Treatment of cyclic heavy menstrual bleeding
(Prior to prescribing LYSTEDA, exclude endometrial pathology that can be
associated with heavy menstrual bleeding)

 

 

 

 

.

Recommended Dosage:
The recommended dose of LYSTEDA for women with normal renal function is two
650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days
during monthly menstruation. LYSTEDA may be administered without regard to
meals. Tablets should be swallowed whole and not chewed or broken apart.
Renal Impairment:
In patients with renal impairment, the plasma concentration of tranexamic acid
increased as serum creatinine concertation increased. Dosage adjustment is needed
in patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).
Table 1. Dosage of LYSTEDA in Patients with Renal Impairment

 

 

 

 

 

.

Thromboembolic Risk: Do not prescribe LYSTEDA to women who are: - Using combination hormonal contraception - Known to have any of the following conditions: 1- Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) 2- A history of thrombosis or thromboembolism, including retinal vein or artery occlusion 3- An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid. Hypersensitivity to Tranexamic Acid: Do not prescribe LYSTEDA to women with known hypersensitivity to tranexamic acid

Thromboembolic Risk:
Concomitant Use of Hormonal Contraceptives
Combination hormonal contraceptives are known to increase the risk of venous
thromboembolism, as well as arterial thromboses such as stroke and myocardial
infarction. Because LYSTEDA is antifibrinolytic, the risk of venous thromboembolism,
as well as arterial thromboses such as stroke, may increase further when hormonal
contraceptives are administered with LYSTEDA. This is of particular concern in
women who are obese or smoke cigarettes, especially smokers over 35 years of age.
Women using hormonal contraception were excluded from the clinical trials
supporting the safety and efficacy of LYSTEDA, and there are no clinical trial data on
the risk of thrombotic events with the concomitant use of LYSTEDA with hormonal
contraceptives. However, there have been US postmarketing reports of venous and
arterial thrombotic events in women who have used LYSTEDA concomitantly with
combination hormonal contraceptives. For this reason, concomitant use of LYSTEDA
with combination hormonal contraceptives is contraindicated.
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.
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. 

Ocular Effects
Retinal venous and arterial occlusion has been reported in patients using tranexamic
acid. Patients should be instructed to report visual and ocular symptoms promptly. In
the event of such symptoms, patients should be instructed to discontinue LYSTEDA
immediately and should be referred to an ophthalmologist for a complete ophthalmic
evaluation, including dilated retinal examination, to exclude the possibility of retinal
venous or arterial occlusion.
Severe Allergic Reaction:
A case of severe allergic reaction to LYSTEDA was reported in the clinical trials,
involving a subject who experienced dyspnea, tightening of her throat, and facial
flushing that required emergency medical treatment. A case of anaphylactic shock
has also been reported in the literature, involving a patient who received an
intravenous bolus of tranexamic acid.
Subarachnoid Hemorrhage:
Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in
women with subarachnoid hemorrhage.
Ligneous Conjunctivitis:
Ligneous conjunctivitis has been reported in patients taking tranexamic acid. The conjunctivitis resolved following cessation of the drug.

Not drug-drug interaction studies were conducted with LYSTEDA 

Hormonal Contraceptives:
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.
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
women 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.
All-Trans Retinoic Acid (Oral Tretinoin):
In a study involving 28 patients with acute promyelocytic leukemia who were given
either orally administered all-trans retinoic acid plus intravenously administered
tranexamic acid, all-trans retinoic acid plus chemotherapy, or all-trans retinoic acid
plus tranexamic acid plus chemotherapy, all 4 patients who were given all-trans
retinoic acid plus tranexamic acid died, with 3 of the 4 deaths due to thrombotic
complications. It appears that the procoagulant effect of all-trans retinoic acid may be
exacerbated by concomitant use of tranexamic acid. Therefore, 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.
 

