Sign Out
General target population: Immune thrombocytopenia: The lowest dose of Revolade should be used to achieve and maintain a platelet count ≥50,000/microL. Dose adjustments are based upon the platelet count response. Revolade should not be used to normalize platelet counts. In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting Revolade and decreased within 1 to 2 weeks after discontinuation.
Initial dose regimen: Adults and pediatric patients aged 6 to 17 years: The recommended starting dose of Revolade is 50 mg once daily.
For adult and pediatric ITP patients aged 6 to 17 years of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 25 mg once daily (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
Pediatric patients aged 1 to 5 years: The recommended starting dose of Revolade is 25 mg once daily.
For pediatric ITP patients aged 1 to 5 years of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 25 mg once daily (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
Monitoring and dose adjustment: Adults and pediatric patients aged 1 to 17 years: After initiating Revolade, the dose should be adjusted to achieve and maintain a platelet count ≥50,000/microL as necessary to reduce the risk for bleeding. A daily dose of 75 mg should not be exceeded.
Clinical hematology and liver function tests should be monitored regularly throughout therapy with Revolade and the dose of Revolade should be modified based on platelet counts as outlined in Table 11. During therapy with Revolade complete blood counts (CBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/microL for at least 4 weeks) has been achieved. CBCs including platelet count and peripheral blood smears should be obtained monthly thereafter. (See Table 11.)
Click on icon to see table/diagram/imageThe standard dose adjustment, either decrease or increase, would be 25 mg once daily. However, in a few patients, a combination of different tablet strengths on different days or less frequent dosing may be required.
After any Revolade dose adjustment, platelet counts should be monitored at least weekly for 2 to 3 weeks. To see the effect of any dose adjustment on the patient's platelet response prior to considering another dose increase, one should wait for at least 2 weeks. In patients with liver cirrhosis (i.e., hepatic impairment), one should wait 3 weeks before increasing the dose (see HEPATIC IMPAIRMENT under SPECIAL POPULATIONS (ALL INDICATIONS) as follows).
When switching between the film-coated tablet and the powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks.
Discontinuation: Adults and pediatric patients aged 1 to 17 years: Treatment with Revolade should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at 75 mg once daily.
Chronic hepatitis C (HCV) associated thrombocytopenia: When Revolade is given in combination with antiviral therapies reference should be made to the full prescribing information of the respective co-administered medicinal products for comprehensive details of administration.
The lowest dose of Revolade to achieve and maintain a platelet count necessary to initiate and optimize antiviral therapy should be used. Dose adjustments should be based upon the platelet count response. Revolade should not be used to normalize platelet counts. In clinical studies, platelet counts generally increased within 1 week of starting Revolade.
Initial dose regimen: Adults: Revolade should be initiated at a dose of 25 mg once daily.
For chronic HCV patients of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 25 mg once daily (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
Monitoring and dose adjustment: The dose of Revolade should be adjusted in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy (see Table 12). Platelet counts should be monitored every week prior to starting antiviral therapy.
During antiviral therapy the dose of Revolade should be adjusted as necessary to avoid dose reduction of peginterferon. Platelet counts should be monitored weekly during antiviral therapy until a stable platelet count is achieved. CBCs, including platelet counts and peripheral blood smears should be obtained monthly thereafter.
A dose of 100 mg Revolade once daily should not be exceeded.
For specific dosage instructions for peginterferon alfa or ribavirin, one should refer to their respective prescribing information. (See Table 12.)
Click on icon to see table/diagram/imageDiscontinuation: In patients with HCV genotype 1/4/6, independent of the decision to continue interferon therapy, discontinuation of Revolade therapy should be considered in patients who do not achieve virological response at week 12. If HCV-RNA remains detectable after 24 weeks of treatment, Revolade therapy should be discontinued.
Revolade treatment should be terminated when antiviral therapy is discontinued. Excessive platelet count responses, as outlined in Table 12, or important liver test abnormalities may also necessitate discontinuation of Revolade (see PRECAUTIONS).
First-line severe aplastic anemia: Revolade should be initiated concurrently with standard immunosuppressive therapy.
The initial dose of Revolade should not be exceeded.
Initial dose regimen: Adult and adolescent patients aged 12 to 17 years: The recommended initial dose of Revolade is 150 mg once daily for 6 months.
For adult and adolescent SAA patients of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 75 mg once daily for 6 months.
Pediatric patients aged 6 to 11 years: The recommended initial dose of Revolade is 75 mg once daily for 6 months. For pediatric SAA patients of East-/Southeast-Asian ancestry aged 6 to 11 years, Revolade should be initiated at a dose of 37.5 mg once daily for 6 months.
Pediatric patients aged 2 to 5 years: The recommended initial dose of Revolade is 2.5 mg/kg once daily for 6 months.
For pediatric SAA patients of East-/Southeast-Asian ancestry aged 2 to 5 years, Revolade should be initiated at a dose of 1.25 mg/kg once daily for 6 months. (See Table 13.)
