HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.
TYMLOS™ (abaloparatide) injection, for subcutaneous use
Initial U.S. Approval: 2017
WARNING: RISK OF OSTEOSARCOMA SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in male and female rats. It is unknown whether TYMLOS will cause osteosarcoma in humans. (5.1, 13.1)
Use of TYMLOS is not recommended in patients at increased risk for osteosarcoma. (5.1)
Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. (5.1)
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. (1)
DOSAGE AND ADMINISTRATION
Recommended dose 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)
DOSAGE FORMS AND STRENGTHS
Injection: 3120 mcg/1.56 mL (2000 mcg/mL) in a single-patient-use prefilled pen. The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcL of sterile, clear, colorless solution. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Orthostatic Hypotension: Instruct patients to sit or lie down if symptoms develop after dose administration. (5.2)
Hypercalcemia: Avoid use in patients with pre-existing hypercalcemia and those known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism. (5.3)
Hypercalciuria and Urolithiasis: Monitor urine calcium if preexisting hypercalciuria or active urolithiasis are suspected. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. (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.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF OSTEOSARCOMA
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Osteosarcoma
5.2 Orthostatic Hypotension
5.3 Hypercalcemia
5.4 Hypercalciuria and Urolithiasis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and Pharmacology
14 CLINICAL STUDIES
16 HOW SUPP |
