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Abaloparatide

Class
Osteoanabolic agents
Subclass
Parathyroid hormone-related protein analogs
Substance name
Abaloparatide
Brand names
Tymlos®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Osteoporosis in males with high risk for fractures
•
80 mcg SC q24h for up to 2 years
Administered into the periumbilical region.
Osteoporosis in postmenopausal females with high risk for fractures
•
80 mcg SC q24h for up to 2 years
Administered into the periumbilical region.
Indications for use
Labeled indications
Adults
•
Treatment of osteoporosis in males with high risk for fractures
•
Treatment of osteoporosis in postmenopausal females with high risk for fractures
Safety risks
Contraindications
Hypersensitivity to abaloparatide or its components
High risk for osteosarcoma
•
Avoid using abaloparatide in patients with open epiphyses, 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 radiotherapy involving the skeleton, or hereditary disorders predisposing to osteosarcoma.
Hypercalcemia
•
Avoid using abaloparatide in patients with pre-existing hypercalcemia or an underlying hypercalcemic disorder, such as primary hyperparathyroidism, as abaloparatide may exacerbate hypercalcemia.
Warnings and precautions
Exacerbation of urolithiasis
•
Use caution in patients with active or recent history of urolithiasis. Consider measuring urinary calcium excretion in patients with suspected active urolithiasis or pre-existing hypercalciuria.
Orthostatic hypotension
•
Maintain a high level of suspicion, as abaloparatide may cause orthostatic hypotension, especially during the first four hours. Administer initial doses of under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Not intended for use in females of childbearing potential.
Breastfeeding
Not intended for use in females of childbearing potential.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
↑ urine calcium, injection site reactions
Common 1-10%
•
Contusion, ↑ serum calcium, diarrhea, abdominal distension, epigastric pain, fatigue, ↑ serum uric acid, arthralgia, orthostatic hypotension, abdominal pain, vertigo, tachycardia, bone pain, dizziness, headache, nausea, palpitations, urolithiasis
Unknown frequency
•
Anaphylaxis, constipation, vomiting, asthenia, lethargy, malaise, insomnia, dyspnea, itching, skin rash, pain in extremity, back pain, muscle spasms
Interactions
Drug(s)
Check Interactions
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