can observe the patient for at least the first hour. Patients should always inject Eladynos in a location where they can sit or lie down immediately if they feel dizzy.
Cardiovascular considerations: Patients with known heart disease or high blood pressure should inform their doctor before starting treatment, as more frequent monitoring may be required. Before initiating therapy, a baseline assessment of blood pressure and cardiac function will be performed.
Hypercalcaemia: Abaloparatide can increase calcium levels in the blood. Patients who experience persistent nausea, vomiting, constipation, fatigue, or muscle weakness should contact their healthcare provider, as these symptoms may indicate excessively high calcium levels. Regular monitoring of serum calcium is recommended during treatment.
Urinary calcium and kidney stones: Eladynos may increase calcium excretion in the urine, which is a very common side effect. Patients with a history of kidney stones or elevated urinary calcium levels are at increased risk of developing new kidney stones during treatment. Your doctor should assess this risk before prescribing Eladynos.
The recommended treatment duration of 18 months must not be exceeded. After completing Eladynos therapy, your doctor will typically recommend transition to an antiresorptive medication (such as a bisphosphonate or denosumab) to consolidate and maintain the bone density improvements achieved.
Children and Adolescents
Eladynos should not be used in children and adolescents under 18 years of age. The safety and efficacy of abaloparatide have not been established in this age group. Bone anabolic agents are not appropriate for the growing skeleton, as they could interfere with normal bone development and epiphyseal plate function.
Pregnancy and Breastfeeding
Eladynos must not be used during pregnancy or breastfeeding, or in women who are still of childbearing potential. While the medication is indicated for postmenopausal women (who are not of childbearing potential by definition), this contraindication serves as an important safety measure. The effects of abaloparatide on foetal development have not been adequately studied, and the medication should be avoided in any situation where pregnancy could occur.
Drug Interactions
Before starting Eladynos, inform your healthcare provider about all medications you are currently taking, have recently taken, or might take. Although abaloparatide has relatively few direct pharmacokinetic interactions, some important pharmacodynamic interactions should be considered.
| Interacting Drug | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Digoxin / Digitalis glycosides | Pharmacodynamic | Abaloparatide may increase blood calcium levels, which can potentiate the effects and toxicity of cardiac glycosides | Monitor serum calcium and digoxin levels closely; watch for signs of digitalis toxicity |
| Antihypertensive agents | Pharmacodynamic | May worsen symptoms of low blood pressure (dizziness, lightheadedness) when combined with abaloparatide | Monitor blood pressure more frequently; adjust doses if necessary |
| Calcium supplements | Additive effect | Concurrent use may increase the risk of hypercalcaemia; however, supplementation is often recommended | Follow your doctor’s guidance on calcium and vitamin D supplementation dosing |
| Other bone-active agents | Pharmacodynamic | Combining anabolic agents with bisphosphonates or denosumab is used sequentially, not concurrently | Discuss treatment sequencing with your specialist |
Driving and Operating Machinery
Some patients may experience dizziness following the injection of Eladynos. If you feel dizzy after your injection, you should not drive or operate machinery until the dizziness has resolved. This effect typically occurs within the first 4 hours after injection and usually subsides relatively quickly.
Sodium Content
Eladynos contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially “sodium-free.” This is important for patients who are on a controlled sodium diet or who have conditions such as heart failure where sodium intake must be carefully monitored.
What Is the Correct Dosage of Eladynos?
Adults (Postmenopausal Women)
The standard dose of Eladynos is one injection of 80 micrograms (mcg) administered once daily by subcutaneous injection into the lower abdomen (belly area). The injection should be given at approximately the same time each day to help establish a consistent routine and improve adherence. The pre-filled injection pen delivers a fixed dose of 80 mcg with each actuation, and each pen contains sufficient medication for 30 daily doses.
Standard Dosing for Postmenopausal Osteoporosis
- Dose: 80 micrograms (mcg) once daily
- Route: Subcutaneous injection in the lower abdomen
- Maximum treatment duration: 18 months
- Supplementation: Calcium and vitamin D as directed by your doctor
The injection site should be varied each day within the lower abdominal area to reduce the risk of injection site reactions. Avoid injecting within 5 centimetres of the navel. Only inject into healthy, intact skin — do not inject into areas that are tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
Your doctor may advise you to take calcium and vitamin D supplements during treatment with Eladynos. This is a common recommendation for patients receiving osteoporosis therapy, as adequate calcium and vitamin D are essential for optimal bone formation. Your doctor will specify the appropriate daily doses for your individual needs.
Children and Adolescents
Eladynos is not approved for use in children and adolescents under 18 years of age. Osteoporosis treatment with bone anabolic agents is not appropriate for the developing skeleton.
