Brand Name

Tymlos

Generic Name
Abaloparatide
View Brand Information
FDA approval date: May 01, 2017
Classification: Parathyroid Hormone-Related Peptide Analog
Form: Injection

What is Tymlos (Abaloparatide)?

As we age, our bones naturally lose strength, a process that can lead to osteoporosis, a condition marked by weak, fragile bones that fracture easily. For many postmenopausal women and some men, the fear of a hip or spine fracture can affect daily confidence and mobility. Tymlos (abaloparatide) offers a proactive solution, helping rebuild bone and reduce the risk of serious fractures.

Tymlos belongs to a class of medications known as parathyroid hormone, related protein (PTHrP) analogs. It’s designed to stimulate new bone formation rather than merely slowing bone loss, making it a valuable option for those at high risk of fractures. Approved by the U.S. Food and Drug Administration (FDA) in 2017, Tymlos represents an important advancement in osteoporosis treatment, especially for patients who haven’t responded well to other therapies.

What does Tymlos do?

Tymlos is prescribed primarily for:

  • Postmenopausal women with osteoporosis who are at high risk for bone fractures
  • Men with osteoporosis, in certain cases, who have not improved with other treatments or cannot tolerate them

Unlike traditional osteoporosis medications that prevent further bone breakdown, Tymlos actively stimulates bone growth, improving both bone density and strength.

In clinical studies, Tymlos significantly reduced the risk of spine and non-spine fractures, including hip fractures, over an 18-month treatment period (FDA, 2017; Miller et al., 2018).

Patients who complete a Tymlos course often transition to a bone-protective maintenance medication, such as a bisphosphonate, to preserve their new bone mass.

For many, Tymlos can mean fewer fractures, greater independence, and renewed confidence in daily activities.

How does Tymlos work?

Healthy bones are constantly being remodeled, old bone tissue breaks down, and new bone forms. In osteoporosis, bone breakdown happens faster than new bone growth, leading to thinning and fragility.

Tymlos (abaloparatide) mimics the natural parathyroid hormone-related protein (PTHrP), which plays a key role in regulating calcium and bone metabolism.

When Tymlos is injected, it binds to specific receptors in bone cells, triggering the body to build new bone tissue. This process increases bone mineral density (BMD) and strengthens the bone’s microstructure, reducing fracture risk.

Clinically, this mechanism matters because it directly addresses the underlying problem in osteoporosis, insufficient bone formation rather than merely slowing bone loss.

Tymlos side effects

Like all medications, Tymlos can cause side effects. Most are mild to moderate and improve as the body adjusts to treatment.

Common side effects include:

  • Dizziness or lightheadedness (especially after injection)
  • Nausea
  • Headache
  • Fatigue
  • Increased heart rate shortly after injection

Less common side effects:

  • Joint or muscle pain
  • Redness, swelling, or itching at the injection site
  • Mild increase in calcium levels in blood or urine

Serious but rare side effects:

  • Orthostatic hypotension: a sudden drop in blood pressure when standing up
  • Hypercalcemia (high calcium levels): may cause weakness, confusion, or irregular heartbeat
  • Osteosarcoma (bone cancer): seen in animal studies with long-term use, though not observed in humans at therapeutic doses

Because of this theoretical cancer risk, Tymlos should not be used for more than two years during a patient’s lifetime (FDA, 2024).

Who should avoid Tymlos:

  • Individuals with a history of bone cancer, radiation exposure to bones, or metabolic bone diseases other than osteoporosis
  • Patients with unexplained high calcium levels or Paget’s disease

If dizziness occurs, patients should sit or lie down immediately after injection and rise slowly. Healthcare providers can help manage side effects or adjust timing to improve tolerance.

Tymlos dosage

Tymlos is given as a once-daily injection under the skin (subcutaneous), usually in the abdomen. The medication comes in a prefilled injection pen that patients can use at home after proper instruction from their healthcare provider.

To maintain its bone-building benefits, Tymlos should be used continuously for up to two years, followed by a transition to another antiresorptive medication (like alendronate or denosumab) to maintain gains in bone density.

Monitoring: During treatment, your doctor may:

  • Measure bone mineral density (BMD) using a DEXA scan
  • Monitor calcium levels in blood and urine
  • Evaluate for dizziness or blood pressure changes after injections
  • Review your progress and decide when to switch to a maintenance therapy

For older adults or those with kidney problems, healthcare providers may monitor more closely, though Tymlos is generally well tolerated in these populations.

Patients should avoid injecting immediately before bedtime or driving until they know how the medication affects them.

Does Tymlos have a generic version?

As of 2025, Tymlos (abaloparatide) does not have an FDA-approved generic version. However, international versions may exist in other markets. Tymlos is a patented, brand-name medication manufactured by Radius Health (now part of Gurnet Point Capital and Patriot Biotech).

