Abaloparatide (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: SUBCUTANEOUS.
Brand Names
- TYMLOS
Contraindications
TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria [see Adverse Reactions (6.2)].
Adverse Reactions
The following adverse reactions are described in greater detail in other sections: Orthostatic Hypotension [see Warnings and Precautions (5.2)] Hypercalcemia [see Warnings and Precautions (5.3)] Hypercalciuria and Urolithiasis [see Warnings and Precautions (5.4)]
Drug Interactions
No specific drug-drug interaction studies have been performed [see Clinical Pharmacology (12.3)].
Mechanism of Action
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 [see Nonclinical Toxicology (13.2)].
Overdosage
In a clinical study, accidental overdose was reported in a patient who received 400 mcg in one day (5 times the recommended clinical dose); dosing was temporarily interrupted. The patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but on the following day the patient’s serum calcium was within the normal range. The effects of overdose may include hypercalcemia, nausea, vomiting, dizziness, tachycardia, orthostatic hypotension, and headache.