Pregnancy (Category B) and Fertility:
LYSTEDA is not indicated for use in pregnant women. Reproduction studies have
been performed in mice, rats and rabbits and have revealed no evidence of impaired
fertility or harm to the fetus due to tranexamic acid. However, tranexamic acid is
known to cross the placenta and appears in cord blood at concentrations
approximately equal to the maternal concentration. There are no adequate and wellcontrolled
studies in pregnant women.
An embryo-fetal developmental toxicity study in rats and a perinatal developmental
toxicity study in rats were conducted using tranexamic acid. No adverse effects were
observed in either study at doses up to 4 times the recommended human oral dose
of 3900 mg/day based on mg/m2 (actual animal dose 1500 mg/kg/day).
Lactation:
Tranexamic acid is present in the mother’s milk at a concentration of about one
hundredth of the corresponding serum concentration. LYSTEDA should be used
during lactation only if clearly needed.
Paediatric Use:
LYSTEDA is indicated for women of reproductive age and is not intended for use in
premenarcheal girls. Based on a pharmacokinetic study in 20 adolescent females, 12
to 16 years of age, no dose adjustment is needed in the adolescent population.
Geriatric Use:
LYSTEDA is indicated for women of reproductive age and is not intended for use by
postmenopausal women.
Renal Impairment:
The effect of renal impairment on the pharmacokinetics of LYSTEDA has not been
studied. Because tranexamic acid is primarily eliminated via the kidneys by
glomerular filtration with more than 95% excreted as unchanged in urine, dosage
adjustment in patient with renal impairment is needed.
Hepatic Impairment:
The effect of hepatic impairment on the pharmacokinetics of LYSTEDA has not been
studied. Because only a small fraction of the drug is metabolized, dosage adjustment in patients with hepatic impairment is not needed.

 

LYSTEDA has no or negligible influence on the ability to drive or use machines.

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.

Short-Term Studies
The efficacy and safety of LYSTEDA in the treatment of heavy menstrual bleeding
(HMB) was demonstrated in one 3-cycle treatment and one 6-cycle treatment,
randomized, double-blind, placebo controlled studies. In these studies, HMB was
defined in these studies as an average menstrual blood loss of ≥ 80 mL as assessed
by alkaline hematin analysis of collected sanitary products over two baseline
menstrual cycles. 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 an HMB history of 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 primary outcome measure was menstrual blood loss (MBL), measured using the
alkaline hematin method. The endpoint was the change from baseline in MBL,
calculated by subtracting the mean MBL during treatment from the mean
pretreatment MBL.
The key secondary outcome measures were based on specific questions concerning
limitations in social or leisure activities (LSLA) and limitations in physical activities
(LPA). Large stains (soiling beyond the undergarment) were also included as a key
secondary outcome measure.
- Three-Cycle Treatment Study
This 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 on MBL over a 3-cycle treatment duration. Of the 294 evaluable
subjects, 115 LYSTEDA 1950 mg/day subjects, 112 LYSTEDA 3900 mg/day
subjects and 67 placebo subjects took at least one dose of study drug and had post-treatment data available.

Results are shown in Table 2. MBL was statistically significantly reduced in
patients treated with 3900 mg/day LYSTEDA compared to placebo. Study
success also required achieving a reduction in MBL that was determined to be
clinically meaningful to the subjects. The 1950 mg/day LYSTEDA dose did not meet the criteria for success. 

 

LYSTEDA also statistically significantly reduced limitations on social, leisure,
and physical activities in the 3900 mg/day dose group compared to placebo
(see Table 3). No statistically significant treatment difference was observed in
response rates on the number of large stains 

 

a Response categories 1=not at all limited; 2=slightly limited; 3=moderately limited; 4=quite a bit limited;
5=extremely limited
b Positive means reflect an improvement from baseline
c p-value <0.05 versus placebo
d Responders are defined as subjects who experienced a reduction from baseline in frequency of large
stains
e Non-significant difference versus placebo
The rates of discontinuation due to adverse events during this clinical trial were
comparable between LYSTEDA and placebo. In this study, the rate in the 3900 mg
LYSTEDA dose group was 0.8% as compared to 1.4% in the placebo group.
- Six-Cycle Treatment Study
This study compared the effects of LYSTEDA 3900 mg/day given daily for up
to 5 days during each menstrual period versus placebo on MBL over a 6-cycle
treatment duration. Of the 187 evaluable subjects, 115 LYSTEDA subjects
and 72 placebo subjects took at least one dose of study drug and had posttreatment
data available
Results are shown in Table 4. MBL was statistically significantly reduced in
patients treated with 3900 mg/day LYSTEDA compared to placebo. Study
success also required achieving a reduction in MBL that was determined to be clinically meaningful to the subjects.