Elderly Patients
No dose adjustment is required for elderly patients. The 80 mcg once-daily dose is appropriate across the postmenopausal age range. However, elderly patients may be more susceptible to orthostatic hypotension and dizziness, so extra caution is warranted during the initial injections. Close monitoring of blood pressure and calcium levels is advisable in older patients, particularly those with concurrent cardiovascular disease or kidney impairment.
Missed Dose
If you forget a dose, take it as soon as you remember, provided it is within 12 hours of your usual scheduled time. Then take your next dose at the normal time the following day. If more than 12 hours have passed since the missed dose, skip that dose entirely and resume your usual injection schedule the next day. Do not take a double dose to compensate for a missed injection, and never inject more than one dose on the same day.
Overdose
If you accidentally take more than the prescribed dose of Eladynos, contact your doctor or pharmacist immediately. Expected effects of an overdose include nausea, vomiting, dizziness (especially on standing), rapid heartbeat, and headache. Treatment is symptomatic and supportive. There is no specific antidote for abaloparatide overdose.
Stopping Treatment
Do not stop using Eladynos without discussing it with your doctor. Abrupt discontinuation of bone anabolic therapy without transition to an antiresorptive agent may result in loss of the bone density gains achieved during treatment. Your doctor will advise you on the optimal timing and selection of follow-on therapy, which is critical for maintaining long-term fracture risk reduction. Current international guidelines recommend transitioning to a bisphosphonate or denosumab after completing the course of anabolic therapy.
| Patient Group | Dose | Route | Duration | Notes |
|---|---|---|---|---|
| Postmenopausal women | 80 mcg once daily | Subcutaneous (lower abdomen) | Up to 18 months | Supplement with calcium and vitamin D as directed |
| Elderly patients | 80 mcg once daily | Subcutaneous (lower abdomen) | Up to 18 months | No dose adjustment; monitor for orthostatic hypotension |
| Renal impairment (mild-moderate) | 80 mcg once daily | Subcutaneous (lower abdomen) | Up to 18 months | Monitor calcium levels more frequently |
| Severe renal impairment | Contraindicated | — | — | Do not use Eladynos |
| Children & adolescents (<18 years) | Not approved | — | — | Safety and efficacy not established |
What Are the Side Effects of Eladynos?
Like all medicines, Eladynos can cause side effects, although not everybody gets them. Understanding the potential side effects and their frequency helps patients and healthcare providers make informed treatment decisions and recognise issues early when they do occur.
Stop taking Eladynos and contact your doctor immediately or go to an emergency department if you experience symptoms of a severe allergic reaction: swelling of the face or tongue, wheezing or breathing difficulties, hives (urticaria), itching and skin redness, severe vomiting or diarrhoea, or feeling faint or losing consciousness. These symptoms are rare but can be serious and potentially life-threatening.
Very Common
May affect more than 1 in 10 users
- Increased calcium levels in urine (hypercalciuria)
- Dizziness
Common
May affect up to 1 in 10 users
- Increased calcium levels in blood (hypercalcaemia)
- Increased uric acid levels in blood
- Headache
- Palpitations and increased heart rate
- Elevated blood pressure
- Abdominal pain
- Constipation and diarrhoea
- Nausea and vomiting
- Weakness, fatigue, and general malaise
- Injection site reactions (bruising, rash, pain)
- Pain in bones, joints, hands, feet, or back
- Muscle spasms (back and legs)
- Difficulty sleeping (insomnia)
- Kidney stones (nephrolithiasis)
- Itching and skin rash
Uncommon
May affect up to 1 in 100 users
- Allergic reactions
- Feeling of abdominal bloating
- Pain
- Dizziness or feeling faint on standing or sitting up (orthostatic hypotension)
The dizziness associated with Eladynos is primarily related to its transient effects on heart rate and blood pressure. It typically occurs within 4 hours of the injection and is usually self-limiting. The risk appears to be highest with the initial injections, which is why medical supervision is recommended for the first dose. If dizziness persists or worsens over time, consult your healthcare provider.
Hypercalciuria (elevated calcium in urine) is the most frequently reported laboratory abnormality. While it is often asymptomatic, it can increase the risk of kidney stone formation in susceptible individuals. Your doctor may perform periodic urine and blood tests to monitor calcium levels during treatment. Adequate fluid intake is recommended to help reduce this risk.
Injection site reactions, while common, are generally mild and include localised bruising, redness, and transient pain at the injection site. Rotating the injection site within the lower abdominal area as recommended can help minimise these reactions.
