Doptelet 20mg Tablets
It is used to raise platelet counts.
Drug Class
Thrombopoietin Receptor Agonist
Pharmacologic Class
Thrombopoietin Receptor Agonist
Pregnancy Category
Not available
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Doptelet is a medication used to help your body make more platelets, which are tiny blood cells that help your blood clot. It's used for people with a condition called chronic immune thrombocytopenia (ITP) who have low platelet counts and haven't responded well to other treatments, or for people with chronic liver disease who need to have a medical procedure and have low platelet counts.
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.
General Administration Instructions
For all uses of this medication, take it with food to help your body absorb the drug properly.
Pre-Procedure Instructions
If you are taking this medication in preparation for a procedure, make sure you understand when to start taking it. If you're unsure, consult with your doctor. If you're unable to complete all your doses before the procedure, contact your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it in its original container at room temperature.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of 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. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
Missing a Dose
If you miss a dose:
For pre-procedure doses, contact your doctor for advice on what to do.
For other situations, take the missed dose as soon as you remember, with food. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take 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.
General Administration Instructions
For all uses of this medication, take it with food to help your body absorb the drug properly.
Pre-Procedure Instructions
If you are taking this medication in preparation for a procedure, make sure you understand when to start taking it. If you're unsure, consult with your doctor. If you're unable to complete all your doses before the procedure, contact your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it in its original container at room temperature.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of 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. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
Missing a Dose
If you miss a dose:
For pre-procedure doses, contact your doctor for advice on what to do.
For other situations, take the missed dose as soon as you remember, with food. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Doptelet with food to help your body absorb it better.
- Do not crush, chew, or split the tablets.
- Take the medication at approximately the same time each day.
- Avoid activities that may increase your risk of bleeding or injury, especially when your platelet counts are low.
- Report any signs of unusual bleeding or clotting to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For chronic immune thrombocytopenia (ITP): Initial 20 mg orally once daily. Adjust dose based on platelet response to maintain platelet count âĨ50 x 10^9/L. Max 40 mg/day. For thrombocytopenia in chronic liver disease (CLD) patients undergoing invasive procedures: 60 mg orally once daily for 5 days, starting 10 to 13 days prior to the scheduled procedure.
Dose Range:
20 - 40 mg
Condition-Specific Dosing:
Chronic Immune Thrombocytopenia (ITP):
Initial 20 mg once daily, adjusted to maintain platelet count âĨ50 x 10^9/L. Max 40 mg/day.
Thrombocytopenia in Chronic Liver Disease (CLD) for Invasive Procedures:
60 mg once daily for 5 days, starting 10-13 days prior to procedure.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No dose adjustment needed.
Hepatic Impairment:
Mild:
For ITP: No dose adjustment needed (Child-Pugh A). For CLD: Dosing is specific to this population.
Moderate:
For ITP: Initial 20 mg orally once daily (Child-Pugh B). For CLD: Dosing is specific to this population.
Severe:
For ITP: Initial 20 mg orally once daily (Child-Pugh C). For CLD: Dosing is specific to this population.
Pharmacology
Mechanism of Action
Avatrombopag is an orally active, small molecule thrombopoietin (TPO) receptor agonist. It binds to the TPO receptor (c-Mpl) on the surface of hematopoietic stem cells and megakaryocytes, stimulating the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. This leads to an increase in platelet production and circulating platelet counts.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (oral absorption is good, but absolute bioavailability not specified)
Tmax:
5-9 hours
FoodEffect:
A high-fat meal increases AUC and Cmax by approximately 2-fold. Should be taken with food.
Distribution:
Vd:
Approximately 180 L
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 19-28 hours
Clearance:
Not available
ExcretionRoute:
Primarily feces (approximately 88%), minor renal excretion (approximately 6%)
Unchanged:
Approximately 30% (in feces)
Pharmacodynamics
OnsetOfAction:
Platelet count increase typically observed within 4-7 days.
PeakEffect:
Peak platelet count typically occurs within 10-14 days.
DurationOfAction:
Platelet counts generally return to baseline within 35 days after discontinuation.
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
Swelling in the arms or legs
Fast heartbeat
Unexplained bruising or bleeding
Purple spots or redness of the skin
Stomach pain
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Fever
Upset stomach
Headache
Feeling tired or weak
Signs of a common cold
Joint pain
* Nose or throat irritation
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
Swelling in the arms or legs
Fast heartbeat
Unexplained bruising or bleeding
Purple spots or redness of the skin
Stomach pain
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Fever
Upset stomach
Headache
Feeling tired or weak
Signs of a common cold
Joint pain
* Nose or throat irritation
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:
- Unusual bruising or bleeding (e.g., nosebleeds, bleeding gums, blood in urine or stool)
- Signs of a blood clot (e.g., sudden chest pain, shortness of breath, pain/swelling in an arm or leg, sudden weakness or numbness on one side of the body, vision changes)
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, nausea, vomiting, unusual tiredness)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 2 weeks after your last dose.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 2 weeks after your last dose.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory assessments should be conducted as directed by your doctor to monitor your condition.
There is a risk of blood clots associated with this medication, which may be increased in individuals with pre-existing blood clotting disorders. If you have a history of blood clots, it is crucial to notify your doctor. If you have any concerns or questions, discuss them with your doctor.
Additionally, this medication may pose a risk to an unborn baby if taken during pregnancy. If you are pregnant or become pregnant while taking this medication, it is vital to contact your doctor immediately to discuss the potential risks and necessary precautions.
There is a risk of blood clots associated with this medication, which may be increased in individuals with pre-existing blood clotting disorders. If you have a history of blood clots, it is crucial to notify your doctor. If you have any concerns or questions, discuss them with your doctor.
Additionally, this medication may pose a risk to an unborn baby if taken during pregnancy. If you are pregnant or become pregnant while taking this medication, it is vital to contact your doctor immediately to discuss the potential risks and necessary precautions.
Overdose Information
Overdose Symptoms:
- Exaggerated pharmacologic effects (e.g., excessive platelet count elevation, increased risk of thrombotic events)
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Monitor platelet counts closely and manage symptoms supportively. Consider platelet apheresis if platelet counts are excessively high.
Drug Interactions
Major Interactions
- Strong CYP2C9 inhibitors (e.g., fluconazole, amiodarone): May increase avatrombopag exposure. Dose reduction of avatrombopag may be necessary.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): May increase avatrombopag exposure. Dose reduction of avatrombopag may be necessary.
- Strong CYP2C9 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease avatrombopag exposure. Dose increase of avatrombopag may be necessary.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort): May decrease avatrombopag exposure. Dose increase of avatrombopag may be necessary.
Moderate Interactions
- Moderate CYP2C9 inhibitors/inducers: Monitor for altered avatrombopag effect.
- Moderate CYP3A4 inhibitors/inducers: Monitor for altered avatrombopag effect.
Monitoring
Baseline Monitoring
Platelet count
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially in CLD patients, and monitor for potential hepatotoxicity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Platelet count
Frequency: For ITP: Weekly until stable platelet count (âĨ50 x 10^9/L) is achieved for at least 4 weeks, then monthly. For CLD: Daily starting on Day 5 of avatrombopag administration and continuing through the day of the procedure.
Target: For ITP: âĨ50 x 10^9/L. For CLD: Target platelet count for procedure (e.g., âĨ50 x 10^9/L).
Action Threshold: For ITP: If platelet count <50 x 10^9/L, consider dose adjustment. If >200 x 10^9/L, consider dose reduction. If >400 x 10^9/L, hold dose and re-evaluate. For CLD: If platelet count does not reach target, consider alternative strategies or postpone procedure.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, as clinically indicated.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant elevations may require dose interruption or discontinuation.
Symptom Monitoring
- Signs and symptoms of bleeding (e.g., petechiae, bruising, epistaxis, melena, hematuria)
- Signs and symptoms of thrombotic/thromboembolic events (e.g., chest pain, shortness of breath, swelling/pain in limb, sudden weakness/numbness, vision changes)
- Signs and symptoms of liver injury (e.g., fatigue, nausea, vomiting, right upper quadrant pain, dark urine, jaundice)
Special Patient Groups
Pregnancy
Based on animal reproduction studies, avatrombopag may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Advise pregnant women of the potential risk.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data.
Lactation
It is not known whether avatrombopag is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment with Doptelet and for at least 2 weeks after the last dose.
Infant Risk:
Potential for serious adverse reactions (e.g., thrombocytopenia, bleeding) in breastfed infant. Risk is unknown but considered moderate to high.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. No dose adjustment is required based on age alone.
Clinical Information
Clinical Pearls
- Avatrombopag must be taken with food to ensure adequate absorption.
- For CLD patients, ensure the 5-day course is completed 10-13 days prior to the procedure to allow sufficient time for platelet count increase.
- For ITP patients, dose adjustments are crucial to maintain platelet counts within the target range (50-200 x 10^9/L) to minimize both bleeding and thrombotic risks.
- Patients should be monitored for signs and symptoms of thromboembolic events, especially those with pre-existing risk factors for thrombosis.
- Liver function tests should be monitored periodically, particularly in patients with underlying liver disease.
Alternative Therapies
- Eltrombopag (Promacta/Revolade) - another oral TPO receptor agonist
- Romiplostim (Nplate) - a subcutaneous TPO receptor agonist
- Corticosteroids (e.g., prednisone) - for ITP
- Intravenous Immunoglobulin (IVIG) - for ITP
- Anti-D immunoglobulin - for ITP (Rh-positive patients)
- Splenectomy - for refractory ITP
- Platelet transfusions - for acute bleeding or pre-procedure in CLD (short-term solution)
Cost & Coverage
Insurance Coverage:
Specialty Tier (requires prior authorization)
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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.