 

Limitations on social, leisure, and physical activities were also statistically
significantly reduced in the LYSTEDA group compared to placebo (see Table
5). No statistically significant treatment difference was observed in response rates on the number of large stains. 

 

a Response categories 1=not at all limited; 2=slightly limited; 3=moderately limited; 4=quite a bit limited;
5=extremely limited
b Positive means reflect an improvement from baseline
c p-value <0.05 versus placebo
d Responders are defined as subjects who experienced a reduction from baseline in frequency of large
stains
e Non-significant difference versus placebo
The rates of discontinuation due to adverse events during this clinical trial were
comparable between LYSTEDA and placebo. In this 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.
MBL Results over Time
The efficacy of LYSTEDA 3900 mg/day over 3 menstrual cycles and over 6
menstrual cycles was demonstrated versus placebo in the double-blind, placebocontrolled
efficacy studies (see Figure 1). The change in MBL from baseline was
similar across all post-baseline treatment cycles.
 

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 6. 

 

a Includes headache and tension headache
b Nasal 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
c Abdominal pain includes abdominal tenderness and discomfort
d Musculoskeletal pain includes musculoskeletal discomfort and myalgia
e Arthralgia includes joint stiffness and swelling
Long-Term Studies
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.
Post-Marketing Experience:
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

- Dizziness

 

There are no known cases of intentional overdose with LYSTEDA and no subjects in
the clinical program took more than 2 times the prescribed amount of LYSTEDA in a
24-hour period (>7800 mg/day). However, cases of overdose of tranexamic acid have
been reported. Based on these reports, symptoms of overdose may include
gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic
symptoms); thromboembolic (arterial, venous, embolic); visual impairment, mental
status changes; myoclonus; or rash. No specific information is available on the
treatment of overdose with LYSTEDA. In the event of overdose, employ the usual
supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patient’s clinical status.

Pharmacotherapeutic group: Blood and Blood Forming Organs, Antihemorrhagics,
Antifibrinolytics, Amino Acids
ATC code: B02AA02
Tranexamic acid, at in vitro concentrations of 25 – 100 M, reduces by 20 – 60% the
maximal rate of plasmin lysis of fibrin catalyzed by tissue plasminogen activator
(tPA).
Elevated concentrations of endometrial, uterine, and menstrual blood tPA are
observed in women with heavy menstrual bleeding (HMB) compared to women with
normal menstrual blood loss. The effect of tranexamic acid on lowering endometrial
tPA activity and menstrual fluid fibrinolysis is observed in women with HMB receiving tranexamic acid total oral doses of 2-3 g/day for 5 days.

In healthy subjects, tranexamic acid at blood concentrations less than 10 mg/mL has
no effect on the platelet count, the coagulation time or various coagulation factors in
whole blood or citrated blood. Tranexamic acid, however, at blood concentrations of
1 and 10 mg/mL prolongs the thrombin time.
Cardiac Electrophysiology
The effect of LYSTEDA on QT interval was evaluated in a randomized, single-dose,
4-way crossover study in 48 healthy females aged 18 to 49 years. Subjects received
(1) LYSTEDA 1300 mg (two 650 mg tablets), (2) LYSTEDA 3900 mg (six 650 mg
tablets; three times the recommended single dose), (3) moxifloxacin 400 mg, and (4)
placebo. There was no significant increase in the corrected QT interval at any time up
to 24 hours after the administration of either dose of LYSTEDA. Moxifloxacin, the
active control, was associated with a maximum 14.11 msec mean increase in
corrected QT interval (moxifloxacin – placebo) at 3 hours after administration.