It is important to report suspected side effects after a medicine has been authorised. This helps to continuously monitor the benefit-risk balance of the medicine. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority (e.g., the MHRA in the United Kingdom, the EMA in Europe, or the FDA in the United States).
How Should You Store Eladynos?
Proper storage of Eladynos is essential to maintain the medication’s efficacy and safety. As a biological peptide in solution, abaloparatide is sensitive to temperature extremes and must be handled according to specific guidelines.
Before first use: Store the pre-filled injection pen in the refrigerator at 2°C to 8°C. Do not freeze the medication. Position the pen away from the freezer compartment of your refrigerator to avoid accidental freezing. If the solution has been frozen at any time, do not use it — discard the pen and use a new one.
After first use: Once the pen has been used for the first time or removed from the refrigerator, it may be stored at room temperature not exceeding 25°C. The pen must be discarded after 30 days, regardless of whether any medication remains. Record the date of first use in the space provided on the carton (Day 1) to ensure you do not use the pen beyond the 30-day limit.
General storage guidelines: Keep the medication out of the sight and reach of children. Do not use Eladynos after the expiry date printed on the carton and injection pen (after “EXP”). The expiry date refers to the last day of the stated month. Always discard your old pen before opening a new one to avoid confusion between pens. Never store the pen with a needle attached.
Checking the solution: Before each use, visually inspect the solution. It should be clear, colourless, and free from particles. If the solution appears cloudy, discoloured, or contains visible particles, do not use it. Small air bubbles in the solution are normal and do not affect the medication.
Disposal: Used pens, needles, and any unused medication should not be disposed of via household waste or wastewater. Ask your pharmacist about safe disposal options in your area. Proper disposal protects the environment and prevents accidental needle-stick injuries.
What Does Eladynos Contain?
Understanding the composition of your medication can help you identify potential allergens and understand what you are taking. Eladynos is formulated as a clear, colourless solution for subcutaneous injection.
Active substance: The active ingredient is abaloparatide. Each dose of 40 microlitres contains 80 micrograms of abaloparatide. Each pre-filled injection pen contains 3 mg of abaloparatide in 1.5 ml of solution, corresponding to a concentration of 2 milligrams per millilitre. Each pen provides 30 daily doses.
Excipients (inactive ingredients):
- Phenol: Used as a preservative to prevent microbial contamination of the multi-dose pen
- Water for injections: The solvent base for the solution
- Sodium acetate trihydrate: Used for pH adjustment (buffering agent)
- Acetic acid: Used for pH adjustment
The medication contains less than 1 mmol (23 mg) of sodium per dose, making it essentially “sodium-free.” This is relevant for patients on sodium-restricted diets.
Packaging: Eladynos is supplied in a carton containing either one or three pre-filled multi-dose injection pens, each containing 30 doses. Not all pack sizes may be marketed in every country. Injection needles are not included with the pen and must be purchased separately. The recommended needles are 8-millimetre, 31-gauge pen needles.
Marketing authorisation holder: Theramex Ireland Limited, Dublin, Ireland. The medication is manufactured by Cilatus Manufacturing Services Ltd, Dublin, Ireland.
How Do You Use the Eladynos Injection Pen?
Using the Eladynos injection pen correctly is essential for receiving the full therapeutic dose. Do not attempt to inject Eladynos until a healthcare professional has demonstrated the proper technique. The following provides a general overview of the injection process; always refer to the detailed Instructions for Use supplied with your pen.
Before your first injection, wash your hands and check the pen label to confirm it is the correct medication. Verify the expiry date has not passed. Remove the pen cap and visually inspect the solution — it should be clear, colourless, and free from particles.
Step-by-step summary:
- Attach a new needle: Remove the paper tab from a new needle and press it straight onto the pen, screwing until firm. Ensure the needle is straight to prevent bending. Remove the outer needle shield (save it) and then carefully remove the inner needle shield (discard it).
- Day 1 only — Prime the pen: On the first day of use with each new pen, perform a test to verify the pen is functioning correctly. Turn the dose dial until “•80” appears, hold the pen with the needle pointing up, and press the green injection button. You should see liquid at the needle tip. This step uses a small amount of medication reserved specifically for testing and should only be done once per pen.
- Set the dose: Turn the white dose dial away from you until it stops and “●80” appears in the dose window.
- Choose and clean the injection site: Select a spot on your lower abdomen, at least 5 cm from the navel. Clean with an alcohol swab and let it dry. Use a different site each day.
- Inject: Insert the needle straight into the skin. Press and hold the green button until “●0” appears in the window. Continue holding for 10 seconds to ensure the full dose is delivered, then withdraw the needle and release the button.
