Lysteda 650mg Tablets
It is used to treat heavy bleeding during monthly periods (menstruation).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antifibrinolytic
Pharmacologic Class
Plasminogen activator inhibitor
Pregnancy Category
Category B
FDA Approved
Nov 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lysteda is a medication used to treat heavy menstrual bleeding. It works by helping your blood to clot more effectively, which reduces the amount of blood loss during your period. It is not a hormone and does not prevent pregnancy.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Use this medication for the duration prescribed by your doctor. Do not take it for longer than recommended, and only take it when you are menstruating.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. Then, take your next dose at least 6 hours later. If it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Use this medication for the duration prescribed by your doctor. Do not take it for longer than recommended, and only take it when you are menstruating.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. Then, take your next dose at least 6 hours later. If it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Take Lysteda exactly as prescribed by your doctor. Do not take more than the recommended dose or for longer than 5 days per menstrual period.
- Take the tablets with or without food, but taking with food may help if you experience stomach upset.
- Do not use Lysteda if you are also using hormonal birth control (pills, patch, ring, injection, or implant) as this can increase your risk of blood clots.
- Be aware of the signs of blood clots (e.g., sudden leg pain/swelling, chest pain, shortness of breath, sudden vision changes, severe headache) and seek immediate medical attention if they occur.
- Inform your doctor if you have a history of blood clots, stroke, heart attack, or certain blood clotting disorders.
- Report any changes in your vision, especially difficulty distinguishing colors, to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1300 mg (two 650 mg tablets) orally three times daily for a maximum of 5 days during menstruation.
Dose Range:
1300 - 1300 mg
Condition-Specific Dosing:
Heavy Menstrual Bleeding (HMB):
1300 mg (two 650 mg tablets) orally three times daily for a maximum of 5 days during menstruation. Treatment should not exceed 5 days per menstrual period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for HMB
Adolescent:
Not established for HMB (safety and efficacy not studied in pediatric patients under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-89 mL/min: 1300 mg twice daily for 5 days.
Moderate:
CrCl 30-59 mL/min: 1300 mg once daily for 5 days.
Severe:
CrCl 15-29 mL/min: 650 mg once daily for 5 days.
Dialysis:
CrCl <15 mL/min: Not recommended for use in patients with severe renal impairment due to lack of data and risk of accumulation.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Use with caution as tranexamic acid is primarily renally eliminated.
Pharmacology
Mechanism of Action
Tranexamic acid is a synthetic derivative of the amino acid lysine. It acts as an antifibrinolytic by reversibly binding to plasminogen and plasmin, thereby blocking the binding of plasminogen and plasmin to fibrin. This prevents the dissolution of fibrin clots, leading to stabilization of the clot and reduction of bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
30-50% (oral)
Tmax:
Approximately 3 hours
FoodEffect:
Food does not significantly affect the extent of absorption, but may slightly delay Tmax.
Distribution:
Vd:
Approximately 9-12 L (after IV administration)
ProteinBinding:
Approximately 3% (to plasminogen)
CnssPenetration:
Limited (crosses blood-brain barrier, but concentrations are low)
Elimination:
HalfLife:
Approximately 2 hours (oral)
Clearance:
Approximately 110 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
More than 95%
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours (oral)
PeakEffect:
Approximately 3 hours (oral)
DurationOfAction:
Approximately 7-8 hours (antifibrinolytic effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Change in eyesight, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain
Back, muscle, or joint pain
Nose stuffiness
Muscle cramps
Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Change in eyesight, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain
Back, muscle, or joint pain
Nose stuffiness
Muscle cramps
Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache
- Sudden vision changes (e.g., blurred vision, loss of vision, difficulty distinguishing colors)
- Sudden numbness or weakness on one side of the body
- Slurred speech
- Chest pain or pressure
- Shortness of breath
- Pain, swelling, or warmth in one leg
- Severe stomach pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, such as:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Use of medications that may increase the risk of blood clots, including:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, such as:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Use of medications that may increase the risk of blood clots, including:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle and engaging in other activities that require alertness.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, notify your doctor and discuss this further with them.
As directed by your doctor, schedule an eye exam to monitor your eye health.
If you are attempting to prevent pregnancy, use a non-hormonal form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
If you continue to experience heavy menstrual bleeding after two cycles or notice that the medication is no longer effective, consult your doctor to determine the best course of action.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, notify your doctor and discuss this further with them.
