Eltrombopag 25mg Tablets

Eltrombopag is an orally bioavailable, small-molecule thrombopoietin (TPO) receptor agonist. It interacts with the transmembrane domain of the human TPO receptor, initiating signaling cascades that lead to the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, thereby increasing platelet production.

Serious Side Effects: Seek Medical Help Immediately

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
Unusual bruising or bleeding 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 do not experience serious side effects, and many have only minor or no side effects at all. 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
Nausea or vomiting
Dizziness
Fatigue or 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 the arms or legs

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.

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.
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 (including 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.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you have with your doctor.

Do not discontinue this medication without consulting your doctor first, 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 about this potential risk and schedule an eye exam as recommended by your doctor.

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. To minimize this risk, take precautions to prevent injuries and avoid falls or accidents. Consult with your doctor to discuss this risk and any concerns you may have.

This medication is contraindicated in individuals with myelodysplastic syndrome (MDS), a certain 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. If MDS transforms into AML, it may reduce your life expectancy. If you have MDS, consult with your doctor to discuss alternative treatment options.

Additionally, this medication may harm 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.

• Polyvalent cation-containing products (e.g., antacids, dairy products, mineral supplements, 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, which can increase exposure to statins. Consider dose reduction of statins.

• Other OATP1B1/BCRP substrates (e.g., Methotrexate, Topotecan, Imatinib): May increase exposure to these drugs. Monitor for increased toxicity.
• CYP1A2 substrates (e.g., Theophylline, Tizanidine): Eltrombopag is a weak CYP1A2 inhibitor. Monitor for increased exposure to these drugs.

• Signs of liver injury (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice)
• Signs of thrombotic/thromboembolic events (e.g., chest pain, shortness of breath, pain/swelling in an arm or leg, sudden numbness or weakness, sudden vision changes, slurred speech)
• Signs of bleeding (e.g., easy bruising, petechiae, nosebleeds, gum bleeding, blood in urine or stool)
• Symptoms of cataracts (e.g., blurred vision, glare, difficulty with night vision)

Eltrombopag can cause fetal harm based on animal studies and its mechanism of action. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment.

It is unknown if eltrombopag is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 21 days after the last dose.

Approved for chronic ITP in patients 1 year and older. Dosing is weight-based for younger children and adjusted for East Asian ancestry. Safety and efficacy for other indications (SAA, HCV) not established in pediatric patients.

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. No specific dose adjustment is required, but monitor closely for adverse effects.

• Always administer eltrombopag on an empty stomach, at least 2 hours before or 4 hours after any food, dairy products, antacids, or mineral supplements containing polyvalent cations (calcium, iron, magnesium, aluminum, selenium, zinc). This is critical for absorption.
• Regular and diligent monitoring of liver function tests (LFTs) and platelet counts is essential due to the risk of hepatotoxicity and thrombotic events.
• Patients of East Asian ancestry typically require a lower starting dose due to higher plasma concentrations.
• For patients with severe hepatic impairment, significant dose reduction is necessary, and careful monitoring is paramount.
• Eltrombopag is not a rescue medication for acute bleeding; it is for chronic management of thrombocytopenia.

• Romiplostim (another TPO receptor agonist)
• Avatrombopag (another TPO receptor agonist)
• Lusutrombopag (another TPO receptor agonist)
• Corticosteroids (e.g., Prednisone, Dexamethasone - for ITP)
• Intravenous Immunoglobulin (IVIG - for ITP)
• Anti-D immunoglobulin (for Rh-positive ITP patients)
• Rituximab (for ITP)
• Splenectomy (for ITP)
• Immunosuppressive therapy (e.g., Cyclosporine, ATG - for SAA)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.