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Eltrombopag) Tablets, for Oral Use Most Patients Chronic Hepatitis C-associated Thrombocytopenia: Initiate HIGHLIGHTS OF PRESCRIBING INFORMATION PROMACTA at 25 mg once daily for all patients. Adjust to achieve target These highlights do not include all the information needed to use platelet count required to initiate antiviral therapy. Do not exceed a daily PROMACTA safely and effectively. See full prescribing information for dose of 100 mg. (2.2) PROMACTA. Severe Aplastic Anemia: Initiate PROMACTA at 50 mg once daily for ® most patients. Reduce initial dose in patients with hepatic impairment or PROMACTA (eltrombopag) tablets, for oral use ® patients of East Asian ancestry. Adjust to maintain platelet count greater PROMACTA (eltrombopag) for oral suspension 9 Initial U.S. Approval: 2008 than 50 x 10 /L. Do not exceed 150 mg per day. (2.3, 8.6, 8.8) WARNING: RISK FOR HEPATIC DECOMPENSATION IN --------------------------DOSAGE FORMS AND STRENGTHS----------------­ PATIENTS WITH CHRONIC HEPATITIS C Tablets: 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg (3) RISK OF HEPATOTOXICITY For oral suspension: 25 mg (3) See full prescribing information for complete boxed warning. ----------------------------------CONTRAINDICATIONS--------------------------­ In patients with chronic hepatitis C, PROMACTA in combination with None. (4) interferon and ribavirin may increase the risk of hepatic decompensation. -------------------------WARNINGS AND PRECAUTIONS---------------------­ (5.1) Hepatotoxicity: Monitor liver function before and during therapy. (5.2) PROMACTA may increase the risk of severe and potentially life- Thrombotic/Thromboembolic Complications: Portal vein thrombosis has threatening hepatotoxicity. Monitor hepatic function and discontinue been reported in patients with chronic liver disease receiving PROMACTA. dosing as recommended. (5.2) Monitor platelet counts regularly. (5.3) ----------------------------RECENT MAJOR CHANGES-------------------------­ ---------------------------------ADVERSE REACTIONS---------------------------­ Boxed Warning 10/2016 In adult patients with ITP, the most common adverse reactions (greater Warnings and Precautions, Hepatotoxicity (5.2) 10/2016 than or equal to 5% and greater than placebo) were: nausea, diarrhea, Warnings and Precautions, Cataracts (5.4) 10/2016 upper respiratory tract infection, vomiting, increased ALT, myalgia, and urinary tract infection. (6.1) ----------------------------INDICATIONS AND USAGE--------------------------­ In pediatric patients age 1 year and older with ITP, the most common PROMACTA is a thrombopoietin receptor agonist indicated for the adverse reactions (greater than or equal to 10% and greater than placebo) treatment of: were upper respiratory tract infection and nasopharyngitis. (6.1) thrombocytopenia in adult and pediatric patients 1 year and older with In patients with chronic hepatitis C-associated thrombocytopenia, the most chronic immune (idiopathic) thrombocytopenia (ITP) who have had an common adverse reactions (greater than or equal to 10% and greater than insufficient response to corticosteroids, immunoglobulins, or placebo) were: anemia, pyrexia, fatigue, headache, nausea, diarrhea, splenectomy. decreased appetite, influenza-like illness, asthenia, insomnia, cough, Limitations of Use: PROMACTA should be used only in patients with ITP pruritus, chills, myalgia, alopecia, and peripheral edema. (6.1) whose degree of thrombocytopenia and clinical condition increase the risk In patients with severe aplastic anemia, the most common adverse for bleeding. (1.1) reactions (greater than or equal to 20%) were: nausea, fatigue, cough, thrombocytopenia in patients with chronic hepatitis C to allow the diarrhea, and headache. (6.1) initiation and maintenance of interferon-based therapy. Limitations of Use: PROMACTA should be used only in patients with To report SUSPECTED ADVERSE REACTIONS, contact Novartis chronic hepatitis C whose degree of thrombocytopenia prevents the initiation Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA­ of interferon-based therapy or limits the ability to maintain interferon-based 1088 or www.fda.gov/medwatch. therapy. Safety and efficacy have not been established in combination with ---------------------------------DRUG INTERACTIONS---------------------------­ direct-acting antiviral agents used without interferon for treatment of chronic Take PROMACTA at least 2 hours before or 4 hours after any medications or hepatitis C infection. (1.2) products containing polyvalent cations such as antacids, calcium-rich foods, patients with severe aplastic anemia who have had an insufficient and mineral supplements. (2.4, 7.1) response to immunosuppressive therapy. (1.3) ---------------------------USE IN SPECIFIC POPULATIONS-------------------­ ---------------------------DOSAGE AND ADMINISTRATION------------------­ Pregnancy: Based on animal data, PROMACTA may cause fetal harm. Take on an empty stomach (1 hour before or 2 hours after a meal). (2.4) (8.1) Chronic ITP: Initiate PROMACTA at 50 mg once daily for most adult and Nursing Mothers: A decision should be made to discontinue PROMACTA pediatric patients 6 years and older and at 25 mg once daily for pediatric or nursing, taking into account the importance of PROMACTA to the patients aged 1 to 5 years. Dose reductions are needed for patients with mother. (8.3) hepatic impairment and some patients of East Asian ancestry. Adjust to 9 maintain platelet count greater than or equal to 50 x 10 /L. Do not exceed See 17 for PATIENT COUNSELING INFORMATION and Medication 75 mg per day. (2.1, 8.6, 8.8) Guide. Revised: 7/2017 Reference ID: 4121711 FULL PRESCRIBING INFORMATION: CONTENTS* 7.3 Protease Inhibitors WARNING: RISK FOR HEPATIC DECOMPENSATION IN 7.4 Peginterferon alfa-2a/b Therapy PATIENTS WITH CHRONIC HEPATITIS C 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Treatment of Thrombocytopenia in Patients with 8.3 Nursing Mothers Chronic ITP 8.4 Pediatric Use 1.2 Treatment of Thrombocytopenia in Patients with 8.5 Geriatric Use Hepatitis C Infection 8.6 Hepatic Impairment 1.3 Treatment of Severe Aplastic Anemia 8.7 Renal Impairment 2 DOSAGE AND ADMINISTRATION 8.8 Ethnicity 2.1 Chronic Immune (Idiopathic) Thrombocytopenia 10 OVERDOSAGE 2.2 Chronic Hepatitis C-associated Thrombocytopenia 11 DESCRIPTION 2.3 Severe Aplastic Anemia 12 CLINICAL PHARMACOLOGY 2.4 Administration 12.1 Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 3.1 Tablets 12.6 Assessment of Risk of QT/QTc Prolongation 3.2 For Oral Suspension 13 NONCLINICAL TOXICOLOGY 4 CONTRAINDICATIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5 WARNINGS AND PRECAUTIONS 13.2 Animal Pharmacology and/or Toxicology 5.1 Hepatic Decompensation in Patients with Chronic 14 CLINICAL STUDIES Hepatitis C 14.1 Chronic ITP 5.2 Hepatotoxicity 14.2 Chronic Hepatitis C-associated Thrombocytopenia 5.3 Thrombotic/Thromboembolic Complications 14.3 Severe Aplastic Anemia 5.4 Cataracts 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 16.1 Tablets 6.1 Clinical Trials Experience 16.2 For Oral Suspension 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS 7.1 Polyvalent Cations (Chelation) * Sections or subsections omitted from the full prescribing information are 7.2 Transporters not listed. _____________________________________________________________________ Reference ID: 4121711 FULL PRESCRIBING INFORMATION WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C 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 Chronic ITP PROMACTA is indicated for the treatment of 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. Limitations of Use: 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. Limitations of Use: 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. Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. 1.3 Treatment of Severe Aplastic Anemia PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 2 DOSAGE AND ADMINISTRATION 2.1 Chronic Immune (Idiopathic) 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 risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use PROMACTA to normalize
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