WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C - In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of...+
Dosing & Administration
Dosing for Adult ITP Patients
ONLY PROMACTA OFFERS THE CONVENIENCE OF ONCE-DAILY ORAL DOSING1-3
Just 1 Pill per Day1
- Initiate at 50 mg/day—the majority of patients are maintained on a 50-mg dose
- For patients of Asian ancestry, initiate at 25 mg/day
- Titrate 25 mg/day up or down as needed to help patients reach target platelet levels ≥50,000/mcL as necessary to reduce the risk of bleeding. PROMACTA® (eltrombopag) is not used to normalize platelet counts
- Patients should be monitored regularly for platelet counts and hepatic function before and during therapy
- PROMACTA should be taken:
- On an empty stomach, 1 hour before or 2 hours after a meal
- At least 2 hours before or 4 hours after consuming >50 mg of calcium*
*This includes calcium-rich foods, other medications (such as antacids), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.
- 87% of patients chose a once-daily oral over an injectable therapy or a twice-daily oral regimen
No Need for Weekly Doctor Visits for Injections1
No Concern Over Additional Weekly Office Co⁃pays for Injections
BENEFITS TO THE PHYSICIAN AND HEALTH CARE SYSTEM
PROMACTA Leads to Less Waste in the Health Care System1,2
- Unlike injectable therapies, which require weight-based dosing, PROMACTA is an oral therapy, leading to less drug waste
Consistently Proven Across All Patient Types, Regardless of1,5-10:
- Baseline platelet count
- Use of concomitant ITP medication at baseline
- Splenectomy status
- PROMACTA does have dosing considerations around mealtime and calcium intake
- PROMACTA requires monitoring of platelets and liver function
BID, twice daily; ITP, immune thrombocytopenia; QD, once daily.
- Promacta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019.
- Nplate [prescribing information]. Thousand Oaks, CA: Amgen Inc; 2018.
- Tavalisse [prescribing information]. South San Francisco, CA: Rigel Pharmaceuticals Inc; 2018.
- Data on file. NO8348 ITP US Team Demonstration. Novartis Pharmaceuticals Corp; April 2018.
- Data on file. Study TRA105325 (EXTEND). Novartis Pharmaceuticals Corp; March 2016.
- Data on file. Study TRA100773A. Novartis Pharmaceuticals Corp; October 2007.
- Wong RSM, Saleh MN, Khelif A, et al. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017;130(23):2527-2536.
- Data on file. Study TRA102537 (RAISE). Novartis Pharmaceuticals Corp; February 2009.
- Data on file. Study TRA100773B. Novartis Pharmaceuticals Corp; October 2008.
- Data on file. Study TRA108057 (REPEAT). Novartis Pharmaceuticals Corp; September 2008.
Indication for PROMACTA® (eltrombopag) Tablets
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with 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.
Limitations of Use
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (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.
Important Safety Information for PROMACTA® (eltrombopag) Tablets
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity.
Treatment of ITP, chronic hepatitis C, and refractory severe aplastic anemia
- Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose-adjustment phase, and monthly following establishment of a stable dose
- PROMACTA inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform fractionation
- Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized
- Discontinue PROMACTA if ALT levels increase to ≥3 times the upper limit of normal (ULN) in patients with normal liver function or ≥3 times baseline in patients with pretreatment elevations in transaminases and are progressively increasing; or persistent for ≥4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation
- If the potential benefit for reinitiating treatment with PROMACTA outweighs the risk for hepatotoxicity, then consider cautiously reintroducing PROMACTA and measure serum liver tests weekly during the dose-adjustment phase. Hepatotoxicity may reoccur if PROMACTA is reinitiated. If liver test abnormalities persist, worsen, or recur, then permanently discontinue PROMACTA
- Thrombotic/thromboembolic complications may result from increases in platelet counts with PROMACTA
- Reported thrombotic/thromboembolic complications included both venous and arterial events, and were observed at low and at normal platelet counts
- Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA
- To minimize the risk for thrombotic/thromboembolic complications, do not use PROMACTA in an attempt to normalize platelet counts. Follow the dose-adjustment guidelines to achieve and maintain target platelet counts
Increased Risk of Death and Progression of Myelodysplastic Syndromes (MDS) to Acute Myeloid Leukemia (AML)
- In a clinical trial of patients with intermediate to high-risk MDS and thrombocytopenia receiving PROMACTA, an increased number of progressions from MDS to AML and deaths have been observed compared to placebo
- PROMACTA is not indicated for the treatment of patients with MDS
- Development or worsening of cataracts with PROMACTA has been reported with a frequency of 5% to 11% in 6 clinical studies
- Perform a baseline ocular examination prior to initiating PROMACTA. Regularly monitor patients for signs and symptoms of cataracts while on PROMACTA
- Monitor serum liver tests
- During therapy with PROMACTA, assess complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Monitor platelet counts monthly thereafter
- Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation of PROMACTA
- When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, then follow standard monthly monitoring
Drug/Drug and Drug/Food Interactions
- PROMACTA must be taken 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
- Take PROMACTA on an empty stomach (1 hour before or 2 hours after a meal)
Across all indications, the most common adverse reactions (≥20% in any indication) were: anemia, nausea, pyrexia, ALT increased, cough, fatigue, headache, and diarrhea.
The most common adverse reactions in 3 placebo-controlled clinical trials in chronic ITP patients (≥3% and greater than placebo) for PROMACTA were nausea (9%), diarrhea (9%), upper respiratory tract infection (7%), vomiting (6%), increased ALT (5%), myalgia (5%), urinary tract infection (5%), oropharyngeal pain (4%), increased AST (4%), pharyngitis (4%), back pain (3%), influenza (3%), paresthesia (3%), and rash (3%).
The most common adverse reactions in 2 placebo-controlled clinical trials in chronic ITP patients 1 year and older (≥3% and greater than placebo) for PROMACTA were upper respiratory tract infection (17%), nasopharyngitis (12%), cough (9%), diarrhea (9%), pyrexia (9%), abdominal pain (8%), oropharyngeal pain (8%), toothache (6%), ALT increased (6%), rash (5%), AST increased (4%), and rhinorrhea (4%).