Molecule
Abaloparatide is a parathyroid hormone-related peptide analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. MedsAcross supplies Abaloparatide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
Source: US FDA prescribing information
Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity. In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in BMD and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites.
Source: US FDA prescribing information
Recommended dosage is 80 mcg subcutaneously once daily, patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Administer as a subcutaneous injection into periumbilical region of abdomen. Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur.
Source: US FDA prescribing information
TYMLOS is contraindicated in patients with a history of severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS. Reactions have included anaphylaxis, angioedema, dyspnea, and urticaria. Severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS.
Source: US FDA prescribing information
Hypersensitivity Reactions: Anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone analogs, including TYMLOS. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with TYMLOS, initiate supportive care, and monitor until signs or symptoms resolve. Discontinue TYMLOS permanently in patients with a severe hypersensitivity reaction to TYMLOS. Osteosarcoma: Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. Orthostatic Hypotension: Instruct patients to sit or lie down if symptoms develop after dose administration.
Source: US FDA prescribing information
The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions Risk of Osteosarcoma Orthostatic Hypotension Hypercalcemia Hypercalciuria and Urolithiasis Osteoporosis in postmenopausal women: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo. Osteoporosis in men: The most common adverse reactions (incidence ≥2%) are injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain.
Source: US FDA prescribing information
No specific drug-drug interaction studies have been performed.
Source: US FDA prescribing information
Before first use, store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Abaloparatide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tymlos 3.12 mg/1.56 mL injectionSubcutaneous Cold chain | Radius Health | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Abaloparatide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Abaloparatide, including Tymlos.
Yes. The US FDA first approved Abaloparatide on 28 April 2017, according to Drugs@FDA.
Yes. Abaloparatide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Abaloparatide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Abaloparatide is classified under ATC code H05AA04 (Abaloparatide).
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