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How does this medication work? What will it do for me?
Eltrombopag belongs to the class of medications called thrombopoietin receptor agonists.
It is used to increase the number of platelets in the blood for adults and children with chronic (long-term) immune thrombocytopenia purpura (ITP). It may be used to treat people who have had their spleen removed and the medications that are used as first-line treatments are no longer working. It may also be used to treat adults for whom removing the spleen is not an option but who have low platelet counts.
Eltrombopag is also used to increase platelet counts for people with chronic hepatitis C virus infection, so that they can use interferon to treat the infection. This medication should only be used by people with chronic hepatitis C infection when the number of platelets in the blood is too low to start treatment with interferon.
Eltrombopag is also used to treat adults with severe aplastic anemia (SAA) when other treatments have not worked.
Eltrombopag works by increasing the production of platelets in the body.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, round, biconvex, film-coated tablet, embossed with ‘GS MZ1′ and ‘12.5’, contains 12.5 mg of eltrombopag as eltrombopag olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, and polysorbate.
Each white, round, biconvex, film-coated tablet, debossed with "GS NX3" and "25", contains 25 mg of eltrombopag as eltrombopag olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, and polysorbate.
Each brown, round, biconvex, film-coated tablet, debossed with "GS UFU" and "50", contains 50 mg of eltrombopag as eltrombopag olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, iron oxide yellow, and iron oxide red.
Each pink, round, biconvex, film-coated tablet, debossed with "GS FFS" and "75", contains 75 mg of eltrombopag as eltrombopag olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, iron oxide red, and iron oxide black.
How should I use this medication?
The recommended starting dose of eltrombopag for adults and children over 6 years of age, for the treatment of ITP is 50 mg taken once daily. Depending on your platelet counts after 2 to 3 weeks, your doctor may increase your dose to a maximum of 75 mg daily.
Children between the ages of 1 and 6 years of age should be given a starting dose of 25 mg taken by mouth once daily, only if they are able to swallow tablets whole. The tablets should not be crushed and mixed with water.
The starting dose for people with chronic hepatitis C is 25 mg taken once daily. This dose may be increased every 2 weeks to a maximum of 100 mg once daily.
The starting dose for people with SAA is 50 mg taken once daily. This dose may be increased every 2 weeks to a maximum of 150 mg once daily.
Eltrombopag tablets should be swallowed whole with water. Do not crush or chew the tablets, or crush the tablets to mix in water. Eltrombopag should be taken at least 2 hours before or 4 hours after antacids, dairy products, mineral supplements or any other products containing aluminum, calcium, iron, magnesium, selenium and zinc. It may be taken with food that contains very little or no calcium.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If it is necessary to stop taking eltrombopag, your doctor should do regular blood tests to ensure that your platelet count does not fall too low.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take eltrombopag if you:
- are allergic to eltrombopag or any ingredients of the medication
- have severely reduced liver function
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- blisters in the mouth
- common cold
- appetite changes
- darkening skin colour
- discolouration of urine or feces
- dry eyes
- dry mouth
- feeling hot
- flu-like symptoms (fever, cough, sore throat, sudden lack of energy)
- increased sweating
- loss of appetite
- motion sickness
- numbness or tingling of the skin
- sore mouth
- sore throat, pain when swallowing
- trouble sleeping
- unusual hair loss or thinning hair
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- aching muscles or bones
- chest muscle pain
- dizziness, lightheadedness or fainting when rising from a sitting or lying position
- muscle and tendon pain
- shortness of breath
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (sharp chest pain that is worse when breathing in, difficulty breathing, coughing, coughing up blood, sweating, or passing out)
- signs of a blood clot in the spleen (severe pain in the upper left side of the abdomen, which may radiate to the left shoulder)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding) after stopping the medication
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- skin rash
- swelling hands, ankles, or feet
- symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
- symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
- unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- vision changes or blurred vision
Stop taking the medication and seek immediate medical attention if any of the following occur:
- blood infection (e.g., rapid heartbeat, fever, shaking chills, nausea, vomiting, rapid breathing, decreased urination)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds) after stopping this medication
- signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in the arm or leg)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
August 25, 2016
Health Canada has issued new restrictions concerning the use of Revolade (eltrombopag). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Blood cell changes: Eltrombopag stimulates cells in the bone marrow that produce platelets as well as other blood cells. Sometimes this causes changes in the blood cells or bone marrow, which can increase the risk of bone marrow cell disorders and blood cancers. Your doctor will do regular blood tests to identify changes in the blood cells or bone marrow before it becomes severe.
The increased speed of blood cell formation may cause certain blood diseases such as blood cancers to progress. Speak to your doctor if you have concerns about this.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.
Cataracts: Eltrombopag has been reported to cause cataracts or to worsen them for people who had the beginnings of cataracts before taking the medication. If you notice changes in your vision while taking this medication, speak with your doctor.
Dizziness: Eltrombopag may cause dizziness, particularly when rising from a sitting or lying position. Rise slowly to help reduce this effect. Dizziness may also affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Hepatitis C infection: People with chronic hepatitis C infection may be at an increased risk of liver failure and death when being treated with interferon and ribavirin. This is more likely to occur when taking eltrombopag as well.
Kidney function: Kidney disease or reduced kidney function may cause this medication to not be as effective. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Additionally, eltrombopag may reduce liver function and can cause life-threatening liver failure. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
People with severely reduced liver function should not take this medication.
People of East Asian descent: When treating ITP and SAA, people of East Asian heritage (Chinese, Japanese, Taiwanese, Thai, or Korean) may need to start at a lower dose of eltrombopag. The dose for treating hepatitis C does not need to be adjusted.
Stopping this medication: When you stop taking this medication, your platelet count will return to what it was before you started taking eltrombopag, usually within 4 weeks. The reduced number of platelets in the blood can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor should check your platelet counts regularly for at least 4 weeks after you stop taking this medication.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if eltrombopag passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication to treat any condition have not been established for children less than 1 year of age. Children who can swallow tablets may be prescribed this medication to treat ITP. It should not be given to children who cannot swallow whole tablets. There is no information regarding the safety and effectiveness of using this medication to treat chronic hepatitis C infection or severe aplastic anemia in children less than 18 years of age.
What other drugs could interact with this medication?
There may be an interaction between eltrombopag and any of the following:
- aluminum hydroxide
- calcium supplements (e.g., calcium carbonate, calcium citrate)
- iron (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
- magnesium (e.g., magnesium hydroxide, magnesium oxide)
- "statin" anticholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Revolade