Elbonix（PROMACTA）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. Elbonix 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. Elbonix 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.
Limitations of Use:
1. Elbonix 50mg 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.
DOSAGE AND ADMINISTRATION
1. Take on an empty stomach (1 hour before or 2 hours after a meal).
2. Chronic ITP: Initiate Elbonix 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 Elbonix 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 Elbonix 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.
Elbonix’s brand name is PROMACTA®by Novartis Pharmaceuticals. Elbonix is a generic oncologic prescription medicine from Beacon, which is one of the biggest pharmaceutical company in Bangladesh.
For more Prescribing information，please check the → “FDA Prescribing Information”.
