a-bal-oh-PAR-a-tide

Therapeutic Classification: hormones

Pharmacologic Classification: parathyroid hormones

• Treatment of osteoporosis in postmenopausal women or men at high risk for fractures or who have failed/not tolerated other available osteoporosis therapy.

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

• Reduction in risk of vertebral and nonvertebral fractures in postmenopausal women and men.

Absorption: 36% absorbed after SUBQ administration.

Distribution: Widely distributed to tissues.

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

Half-life: 1.7 hr.

(serum concentrations)

Contraindicated in:

• Hypersensitivity
• Paget's disease of the bone, radiation therapy, open epiphyses, hereditary disorders predisposing to osteosarcoma, bone metastases, or skeletal malignancy (↑ risk of osteosarcoma)
• Hypercalcemia or primary hyperparathyroidism

Use Cautiously in:

• Active or recent urolithiasis
• Severe renal impairment.

CV: orthostatic hypotension, palpitations, tachycardia.

EENT: vertigo.

F and E: hypercalcemia.

GI: abdominal pain, nausea.

GU: hypercalciuria, urolithiasis.

Local: injection site reactions.

Metab: hyperuricemia.

Neuro: dizziness, fatigue, headache.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• None known.

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

• Solution for SUBQ injection (prefilled pens): 3120 mcg/1.56 mL;

• 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.

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

• Use of abaloparatide should not continue longer 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.

• 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 Tymlos pens. Patient should read Medication Guide before starting therapy and reread 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 patient to notify health care professional if signs and symptoms of hypersensitivity reactions (dyspnea, urticaria) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications during therapy.
• Rep: Abaloparatide is not indicated for females of reproductive potential. Advise females to notify health care professional if pregnancy is suspected.
• Emphasize the importance of follow-up tests for bone mineral density.

• Reduction in risk of vertebral and nonvertebral fractures in postmenopausal women and men.

Tymlos

NDC Code^*

• 70539- Radius Health, Inc.
  • 70539-001- Tymlos
    • 70539-001-02- 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) > 1.56 mL in 1 CARTRIDGE (70539-001-01)

• 70539- Radius Health, Inc.
  • 70539-001- Tymlos
    • 70539-001-98- 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) > 1.56 mL in 1 CARTRIDGE (70539-001-99)