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Promacta

Last reviewed on RxList: 5/18/2020
Promacta Side Effects Center

What Is Promacta?

Promacta (eltrombopag) is a thrombopoietin (TPO) receptor agonist, a man-made form of a protein, used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. Promacta is usually given after other medications or surgery have been tried without successful treatment of symptoms.

What Are Side Effects of Promacta?

Common side effects of Promacta include:

Dosage for Promacta

The starting dose of Promacta is 50 mg once daily. In patients of East Asian ancestry or who have mild to severe hepatic impairment, start at a dose of 25 mg once daily.

What Drugs, Substances, or Supplements Interact with Promacta?

Promacta may interact with acyclovir, antacids, atazanavir, birth control pills, cimetidine, famotidine, fluvoxamine, gemfibrozil, methotrexate, rifampin, ticlopidine, trimethoprim, zileuton, antibiotics, cholesterol-lowering medicines, oral diabetes medications, or heart rhythm medications. Tell your doctor all medications and supplements you use.

Promacta During Pregnancy and Breastfeeding

During pregnancy, Promacta should be taken only if prescribed. Your name may need to be listed on a pregnancy registry if you become pregnant while taking Promacta. The registry tracks the outcome of the pregnancy and delivery to evaluate whether Promacta had any effect on the baby. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Promacta (eltrombopag) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Promacta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You could develop a blood clot if your platelet count gets too high while you are using eltrombopag. Call your doctor or get emergency medical help if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the stomach--severe stomach pain, vomiting, diarrhea;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Call your doctor at once if you have:

  • any bruising or bleeding episodes during or after treatment with eltrombopag;
  • vision changes, tunnel vision, eye pain, or seeing halos around lights;
  • pain or burning when you urinate;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • liver problems--confusion, tiredness, stomach pain (upper right side), stomach swelling, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, diarrhea;
  • fever;
  • cough;
  • headache, tiredness;
  • anemia; or
  • abnormal bone marrow or liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Promacta (Eltrombopag Tablets)

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Promacta Professional Information

SIDE EFFECTS

The following serious adverse reactions associated with PROMACTA are described in other sections.

  • Hepatic Decompensation in Patients with Chronic Hepatitis C [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia [see WARNINGS AND PRECAUTIONS]
  • Thrombotic/Thromboembolic Complications [see WARNINGS AND PRECAUTIONS]
  • Cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Chronic Immune Thrombocytopenia

Adults

In clinical trials, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of PROMACTA. Other serious adverse reactions included thrombotic/thromboembolic complications [see WARNINGS AND PRECAUTIONS]. The data described below reflect exposure of PROMACTA to patients with chronic ITP aged 18 to 85 years, of whom 66% were female, in three placebo-controlled trials and one open-label extension trial [see Clinical Studies]. PROMACTA was administered to 330 patients for at least 6 months and 218 patients for at least 1 year.

Table 8 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of patients receiving PROMACTA) from the three placebo-controlled trials, with a higher incidence in PROMACTA versus placebo.

Table 8. Adverse Reactions (≥ 3%) from Three Placebo-controlled Trials in Adults with Chronic Immune Thrombocytopenia

Adverse ReactionPROMACTA 50 mg
n = 241
(%)
Placebo
n = 128
(%)
Nausea93
Diarrhea97
Upper respiratory tract infection76
Vomiting6<1
Urinary tract infectiona54
Increased ALT53
Myalgia52
Oropharyngeal pain43
Increased AST42
Pharyngitis42
Back pain32
Influenza32
Paresthesia32
Rash32
a Includes PTs of Urinary tract infection, Cystitis, Urinary tract infection bacterial, and Bacteriuria.

In the three controlled clinical chronic ITP trials, alopecia, musculoskeletal pain, blood alkaline phosphatase increased, and dry mouth were the adverse reactions reported in 2% of patients treated with PROMACTA and in no patients who received placebo.

Among 302 patients with chronic ITP who received PROMACTA in the single-arm extension trial, the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled trials. Table 9 presents the most common treatment-related adverse reactions (experienced by greater than or equal to 3% of patients receiving PROMACTA) from the extension trial.

Table 9. Treatment-related Adverse Reactions (≥ 3%) from Extension Trial in Adults with Chronic Immune Thrombocytopenia

Adverse ReactionPROMACTA 50 mg
n = 302
(%)
Headache10
ALT increased5
AST increased5
Cataract5
Fatigue5
Blood bilirubin increased4
Nausea4
Hyperbilirubinemia3
Diarrhea3

In the three controlled chronic ITP trials, serum liver test abnormalities (predominantly Grade 2 or less in severity) were reported in 11% and 7% of patients for PROMACTA and placebo, respectively. Four patients (1%) treated with PROMACTA and three patients in the placebo group (2%) discontinued treatment due to hepatobiliary laboratory abnormalities. Seventeen of the patients treated with PROMACTA in the controlled trials with hepatobiliary laboratory abnormalities were re-exposed to PROMACTA in the extension trial. Eight of these patients again experienced liver test abnormalities (less than or equal to Grade 3) resulting in discontinuation of PROMACTA in one patient. In the extension chronic ITP trial, six additional patients had PROMACTA discontinued due to liver test abnormalities (less than or equal to Grade 3).

