Eltrombopag olamine tablet 25 mg (Elopag)

What is Eltrombopag?

Eltrombopag olamine tablet 25 mg (Elopag) is a prescription medicine used to treat low blood platelet count in adult patients diagnosed with chronic immune (idiopathic) thrombocytopenia, when certain other medications or surgery to remove the spleen have not worked well enough. Immune thrombocytopenia causes unusual bleeding or bruising due to an abnormally low number of platelets in the blood.  

On January 4, 2018, the United States Food and Drug Administration approved this medication in combination with standard immunosuppressive therapy as a first-line treatment for severe aplastic anemia (SAA). 

It is pronounced as “el-TROM-boe-pag,” and the brand name of the medication is PROMACTA, which has been innovated and developed by Novartis Pharmaceuticals. On the other hand, Elopag is a generic of PROMACTA, manufactured and marketed by Everest Pharmaceuticals.

Eltrombopag Indications and Uses

In 2008, Eltrombopag got initial approval by the FDA to treat the following indications 

• To treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
• Later in 2018, it was also approved for severe aplastic anemia (SAA) in combination with immunosuppressive therapy as a first-line treatment option. 
• It should be used only in patients with Immune thrombocytopenia purpura whose stage of thrombocytopenia and medical condition increase the risk of bleeding. 
• It should not only be used to normalize the lower platelet count.

How does Eltrombopag work?

It is an orally bioavailable thrombocytopenia receptor agonist that interacts with the transmembrane domain of the human TPO-receptor agonist and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. In simple words, it works by stimulating the bone marrow to produce more platelets in immune thrombocytopenia disease.

Eltrombopag 25 mg Dose Information

• The starting dose of Elopag is 50 mg once ( two 25 mg tablets) daily for most patients of East Asian ancestry.
• For patients with moderate or severe hepatic insufficiency, the starting dose is 25 mg once daily.
• Ask your doctor for the exact dose for severe aplastic anemia. 
• Take the medication on an empty stomach at least one hour before or two hours after a meal.
• There should be a 4-hour gap between the Elopag tablet and other medications, foods, and supplements containing iron, magnesium, calcium, aluminum, selenium, and zinc.
• Daily dosage should not exceed 75 mg. 
• Ask your healthcare provider for a dosage adjustment to maintain a platelet count and to reduce the risk of bleeding.
• Discontinue Elopag 25 mg if the platelet count does not increase after 4 weeks at the maximum dose. Also, discontinue the medication for important liver test abnormalities and excessive platelet count.

Eltrombopag 25 mg Side Effects

Common Side Effects

• Gastrointestinal Symptoms: (Nausea, Vomiting, Diarrhea)
• Neurological Symptoms: (Headache, Dizziness, Fatigue)
• Skin and Hair: (Rash, Itching, Hair discoloration)
• Liver Effects: (Elevated liver enzymes, Jaundice)

Less Common but Serious Side Effects

• Thromboembolic Events: In this condition, it can increase the risk of blood clotting. Also, it is riskier for those patients who already have blood-clotting problems.
• Bone Marrow Fibrosis: Long-term use of this medication can distract bone marrow from regular blood production. It is rare, but it can be harmful in long-term use.
• Liver Toxicity: Regular liver monitoring is required to reduce the risk of liver damage or liver failure, including liver function tests (LFTs).
• Cataracts: There is a potential risk of cataracts with long-term use.
• Hypersensitivity Reactions: Allergic reactions such as swelling, difficulty breathing, or severe rash.
• Bleeding After Treatment Withdrawal: Platelet counts may drop below baseline levels after stopping the Elopag alternative, increasing bleeding risk.

What should I tell my doctor before taking the medication?

