Revolade (Eltrombopag) 50mg is a thrombopoietin receptor agonist indicated for the treatment of:
1.Thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
2. Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
3. patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
DOSAGE AND ADMINISTRATION
1.Take on an empty stomach (1 hour before or 2 hours after a meal).
2.Chronic ITP: Initiate PROMACTA at 50 mg once daily for most adult and pediatric patients 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of East Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day
3.Chronic Hepatitis C-associated Thrombocytopenia: Initiate PROMACTA at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.
4.Severe Aplastic Anemia: Initiate PROMACTA at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East Asian ancestry. Adjust to maintain platelet count greater than 50 x 109/L. Do not exceed 150 mg per day.
Limitations of Use:
1. Tltrombopag is not indicated for the treatment of patients with myelodysplastic syndrome (MDS).
2. Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
Revolade (Eltrombopag) 50mg Side effects:
Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML).
Revolade (Eltrombopag) 25mgis not for treatment of people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive Revolade (Eltrombopag), your MDS condition may worsen and become AML. If MDS worsens to become AML you may die sooner from AML.
Abnormal liver function tests.
Your healthcare provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases treatment with Revolade (Eltrombopag) may need to be stopped due to changes in your liver function tests.
High platelet counts and higher risk for blood clots.
Your risk of getting a blood clot is increased if your platelet count is too high during treatment with Revolade (Eltrombopag). Your risk of getting a blood clot may also be increased during treatment with PROMACTA if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Revolade (Eltrombopag) if your platelet counts get too high. Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg. People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your healthcare provider right away if you have stomach area pain that may be a symptom of this type of blood clot.