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

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.

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

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

Tymlos

• 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.

Therapeutic Classification: hormones

Pharmacologic Classification: parathyroid hormones

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)

• 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.

a-bal-oh-PAR-a-tide

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)