Tranexamic acid (Lysteda)

Tranexamic acid is a synthetic version of an amino acid (protein) known as lysine. Tranexamic acid stops enzymes in the body from breaking down blood clots.

Lysteda is used to treat heavy menstrual bleeding. This medication will not treat premenstrual syndrome (PMS).

Tranexamic acid may also be used for reasons not mentioned in this medication guide.

Take exactly as prescribed by your doctor. Do not take larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not start taking Lysteda until your period has started. Do not take it for longer than 5 days in a row.

Lysteda is usually taken three times per day for up to 5 days during your menstrual period. Do not take more than 6 tablets in one 24-hour period.

Take tranexamic acid with a full glass of water.

You may take Lysteda with or without food.

Do not crush, chew, or break a Lysteda tablet. Swallow it whole.

Talk with your doctor if your symptoms do not improve after 2 cycles of treatment.

Store this medication at room temperature away from moisture and heat.

You should not use this medication if you are allergic to tranexamic acid, if you have problems with the blood vessels in your eyes, or if you have ever had a stroke, blood clot, or bleeding in your brain.

Before using tranexamic acid, tell your doctor if you have kidney disease, leukemia, a history of endometriosis, or if your menstrual cycles are less than 21 days apart or longer than 35 days apart.

Do not start taking Lysteda until your period has started. Do not take it for longer than 5 days in a row. Talk with your doctor if your symptoms do not improve after 2 cycles of treatment.

Do not take more than 6 tablets in one 24-hour period.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may increase your risk of stroke, blood clot, or heart attack if they are used at the same time as Lysteda.

Do not share Lysteda with another person, even if they have the same symptoms you have.

You should not take Lysteda if you are allergic to tranexamic acid, or if you have:

• color blindness;
• problems with the blood vessels in your eyes;
• a history of stroke;
• a history of bleeding in your brain; or
• recently had a blood clot.

To make sure you can safely take Lysteda, tell your doctor if you have any of these other conditions:

• kidney disease;
• leukemia;
• a history of endometriosis; or
• if your menstrual cycles are less than 21 days apart or longer than 35 days apart.

It is not known whether tranexamic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tranexamic acid can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without your doctor's advice.

Do not share Lysteda with another person, even if they have the same symptoms you have.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Lysteda and call your doctor at once if you have a serious side effect such as:

• problems with your vision (including color vision);
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• sudden chest pain or trouble breathing;
• pain or swelling in one or both legs;
• migraine headache;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• feeling like you might pass out.

Less serious side effects include:

• mild headache;
• runny or stuffy nose;
• stomach pain;
• tired feeling;
• eye redness; or
• back pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Bleeding:

Initial dose: 10 mg/kg intravenously, immediately before dental extraction Maintenance dose: 10 mg/kg intravenously three to four times dailyDuration of therapy: 2 to 8 daysComment: Infuse no more than 1 mL/minute to avoid hypotension.Use: Short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following a tooth extraction.

Usual Adult Dose for Menstrual Disorders:

Tablets:Dose: 1300 mg (two 650 mg tablets) orally three times a day (3900 mg/day) during monthly menstruationDuration: Maximum of 5 daysUse: For the treatment of cyclic heavy menstrual bleeding

Usual Pediatric Dose for Bleeding:

Initial dose: 10 mg/kg intravenously, immediately before dental extraction Maintenance dose: 10 mg/kg intravenously three to four times dailyDuration of therapy: 2 to 8 daysComments: -The limited data suggest that dosing instructions for adults can be used for pediatric patients needing therapy for tooth extractions. -Infuse no more than 1 mL/minute to avoid hypotension.Use: Short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during tooth extractions.

Usual Pediatric Dose for Menstrual Disorders:

Tablets: Dose: 1300 mg orally three times a day (3900 mg/day) during monthly menstruationDuration: Maximum of 5 days Use: For the treatment of cyclic heavy menstrual bleeding in post-menarchal females

Take the missed dose as soon as you remember. After that, take your next dose at least 6 hours later. Do not take extra medicine to compensate for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe versions of some side effects mentioned in this medication guide.

Avoid using hormonal birth control methods like birth control pills, injections, implants, skin patches, and vaginal rings. Hormonal contraception may increase your risk of stroke, blood clot, or heart attack while taking Lysteda. If you need to use birth control during treatment with Lysteda, use a barrier method (such as a condom or diaphragm with spermicide).

Tell your doctor about all other medicines you are taking, especially:

• hormonal birth control (like birth control pills, injections, implants, skin patches, and vaginal rings);
• tretinoin (Vesanoid);
• chemotherapy medication for leukemia;
• any medication for a bleeding episode or a blood clot; or
• factor IX (Bebulin VH, Konyne 80, Profilnine SD, Proplex T, and others).

This list is not complete, and there may be other drugs that can interact with Lysteda. Inform your doctor about all medications you take. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.