Absorption:
After a single oral administration of two 650 mg tablets of LYSTEDA, the peak
plasma concentration (Cmax) occurred at approximately 3 hours (Tmax). The absolute
bioavailability of LYSTEDA in women aged 18-49 is approximately 45%. Following
multiple oral doses (two 650 mg tablets three times daily) administration of LYSTEDA
for 5 days, the mean Cmax increased by approximately 19% and the mean area under
the plasma concentration-time curve (AUC) remained unchanged, compared to a
single oral dose administration (two 650 mg tablets). Plasma concentrations reached
steady state at the 5th dose of LYSTEDA on Day 2.
The mean plasma pharmacokinetic parameters of tranexamic acid determined in 19
healthy women following a single (two 650 mg tablets) and multiple (two 650 mg
tablets three times daily for 5 days) oral dose of LYSTEDA are shown in Table 7.
Table 7. Mean (CV%) Pharmacokinetic parameters following a single (two 650 mg tablets) and
multiple oral dose (two 650 mg tablets three times daily for 5 days) administration of LYSTEDA in 19 healthy women under fasting conditions

Cmax = Maximum concentration
AUCtldc = Area under the drug concentration curve from time 0 to time of last determinable concentration
AUCinf = Area under the drug concentration curve from time 0 to infinity
Tmax = Time to maximum concentration
T1/2 = Terminal elimination half-life
aAUC0-tau (mcg.h/mL) = Area under the drug concentration curve from time 0 to 8 hours
bData preseted as median (range) Effect of food: LYSTEDA may be administered without regard to meals. A single
dose administration (two 650 mg tablets) of LYSTEDA with food increased both Cmax
and AUC by 7% and 16% respectively.
Distribution:
Tranexamic acid is 3% bound to plasma proteins with no apparent binding to
albumin. Tranexamic acid is distributed with an initial volume of distribution of 0.18
L/kg and steady-state apparent volume of distribution of 0.39 L/kg.
Tranexamic acid crosses the placenta. The concentration in cord blood after an
intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in
the maternal blood.
Tranexamic acid concentration in cerebrospinal fluid is about one tenth of the plasma
concentration.
The drug passes into the aqueous humor of the eye achieving a concentration of
approximately one tenth of plasma concentrations.
Metabolism:
A small fraction of the tranexamic acid is metabolized.
Excretion:
Tranexamic acid is eliminated by urinary excretion primarily via glomerular filtration
with more than 95% of the dose excreted unchanged. Excretion of tranexamic acid is
about 90% at 24 hours after intravenous administration of 10 mg/kg. Most elimination
post intravenous administration occurred during the first 10 hours, giving an apparent
elimination half-life of approximately 2 hours. The mean terminal half-life of
LYSTEDA is approximately 11 hours. Plasma clearance of tranexamic acid is 110- 116 mL/min. 

Specific Populations
Pregnancy (Category B)
LYSTEDA is not indicated for use in pregnant women. Tranexamic acid is known to
cross the placenta and appears in cord blood at concentrations approximately equal
to maternal concentration. There are no adequate and well-controlled studies in
pregnant women
Nursing Mothers
Tranexamic acid is present in the mother’s milk at a concentration of about one
hundredth of the corresponding serum concentrations. LYSTEDA should be used
during lactation only if clearly needed.
Pediatric Use
LYSTEDA is indicated for women of reproductive age and is not intended for use in
premenarcheal girls. In a randomized, single dose, two-way crossover study of two
dose levels (650 mg and 1,300 mg [two 650 mg tablets]), pharmacokinetics of
tranexamic acid was evaluated in 20 female adolescents (12 to 16 years of age) with
heavy menstrual bleeding. The Cmax and AUC values after a single oral dose of 650
mg in the adolescent females were 32 – 36% less than those after a single oral dose
of 1,300 mg in the adolescent females. The Cmax and AUC values after a single oral
dose of 1300 mg in the adolescent females were 20 – 25% less than those in the adult females given the same dose in a separate study.

