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LYSTEDA^® (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding. Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.

LYSTEDA is indicated for women of reproductive age and is not intended for use in premenarcheal girls. LYSTEDA has not been studied in adolescents under age 18 with heavy menstrual bleeding.

Important Safety Information

Do not prescribe LYSTEDA to women who are known to have: active thromboembolic disease, a history of thrombosis or thromboembolism, including retinal vein or artery occlusion, an intrinsic risk of thrombosis or thromboembolism. Venous and arterial thrombosis or thromboembolism, and retinal artery and retinal vein occlusions, have been reported with tranexamic acid.

Do not prescribe LYSTEDA to women with known hypersensitivity to tranexamic acid.

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. Women using hormonal contraception, especially those who are obese or smoke, should use LYSTEDA only if there is a strong medical need and the treatment benefit will outweigh the potential increased risk of a thrombotic event. Do not use LYSTEDA in women who are taking more than the approved dose of a hormonal contraceptive.

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.

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.

Retinal venous and arterial occlusion has been reported in patients using tranexamic acid. Immediately discontinue LYSTEDA if visual or ocular symptoms occur.

In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention. A case of severe allergic reaction (dyspnea, tightening of the throat, and facial flushing) to LYSTEDA was reported in clinical trials and a case of anaphylactic shock was reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid.

Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.

Ligneous conjunctivitis also has been reported in patients taking tranexamic acid which resolved with drug discontinuation.

The most common adverse reactions in clinical trials (≥ 5% and more frequent in LYSTEDA subjects compared to placebo subjects) were: headache, nasal and sinus symptoms, back pain, abdominal pain, musculoskeletal pain, arthralgia, muscle cramps and spasms, migraine, anemia, and fatigue.

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