Eltrombopag Side Effects

Serious side effects

• Urination complications including burning while urinating, frequent, urgent and painful urination,
• Vision problems including worsening cloudy vision, blurred vision, halo vision around lights or eye pain
• Lightheadedness, dizziness and fainting including persistent and unusual tiredness/weakness
• Signs of liver complications including dark urine, pale or clay colored stools, jaundice of the skin and eyes
• Stroke and heart attack with weakness or numbness of an arm or leg
• Slow and difficult speech with fits of cold sweats and chest pain
• possible fast heartbeat and fast breathing or pain when breathing deeply and shortness of breath
• Stomach problems like severe or persistent nausea with vomiting and diarrhea, as well as upper stomach pain and loss of appetite
• swelling, pain, tenderness, warmth or redness in one or any appendages
• easy and unusual bruising or bleeding, with purple/red spots under the skin and unusual tingling under the skin
• coughing up blood and pain in the back, neck, throat or jaw

Common side effects

• Mild nausea, vomiting, diarrhea and heartburn, with mild loss of appetite
• Hair loss and sleep problems like insomnia
• Flu or cold-like symptoms such as fever, chills, stuffy/runny nose, sneezing, cough, sore throat and body aches
• Some muscle pain and numbness, swelling or tingling in hands or feet
• Mild itching or rashes on the skin, with red patches on the whites of the eyes or inside the eyelids
• unusually long and heavy menstrual periods

Warnings & Recalls for Eltrombopag

Black Box Warning

• Eltrombopag can cause fatal liver problems when used with interferon and ribavirin. Regular blood tests should be performed by a physician for consistent liver check ups. Symptoms such as yellowing of the skin or eyes, dark urine, pale stools, upper right stomach pain or unusual/excessive tiredness need to be taken with caution, as these are signs of liver damage or failure.
• A program organized by Promacta called Promacta CARES ensures that eltrombopag is used with caution. Patients, pharmacies and physicians alike are required to enroll in the program before the medication begins. The program also requires that the patient receives information on the risks of taking eltrombopag, and that the physician is informing Promacta CARES on the patient's progress. The final part of this program requires the pharmacy to receive confirmation that a physician has stated that the patient is being monitored while on this medication.

Warnings

• Eltrombopag can cause permanent and fatal changes in bone marrow by producing fewer or abnormal blood cells.
• Blood clots caused by too high platelet levels can increase the risk of a heart attacks and strokes.
• After discontinuation of the drug, platelet levels can drop even lower than before the medication. This increases risk of particular bleeding problems, especially if the patient is taking anticoagulants and antiplatelet medications.
• Patients on eltrombopag should avoid any activities that can cause bruising or bleeding.
• Eltrombopag may cause new cataracts to develop and can worsen existing cataracts.
• Caution should be exerted while taking eltrombopag in patients of East Asian ancestry (Chinese, Japanese, Taiwanese, Korean) as these patients may be more sensitive to this medication.
• The safety or effectiveness in children has not been confirmed therefore this medication should be used with caution in those younger than 18 years old.
• Patients with a history of bone marrow problems, strokes, liver or kidney problems, cataracts, bleeding complications such as blood clots, past splenectomies or cancer should disclose this information to their doctor prior to taking Eltrombopag.
• Those who use any tobacco products should avoid use of Eltrombopag.

• Blood thinners (anticoagulants) and antiplatelet medications
• acetaminophen, benzylpenicillin, bosentan, Lopinavir, Ritonavir, ezetimibe, sulfasalazine, methotrexate, glyburide, irinotecan
• simvastatin acid, SN-38, topotecan, olmesartan, mitoxantrone, meglitinides, imatinib, doxorubicin, valsartan, lapatinib
• aspirin and nonsteroidal anti-inflammatory medications like ibuprofen and naproxen
• cholesterol medications likeatorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin
• ciprofloxacin, fluvoxamine, gemfibrozil, methotrexate
• narcotic medications for pain
• nateglinide, omeprazole, penicillin G, repaglinide, rifampin and trimethoprim
• antacids containing calcium, aluminum, or magnesium
• vitamins or supplements containing calcium, iron, zinc or selenium

• It is unknown if Eltrombopag can cause harm to the fetus. If the patient has any possiblity of becoming pregnant, she should contact her doctor to discuss if the benefits to the mother outweighs the risk to the infant while on this medication.
• Promacta has established a pregnancy registry for women who become pregnant while on eltrombopag. The registry collects health information for the safety of women and their unborn children. Pregnant women can either enroll themselves in the program or they may choose to have their physician enroll for them. The registry can be found by calling 1-888-825-5249.
• It is unknown if this medication passes through breastmilk, therefore nursing mothers should discuss their options with a physician.

Eltrombopag Treatment and Use

Eltrombopag | Promacta | Revolade is a thrombopoietin receptor agonist used for the treatment of thrombocytopenia (low amounts of platelets in the blood) in those suffering from chronic immune thrombocytopenia (chronic idiopathic thrombocytopenic purpura) which can cause unusual bleeding due to improper blood clotting. This drug is for use after medications like corticosteroids, immunoglobulins and splenectomies have failed to relieve symptoms. Eltrombopag should not be used to normalize platelet counts but is only used in patients whose severe condition increases the risk of serious bleeding.

How does Eltrombopag work?

Eltrombopag contains eltrombopag olamine which works by reacting with the TPO receptor, thus causing bone marrow cells to produce more platelets. The medication controls the symptoms of chronic idiopathic thrombocytopenic purpura, but does not cure it.

Dosage Information

Eltrombopag should be taken orally on an empty stomach, allowing 1 hour before a meal and 2 hours after a meal. Some medications and foods should be taken at least 4 hours before or 4 hours after the patient takes Eltrombopag, these include antacids, calcium rich foods, iron, calcium, aluminum, magnesium, selenium and zinc.

Eltrombopag dosage will be determined by a doctor but the patient will usually be started at the low dose of 25 mg to 50 mg per day, and be adjusted by a physician depending on the patient’s responses to the medication. Patients of Eastern Asian descent may be started at 12.5 mg per day. The maximum dose per day is 75 mg.

This medication should be taken at the same time every day. If a dose is missed, the patient should skip that dose and go back to the regular dosing schedule. Patient should only take 1 dose per day. Eltrombopag should not be suddenly discontinued as a physician will need to monitor the patient’s condition.

Platelet count will be checked at the start of medication, regularly throughout the treatment process and for at least 4 weeks after the treatment ends. Medications for chronic idiopathic thrombocytopenic purpura may also be prescribed alongside Eltrombopag.

Eletrombopag comes in 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg tablets.

Other Names for Eltrombopag

Lawsuits & Legal Information for Eltrombopag