abaloparatide

General

Pronunciation:
a-bal-oh-par-a-tide

Trade Name(s)

  • Tymlos

Ther. Class.
hormones

Pharm. Class.
parathyroid hormones

Indications

Treatment of osteoporosis in postmenopausal women at high risk for fractures.

Action

Regulates calcium and phosphate metabolism in bone and kidney by binding to parathyroid hormone (PTH) receptors; stimulates osteoblastic activity.

Therapeutic Effect(s):

Reduction in risk of vertebral and nonvertebral fractures.

Pharmacokinetics

Absorption: 36% absorbed after subcut administration.

Distribution: Widely distributed to tissues.

Metabolism and Excretion: Metabolized by the liver into peptide fragments which are renally excreted.

Half-life: 1.7 hr.

TIME/ACTION PROFILE (serum concentrations)

ROUTEONSETPEAKDURATION
subcutunknown0.51 hrunknown

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity
  • Paget's disease of the bone, unexplained ↑ alkaline phosphatase, radiation therapy, open epiphyses, hereditary disorders predisposing to osteosarcoma, bone metastases, or skeletal malignancy (↑ risk of osteosarcoma)
  • Hypercalcemia or primary hyperparathyroidism
  • OB: Avoid use in pregnancy
  • OB: Lactation: Avoid use during breastfeeding; .
  • Pedi: Safety and effectiveness not established.

Use Cautiously in:

  • Active or recent urolithiasis;
  • Severe renal impairment.

Adverse Reactions/Side Effects

CNS: dizziness, fatigue, headache

CV: orthostatic hypotension, palpitations, tachycardia

EENT: vertigo

F and E: hypercalcemia

GI: abdominal pain, nausea

GU: hypercalciuria, urolithiasis

Local: injection site reactions

Metabolic: hyperuricemia

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None known.

Route/Dosage

SC (Adults) 80 mcg once daily. Cumulative use of abaloparatide or other parathyroid analogs should not exceed 2 yr.

Availability

Solution for subcutaneous injection (in prefilled pens): 3120 mcg/1.56 mL (delivers 30 daily doses of 80 mcg)

Assessment

  • Assess patient for bone mineral density before and periodically during therapy.
  • Monitor for signs and symptoms of orthostatic hypotension (dizziness, palpitations, tachycardia, nausea) following injection. Usually occurs within 4 hrs of injection.

Lab Test Considerations:

May cause hypercalcemia, hyperuricemia, and hypercalciuria. Monitor urinary calcium excretion if hypercalciuria suspected.

Potential Diagnoses

Implementation

  • Use of abaloparatide should not continue more than 2 yr.
  • Provide dietary supplements of vitamin D and calcium if dietary intake is not sufficient.
  • Administer first few doses where patient can sit or lie down in case of orthostatic hypotension.
  • SC Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter. Administer at the same time each day in periumbilical area, rotating sites daily. Do not inject IM or IV. Refrigerate before 1st use, then stable at room temperature for up to 30 days.

Patient/Family Teaching

  • Advise patient to administer medication at same time each day. Administer missed doses as soon as remembered that day. Do not take more than one injection/day.
  • Instruct patient on proper administration technique and disposal of needles. Patient should read Medication Guide before starting therapy and re-read them each time prescription is refilled. Caution patient to throw pen away after 30-day use period and not to share their pen with other patients.
  • Discuss the importance of other treatments for osteoporosis (supplemental calcium and/or vitamin D, weight-bearing exercise, modification of behavioral factors such as smoking and/or alcohol consumption).
  • May cause orthostatic hypotension during first several doses. Caution patient to administer medication in a lying or sitting position. If light-headedness or palpitations occur, lie down until symptoms resolve. Notify health care professional if symptoms persist or worsen.
  • Instruct patient to notify health care professional if persistent symptoms of hypercalcemia (nausea, vomiting, constipation, lethargy, muscle weakness) occur.
  • Inform patient of increased risk or osteosarcoma. Advise patient to notify health care professional promptly if signs and symptoms of osteosarcoma (persistent localized pain or occurrence of new soft tissue mass that is tender to palpation) occurs.
  • Advise women of childbearing potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Emphasize the importance of follow-up tests for bone mineral density.

Evaluation/Desired Outcomes

Reduction in risk of vertebral and nonvertebral fractures.

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