zziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary [see Adverse Reactions (6.1)].
5.3 Hypercalcemia
TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia [see Adverse Reactions (6.1)].
5.4 Hypercalciuria and Urolithiasis
TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered [see Adverse Reactions (6.1)].
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)]
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.
Postmenopausal Women with Osteoporosis
The safety of TYMLOS was eva luated in a randomized, multicenter, double-blind, placebo-controlled clinical trial in postmenopausal women with osteoporosis aged 49 to 86 years (mean age 69 years) who were randomized to receive 80 mcg of TYMLOS (N = 824) or placebo (N = 821), given subcutaneously once daily for 18 months [see Clinical Studies (14)].
In this study, the incidence of all-cause mortality was 0.4% in the TYMLOS group and 0.6% in the placebo group. The incidence of serious adverse events was 10% in the TYMLOS group and 11% in the placebo group. The percentage of patients who discontinued study drug due to adverse events was 10% in the TYMLOS group and 6% in the placebo group. The most common adverse reactions leading to study drug discontinuation in the TYMLOS group were nausea (2%), dizziness (1%), headache (1%), and palpitations (1%).
TABLE 1 shows the most common adverse reactions in the trial. These adverse reactions were generally not present at baseline, occurred more commonly with TYMLOS than with placebo, and occurred in at least 2% of the patients treated with TYMLOS.
Table 1: Common Adverse Reactions Reported in Postmenopausal Women with Osteoporosis*
*Adverse reactions reported in ≥2% of TYMLOS-treated patients.
Preferred term TYMLOS
(N=822)
(%) Placebo
(N=820)
(%)
Hypercalciuria 11 9
Dizziness 10 6
Nausea 8 3
Headache 8 6
Palpitations 5 0.4
Fatigue 3 2
Abdominal pain upper 3 2
Vertigo 2 2
Orthostatic Hypotension
In the clinical trial of women with postmenopausal osteoporosis, the incidence of orthostatic blood pressure decline ≥20 mmHg systolic or ≥10 mmHg diastolic at 1 hou |