Before taking Elopag 25 mg tablet, tell your doctor about your

• Medical history
• Liver Conditions, including cirrhosis and hepatitis, and other liver problems may occur during the treatment. Regular liver function tests are necessary to reduce the risk of hepatotoxicity during treatment with the Elopag tablet.
• Blood Disorders, including blood clots, may increase the risk. Inform your healthcare provider if you see any unusual bleeding, bruising, red spots on your arms or legs, bleeding with urine or stool, or bleeding gums while brushing your teeth. Also, tell your healthcare provider if you have a previous history of bleeding or blood-clotting issues.
• If you have cataracts or eye-sight problems, tell your doctor before starting treatment.
• Any bone marrow disorder may increase the risk of leukemia progression in the future.
• Allergic Reactions: Allergic reactions to the drug may hamper your regular life. Take beneficiary steps to reduce this risk. If necessary, consult with your doctor.

Eltrombopag Interactions

It has an interaction history with other medicines. Consult with your doctor if you are taking other medicines

• This drug is an inhibitor of OATP1B1; close monitoring is mandatory for patients to reduce the overexposure of the drugs that are substrates of the OATP1B1.
•  Iron, calcium, aluminum, magnesium, selenium, and zinc significantly reduce the absorption of the medication. It should not be taken within 4 hours of any medications or products that contain polyvalent cations, such as antacids, dairy products, minerals, supplements, or antiplatelet medication

Uses in special populations

Pregnancy and Breastfeeding

• Pregnancy: It is not proven that this drug can provide you secure pregnancy. It is better to consult with your doctor if you are planning to get pregnant. They may help you in a secure pregnancy. If it is not possible, use proper contraception.
• Breastfeeding: Breastfeeding may harm your children if it passes through your breast milk. Consult your doctor and ask them how much time you should wait even after discontinuing the treatment.

• Children: For children, dosage may differ from adults. The doctor will tell you about that.
• Elderly Patients: To treat elderly patients, use it with caution.

Stopping Treatment

Abruptly stopping can cause a rapid drop in platelet levels, increasing the risk of severe bleeding. Always follow your doctor’s instructions when discontinuing the medication. Avoid treatment if you are allergic to medicines containing Eltrombopag and inform your doctor if you see any allergic reactions, such as itching, rashes on the skin, tearing, or irritation of the skin.

How long does Eltrombopag take to work?

The duration of effective treatment differs from depending on the medical conditions of the patients. It starts increasing the platelets within 1 to 2 weeks of the first dose. However, to get the full effect of the treatment may take 4 to 6 weeks.

Who is the manufacturer of the Eltrombopag 25 mg (Elopag)?

Elopag is manufactured and marketed by Everest Pharmaceuticals. Though it is manufactured in Bangladesh, this generic medication is available in East Asia, including China, Singapore, Thailand, Indonesia, India, and many.

What is the price of Eltrombopag olamine tablet in Bangladesh?

The price depends on the manufacturer, region, and availability. Estimating the exact cost is not possible due to different factors. You can query about the cost with an online supplier of the medication or directly to the manufacturer.

What is the difference between Avatrombopag and Eltrombopag?

Avatrombopag and eltrombopag are both thrombopoietin receptor agonists used to treat low platelet counts, but they differ in key aspects. Avatrombopag is taken orally with food and has no dietary restrictions, with a safer liver profile, making it suitable for patients with chronic liver disease and ITP. In contrast, Elopag requires strict food restrictions due to absorption issues, carries a risk of liver toxicity and cataracts, and has broader approvals, including aplastic anemia and hepatitis C-related thrombocytopenia.

What is the efficacy and safety of Eltrombopag in adult refractory immune thrombocytopenia​?

In two clinical studies of PROMACTA 50 mg, out of 106 patients, about 22% were 65 years or older, and 9% were 75 years or older. The studies didn’t find any major differences in how well the medicine worked or how safe it was between younger and older patients. However, some older people might be more sensitive to the medicine. Because older adults often have changes in how their liver, kidneys, or heart work, and may be taking other medications or have other health conditions, doctors usually start with a cautious dose and adjust it carefully for elderly patients.

Disclaimer: Do not use this information as a medical substitute; always consult your doctor before taking any prescription medicines.