STEPS

New Drug Reviews

Abaloparatide (Tymlos) for Osteoporosis

 

Am Fam Physician. 2019 Feb 15;99(4):260-261.

Abaloparatide (Tymlos) is a daily injectable parathyroid hormone–related peptide analog. It is labeled for the treatment of postmenopausal osteoporosis in women at high risk of fracture because of a history of osteoporotic fracture, failure of treatment with other osteoporotic medications, smoking, excessive alcohol consumption, chronic steroid use, or a family history of fractures.1 Intermittent administration of abaloparatide has an anabolic effect on bone similar to teriparatide (Forteo), a recombinant human parathyroid hormone.13

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DrugDosageDose formCost*

Abaloparatide (Tymlos)

One 80-mcg injection administered once daily

1.56-mL multidose prefilled injector pen

$1,768


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed October 23, 2018).

DrugDosageDose formCost*

Abaloparatide (Tymlos)

One 80-mcg injection administered once daily

1.56-mL multidose prefilled injector pen

$1,768


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed October 23, 2018).

Safety

Abaloparatide is associated with a dose-dependent risk of osteosarcoma in rats. As such, its use is limited to a total duration of two years. It should not be used in patients with a history of Paget disease of bone or unexplained elevated alkaline phosphatase levels.1 Abaloparatide has been shown to increase serum calcium levels, and the manufacturer recommends against use in patients with preexisting hypercalcemia.1 The manufacturer also recommends measuring urinary calcium excretion in patients with active urolithiasis or a history of urolithiasis.1

Tolerability

Abaloparatide was well tolerated in clinical studies with few adverse effects that led to discontinuation. Orthostatic hypotension can occur up to four hours following injection in as many as 31% of patients, although the clinical significance of this occurrence is not known. The most common adverse effects of abaloparatide vs. placebo include palpitations (5% vs. 0.4%), nausea (8% vs. 3%), headache (8% vs. 6%), and dizziness (10% vs. 6%).1 Other adverse effects of abaloparatide include pain (9% vs. 7% with placebo), edema (10% vs. 3%), and injection site redness (58% vs. 28%).1

Effectiveness

Treatment with abaloparatide increases bone mineral density (BMD) over 24 months compared with placebo at the femoral neck (4.5%), the total hip (5.5%), and the lumbar spine (12.8%),

Address correspondence to Anthony J. Caprio, MD, at Anthony.Caprio@AtriumHealth.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. National Library of Medicine. Daily Med. Drug label information: Tymlos–abaloparatide injection, solution. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8&type=display. Accessed April 9, 2018....

2. Tella SH, Gallagher JC. Prevention and treatment of postmenopausal osteoporosis. J Steroid Biochem Mol Biol. 2014;142:155–170.

3. Miller PD, Hattersley G, Riis BJ, et al.; ACTIVE Study Investigators. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial [published correction appears in JAMA. 2017;317(4):442]. JAMA. 2016;316(7):722–733.

4. Cosman F, Miller PD, Williams GC, et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc. 2017;92(2):200–210.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Assistant Medical Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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