Abaloparatide
Indications
Abaloparatide is used for:
Osteoporosis
Adult Dose
Subcutaneous injection
Osteoporosis
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
80 mcg SC once daily
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
80 mcg SC once daily
Child Dose
Renal Dose
Renal impairment
Mild or moderate: No dosage adjustment is required
Severe: No dosage adjustment required; severe renal impairment may have increased abaloparatide systemic exposure and increased risk of adverse reactions; therefore, monitor for adverse reactions
Administration
SC Preparation
Clear and colorless solution
Visually inspect for particulate matter and discoloration prior to administration
Do not use if solid particles appear or if the solution is cloudy or colored
Provide appropriate training and instruction to patients and caregivers on the proper use of the pen
SC Administration
Administer as a SC injection into the periumbilical region of the abdomen
Rotate the site of the injection every day and administer at approximately the same time every day
Do not administer IV or IM
Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur
Contra Indications
History of systemic hypersensitivity to drug or components of product formulation.
Precautions
Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown if Abaloparatide will cause osteosarcoma in humans.
The use of Abaloparatide is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
Cumulative use of Abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.
Pregnancy-Lactation
Pregnancy
Not indicated for females of reproductive potential
Lactation
Not indicated for females of reproductive potential
Interactions
No specific drug-drug interaction studies have been performed.
Adverse Effects
Side effects of Abaloparatide :
>10%
Women
Injection site redness (58%)
Hypercalciuria (11%)
Injection site edema (11%)
Men
Injection site erythema (13%)
1-10%
Women
Dizziness (10%)
Nausea (8%)
Headache (8%)
Palpitations (5%)
Orthostatic hypotension (4%)
Fatigue (3%)
Upper abdominal pain (3%)
Hypercalcemia (3%)
Vertigo (2%)
Tachycardia (2%)
Men
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%)
Mechanism of Action
Synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP); hPTHrP is a naturally occurring hormone that, among other functions, regulates bone formation
Elicits anabolic effect on bone, demonstrated by increases in bone mineral density and content that correlated with increases in bone strength at vertebral and/or nonvertebral sites