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Abaloparatide

Pronunciation

(a bal oh PAR a tide)

Index Terms

  • Tymlos

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous:

Tymlos: 3120 mcg/1.56 mL (1.56 mL) [contains phenol]

Brand Names: U.S.

  • Tymlos

Pharmacologic Category

  • Parathyroid Hormone Analog

Use: Labeled Indications

Osteoporosis: Treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Drug Interactions

There are no known significant interactions.

ALERT: U.S. Boxed Warning

Osteosarcoma

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown whether abaloparatide will cause osteosarcoma in humans.

Use of abaloparatide is not recommended in patients at increased risk for osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.

Cumulative use of abaloparatide and parathyroid hormone analogs (eg, teriparatide) for more than 2 years during a patient's lifetime is not recommended.

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