Click on icon to see table/diagram/imageMonitoring and dose adjustment for eltrombopag: Clinical hematology and liver tests should be performed regularly throughout therapy with Revolade.
The dosage regimen of Revolade should be modified based on platelet counts as outlined in Table 14.
Table 15 summarizes the recommendations for dose interruption, reduction, or discontinuation of Revolade in the management of liver function abnormalities and thrombosis/embolism events. (See Tables 14 and 15.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageDiscontinuation: The total duration of Revolade treatment is 6 months.
Excessive platelet count responses (as outlined in Table 14) or certain adverse events (as outlined in Table 15) also necessitate discontinuation of Revolade.
Refractory severe aplastic anemia: Initial dose regimen: Adults: Revolade should be initiated at a dose of 50 mg once daily.
For SAA patients of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 25 mg once daily (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
Monitoring and dose adjustment: Hematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting Revolade (see Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions). The dose of Revolade should be adjusted in 50 mg increments every 2 weeks as necessary to achieve the target platelet count ≥50,000/microL. A dose of 150 mg daily should not be exceeded. Clinical hematology and liver tests should be monitored regularly throughout therapy with Revolade and the dosage regimen of Revolade should be modified based on platelet counts as outlined in Table 16. (See Table 16.)
Click on icon to see table/diagram/imageTapering for tri-lineage (white blood cells, red blood cells, and platelets) responders: Once platelet count is >50,000/microL, hemoglobin is >10 g/dL in the absence of red blood cell (RBC) transfusion, and absolute neutrophil count (ANC) is >1 x 109/L for more than 8 weeks, the dose of Revolade should be reduced by up to 50%. If counts stay stable after 8 weeks at the reduced dose, then Revolade should be discontinued and blood counts monitored. If platelet counts drop to <30,000/microL, hemoglobin drops to <9 g/dL or ANC to <0.5 x 109/L, Revolade may be reinitiated at the previous dose.
Discontinuation: If no hematological response has occurred after 16 weeks of therapy with Revolade, therapy should be discontinued. Discontinuation should be considered if new cytogenetic abnormalities are observed (see ADVERSE REACTIONS). Excessive platelet count responses (as outlined in Table 16) or important liver test abnormalities also necessitate discontinuation of Revolade (see PRECAUTIONS).
Special populations (all indications): Renal impairment: No dose adjustment is necessary in patients with renal impairment. However, because of limited clinical experience, patients with impaired renal function should use Revolade with caution and close monitoring (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
Hepatic impairment: ITP patients with liver cirrhosis (hepatic impairment, Child-Pugh score ≥5) should use Revolade with caution and close monitoring (see PRECAUTIONS, PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
If the use of Revolade is deemed necessary for ITP patients with hepatic impairment the starting dose must be 25 mg once daily. After initiating the dose of Revolade in patients with hepatic impairment, one should wait 3 weeks before increasing the dose.
Chronic HCV patients with hepatic impairment and refractory severe aplastic anemia patients with hepatic impairment should initiate Revolade at a dose of 25 mg once daily (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
In a clinical study in definitive immunosuppressive therapy-naïve severe aplastic anemia, patients with baseline AST/ALT >5 x ULN were ineligible to participate. The initial dose of Revolade in patients with hepatic impairment in the first-line setting should be determined as necessary based on clinical judgement, tolerability, and close monitoring of liver function.
Pediatric patients (below 18 years): The safety and efficacy of Revolade have not been established in pediatric patients with ITP younger than 1 year of age, chronic HCV, refractory SAA, and definitive immunosuppressive therapy-naïve SAA patients younger than 2 years of age (see ADVERSE REACTIONS and Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions).
Geriatric patients (65 years of age or older): There are limited data on the use of Revolade in patients aged 65 years and older. In the clinical studies of Revolade, overall no clinically significant differences in safety of Revolade were observed between patients aged 65 years and older compared to younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see PHARMACOLOGY: Pharmacokinetics: SPECIAL POPULATIONS under Actions).
East-/Southeast-Asian patients: For adult and pediatric patients of East-/Southeast-Asian ancestry, Revolade should be initiated at a dose of 25 mg once daily for the treatment of ITP, HCV-associated thrombocytopenia, and refractory SAA. For the treatment of patients with first-line SAA refer to INITIAL DOSE REGIMEN as previously mentioned).
Method of administration: Revolade should be taken at least two hours before or four hours after any products such as antacids, dairy products, or mineral supplements containing polyvalent cations (e.g., aluminium, calcium, iron, magnesium, selenium, and zinc) (see DRUG-FOOD/DRINK INTERACTIONS under INTERACTIONS).
Revolade may be taken with food containing little (< 50 mg) or preferably no calcium (see DRUG-FOOD/DRINK INTERACTIONS under INTERACTIONS).
