Abaloparatide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Abaloparatide

Parathyroid Hormones and Analogues

Sold as ELADYNOS

GB MHRAEU EMA

Drug class: Parathyroid Hormones and Analogues
Availability: See label
Markets covered: 2
Products on record: 3

Overview

Abaloparatide is an active pharmaceutical ingredient in the Parathyroid Hormones and Analogues group (H05AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	May 15, 2026
EU European Union	EMA	1	April 12, 2024

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

1).

How to take

GBOfficial regulatory label· revised May 15, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 12, 2024[2]

1).

How to take

EUOfficial regulatory label· revised April 12, 2024

Drug interactions

Known interactions involving Abaloparatide. Select one for details. This list is informational and not a complete interaction checker.

Calcitriol Digitoxin Digoxin

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB498760025 · revised May 15, 2026
[2]European Medicines Agency · EMEA/H/C/005928 · revised April 12, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

6%). 4% of the placebo patients reported at least 1 adverse event. The adverse reactions associated with the use of abaloparatide in osteoporosis in the ACTIVE study and in postmarketing exposure are summarised in the table below. The following MedDRA convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), and frequency not known (cannot be estimated from the available data).
5 beats per minute (bpm) 15 minutes after administration. This increase in heart rate was most prominent during the first hour post dose but was seen up to 6 hours in some subjects. In the ACTIVE study, heart rate was measured one hour post dose of every study visit, with median heart rate increase from pre-dose of 14 bpm in abaloparatide treated patients as compared to 7 bpm in placebo treated patients.
Patients with >20 bpm increase in heart rate at 1 hour after the first dose were more likely to experience palpitations and/or increases in heart rate >20 bpm during subsequent treatment. 4% of patients in the placebo group. 6% of patients in the placebo group.
Injection site reactions Abaloparatide can cause injection site reactions including injection site bruising, erythema, haemorrhage, hypersensitivity, pain, rash, and swelling. 0% in the placebo group. Laboratory findings Serum calcium Abaloparatide can cause transient increases in serum calcium levels measured 4 hours post-dose.
4%). Serum uric acid Abaloparatide increased serum uric acid concentrations. In the ACTIVE study, 25% of patients in the abaloparatide group had normal baseline uric acid concentrations which were increased above the normal range at post-baseline, compared with 5% in the placebo group.
00113 mmol/μmol (or >400 mg/g) was higher with abaloparatide than with placebo (20% vs 15%, respectively). 2% of placebo-treated patients. 5% developed in vitro neutralising antibodies. Formation of anti-abaloparatide antibodies is associated with increased clearance of abaloparatide.
These changes in clearance could be related to anti-abaloparatide antibodies interfering with the accurate measurement of abaloparatide plasma concentrations. Compared to antibody negative patients, no clinically relevant differences in safety or efficacy were observed for patients who were antibody positive or who were positive for in vitro neutralising antibodies.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

Orthostatic hypotension and increased heart rate Orthostatic hypotension and transient episodes of increase in heart rate may occur with abaloparatide, typically within 4 hours of injection. Symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down.
The first injection(s) of abaloparatide should be performed under the guidance of an appropriately qualified health care professional who may observe the patient during the first hour after injection. Abaloparatide should always be administered where the patient can sit or lie down if necessary.
Abaloparatide may have vasodilating effect on vascular smooth muscle and positive chronotropic/inotropic effects on cardiac muscle. Individual benefit risk assessment is important. Blood pressure, cardiac status and ECG should be assessed prior to beginning treatment with abaloparatide.
Patients with cardiac disease should be monitored for worsening of their disease. If severe orthostatic hypotension or severe cardiovascular symptoms occur, the treatment should be discontinued. Hypercalcaemia In normocalcaemic patients, transient elevations of serum calcium concentrations have been observed following abaloparatide injection.
Serum calcium concentrations reach a maximum at approximately 4 hours and return to baseline by 24 hours after each dose. Therefore, if blood samples for serum calcium measurements are taken, this should be done approximately 24 hours after the most recent injection.
Routine calcium monitoring during therapy is not required in patients without additional risk factors for hypercalcaemia. Hypercalciuria and urolithiasis Abaloparatide may cause hypercalciuria. It is unknown whether abaloparatide may exacerbate urolithiasis in patients with active or a history of urolithiasis.
If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Duration of treatment The maximum total duration of treatment with abaloparatide should be 18 months.
3). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

This is not medical advice. Consult a qualified healthcare professional.