Geriatric Use
LYSTEDA is indicated for women of reproductive age and is not intended for use by
postmenopausal women.
Renal Impairment
The effect of renal impairment on the disposition of LYSTEDA has not been
evaluated. Urinary excretion following a single intravenous injection of tranexamic
acid declines as renal function decreases. Following a single 10 mg/kg intravenous
injection of tranexamic acid in 28 patients, the 24-hour urinary fractions of tranexamic
acid with serum creatinine concentrations 1.4 – 2.8, 2.8 – 5.7, and greater than
5.7 mg/dL were 51, 39, and 19%, respectively. The 24-hour tranexamic acid plasma
concentrations for these patients demonstrated a direct relationship to the degree of
renal impairment. Therefore, dose adjustment is needed in patients with renal
impairment.
Hepatic Impairment
The effect of hepatic impairment on the disposition of LYSTEDA has not been
evaluated. One percent and 0.5 percent of an oral dose are excreted as a
dicarboxylic acid and acetylated metabolite, respectively. Because only a small
fraction of the drug is metabolized, no dose adjustment is needed in patients with hepatic impairment.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Carcinogenicity studies with tranexamic acid in male mice at doses as high as 6
times the recommended human dose of 3900 mg/day showed an increased
incidence of leukemia which may have been related to treatment. Female mice were
not included in this experiment.
The dose multiple referenced above is based on body surface area (mg/m2). Actual
daily dose in mice was up to 5000 mg/kg/day in food.
Hyperplasia of the biliary tract and cholangioma and adenocarcinoma of the
intrahepatic biliary system have been reported in one strain of rats after dietary
administration of doses exceeding the maximum tolerated dose for 22 months.
Hyperplastic, but not neoplastic, lesions were reported at lower doses. Subsequent
long-term dietary administration studies in a different strain of rat, each with an
exposure level equal to the maximum level employed in the earlier experiment, have
failed to show such hyperplastic/neoplastic changes in the liver.
Mutagenesis
Tranexamic acid was neither mutagenic nor clastogenic in the in vitro Bacterial
Reverse Mutation Assay (Ames test), in vitro chromosome aberration test in Chinese
hamster cells, and in in vivo chromosome aberration tests in mice and rats.
Impairment of Fertility
Reproductive studies performed in mice, rats and rabbits have not revealed any
evidence of impaired fertility or adverse effects on the fetus due to tranexamic acid. In a rat embryo-fetal developmental toxicity study, tranexamic acid had no adverse
effects on embryofetal development when administered during the period of
organogenesis (from gestation days 6 through 17) at doses 1, 2 and 4 times the recommended human oral dose of 3900 mg/day. In a perinatal-postnatal study in
rats, tranexamic acid had no adverse effects on pup viability, growth or development
when administered from gestation day 6 through postnatal day 20 at doses 1, 2 and
4 times the recommended human oral dose of 3900 mg/day.
The dose multiples referenced above are based on body surface area (mg/m2).
Actual daily doses in rats were 300, 750 or 1500 mg/kg/day.
Animal Toxicology and/or Pharmacology
Ocular Effects
In a 9-month toxicology study, dogs were administered tranexamic acid in food at
doses of 0, 200, 600, or 1200 mg/kg/day. These doses are approximately 2, 5, and 6
times, respectively, the recommended human oral dose of 3900 mg/day based on
AUC. At 6 times the human dose, some dogs developed reversible reddening and
gelatinous discharge from the eyes. Ophthalmologic examination revealed reversible
changes in the nictitating membrane/conjunctiva. In some female dogs, the presence
of inflammatory exudate over the bulbar conjunctival mucosa was observed.
Histopathological examinations did not reveal any retinal alteration. No adverse
effects were observed at 5 times the human dose.
In other studies, focal areas of retinal degeneration were observed in cats, dogs and
rats following oral or intravenous tranexamic acid doses at 6-40 times the
recommended usual human dose based on mg/m2 (actual animal doses between 250-1600 mg/kg/day). 

Microcrystalline Cellulose NF, Colloidal Silicon Dioxide, Pregelatinized Corn Starch, Povidone, Hypromellose, Stearic Acid and Magnesium Stearate

Not applicable.

48 Months

Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F).

LYSTEDA (tranexamic acid) tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking “FP650” and are supplied as:

 

 

 

No special precautions.