tal hip and femoral neck, each with p<0.0001 (TABLE 3). Similar findings were seen following 6 months of alendronate treatment in Study 005 (TABLE 3).
Table 3: Mean Percent Changes in Bone Mineral Density (BMD) From Baseline to Endpoint in Postmenopausal Women with Osteoporosis (Intent to Treat Population)* † ‡
* Includes patients randomized in Study 003
† Includes patients enrolled in Study 005
‡Last-observation-carried-forward
§Confidence Interval
TYMLOS
(N=824*)
(%) Placebo
(N=821*)
(%) Treatment Difference (%)
(95% CI§)
18 Months
Lumbar Spine 9.2 0.5 8.8 (8.2, 9.3)
Total Hip 3.4 -0.1 3.5 (3.3, 3.8)
Femoral Neck 2.9 -0.4 3.3 (3.0, 3.7)
TYMLOS/ Alendronate (N=558†) (%) Placebo/ Alendronate (N=581†) (%)
25 Months
Lumbar Spine 12.8 3.5 9.3 (8.6, 10.1)
Total Hip 5.5 1.4 4.1 (3.7, 4.5)
Femoral Neck 4.5 0.5 4.1 (3.6, 4.6)
TYMLOS demonstrated consistent increases in BMD regardless of age, years since menopause, race, ethnicity, geographic region, presence or absence of prior fracture (vertebral, nonvertebral), and BMD at baseline.
Effect on Bone Histology
Bone biopsy specimens were obtained from 71 patients with osteoporosis after 12 – 18 months of treatment (36 in the TYMLOS group and 35 in the placebo group). Of the biopsies obtained, 55 were adequate for quantitative histomorphometry assessment (27 in the TYMLOS group and 28 in the placebo group). Qualitative and quantitative histology assessment showed normal bone architecture and no evidence of woven bone, marrow fibrosis, or mineralization defects.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TYMLOS injection is supplied as a pre-assembled single-patient-use disposable pen (NDC 70539-001-01) packaged in a cardboard carton (NDC 70539-001-02) with the INSTRUCTIONS FOR USE and MEDICATION GUIDE. Each disposable pen embodies a glass cartridge that contains 3120 mcg of abaloparatide in 1.56 mL (2000 mcg/mL) of sterilized, clear, colorless fluid. Each pen provides a 30-day supply for once daily injection of 80 mcg abaloparatide in 40 mcL.
Sterile needles are not included.
16.2 Storage and Handling
Before first use, store TYMLOS in a refrigerator between 2°C to 8°C (36°F to 46°F).
After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F).
Do not freeze or subject to heat.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (MEDICATION GUIDE and INSTRUCTIONS FOR USE).
Risk of Osteosarcoma
Advise patients that the active ingredient in TYMLOS, abaloparatide, caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats and that it is unknown whether TYMLOS will cause osteosarcoma in humans [see Warnings and Precautions (5.1)].
Instruct patients to promptly report signs and symptoms of possible osteosarcoma such as persistent localized pain or occurrence of a new soft tissue mass that is tender to palpation.
Hypercalcemia
Advise patients that TYMLOS may cause hypercalcemia and discuss the symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, muscle weakness) [see Warnings and Precautions (5.3)].
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