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Prescribing Information HIGHLIGHTS OF PRESCRIBING INFORMATION Chronic Hepatitis C-associated Thrombocytopenia: Initiate These highlights do not include all the information needed to use PROMACTA at 25 mg once daily for all patients. Adjust to achieve target PROMACTA safely and effectively. See full prescribing information for platelet count required to initiate antiviral therapy. Do not exceed a daily PROMACTA. dose of 100 mg. (2.2) PROMACTA® (eltrombopag) tablets, for oral use First-line Severe Aplastic Anemia: Initiate PROMACTA once daily at 2.5 PROMACTA® (eltrombopag) for oral suspension mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients Initial U.S. Approval: 2008 aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose WARNING: RISK FOR HEPATIC DECOMPENSATION IN in patients of Asian ancestry. Modify dosage for toxicity or elevated platelet PATIENTS WITH CHRONIC HEPATITIS C and RISK OF counts. (2.3, 8.7) HEPATOTOXICITY Refractory Severe Aplastic Anemia: Initiate PROMACTA at 50 mg once See full prescribing information for complete boxed warning. daily. Reduce initial dose in patients with hepatic impairment or patients of Asian ancestry. Adjust to maintain platelet count greater than 50 x 109/L. Do In patients with chronic hepatitis C, PROMACTA in combination with not exceed 150 mg per day. (2.3, 8.6, 8.7) interferon and ribavirin may increase the risk of hepatic decompensation. (5.1) --------------------------DOSAGE FORMS AND STRENGTHS----------------- Tablets: 12.5 mg, 25 mg, 50 mg, and 75 mg (3) PROMACTA may increase the risk of severe and potentially life- For oral suspension: 12.5 mg and 25 mg (3) threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. (5.2) ----------------------------------CONTRAINDICATIONS--------------------------- None. (4) ----------------------------RECENT MAJOR CHANGES-------------------------- Dosage and Administration, Administration (2.4) 4/2020 -------------------------WARNINGS AND PRECAUTIONS---------------------- Hepatotoxicity: Monitor liver function before and during therapy. (5.2) ----------------------------INDICATIONS AND USAGE--------------------------- Increased Risk of Death and Progression of Myelodysplastic Syndromes PROMACTA is a thrombopoietin receptor agonist indicated: to Acute Myeloid Leukemia. (5.3) for the treatment of thrombocytopenia in adult and pediatric patients Thrombotic/Thromboembolic Complications: Portal vein thrombosis has 1 year and older with persistent or chronic immune thrombocytopenia been reported in patients with chronic liver disease receiving PROMACTA. (ITP) who have had an insufficient response to corticosteroids, Monitor platelet counts regularly. (5.4) immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical ---------------------------------ADVERSE REACTIONS---------------------------- condition increase the risk for bleeding. (1.1) Across all indications, the most common adverse reactions (≥ 20% in any for the treatment of thrombocytopenia in patients with chronic hepatitis indication) were: anemia, nausea, pyrexia, alanine aminotransferase C to allow the initiation and maintenance of interferon-based therapy. increased, cough, fatigue, headache, and diarrhea. (6.1) PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon- To report SUSPECTED ADVERSE REACTIONS, contact Novartis based therapy or limits the ability to maintain interferon-based therapy. Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA- (1.2) 1088 or www.fda.gov/medwatch. in combination with standard immunosuppressive therapy for the first- ---------------------------USE IN SPECIFIC POPULATIONS-------------------- line treatment of adult and pediatric patients 2 years and older with Lactation: Advise women not to breastfeed during treatment. (8.2) severe aplastic anemia. (1.3) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Limitations of Use: PROMACTA is not indicated for the treatment of patients with Revised: 2/2021 myelodysplastic syndrome (MDS). (1.4) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4) ---------------------------DOSAGE AND ADMINISTRATION------------------- Take PROMACTA without a meal or with a meal low in calcium (≤ 50 mg). Take PROMACTA 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. (2.4, 7.1, 12.3) Persistent or 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 Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day. (2.1, 8.6, 8.7) FULL PRESCRIBING INFORMATION: CONTENTS* 7.2 Transporters WARNING: RISK FOR HEPATIC DECOMPENSATION IN 7.3 Protease Inhibitors PATIENTS WITH CHRONIC HEPATITIS C and 7.4 Peginterferon Alfa-2a/b Therapy RISK OF HEPATOTOXICITY 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Treatment of Thrombocytopenia in Patients With 8.2 Lactation Persistent or Chronic Immune Thrombocytopenia 8.3 Females and Males of Reproductive Potential 1.2 Treatment of Thrombocytopenia in Patients With 8.4 Pediatric Use Hepatitis C Infection 8.5 Geriatric Use 1.3 Treatment of Severe Aplastic Anemia 8.6 Hepatic Impairment 1.4 Limitations of Use 8.7 Ethnicity 2 DOSAGE AND ADMINISTRATION 10 OVERDOSAGE 2.1 Persistent or Chronic Immune Thrombocytopenia 11 DESCRIPTION 2.2 Chronic Hepatitis C-associated Thrombocytopenia 12 CLINICAL PHARMACOLOGY 2.3 Severe Aplastic Anemia 12.1 Mechanism of Action 2.4 Administration 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 13 NONCLINICAL TOXICOLOGY 5 WARNINGS AND PRECAUTIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.1 Hepatic Decompensation in Patients With Chronic 13.2 Animal Pharmacology and/or Toxicology Hepatitis C 14 CLINICAL STUDIES 5.2 Hepatotoxicity 14.1 Persistent or Chronic ITP 5.3 Increased Risk of Death and Progression of 14.2 Chronic Hepatitis C-associated Thrombocytopenia Myelodysplastic Syndromes to Acute Myeloid Leukemia 14.3 Severe Aplastic Anemia 5.4 Thrombotic/Thromboembolic Complications 16 HOW SUPPLIED/STORAGE AND HANDLING 5.5 Cataracts 16.1 Tablets 6 ADVERSE REACTIONS 16.2 For Oral Suspension 6.1 Clinical Trials Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience 7 DRUG INTERACTIONS *Sections or subsections omitted from the full prescribing information are 7.1 Polyvalent Cations (Chelation) not listed. FULL PRESCRIBING INFORMATION WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)]. PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions (5.2)]. 1 INDICATIONS AND USAGE 1.1 Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia PROMACTA is 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. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. 1.2 Treatment of Thrombocytopenia in Patients With Hepatitis C Infection PROMACTA is indicated for the treatment of 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. 1.3 Treatment of Severe Aplastic Anemia PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)]. Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. 2 DOSAGE AND ADMINISTRATION 2.1 Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of PROMACTA to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the
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