Tymlos 3.12 mg/1.56mL
abaloparatide · INJECTION, SOLUTION · Radius Health, Inc.
Tymlos is a injection, solution containing abaloparatide at 3.12 mg/1.56mL, taken subcutaneous. Manufactured by Radius Health, Inc..
Key Facts
- Brand Name
- Tymlos
- Generic Name
- abaloparatide
- NDC Code (Product)
70539-001- Manufacturer
- Radius Health, Inc.
- Strength
- 3.12 mg/1.56mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA208743
- Drug Class
- Parathyroid Hormone-Related Peptide Analog [EPC]
- Marketing Start
- 05/01/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.1 ) Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.2 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. 1.2 Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture TYMLOS is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple ris…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. ( 2.1 ) Administer as a subcutaneous injection into periumbilical region of abdomen. ( 2.2 ) Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur. ( 2.2 , 5.2 ) 2.1 Recommended Dosage The recommended dosage of TYMLOS is 80 mcg administered subcutaneously once daily. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. 2.2 Administration Instructions Administer TYMLOS as a subcutaneous 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 intravenously or intramuscularly. Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . Visually inspect TYMLOS for particulate matter and discoloration prior to administration. TYMLOS is a clear and colorless sol…
Contraindications
4 CONTRAINDICATIONS 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 [see Adverse Reactions ( 6.2 )] . Known hypersensitivity to TYMLOS. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No specific drug-drug interaction studies have been performed [see Clinical Pharmacology ( 12.3 )] .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Orthostatic Hypotension [see Warnings and Precautions ( 5.2 )] Hypercalcemia [see Warnings and Precautions ( 5.3 )] Hypercalciuria and Urolithiasis [see Warnings and Precautions ( 5.4 )] Osteoporosis in postmenopausal women: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo. ( 6.1 ) Osteoporosis in men: The most common adverse reactions (incidence ≥2%) are injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Radius Health, Inc. at 1-855-672-3487 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Adverse Reacti…
Frequently Asked Questions
What is Tymlos used for?
Tymlos contains abaloparatide. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Tymlos a controlled substance?
Tymlos is not classified as a controlled substance by the DEA.
What is the generic name for Tymlos?
The generic name for Tymlos is abaloparatide. There are no other listed brand versions of abaloparatide.
What is the NDC code for Tymlos 3.12 mg/1.56mL?
The NDC (National Drug Code) for Tymlos 3.12 mg/1.56mL is 70539-001, listed by Radius Health, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)