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Information ⬇

abaloparatide

a-bal-oh-par-a-tide

Trade Name(s): (Tymlos)

BLACK BOX ALERT May cause a dose-dependent increase in the incidence of osteosarcoma. It is unknown whether abaloparatide will cause osteosarcoma in humans. Avoid use in pts at risk for osteosarcoma (e.g., pts with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adults with open epiphyses, pts with bone metastasis or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior history of external beam or implant radiation involving the skeleton. Cumulative use of parathyroid analogs (e.g., teriparatide) for more than 2 yrs during a pt's lifetime is not recommended.

Do not confuse abaloparatide with teriparatide.

Classification ⬆ ⬇

Uses ⬆ ⬇

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

Precautions ⬆ ⬇

Contraindications: Hypersensitivity to abaloparatide. Cautions: Pts at risk for hypercalcemia (e.g., hyperparathyroidism, renal impairment, severe dehydration; history of hypercalciuria, urolithiasis). Avoid use in pts at increased risk for osteosarcoma (e.g., pts with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, prior radiation therapy involving the skeleton). Not recommended in pts with cumulative use of parathyroid analogs greater than 2 yrs during lifetime.

Action ⬆ ⬇

Acts as an agonist at the PTH1 receptor. Therapeutic Effect: Stimulates osteoblast function and increases bone mass, decreasing risk of fractures.

Pharmacokinetics ⬆ ⬇

Widely distributed. Metabolism not specified. Degraded into small peptides via proteolytic enzymes. Protein binding: 70%. Peak plasma concentration: 0.51 hrs. Excreted primarily in urine. Not expected to be removed by dialysis. Half-life: 1.7 hrs.

Lifespan Considerations ⬆ ⬇

Pregnancy/Lactation: Not indicated in females of reproductive potential. Unknown if distributed in breast milk or crosses the placenta. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions ⬆ ⬇

DRUG: None known. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum calcium, uric acid; urine calcium.

Availability ⬆ ⬇

Prefilled Injector Pens: 3,120 mcg/1.56 mL (2,000 mcg/mL). Delivers 30 doses of 80 mcg.

Administration/Handling ⬆ ⬇

SQ

Storage

  • Visually inspect for particulate matter or discoloration. Solution should appear clear, colorless.
  • Do not use if solution is cloudy, discolored, or if visible particles are observed.
  • Insert needle subcutaneously into the periumbilical region of the abdomen (avoid a 2-inch area around the navel) and inject solution.
  • Do not inject into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, skin infections, or active psoriasis.
  • Do not administer IV or intramuscularly.
  • Rotate injection sites.
  • Refrigerate unused injector pens.
  • After first use, store at room temperature for up to 30 days.
  • Do not freeze or expose to heating sources.

Indications/Routes/Dosage ⬆ ⬇

Postmenopausal Osteoporosis

SQ: ADULTS, ELDERLY: 80 mcg once daily. Give with supplemental calcium and vitamin D if dietary intake is inadequate.

Dosage in Renal Impairment

No dose adjustment.

Dosage in Hepatic Impairment

Not specified; use caution.

Side Effects ⬆ ⬇

Frequent (58%): Injection site reactions (edema, pain, redness). Occasional (10%–5%): Dizziness, nausea, headache, palpitations. Rare (3%–2%): Fatigue, upper abdominal pain, vertigo.

Adverse Effects/Toxic Reactions ⬆ ⬇

May increase risk of osteosarcoma. Hypercalcemia reported in 3% of pts. Tachycardia occurred in 2% of pts (usually within 15 min after injection). Orthostatic hypotension reported in 4% of pts (usually within 4 hrs after injection). Hypercalciuria and urolithiasis reported in 20% and 2% of pts, respectively. Immunogenicity (auto-abaloparatide antibodies) occurred in 49% of pts.

Nursing Considerations ⬆

  • BASELINE ASSESSMENT Obtain parathyroid hormone level. Screen for risk of osteosarcoma, hypercalcemia (as listed in Precautions); prior use of parathyroid analogs. Assess pt's willingness to self-inject medication. INTERVENTION/EVALUATION Monitor bone mineral density, parathyroid hormone level; serum calcium. Monitor urinary calcium levels, esp. in pts with preexisting hypercalciuria or active urolithiasis. Due to risk of orthostatic hypotension, administer the first several doses with the pt in the lying or sitting position. Monitor for orthostatic hypotension (dizziness, palpitations, tachycardia, nausea, syncope). If orthostatic hypotension occurs, place pt in supine position. Assess need for calcium, vitamin D supplementation. PATIENT/FAMILY TEACHING
  • Receive the first several injections while lying or sitting down. Slowly go from lying to standing to avoid an unusual drop in blood pressure. Immediately sit or lie down if dizziness, near-fainting, palpitations occur.
  • Report symptoms of high calcium levels (e.g., constipation, lethargy, nausea, vomiting, weakness); severe bone pain.
  • An increased heart rate may occur after injection and will usually subside within 6 hrs.
  • A healthcare provider will show you how to properly prepare and inject your medication. You must demonstrate correct preparation and injection techniques before using medication at home.
  • Vitamin D and calcium supplementation may be required if dietary intake is inadequate.