In the three controlled chronic ITP trials, cataracts developed or worsened in 7% of patients treated with PROMACTA and 7% of patients in the placebo group. All patients had documented, preexisting risk factors for cataractogenesis including corticosteroid use. In the extension trial, cataracts developed or worsened in 11% of patients who underwent ocular examination prior to therapy with PROMACTA. Seventy-two percent of patients had preexisting risk factors, including corticosteroid use.

The safety of PROMACTA was also assessed in all patients treated in 7 adult chronic ITP clinical trials (N = 763 PROMACTA-treated patients and 179 placebo-treated patients). Thromboembolic events were reported in 6% of PROMACTA-treated patients versus 0% of placebo-treated patients and thrombotic microangiopathy with acute renal failure was reported in < 1% of PROMACTA-treated patients versus 0% of placebo-treated patients.

In a placebo-controlled trial of PROMACTA in patients with chronic liver disease and thrombocytopenia not related to ITP, six patients treated with PROMACTA and one patient in the placebo group developed portal vein thromboses [see WARNINGS AND PRECAUTIONS].

Pediatric Patients

The data described below reflect median exposure to PROMACTA of 91 days for 107 pediatric patients (aged 1 to 17 years) with chronic ITP, of whom 53% were female, across the randomized phase of two placebo-controlled trials.

Table 10 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of pediatric patients 1 year and older receiving PROMACTA) across the two placebo-controlled trials, with a higher incidence for PROMACTA versus placebo.

Table 10. Adverse Reactions (≥ 3%) with a Higher Incidence for PROMACTA versus Placebo from Two Placebo-controlled Trials in Pediatric Patients 1 Year and Older with Chronic Immune Thrombocytopenia

Adverse ReactionPROMACTA
n = 107
(%)
Placebo
n = 50
(%)
Upper respiratory tract infection176
Nasopharyngitis124
Cough90
Diarrhea92
Pyrexia98
Abdominal pain84
Oropharyngeal pain82
Toothache60
ALT increaseda60
Rash52
AST increased40
Rhinorrhea40
a Includes adverse reactions or laboratory abnormalities > 3 x ULN.

In the two controlled clinical chronic ITP trials, cataracts developed or worsened in 2 (1%) patients treated with PROMACTA. Both patients had received chronic oral corticosteroids, a risk factor for cataractogenesis.

Chronic Hepatitis C-Associated Thrombocytopenia

In the two placebo-controlled trials, 955 patients with chronic hepatitis C-associated thrombocytopenia received PROMACTA. Table 11 presents the most common adverse drug reactions (experienced by greater than or equal to 10% of patients receiving PROMACTA compared with placebo).

Table 11. Adverse Reactions (≥ 10% and Greater than Placebo) from Two Placebo-controlled Trials in Adults with Chronic Hepatitis C

Adverse ReactionPROMACTA + Peginterferon/ Ribavirin
n = 955
(%)
Placebo + Peginterferon/ Ribavirin
n = 484
(%)
Anemia4035
Pyrexia3024
Fatigue2823
Headache2120
Nausea1914
Diarrhea1911
Decreased appetite1814
Influenza-like illness1816
Insomniaa1615
Asthenia1613
Cough1512
Pruritus1513
Chills149
Myalgia1210
Alopecia106
Peripheral edema105
a Includes PTs of Insomnia, Initial insomnia, and Poor quality sleep.

Rash was reported in 9% and 7% of patients receiving PROMACTA and placebo, respectively.

In the two controlled clinical trials in patients with chronic hepatitis C, hyperbilirubinemia was reported in 8% of patients receiving PROMACTA compared with 3% for placebo. Total bilirubin greater than or equal to 1.5 x ULN was reported in 76% and 50% of patients receiving PROMACTA and placebo, respectively. ALT or AST greater than or equal to 3 x ULN was reported in 34% and 38% of patients for PROMACTA and placebo, respectively.

In the two controlled clinical trials in patients with chronic hepatitis C, cataracts developed or worsened in 8% of patients treated with PROMACTA and 5% of patients treated with placebo.

The safety of PROMACTA was also assessed in all patients treated with PROMACTA in the two controlled trials, including patients who initially received PROMACTA in the pre-antiviral treatment phase of the trial and were later randomized to the placebo arm (N = 1520 PROMACTA-treated patients). Hepatic failure was reported in 0.8% of PROMACTA-treated patients and 0.4% of placebo-treated patients.

Severe Aplastic Anemia

First-Line Treatment of Severe Aplastic Anemia

The safety of PROMACTA was established based upon a single-arm trial of 153 patients with severe aplastic anemia who had not received prior definitive immunosuppressive therapy. In this trial, PROMACTA was administered in combination with horse antithymocyte globulin (h-ATG) and cyclosporine [see Clinical Studies]. Among the 153 patients who were dosed in this trial, 92 patients were evaluable for safety of the concurrent use of PROMACTA, h-ATG, and cyclosporine at the recommended dose and schedule.

