HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LuciElo safely and effectively. See full prescribing information for LuciElo.
INDICATIONS AND USAGE
LuciElo is a thrombopoietin receptor agonist indicated:
• for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. LuciElo should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
• for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. LuciElo 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.
• in combination with standard immunosuppressive therapy for the firstline treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
• for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Limitations of Use:
• LuciElo is not indicated for the treatment of patients with myelodysplastic syndrome (MDS).
• 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
• Take LuciElo without a meal or with a meal low in calcium (≤ 50 mg). Take LuciElo at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements.
• Persistent or Chronic ITP: Initiate LuciElo 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-/Southeast Asian ancestry. Adjust to maintain platelet count greater than or equal to 50×109/L. Do not exceed 75 mg per day.
• Chronic Hepatitis C-associated Thrombocytopenia: Initiate LuciElo 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.
• First-line Severe Aplastic Anemia: Initiate LuciElo once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of East-/Southeast-Asian ancestry. Modify dosage for toxicity or elevated platelet counts.
• Refractory Severe Aplastic Anemia: Initiate LuciElo at 50 mg once daily. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than 50×109/L. Do not exceed 150 mg per day.
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg×28 tablets、50 mg×28 tablets
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
• Hepatotoxicity: Monitor liver function before and during therapy.
• Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia.
• Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving LuciElo. Monitor platelet counts regularly.
ADVERSE REACTIONS
Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase increased, cough, fatigue, headache, and diarrhea.
USE IN SPECIFIC POPULATIONS
• Lactation: Advise women not to breastfeed during treatment.
Storage
Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.