Generic or biosimilar forms may become available once patent exclusivity expires, but for now, Tymlos is the only brand of abaloparatide approved in the United States.

Some patients may qualify for manufacturer assistance programs or insurance coverage options that help reduce out-of-pocket costs. Your healthcare provider or pharmacist can guide you to available financial support resources.

Conclusion

Tymlos (abaloparatide) is an innovative osteoporosis treatment that helps rebuild bone from within, reducing the risk of fractures and improving bone strength. By mimicking natural bone-forming hormones, it provides a unique and powerful approach for patients at high fracture risk or those who haven’t responded to traditional therapies.

Although side effects such as dizziness or nausea may occur, most are manageable and temporary. With proper training, regular monitoring, and adherence to your doctor’s plan, Tymlos can play a crucial role in restoring bone health and confidence.

When prescribed and monitored by a qualified healthcare professional, Tymlos is a safe and effective therapy that empowers patients to take control of their bone health and maintain an active, independent lifestyle.

References

  1. U.S. Food and Drug Administration (FDA). (2024). Tymlos (abaloparatide) – Prescribing Information. https://www.fda.gov/
  2. Mayo Clinic. (2024). Abaloparatide (subcutaneous route): Description and side effects. https://www.mayoclinic.org/
  3. National Institutes of Health (NIH). (2024). Osteoporosis: Overview and management. https://www.nih.gov/

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Brand Information

Tymlos (abaloparatide)
1DOSAGE FORMS AND STRENGTHS
Injection: 3120 mcg/1.56 mL (2000 mcg/mL) of abaloparatide in clear, colorless solution in a single-patient-use prefilled pen. The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL.
2CONTRAINDICATIONS
TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria
3ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections:
  • Orthostatic Hypotension
  • Hypercalcemia
  • Hypercalciuria and Urolithiasis
3.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during the post-approval use of TYMLOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Abdominal distension, abdominal pain, abdominal discomfort
  • Constipation, diarrhea, vomiting, decreased appetite
  • Asthenia, lethargy, malaise, feeling abnormal, hot flush
  • Insomnia
  • Hypersensitivity and anaphylactic reactions, dyspnea (in the context of allergic reactions)
  • Pruritus, rash
  • Generalized pain and pain in bone, joint, back, and extremity
  • Blood pressure increased
  • Muscle spasms of the leg and back
  • Injection site reactions including bruising, hemorrhage, pruritus, and rash
4DRUG INTERACTIONS
No specific drug-drug interaction studies have been performed
5OVERDOSAGE
In a clinical study, accidental overdose was reported in a patient who received 400 mcg in one day (5 times the recommended clinical dose); dosing was temporarily interrupted. The patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but on the following day the patient's serum calcium was within the normal range. The effects of overdose may include hypercalcemia, nausea, vomiting, dizziness, tachycardia, orthostatic hypotension, and headache.
6DESCRIPTION
TYMLOS injection for subcutaneous administration contains abaloparatide, a synthetic 34 amino acid peptide. Abaloparatide is an analog of human parathyroid hormone related peptide, PTHrP(1-34). It has 41% homology to hPTH(1-34) (human parathyroid hormone 1-34) and 76% homology to hPTHrP(1-34) (human parathyroid hormone-related peptide 1-34).
Abaloparatide has a molecular formula of C
  • Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH
TYMLOS injection is supplied as a sterile, colorless, clear solution in a glass cartridge which is pre-assembled into a disposable single-patient-use pen. The pen is intended to deliver 30 once daily abaloparatide doses of 80 mcg in 40 mcL. Each cartridge contains 1.56 mL of TYMLOS solution which contains 3.12 mg of abaloparatide, and the following inactive ingredients: 1.2 mg glacial acetic acid, 7.8 mg phenol, 7.92 mg sodium acetate trihydrate, and water for injection to a target pH range of 5.1 to 5.2.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
8PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Label
NDC 70539-001-01
Read Instructions for Use BEFORE injecting.
Date of first use ________/________/________.
TYMLOS
80 mcg per dose
For subcutaneous use
Lot:
PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Label
9PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box
NDC 70539-001-02
TYMLOS
80 mcg per dose
For subcutaneous use
Rx only
1 prefilled pen
Each prefilled pen will deliver
Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box
10PRINCIPAL DISPLAY PANEL - Sample 80 mcg Prefilled Pen Label
NDC 70539-001-99
Read Instructions for Use BEFORE injecting.
Date of first use ________/________/________.
TYMLOS
SAMPLE—NOT FOR SALE
80 mcg per dose
For subcutaneous use
Lot:
PRINCIPAL DISPLAY PANEL - Sample 80 mcg Prefilled Pen Label
11PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box - Sample
NDC 70539-001-98
TYMLOS
80 mcg per dose
For subcutaneous use
Sterile
Rx only
1 prefilled pen
Each prefilled pen will deliver
Dispense the enclosed
PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box - Sample