Important Safety Information

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...+

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Indication for PROMACTA® (eltrombopag)
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.

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.

Dosing & Administration

Dosing Guide

For adult patients with persistent or chronic ITP who failed their first therapy...

See the convenient once-daily oral dosing of nonimmunosuppressive PROMACTA1

Starting dose: Initiate at 50 mg/day. The majority of patients take a 50-mg dose.

Dose Titration

Initiate at 50 mg per day. If after at least 2 weeks platelet count is less than 50,000 microliters, then titrate up to 75 mg per day. Decrease daily dose by 25 mg if platelet count is greater than or equal to 200,000 microliters to less than or equal to 400,000 microliters at any time. Stop Promacta if platelet count is greater than 400,000 microliters. Discontinue Promacta if platelet count is greater than 400,000 microliters after 2 weeks of therapy at lowest dose of Promacta.

aFor patients of Asian ancestry, initiate at 25 mg/day. For patients with mild, moderate, or severe hepatic impairment, initiate at a reduced dose of 25 mg once daily; for patients of Asian ancestry with hepatic impairment, consider initiating at a reduced dose of 12.5 mg once daily.1

bDo not exceed a dose of 75 mg daily. For patients taking 25 mg once daily, increase daily dose by 25 mg; for patients taking 12.5 mg once daily, increase the dose to 25 mg daily before increasing the dose amount by 25 mg.1

cWait 2 weeks to assess the effects of this and any subsequent dose adjustments. For patients taking 25 mg once daily, decrease the dose to 12.5 mg once daily.1

dIncrease the frequency of platelet monitoring to twice weekly. Once the platelet count is <150,000/mcL, reinitiate therapy at a daily dose reduced by 25 mg. For patients taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.1

  • Monitor clinical hematology and liver tests regularly throughout therapy1
  • If platelet counts do not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at 75 mg, discontinue therapy1

Additional Dosing Considerations

More formulations for your patients than any other TPO-RA1,3,4

Promacta is available in oral tablets in 12.5 mg, 25 mg, 50 mg, and 75 mg doses and in an oral suspension in 12.5 mg and 25 mg.

The only oral TPO-RA with once-daily dosing regardless of dosage needs1,3

PROMACTA helps your patients manage their ITP on their schedule1

  • PROMACTA® (eltrombopag) is the only oral TPO-RA that can be taken without a meal or with a meal low in calcium (≤50 mg)1,3
  • PROMACTA should be taken 2 hours before or 4 hours after medications such as antacids and mineral supplements or foods high in calcium1
  • Any time of day1
  • No need for office visits for weekly injections and less drug wastage1,4

APLD, anonymous patient-level data; ITP, immune thrombocytopenia; TPO-RA, thrombopoietin receptor agonist.

References:

  1. Promacta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.
  2. Data on file. IQVIA APLD December 2018 to May 2019. Novartis Pharmaceuticals Corp; August 2019.
  3. Doptelet [prescribing information]. Durham, NC: Dova Pharmaceuticals Inc; 2020.
  4. Nplate [prescribing information]. Thousand Oaks, CA: Amgen Inc; 2021.

Indication and Important Safety Information

Indication for PROMACTA® (eltrombopag)
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.

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)

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 hepatic decompensation.

RISK OF HEPATOTOXICITY
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.

Hepatotoxicity
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 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

  • 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

Cataracts

  • 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

Laboratory Monitoring

  • 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 without a meal or with a meal low in calcium (≤50 mg)

Adverse Reactions
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 patients with persistent or chronic ITP (≥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 patients with persistent or chronic ITP 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%).

Please see full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide.