Eltrombopag 25mg Pwd Oral Susp Kit
Overview
What is this medicine?
How to Use This Medicine
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Timing of Doses: Take this medication without food or with a meal that is low in calcium. If you take other medications, you may need to take this medication at a different time to avoid interactions.
3. Avoiding Interactions with Other Substances: Take this medication at least 2 hours before or 4 hours after consuming foods or drinks high in calcium, antacids, or products containing calcium, iron, aluminum, magnesium, selenium, or zinc. Examples of foods and drinks high in calcium include dairy products, certain fruits, vegetables, and juices.
4. Preparing Your Dose: Before taking your medication, make sure you understand how to mix and measure your dose correctly. If you are unsure, consult with your doctor or pharmacist.
5. Using the Oral Dosing Syringes: This medication comes with single-use oral dosing syringes. Use each syringe only once and discard it after use. Do not reuse syringes.
6. Mixing the Medication: Mix the powder with water only, as instructed. Avoid using hot water to mix your medication.
7. Taking Your Dose: Take your dose within 30 minutes after mixing the medication. Discard any unused portion within 30 minutes of mixing.
Storing and Disposing of Your Medication
1. Storage: Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom.
2. Disposal: Dispose of your medication and any unused portions according to the instructions provided with your medication.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Take this medicine on an empty stomach, at least 2 hours before or 4 hours after any foods or supplements containing calcium, iron, magnesium, aluminum, selenium, or zinc (e.g., dairy products, antacids, mineral supplements).
- Do not crush, chew, or break the tablets. For the oral suspension, follow mixing instructions carefully.
- Report any signs of liver problems (yellow skin/eyes, dark urine, severe tiredness, stomach pain) or blood clots (pain/swelling in arm/leg, shortness of breath, chest pain, sudden vision changes) immediately.
- Regular blood tests (platelet counts, liver function) are crucial to monitor your treatment and adjust the dose.
- Do not stop taking this medicine without talking to your doctor, as platelet counts may drop significantly.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
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
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, including:
+ Change in eyesight
+ Eye pain
+ Severe eye irritation
Bleeding or bruising while taking or after stopping the medication
Confusion
Swelling of the abdomen
Swelling in the arms or legs
Fever or chills
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
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Fatigue
Weakness
Cough
Muscle or joint pain
Signs of a common cold
Muscle spasm
Nose or throat irritation
Mouth pain
Tooth pain
Change in skin color
* Pain in arms or legs
Reporting Side Effects
This is not an exhaustive list of possible 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:
- Yellowing of skin or eyes (jaundice)
- Unusual tiredness or weakness
- Nausea, vomiting, or stomach pain (especially upper right side)
- Dark urine
- Swelling, pain, or tenderness in an arm or leg (signs of blood clot)
- Shortness of breath or chest pain (signs of blood clot in lungs)
- Sudden changes in vision (signs of blood clot in eye)
- New or worsening bruising or bleeding (despite increased platelets)
- New or worsening fatigue, pale skin, or frequent infections (signs of bone marrow changes)
Before Using This Medicine
It is essential to inform your doctor about the following:
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 low platelet count caused by underlying health conditions.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
Do not discontinue this medication without first consulting your doctor, as this may increase your risk of developing severe thrombocytopenia (very low platelet count) and bleeding. If you need to stop taking this drug, consult with your doctor to determine the best course of action.
This medication may exacerbate existing cataracts or increase the risk of developing new cataracts. Consult with your doctor and undergo eye exams as recommended to monitor your eye health.
If you are of East or Southeast Asian descent, discuss your treatment options with your doctor, as you may require a lower initial dose of this medication.
Be aware that this medication has been associated with an increased risk of blood clots, which can be life-threatening and may lead to heart attack or stroke. Take precautions to prevent injuries and avoid falls or accidents. Consult with your doctor to discuss any concerns you may have.
This medication is contraindicated in individuals with myelodysplastic syndrome (MDS), a specific bone marrow disorder. If you have MDS and take this medication, your condition may worsen and potentially progress to acute myelogenous leukemia (AML), a type of blood cancer that can be fatal. If you have MDS, consult with your doctor to discuss alternative treatment options.
Additionally, this medication may cause harm to an unborn baby if taken during pregnancy. If you are pregnant or may become pregnant, it is crucial to use effective birth control while taking this medication and for a specified period after the last dose. Consult with your doctor to determine the recommended duration of birth control use. If you become pregnant while taking this medication, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Excessive platelet counts (thrombocytosis)
- Increased risk of thromboembolic events (blood clots)
- Liver enzyme elevations
What to Do:
In case of overdose, monitor platelet counts closely. If platelet counts are excessively high, discontinue eltrombopag and consider supportive measures. Activated charcoal may be considered if administered soon after ingestion. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Polyvalent cation-containing products (e.g., antacids, dairy products, mineral supplements like iron, calcium, magnesium, aluminum, selenium, zinc): Significantly reduce eltrombopag absorption. Administer eltrombopag at least 2 hours before or 4 hours after these products.
