Abaloparatide

DEA Class; Rx

Common Brand Names; Tymlos

Women

• Indicated for treatment of osteoporosis in postmenopausal women at high risk for fracture (defined as history of osteoporotic fracture, multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy

• Shown to reduce risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis

Men

• Indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy

History of systemic hypersensitivity to drug or components of product formulation

Women

• Injection site redness (58%)

• Hypercalciuria (11%)

• Injection site edema (11%)

• Dizziness (10%)

• Nausea (8%)

• Headache (8%)

• Palpitations (5%)

• Orthostatic hypotension (4%)

• Fatigue (3%)

• Upper abdominal pain (3%)

• Hypercalcemia (3%)

• Vertigo (2%)

• Tachycardia (2%)

Men

• Injection site erythema (13%)

• Dizziness (9%)

• Arthralgia (7%)

• Injection site swelling (7%)

• Increased serum uric acid (7%)

• Injection site pain (6%)

• Orthostatic hypotension (6%)

• Contusion (3%)

• Abdominal distention (3%)

• Diarrhea (3%)

• Nausea (3%)

• Hypercalcemia (3%)

• Abdominal pain (2%)

• Bone pain (2%)

• Urolithiases (2%)

May cause orthostatic hypotension, typically within 4 hr after injection; associated symptoms may include dizziness, palpitations, tachycardia, or nausea; advise patients to sit or lie down for first several doses if necessary; administer where patient can sit or lie down if necessary

May cause hypercalcemia; not recommended with preexisting hypercalcemia or in patients who have an underlying hypercalcemic disorder (eg, primary hyperparathyroidism) because of the possibility of exacerbating hypercalcemia

May cause hypercalciuria; unknown whether the drug may exacerbate urolithiasis in patients with active or a history of urolithiasis; if active urolithiasis or preexisting hypercalciuria is suspected, consider measuring urinary calcium excretion

Pregnancy

Not indicated for females of reproductive potential

Lactation

Not indicated for females of reproductive potential