Abaloparatide
TYMLOS
What it isPTH-related peptide analog stimulating bone formation; severe osteoporosis.
Why this oneCompared with teriparatide, it retains anabolic fracture benefit with less hypercalcemia.
What limits itDaily injection is time-limited, and gains are lost unless an antiresorptive follows. Post-dose orthostasis can end treatment.
FDA-approved for
- osteoporosis (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Osteoporosis at high fracture risk (postmenopausal women; men) | adult | 80 mcg SC QD | 80 mcg SC QD | 80 mcg/day |
Renal No dosage adjustment for mild–severe impairment; monitor for adverse reactions in severe impairment.
Hepatic Undefined
Cumulative use beyond 2 years during a patient's lifetime is not recommended.
Instructions
- Inject subcutaneously into the periumbilical abdomen; rotate site daily and give at about the same time each day.
- Administer the first several doses where the patient can sit or lie down (orthostatic hypotension).
- Do not administer intravenously or intramuscularly.
- Give supplemental calcium and vitamin D if dietary intake is inadequate.
Cautions
- Hypersensitivity reactions (anaphylaxis, angioedema, urticaria)
- Osteosarcoma risk — avoid in patients at increased baseline risk (open epiphyses, Paget's, prior skeletal radiation, bone metastases/malignancy, hereditary predisposition)
- Orthostatic hypotension (typically within 4 h of injection)
- Hypercalcemia — avoid in pre-existing hypercalcemia or primary hyperparathyroidism
- Hypercalciuria and urolithiasis
Adverse reactions
- Postmenopausal women (≥2%): hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, vertigo
- Men (≥2%): injection-site erythema/swelling/pain, dizziness, arthralgia, contusion, nausea, diarrhea, abdominal distension/pain, bone pain
Pregnancy Not indicated for females of reproductive potential; no human data.
Lactation Not indicated for females of reproductive potential; no data on presence in human milk.
NO BOXED WARNINGS
Principal riskGain is lost unless an antiresorptive follows
Cost, est. cash$100–$5,000/month
Generic entry2040 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Abaloparatide ballicule
