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Important safety information for Revolade

Revolade ( Eltrombopag ) is used in adults for the treatment of:

• long-term immune thrombocytopenic purpura ( ITP ), a disease in which the patient’s immune system destroys the platelets ( components in the blood that help it to clot ). Patients with ITP have low platelet counts in the blood ( thrombocytopenia ) and are at risk of bleeding. Revolade is used in patients who have had their spleen removed and who do not respond to treatment with medicines such as corticosteroids or immunoglobulins. It can also be considered for use in patients who have previously been treated for ITP who cannot have surgery to remove their spleen. The spleen is an organ that is involved in the destruction of platelets;

• thrombocytopenia in patients with chronic hepatitis C, a disease of the liver caused by infection with the hepatitis C virus, when the severity of thrombocytopenia is preventing antiviral therapy;

• acquired severe aplastic anaemia ( a disease in which the bone marrow does not make enough blood cells ). Revolade is used in patients who did not respond to or had received multiple courses of immunosuppressive therapy ( medicines that lower the body’s immune defenses ) and cannot receive haematopoietic stem cell transplantation.

Revolade may cause serious side effects, such as liver problems, high platelet counts and a higher chance for blood clots, bleeding after stopping treatment, and bone marrow problems.

Revolade may damage the liver and cause serious, even life threatening, illness. Blood tests to check the liver are needed before taking Revolade and during treatment. When certain antiviral treatments are given together with Revolade for the treatment of thrombocytopenia due to hepatitis C virus ( HCV ) infections, some liver problems can get worse.

In some cases Revolade treatment may need to be stopped. Patients should tell a doctor right away if they have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes ( jaundice ), unusual darkening of the urine, unusual tiredness, right upper stomach area pain.

Patients have a higher chance of getting a blood clot if their platelet count is too high during treatment with Revolade, but blood clots can occur with normal or even low platelet counts.
Patients who have cirrhosis of the liver are at risk of a blood clot in a blood vessel that feeds the liver.
Patients may have severe complications from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. A doctor will check the patient's blood platelet counts, and change the dose or stop Revolade if platelet counts get too high.
Patients should tell their doctor right away if they have signs and symptoms of a blood clot in the leg, such as swelling or pain/tenderness of one leg.
When patients stop taking Revolade, their blood platelet count will drop back down to what it was before they started taking Revolade. These effects are most likely to happen within 4 weeks after patients stop taking Revolade. The lower platelet counts may increase risk of bleeding. A doctor will check platelet counts for at least 4 weeks after patients stop taking Revolade. Patients should tell their doctor or pharmacist if they have any bruising or bleeding after they stop taking Revolade.

Patients being treated for the disease may have problems with their bone marrow. Medicines like Revolade could make this problem worse. Signs of bone marrow changes may show up as abnormal results in blood tests. A doctor may also carry out tests to directly check the bone marrow during treatment with Revolade.

The most common side effects of Revolade when used to treat patients with chronic immune thrombocytopenic purpura include nausea, diarrhea, increase of liver enzymes, dry mouth, vomiting, unusual hair loss or thinning, rash, back pain, muscle pain, sore throat and discomfort when swallowing, urinary tract infection.

The most common side effects of Revolade when used to treat patients with chronic HCV and antiviral agents include fever, feeling very tired, chills, headache, cough, nausea, diarrhea, unusual hair loss or thinning, muscle pain, itching, feeling weak, difficulty sleeping, loss of appetite, flu-like symptoms, and swelling of the hands, ankles or feet.

The most common side effects of Revolade when used to treat patients with severe aplastic anemia ( SAA ) include cough, headache, shortness of breath, pain in the nose and throat, runny nose, abdominal pain, diarrhea, bruising, joint pain, muscle spasms, pain in extremities, dizziness, feeling very tired, fever, inability to sleep ( insomnia ).
Common side effects that may show up in blood tests include increase in some liver enzymes and laboratory tests that may show abnormal changes to the cells in the bone marrow. ( Xagena )

Source: Novartis, 2015