- Remove the needle: Carefully replace the outer needle shield, then unscrew and dispose of the used needle safely in a sharps container.
- Replace the pen cap and store appropriately until the next injection.
- Never share your pen or needles with another person
- Use a new needle for every injection
- Do not press the green button unless a needle is attached
- If the dose dial does not turn to “●80,” the pen may not contain enough medication for a full dose — use a new pen
- If the green button is difficult to press, the needle may be blocked — replace it with a new needle
Frequently Asked Questions About Eladynos
Eladynos (abaloparatide) is used to treat osteoporosis in postmenopausal women who are at increased risk of fractures. It works by stimulating new bone formation, increasing bone mineral density, and significantly reducing the risk of both vertebral (spinal) and non-vertebral fractures. It is classified as a bone anabolic (bone-building) agent and is typically reserved for patients at high or very high fracture risk.
The maximum recommended treatment duration for Eladynos is 18 months. This time limit is based on the duration of clinical trials and safety considerations. After completing the 18-month course, your doctor will typically recommend transitioning to an antiresorptive medication (such as alendronate, risedronate, zoledronic acid, or denosumab) to consolidate and maintain the bone density improvements achieved during anabolic therapy.
The most common side effects are increased calcium in the urine (hypercalciuria) and dizziness, both of which are classified as “very common” (affecting more than 1 in 10 patients). Common side effects (affecting up to 1 in 10 patients) include headache, increased heart rate, elevated blood pressure, nausea, constipation, injection site reactions, fatigue, musculoskeletal pain, and kidney stones. Most side effects are mild to moderate and often improve with continued use.
Before first use, store the Eladynos pen in the refrigerator at 2–8°C. Do not freeze it. After the first injection (or after removing from the refrigerator), store the pen at room temperature not exceeding 25°C. Discard the pen after 30 days, even if it still contains medication. Never store the pen with a needle attached. Always check that the solution is clear and colourless before injecting.
Yes, dizziness is one of the most common side effects of Eladynos, affecting more than 1 in 10 users. Some patients may also experience an increase in heart rate. These effects typically occur within 4 hours of the injection and usually resolve on their own. For this reason, your first injection should be given under the supervision of a healthcare professional. Always inject in a place where you can sit or lie down immediately if you feel dizzy. Avoid driving or operating machinery if you experience dizziness.
Both Eladynos (abaloparatide) and teriparatide (e.g., Forteo) are injectable bone anabolic agents used to treat osteoporosis, but they differ in their molecular mechanism. Abaloparatide is an analogue of PTHrP (parathyroid hormone-related protein), while teriparatide is an analogue of PTH (parathyroid hormone). Abaloparatide selectively activates the RG conformation of the PTH1 receptor, which may result in a stronger anabolic signal with less stimulation of bone resorption and less hypercalcaemia compared to teriparatide. Both are limited to 18–24 months of treatment and require follow-up with antiresorptive therapy.
References
- European Medicines Agency (EMA). Eladynos (abaloparatide) – Summary of Product Characteristics. Available at: ema.europa.eu/en/medicines/human/EPAR/eladynos.
- Miller PD, Hattersley G, Riis BJ, et al. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial (ACTIVE). JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136.
- Bone HG, Cosman F, Miller PD, et al. ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018;103(8):2949-2957.
- World Health Organization (WHO). Prevention and management of osteoporosis. WHO Technical Report Series 921. Geneva: WHO; 2003.
- International Osteoporosis Foundation (IOF). Osteoporosis: epidemiology, diagnosis and treatment guidelines. Available at: osteoporosis.foundation.
- Kanis JA, Cooper C, Rizzoli R, Reginster JY. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019;30(1):3-44.
- Shoback D, Rosen CJ, Black DM, Cheung AM, Murad MH, Eastell R. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin Endocrinol Metab. 2020;105(3):dgaa048.
- National Institute for Health and Care Excellence (NICE). Osteoporosis: assessing the risk of fragility fracture. Clinical guideline CG146. Updated 2017.
- Leder BZ, O’Dea LS, Zanchetta JR, et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015;100(2):697-706.
- Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016;375:1532-1543.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in endocrinology, rheumatology, and clinical pharmacology. Our team follows international guidelines from the WHO, IOF, AACE/ACE, and NICE to ensure accuracy and clinical relevance.
Evidence-based content developed from peer-reviewed clinical trial data, EMA assessment reports, and international osteoporosis treatment guidelines. All medical claims are supported by Level 1A evidence where available.
All content independently reviewed by board-certified physicians specialising in bone metabolism and osteoporosis management. Reviewed according to the GRADE evidence framework with regular updates as new evidence emerges.
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