In this cohort, PROMACTA was administered at up to 150 mg once daily on Day 1 to Month 6 (D1-M6) in combination with h-ATG on Days 1 to 4 and cyclosporine for 6 months, followed by low dose of cyclosporine (maintenance dose) for an additional 18 months for patients who achieved a hematologic response at 6 months. The median duration of exposure to PROMACTA in this cohort was 183 days with 70% of patients exposed for > 24 weeks.

Table 12 presents the most common adverse reactions (experienced by greater than or equal to 5% of patients) associated with PROMACTA in the D1-M6 cohort.

Table 12. Adverse Reactions (≥ 5%) from One Open-label Trial in First-line Treatment of Patients with Severe Aplastic Anemia

Adverse ReactionPROMACTA
n = 92
(%)
ALT increased29
AST increased17
Blood bilirubin increased17
Rash8
Skin discoloration including hyperpigmentation5

In the PROMACTA D1-M6 cohort, ALT increased (29%), AST increased (17%), and blood bilirubin increased (17%) were reported more frequently than in patients with refractory severe aplastic anemia (see Table 13).

New or worsening liver function laboratory abnormalities (CTCAE Grade 3 and Grade 4) in the Promacta D1M6 cohort were 15% and 2% for AST, 26% and 4% for ALT, and 12% and 1% for bilirubin, respectively.

In this single-arm open-label clinical trial, ALT or AST > 3 x ULN with total bilirubin > 1.5 x ULN and ALT or AST > 3 x ULN with total bilirubin > 2 x ULN were reported in 44% and 32% of patients, respectively, in the PROMACTA D1-M6 cohort.

Pediatric Patients

A total of 34 pediatric patients (2 patients 2 to 5 years of age, 12 patients 6 to 11 years of age, and 20 patients 12 to 16 years of age) were enrolled in this single-arm trial of which 26 pediatric patients were enrolled in the PROMACTA D1-M6 cohort. In this cohort, the most frequent serious adverse reactions (experienced by ≥ 10% of patients) were upper respiratory tract infection (12% in patients age 2 to 16 years compared to 5% in patients 17 years of age and older, respectively) and rash (12% compared to 2%). The most common adverse reactions (experienced by ≥ 10% of patients) associated with PROMACTA were ALT increased (23% in patients age 2 to 16 years compared to 32% in patients 17 years of age and older, respectively), blood bilirubin increased (12% compared to 20%), AST increased (12% compared to 20%), and rash (12% compared to 6%).

Cytogenetic Abnormalities

In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Seven patients in the PROMACTA D1-M6 cohort had a new cytogenetic abnormality reported of which 4 had the loss of chromosome 7; these 4 occurred within 6.1 months. Across all cohorts, clonal cytogenetic evolution occurred in 15 out of 153 (10%) patients. Of the 15 patients who experienced a cytogenetic abnormality: 7 patients had the loss of chromosome 7, 6 of which occurred within 6.1 months; 4 patients had chromosomal aberrations which were of unclear significance; 3 patients had a deletion of chromosome 13; and 1 patient had a follow-up bone marrow assessment at 5 years with features of dysplasia with hypercellularity concerning for potential development of MDS. It is unclear whether these findings occurred due to the underlying disease, the immunosuppressive therapy, and/or treatment with PROMACTA.

Refractory Severe Aplastic Anemia

In the single-arm, open-label trial, 43 patients with refractory severe aplastic anemia received PROMACTA. Eleven patients (26%) were treated for greater than 6 months and 7 patients (16%) were treated for greater than 1 year. The most common adverse reactions (greater than or equal to 20%) were nausea, fatigue, cough, diarrhea, and headache.

Table 13. Adverse Reactions (≥ 10%) from One Open-label Trial in Adults with Refractory Severe Aplastic Anemia

Adverse ReactionPROMACTA
n = 43
(%)
Nausea33
Fatigue28
Cough23
Diarrhea21
Headache21
Pain in extremity19
Pyrexia14
Dizziness14
Oropharyngeal pain14
Abdominal pain12
Muscle spasms12
Transaminases increased12
Arthralgia12
Rhinorrhea12

Rash and hyperbilirubinemia were reported in 7% of patients; cataract was reported in 2% of patients.

In this trial, concurrent ALT or AST greater than 3 x ULN with total bilirubin greater than 1.5 x ULN were reported in 5% of patients. Total bilirubin greater than 1.5 x ULN occurred in 14% of patients.

In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported on therapy, including 5 patients who had complex changes in chromosome 7.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROMACTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders: Skin discoloration including hyperpigmentation and skin yellowing.

Read the entire FDA prescribing information for Promacta (Eltrombopag Tablets)

Related Resources for Promacta

© Promacta Patient Information is supplied by Cerner Multum, Inc. and Promacta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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