Abaloparatide Dosage: The FDA Label Schedule
Abaloparatide dosage exactly as the FDA label states it: 80 mcg once daily, the 2-year duration limit, and who should not use it.
The short version
Abaloparatide has one approved dose: 80 mcg by subcutaneous injection once daily, from a prefilled pen. Teriparatide's lifetime-use cap was removed in 2020, but abaloparatide's label still recommends against use beyond 2 years, because safety and efficacy past that point have not been evaluated. None of this applies to an unlabelled "research" vial, which has no FDA-reviewed dose at all.
- 80 mcg once daily, subcutaneous injection, from a prefilled pen. It is the only approved dose.
- No titration: the dose does not change during treatment.
- The label recommends against more than 2 years of lifetime treatment, because longer use has not been evaluated.
- The pen is injected into the periumbilical region of the abdomen, with the site rotated daily.
Abaloparatide dosage chart
The FDA-approved Abaloparatide product is dosed as its label directs and a prescriber sets the dose. For vials that need mixing, this is each label dose in units on a U-100 insulin syringe, by vial size.
3 mg vialwith 2 mL water
| Dose | Units | Volume | Doses per vial |
|---|---|---|---|
| 80 mcg | 5.5 units | 0.055 mL | 37 |
U-100 insulin syringe (100 units = 1 mL), to the nearest half unit. Arithmetic only. Other numbers: peptide calculator.
Abaloparatide dosage has one approved number. This page states the label’s dose, duration limit and administration instructions. For what it is approved for and its full safety profile, see the abaloparatide guide.
US legal status - FDA-approved · prescription only
FDA-approved as Tymlos, requiring a prescriber who sets and monitors the treatment course.
AU legal status - Not on the ARTG
I could not verify a Therapeutic Goods Administration approval for abaloparatide.
Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.
Abaloparatide dosage: the FDA-approved schedule
The dose is 80 mcg by subcutaneous injection once daily, from a prefilled pen. There is no titration: the dose does not change during treatment, and no other dose is approved for any indication.
How it’s injected
Per the label, inject subcutaneously into the periumbilical region of the abdomen, rotating the injection site each day. Give the first several doses where the patient can immediately sit or lie down, since transient hypercalcemia or orthostatic hypotension can occur shortly after injection.
Duration of use
The label states safety and efficacy have not been evaluated beyond 2 years of treatment, and use for more than 2 years during a patient’s lifetime is not recommended. FDA removed teriparatide’s equivalent limit in 2020 after real-world safety surveillance. Abaloparatide’s label still carries it.
What is not established
No dose is approved for abaloparatide outside this labelled 80 mcg schedule, and there is no established safety or efficacy data past 2 years of use. An unlabelled “research” vial with dosing instructions printed on a sheet has not gone through the review that produced this schedule. This page does not describe or endorse dosing such a product.
Who should not use it
The label advises against use in anyone at increased baseline osteosarcoma risk. That includes open epiphyses, metabolic bone diseases, bone metastases or skeletal malignancies, prior skeletal radiation therapy, and hereditary disorders predisposing to osteosarcoma. See the main guide for the trial evidence and warning language in full.
When to stop and get medical care
Seek emergency care (call 911 in the US) for signs of a severe allergic reaction, or for symptoms suggesting hypercalcemia such as nausea, confusion or severe constipation. For questions about an accidental extra dose, the US National Poison Control Center is reachable at 1-800-222-1222, free and confidential, 24 hours a day.
Related
Where to get Abaloparatide legally
Abaloparatide is an FDA-approved prescription medicine, so the legal route is a licensed prescriber, in person or by telehealth, and a licensed pharmacy.
How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.
Common questions
What is the usual abaloparatide dose?
80 mcg once daily by subcutaneous injection from a prefilled pen, per the FDA label for Tymlos. It is a single fixed dose with no titration schedule.
Is there an FDA-approved abaloparatide dose?
Yes. 80 mcg once daily subcutaneously is the only approved dose. It covers both approved uses: osteoporosis at high fracture risk in postmenopausal women, and in men.
How long can I take abaloparatide?
The label states safety and efficacy have not been evaluated beyond 2 years of treatment, and use for more than 2 years during a lifetime is not recommended. Unlike teriparatide's, this limit has not been removed from the label.
Where do I inject abaloparatide?
The label directs injecting into the periumbilical region of the abdomen, rotating the site each day. It is not injected into the thigh or arm, as some other daily-injection peptides are.
Who should not use abaloparatide?
The label advises against use in anyone at increased baseline osteosarcoma risk. That includes open epiphyses, metabolic bone diseases (including Paget's disease), bone metastases or skeletal malignancies, prior skeletal radiation therapy, and hereditary disorders predisposing to osteosarcoma. A prescriber who knows the full medical history should make this call.
References (2 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.TYMLOS (abaloparatide) injection - full prescribing information, including the 80 mcg daily dose, injection-site instructions and the 2-year duration limit.- DailyMed, US National Library of Medicinelabel
- 2.National Poison Control Center - 1-800-222-1222, free and confidential.- America's Poison Centersother