Dosing & Uses
Dosage Forms & Strengths
solution for SC injection
- 80mcg/40mcL (prefilled pen delivers 30 daily doses of 80mcg)
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 qDay
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 qDay
Dosage Modifications
Renal impairment
- Mild or moderate: No dosage adjustment 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
Dosing Considerations
Cumulative use of abaloparatide and parathyroid hormone (PTH) analogs for >2 yr not recommended
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate
Safety and efficacy not established
Adverse Effects
>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%)
Postmarketing Reports
Abdominal distension, abdominal pain
Constipation, diarrhea, vomiting
Asthenia, lethargy, malaise
Insomnia
Hypersensitivity and anaphylactic reactions, dyspnea (in the context of allergic reactions)
Pruritus, rash
Generalized pain and pain in bone, joint, back, and extremity
Muscle spasms of the leg and back
Injection site reactions including bruising, hemorrhage, pruritus, and rash
Warnings
Contraindications
History of systemic hypersensitivity to drug or components of product formulation
Cautions
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
Osteosarcoma
- Dose-dependent increase in incidence of osteosarcoma in rats observed; unknown whether it will occur in humans
- Osteosarcoma reported in post-marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans
- There are limited data assessing the risk of osteosarcoma beyond 2 years of this drug and/or use of a PTH-analog; therapy >2 years not recommended
-
Avoid use in the following patients
- Open epiphyses (pediatric and young adult patients) (not approved in pediatric patients)
- Metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone
- Bone metastases or a history of skeletal malignancies
- Prior external beam or implant radiation therapy involving the skeleton
- Hereditary disorders predisposing to osteosarcoma
Pregnancy
Pregnancy
Not indicated for females of reproductive potential
Lactation
Not indicated for females of reproductive potential
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
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
Absorption
Absolute bioavailability: 36%
Peak plasma time: 0.51 hr
Peak plasma concentration: 312 pg/mL
AUC: 1622 pg·hr/mL
Distribution
Protein bound: 70%
Vd: ~50 L
Metabolism
No specific metabolism or excretion studies have been performed
Metabolism is consistent with nonspecific proteolytic degradation into smaller peptide fragments, followed by elimination by renal clearance
Elimination
Half-life: 1.7 hr
Excretion: Primarily in urine
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
Storage
Before first use: Refrigerate between 2-8°C (36-46°F)
After first use: Store for up to 30 days at 20-25°C (68-77°F)
Do not freeze or subject to heat
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Formulary
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