- Statins (e.g., Rosuvastatin, Atorvastatin): Eltrombopag is an OATP1B1 and BCRP inhibitor, increasing statin exposure. Consider reducing statin dose and monitor for adverse effects.
Moderate Interactions
- Other OATP1B1/BCRP substrates (e.g., Methotrexate, Topotecan, Irinotecan): Potential for increased exposure of these drugs. Monitor for toxicity.
- UGT1A1 and UGT1A3 substrates (e.g., Irinotecan, Raltegravir): Eltrombopag is a UGT1A1 and UGT1A3 inhibitor, potentially increasing exposure of these drugs. Monitor for toxicity.
- Protease inhibitors (e.g., Lopinavir/Ritonavir): May increase eltrombopag exposure. Monitor platelet counts and adjust eltrombopag dose if needed.
Minor Interactions
- Warfarin: No significant interaction observed, but caution advised due to potential for increased bleeding risk with increased platelet counts.
Monitoring
Baseline Monitoring
Rationale: To establish baseline platelet count and assess overall hematologic status before initiating therapy.
Timing: Prior to initiation
Rationale: Eltrombopag can cause hepatotoxicity. To establish baseline liver function.
Timing: Prior to initiation
Rationale: To assess baseline renal function, though dose adjustment is not typically needed for renal impairment.
Timing: Prior to initiation
Rationale: To establish baseline for potential cataract development.
Timing: Prior to initiation
Routine Monitoring
Frequency: Weekly until stable platelet count (âĨ 50 x 10^9/L for ITP/HCV, or target for SAA) is achieved for at least 4 weeks, then monthly.
Target: âĨ 50 x 10^9/L (for ITP/HCV); individualized for SAA
Action Threshold: If platelet count > 400 x 10^9/L, reduce dose or hold therapy. If platelet count > 200 x 10^9/L for 4 consecutive weeks, consider dose reduction. If platelet count < 50 x 10^9/L after 4 weeks of max dose, discontinue for ITP/HCV.
Frequency: Every 2 weeks during dose adjustment, then monthly after stable dose. More frequently if abnormal.
Target: Within normal limits
Action Threshold: If ALT/AST > 3x ULN and progressive, or > 5x ULN, or > 3x ULN with elevated direct bilirubin or symptoms of liver injury, discontinue eltrombopag.
Frequency: Regularly throughout therapy
Target: Absence of symptoms
Action Threshold: Prompt evaluation and management if symptoms occur.
Frequency: Periodically, especially if cytopenias worsen or new cytopenias develop.
Target: Absence of symptoms
Action Threshold: Consider bone marrow biopsy if clinically indicated.
Frequency: Annually
Target: No new cataracts or worsening of existing ones
Action Threshold: Consult ophthalmologist if changes occur.
Symptom Monitoring
- Signs of liver injury (e.g., fatigue, nausea, vomiting, right upper quadrant pain, dark urine, jaundice)
- Signs of thromboembolism (e.g., pain, swelling, tenderness in a limb, shortness of breath, chest pain, sudden vision changes)
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, gingival bleeding)
- Signs of bone marrow changes (e.g., new or worsening cytopenias, splenomegaly)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal studies, eltrombopag may cause fetal harm. A pregnancy registry is available.
Trimester-Specific Risks:
Lactation
It is not known if eltrombopag 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 eltrombopag and for at least 21 days after the last dose.
Pediatric Use
Approved for chronic ITP in patients 1 year and older. Dosing is weight-based for younger children. Safety and efficacy in SAA and HCV-related thrombocytopenia have not been established in pediatric patients.
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 not routinely required based on age alone.
Clinical Information
Clinical Pearls
- Eltrombopag must be taken on an empty stomach, at least 2 hours before or 4 hours after any food, supplements, or medications containing polyvalent cations (e.g., calcium, iron, magnesium, aluminum, selenium, zinc). This is critical for absorption.
- The oral suspension formulation is crucial for patients who cannot swallow tablets, especially children. Ensure proper mixing and administration.
- Close monitoring of platelet counts is essential to prevent both thrombocytopenia and thrombocytosis. Over-response can lead to thromboembolic events.
- Liver function tests must be monitored regularly due to the risk of hepatotoxicity. Patients should be educated on symptoms of liver injury.
- Patients with chronic liver disease (Child-Pugh B/C) require a lower starting dose and careful monitoring due to increased eltrombopag exposure.
- Discontinuation of eltrombopag can lead to a transient drop in platelet counts below baseline (rebound thrombocytopenia), increasing bleeding risk. Monitor platelet counts for at least 4 weeks after discontinuation.
Alternative Therapies
- Romiplostim (another TPO-RA, injectable)
- Avatrombopag (another TPO-RA, oral)
- Fostamatinib (Syk inhibitor, oral, for ITP)
- Corticosteroids (e.g., Prednisone, Dexamethasone for ITP, SAA)
- Intravenous Immunoglobulin (IVIG for ITP)
- Anti-D immunoglobulin (for Rh-positive ITP patients)
- Splenectomy (for refractory ITP)
- Immunosuppressants (e.g., Cyclosporine, ATG for SAA)