abaloparatide
Eladynos · ATC code H05AA04
Also known as: Abaloparatid
- Key facts
- Active substance
- abaloparatide
- ATC code
- H05AA04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Eladynos 80 micrograms/dose solution for injection in pre-filled pen.
- Marketing authorisation holder
- Theramex Ireland Limited
- Information as of
- 2026-10-29
Key facts
Abaloparatide is a parathyroid hormone-related peptide analogue used to treat osteoporosis in postmenopausal women at increased risk of fracture (Eladynos).
What it is used for
- Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Dosing
- Eladynos: 80 micrograms once daily by subcutaneous injection into the lower abdomen, at approximately the same time every day; rotate the injection site daily.
- The maximum total duration of treatment is 18 months.
- Supplemental calcium and vitamin D should be given if dietary intake is inadequate.
- Missed dose: it can be injected within 12 hours of the scheduled time; no more than one injection on the same day.
- No dose adjustment in elderly patients, mild to moderate renal impairment or hepatic impairment; must not be used in severe renal impairment.
- Should not be used in children and adolescents under 18 years.
- The first injection(s) should be performed under the guidance of a qualified health care professional.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Pregnancy, breast-feeding and women of childbearing potential.
- Pre-existing hypercalcaemia.
- Severe renal impairment.
- Unexplained elevations of serum alkaline phosphatase.
- Known risks for osteosarcoma (e.g. prior radiation therapy involving the skeleton), skeletal malignancies or bone metastases.
Important warnings
- Orthostatic hypotension and transient increases in heart rate may occur, typically within 4 hours of injection; it should be administered where the patient can sit or lie down.
- Blood pressure, cardiac status and ECG should be assessed before treatment; patients with cardiac disease should be monitored for worsening. Discontinue if severe orthostatic hypotension or severe cardiovascular symptoms occur.
- Transient elevations of serum calcium; blood samples for calcium should be taken approximately 24 hours after the most recent injection.
- Abaloparatide may cause hypercalciuria; if active urolithiasis or pre-existing hypercalciuria is suspected, urinary calcium excretion should be considered.
- Rat studies showed an increased incidence of osteosarcoma with long-term administration; hence the 18-month limit.
Side effects
- Most common in the ACTIVE study: hypercalciuria (15.6%), dizziness (11.1%), back pain (8.6%), nausea (8.5%), headache (8.5%), arthralgia (8.4%), hypertension (6.8%), injection site reaction (6.2%) and palpitations (5.6%).
- Common: hypercalcaemia, hyperuricaemia, insomnia, tachycardia.
- Uncommon: hypersensitivity, orthostatic hypotension; frequency not known: anaphylactic reaction.
Interactions
- Concomitant vasoactive medicinal products may predispose to orthostatic hypotension.
- Use with caution in patients taking digitalis, as hypercalcaemia may predispose to digitalis toxicity.
Pregnancy and breastfeeding
- Abaloparatide is contraindicated during pregnancy and breast-feeding and in women of childbearing potential.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- EladynosTheramex Ireland Limited · EMEA/H/C/005928
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Eladynos
- Liechtenstein
- Eladynos
- Norway
- Eladynos
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Eladynos – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/eladynos-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.