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, affecting 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 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 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 have not been established for children.