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Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of LYSTEDA in the treatment of heavy menstrual bleeding (HMB) was studied in two randomized, double-blind, placebo-controlled studies [see Clinical Studies]. One study compared the effects of two doses of LYSTEDA (1950 mg and 3900 mg given daily for up to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304 women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of LYSTEDA. A second study compared the effects of LYSTEDA (3900 mg/day) versus placebo over a 6-cycle treatment duration. A total of 196 women were randomized to this study, with 117 receiving at least one dose of LYSTEDA. In both studies, subjects were generally healthy women who had menstrual blood loss of ≥ 80 mL.
In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m² . On average, subjects had a history of HMB for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin. Women using hormonal contraception were excluded from the trials.
The rates of discontinuation due to adverse events during the two clinical trials were comparable between LYSTEDA and placebo. In the 3-cycle study, the rate in the 3900 mg LYSTEDA dose group was 0.8% as compared to 1.4% in the placebo group. In the 6-cycle study, the rate in the LYSTEDA group was 2.4% as compared to 4.1% in the placebo group. Across the studies, the combined exposure to 3900 mg/day LYSTEDA was 947 cycles and the average duration of use was 3.4 days per cycle.
A list of adverse events occurring in ≥ 5% of subjects and more frequently in LYSTEDA treated subjects receiving 3900 mg/day compared to placebo is provided in Table 2.
Table 2: Adverse Events Reported by ≥ 5% of
Subjects Treated with LYSTEDA and More Frequently in LYSTEDA-treated Subjects
|LYSTEDA 3900 mg/day
|Total Number of Adverse Events||1500||923|
|Number of Subjects with at Least One Adverse Event||208 (89.7%)||122 (87.8%)|
|HEADACHEa||117 (50.4%)||65 (46.8%)|
|NASAL & SINUS SYMPTOMSb||59 (25.4%)||24 (17.3%)|
|BACK PAIN||48 (20.7%)||21 (15.1%)|
|ABDOMINAL PAINc||46 (19.8%)||25 (18.0%)|
|MUSCULOSKELETAL PAINd||26 (11.2%)||4 (2.9%)|
|ARTHRALGIe||16 (6.9%)||7 (5.0%)|
|MUSCLE CRAMPS & SPASMS||15 (6.5%)||8 (5.8%)|
|MIGRAINE||14 (6.0%)||8 (5.8%)|
|ANEMIA||13 (5.6%)||5 (3.6%)|
|FATIGUE||12 (5.2%)||6 (4.3%)|
|aIncludes headache and tension headache
bNasal and sinus symptoms include nasal, respiratory tract and sinus congestion, sinusitis, acute sinusitis, sinus headache, allergic sinusitis and sinus pain, and multiple allergies and seasonal allergies
cAbdominal pain includes abdominal tenderness and discomfort
dMusculoskeletal pain includes musculoskeletal discomfort and myalgia
eArthralgia includes joint stiffness and swelling
Long-term safety of LYSTEDA was studied in two open-label studies. In one study, subjects with physician-diagnosed heavy menstrual bleeding (not using the alkaline hematin methodology) were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 27 menstrual cycles. A total of 781 subjects were enrolled and 239 completed the study through 27 menstrual cycles. A total of 12.4% of the subjects withdrew due to adverse events. Women using hormonal contraception were excluded from the study. The total exposure in this study to 3900 mg/day LYSTEDA was 10,213 cycles. The average duration of LYSTEDA use was 2.9 days per cycle.
A long-term open-label extension study of subjects from the two short-term efficacy studies was also conducted in which subjects were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 9 menstrual cycles. A total of 288 subjects were enrolled and 196 subjects completed the study through 9 menstrual cycles. A total of 2.1% of the subjects withdrew due to adverse events. The total exposure to 3900 mg/day LYSTEDA in this study was 1,956 cycles. The average duration of LYSTEDA use was 3.5 days per cycle.
The types and severity of adverse events in these two long-term open-label trials were similar to those observed in the double-blind, placebo-controlled studies although the percentage of subjects reporting them was greater in the 27-month study, most likely because of the longer study duration.
A case of severe allergic reaction to LYSTEDA was reported in the extension trial, involving a subject on her fourth cycle of treatment, who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.
The following adverse reactions have been identified from postmarketing experience with tranexamic acid. 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.
Based on US and worldwide postmarketing reports, the following have been reported in patients receiving tranexamic acid for various indications:
- Nausea, vomiting, and diarrhea
- Allergic skin reactions
- Anaphylactic shock and anaphylactoid reactions
- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives
- Impaired color vision and other visual disturbances
Read the Lysteda (tranexamic acid tablets) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies were conducted with LYSTEDA.
Because LYSTEDA is antifibrinolytic, concomitant use of hormonal contraception and LYSTEDA may further exacerbate the increased thrombotic risk associated with combination hormonal contraceptives. For this reason, concomitant use of LYSTEDA with combination hormonal contraceptives is contraindicated [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Tissue Plasminogen Activators
Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both LYSTEDA and tissue plasminogen activators. Therefore, exercise caution if a woman taking LYSTEDA therapy requires tissue plasminogen activators.
Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates
LYSTEDA is not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
All-Trans Retinoic Acid (Oral Tretinoin)
Exercise caution when prescribing LYSTEDA to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Read the Lysteda Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/25/2013
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