As directed by your doctor, schedule an eye exam to monitor your eye health.
If you are attempting to prevent pregnancy, use a non-hormonal form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
If you continue to experience heavy menstrual bleeding after two cycles or notice that the medication is no longer effective, consult your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Hypotension (low blood pressure)
- Dizziness
- Headache
- Convulsions (seizures)
What to Do:
Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention immediately. Treatment is supportive and symptomatic. Hemodialysis may be considered.
Drug Interactions
Contraindicated Interactions
- Combined hormonal contraceptives (e.g., oral contraceptives, vaginal rings, transdermal patches) - increased risk of thrombosis.
- Factor IX complex concentrates or anti-inhibitor coagulant concentrates - increased risk of thrombosis.
Major Interactions
- Tretinoin (oral) - theoretical increased risk of thrombosis.
- Chlorpromazine - theoretical increased risk of thrombosis.
Moderate Interactions
- Thrombolytic agents (e.g., alteplase, reteplase, tenecteplase) - antagonism of effect.
- Anticoagulants (e.g., warfarin, heparin, DOACs) - theoretical antagonism of effect, though often used together in specific clinical scenarios with careful monitoring.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Tranexamic acid is primarily renally eliminated; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation of therapy.
Ophthalmologic examination (e.g., color vision, visual acuity)
Rationale: Tranexamic acid has been associated with visual disturbances, including acquired color vision defects. Baseline assessment is important.
Timing: Prior to initiation of therapy, especially if long-term use is anticipated or if patient reports visual symptoms.
Routine Monitoring
Signs and symptoms of thromboembolic events (e.g., DVT, PE, stroke, MI)
Frequency: Throughout therapy and for a period after discontinuation.
Target: Absence of symptoms.
Action Threshold: Discontinue Lysteda and seek immediate medical attention if symptoms occur.
Ophthalmologic examination (e.g., color vision, visual acuity)
Frequency: Periodically (e.g., annually) if long-term use, or if visual disturbances are reported.
Target: Normal vision.
Action Threshold: Discontinue Lysteda if visual disturbances or color vision changes occur.
Symptom Monitoring
- Leg pain or swelling (especially in one leg)
- Sudden shortness of breath
- Chest pain
- Sudden numbness or weakness on one side of the body
- Sudden severe headache
- Vision changes (e.g., blurred vision, difficulty distinguishing colors)
- Speech changes
- Abdominal pain (severe)
Special Patient Groups
Pregnancy
Pregnancy Category B. Studies in animals have not shown evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Tranexamic acid is excreted into breast milk at concentrations approximately one-hundredth of the corresponding serum concentrations. The amount ingested by a breastfed infant is likely to be very small. However, caution should be exercised when Lysteda is administered to a nursing woman. The American Academy of Pediatrics considers tranexamic acid to be compatible with breastfeeding.
Infant Risk:
Low risk; monitor infant for potential adverse effects (e.g., diarrhea).
Pediatric Use
Safety and efficacy of Lysteda in pediatric patients under 18 years of age have not been established for the treatment of heavy menstrual bleeding. Use is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is necessary based on renal function, which may be diminished in elderly patients.
Clinical Information
Clinical Pearls
- Lysteda is specifically approved for heavy menstrual bleeding (HMB) and should only be used during the menstrual period, for a maximum of 5 days.
- It is crucial to screen patients for a history of thromboembolic events or risk factors before initiating therapy, as tranexamic acid increases the risk of thrombosis.
- Concomitant use with combined hormonal contraceptives is a contraindication due to a significantly increased risk of thrombosis.
- Patients should be advised to report any visual disturbances, especially changes in color vision, immediately.
- Renal dose adjustments are critical to prevent accumulation and potential toxicity.
- Lysteda is not a contraceptive and does not affect fertility.
Alternative Therapies
- Nonsteroidal anti-inflammatory drugs (NSAIDs) - e.g., ibuprofen, naproxen
- Hormonal therapies - e.g., oral contraceptives, progestin-only pills, levonorgestrel-releasing intrauterine system (Mirena)
- GnRH agonists (e.g., leuprolide) - for severe cases, often short-term
- Endometrial ablation
- Hysterectomy
Cost & Coverage
Average Cost:
$150 - $300 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.