Lysteda

What is Lysteda?

• Lysteda (tranexamic acid) is an antifibrinolytic used for the treatment of cyclic heavy menstrual bleeding.

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Tranexamic acid Structural Formulae

Tranexamic acid ball-and-stick

What are the uses of this medicine?

• Lysteda (tranexamic acid) is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities.
• LYSTEDA does not contain any hormones.
• On average, LYSTEDA has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period.
• LYSTEDA is taken only during your period and is not meant to treat pre-menstrual symptoms (symptoms that occur before your bleeding starts).
• LYSTEDA does not affect your fertility and cannot be used as birth control.
• LYSTEDA does not protect you against diseases that you may get if you have unprotected sex.
• LYSTEDA has not been studied in adolescents younger than 18 years of age.
• LYSTEDA is not for women who have already gone through menopause (post-menopausal).

How does this medicine work?

• Tranexamic acid A synthetic derivative of the amino acid lysine with antifibrinolytic activity.
• With strong affinity for the five lysine-binding sites of plasminogen, transexamic acid competitively inhibits the activation of plasminogen to plasmin, resulting in inhibition of fibrinolysis; at higher concentrations, this agent noncompetitively inhibits plasmin.
• This agent has a longer half-life, is approximately ten times more potent, and is less toxic than aminocaproic acid, which possesses similar mechanisms of action.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Ask your healthcare provider before taking LYSTEDA if you are not sure if your birth control method contains estrogen and a progestin.
• Currently have a blood clot.
• Have ever had a blood clot.
• Have been told that you are at risk of having a blood clot.
• Are allergic to LYSTEDA or tranexamic acid.

What drug interactions can this medicine cause?

LYSTEDA and other medicines can affect each other, causing side effects. LYSTEDA can affect the way other medicines work and other medicines can affect how LYSTEDA works.

Especially tell your healthcare provider if you take:

• Birth control pills or other hormonal birth control
• Medicines used to help your blood form clots
• Medicines used to break up blood clots
• Any medicines to treat leukemia

• Because LYSTEDA is antifibrinolytic, concomitant use of hormonal contraception and LYSTEDA may further exacerbate the increased thrombotic risk associated with combination hormonal contraceptives.
• 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.
• Exercise caution if a woman taking LYSTEDA therapy requires tissue plasminogen activators.

Is this medicine FDA approved?

• The U.S. Food and Drug Administration (FDA) approved tranexamic acid oral tablets (brand name Lysteda) for treatment of heavy menstrual bleeding on 13 November 2009.

How should this medicine be used?

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.

Renal impairment: Dosage adjustment is needed if serum creatinine concentration (Cr) is higher than 1.4 mg/dL.

• Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg (two 650 mg tablets) two times a day (2,600 mg/day) for a maximum of 5 days during menstruation
• Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg (two 650 mg tablets) once a day (1,300 mg/day) for a maximum of 5 days during menstruation
• Cr above 5.7 mg/dL: 650 mg (one 650 mg tablet) once a day (650 mg/day) for a maximum of 5 days during menstruation

Administration:

• Take LYSTEDA exactly as your healthcare provider tells you.
• Do not take LYSTEDA until your period has started.
• Do not take LYSTEDA for more than 5 days in a row.
• Do not take LYSTEDA when you do not have your period.
• Once your period has started, take 2 tablets of LYSTEDA three times per day (e.g., in the morning, afternoon, and evening).
• LYSTEDA tablets should be swallowed whole and not chewed or broken apart.
• LYSTEDA may be taken with or without food.
• Do not take more than 6 tablets of LYSTEDA in a day. If you take more than 6 tablets, call your healthcare provider.
• If you miss a dose, take it when you remember, and then take your next dose at least six hours later. Do not take more than two tablets at a time to make up for missed doses.
• If LYSTEDA does not help to lessen bleeding with your periods after 2 cycles or seems to stop working, talk to your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 650 mg

This medicine is available in fallowing brand namesː

• LYSTEDA

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headaches
• Sinus and nasal problems
• Back pain
• Pain in your abdomen
• Pain in your muscles or joints
• Anemia
• Fatigue

LYSTEDA can cause serious side effects, including:

• Blood clots
• Eye changes
• Allergic reaction

What special precautions should I follow?

• Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis.
• Visual or ocular adverse effects may occur with LYSTEDA. Immediately discontinue use if visual or ocular symptoms occur.
• A case of severe allergic reaction to LYSTEDA was reported. In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention.
• Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.
• Ligneous conjunctivitis has been reported in patients taking tranexamic acid. The conjunctivitis resolved following cessation of the drug.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• gastrointestinal (nausea, vomiting, diarrhea)
• hypotensive (e.g., orthostatic symptoms)
• thromboembolic (arterial, venous, embolic)
• visual impairment
• mental status changes
• myoclonus
• rash

Management of overdosage:

• 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.

Can this medicine be used in pregnancy?

• LYSTEDA is not indicated for use in pregnant women.
• There are no adequate and well-controlled studies in pregnant women.

Can this medicine be used in children?

• LYSTEDA is indicated for women of reproductive age and is not intended for use in premenarcheal girls.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tranexamic acid
• Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

Who manufactures and distributes this medicine?

Manufactured for:

• Ferring Pharmaceuticals Inc.
• Parsippany, NJ

Manufactured By:

• Mikart, LLC
• Atlanta, GA

What should I know about storage and disposal of this medication?

• Store LYSTEDA at room temperature between 59°F to 86°F (15°C to 30°C).

• Dailymed label info on Lysteda
• FDA Lysteda

Lysteda Resources
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