July 27, 2015
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Promacta

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Promacta




Promacta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/23/2015

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. It is usually given after other medications or surgery have been tried without successful treatment of symptoms. Common side effects of Promacta include nausea, vomiting, upset stomach, muscle pain, back pain, swelling in the hands or feet, numbness or tingly feeling, itching or rash, redness of the eyes, heavy vaginal bleeding, sleep problems (insomnia), temporary hair loss, or cold symptoms such as stuffy nose, sneezing, cough, or sore throat.

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. 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. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Promacta in Detail - Patient Information: Side Effects

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

Stop using eltrombopag and call your doctor at once if you have:

  • pain or burning when you urinate;
  • fever, chills, body aches, flu symptoms, unusual weakness or tired feeling;
  • nausea, upper stomach pain, itching, loss of appetite;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes);
  • pain, swelling, warmth, or redness in one or both legs;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • blurred vision, eye pain, or seeing halos around lights.

Common side effects may include:

  • diarrhea, vomiting, upset stomach;
  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;
  • headache, muscle pain, back pain, swelling in your hands or feet;
  • tingly feeling;
  • mild itching or rash;
  • sleep problems (insomnia); or
  • temporary hair loss.

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)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Promacta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 (Idiopathic) 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 446 patients with chronic ITP aged 18 to 85 years, of whom 65% were female, across the ITP clinical development program including three placebo-controlled trials. PROMACTA was administered to 277 patients for at least 6 months and 202 patients for at least 1 year.

Table 4 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 4: Adverse Reactions ( ≥ 3%) from Three Placebo-controlled Trials in Adults with Chronic Immune (Idiopathic) Thrombocytopenia

Adverse Reaction PROMACTA 50 mg
n = 241 (%)
Placebo
n = 128 (%)
Nausea 9 3
Diarrhea 9 7
Upper respiratory tract infection 7 6
Vomiting 6 < 1
Increased ALT 5 3
Myalgia 5 2
Urinary tract infection 5 3
Oropharyngeal pain 4 3
Increased AST 4 2
Pharyngitis 4 2
Back pain 3 2
Influenza 3 2
Paresthesia 3 2
Rash 3 2

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 299 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 placebocontrolled trials. Table 5 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 5: Treatment-related Adverse Reactions ( ≥ 3%) from Extension Trial in Adults with Chronic Immune (Idiopathic) Thrombocytopenia

Adverse Reaction PROMACTA 50 mg
n = 299 (%)
Headache 10
Hyperbilirubinemia 6
ALT increased 6
Cataract 5
AST increased 4
Fatigue 4
Nausea 4

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. Seven of the patients treated with PROMACTA in the controlled trials with hepatobiliary laboratory abnormalities were re-exposed to PROMACTA in the extension trial. Six of these patients again experienced liver test abnormalities (predominantly Grade 1) resulting in discontinuation of PROMACTA in one patient. In the extension chronic ITP trial, one additional patient had PROMACTA discontinued due to liver test abnormalities (less than or equal to Grade 3).

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 82 pediatric patients (aged 6 to 17 years) with chronic ITP, of whom 52% were female, across the randomized phase of two placebo-controlled trials.

Table 6 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of pediatric patients 6 years and older receiving PROMACTA) across the two placebo-controlled trials, with a higher incidence for PROMACTA versus placebo.

Table 6: Adverse Reactions ( ≥ 3%) with a Higher Incidence for PROMACTA versus Placebo from Two Placebo-controlled Trials in Pediatric Patients 6 Years and Older with Chronic Immune (Idiopathic) Thrombocytopenia

Adverse Reaction PROMACTA
n = 82 (%)
Placebo
n = 40 (%)
Upper respiratory tract infection 16 5
Nasopharyngitis 12 5
Rhinitis 11 8
Abdominal pain 9 5
Cough 9 0
Oropharyngeal pain 9 3
Toothache 6 0
AST increased 5 0
Diarrhea 5 3
Rash 5 3
ALT increaseda 6 0
Vitamin D deficiency 4 0
a Includes adverse reactions or laboratory abnormalities > 3 x ULN.

Chronic Hepatitis C-associated Thrombocytopenia

In the two placebo-controlled trials, 955 patients with chronic hepatitis C-associated thrombocytopenia received PROMACTA. Table 7 presents the most common adverse drug reactions (experienced by greater than or equal to 10% of patients receiving PROMACTA compared with placebo).

Table 7: Adverse Reactions ( ≥ 10% and Greater than Placebo) from Two Placebocontrolled Trials in Adults with Chronic Hepatitis C

Adverse Reaction PROMACTA + Peginterferon/ Ribavirin
n = 955 (%)
Placebo + Peginterferon/ Ribavirin
n = 484 (%)
Anemia 40 35
Pyrexia 30 24
Fatigue 28 23
Headache 21 20
Nausea 19 14
Diarrhea 19 11
Decreased appetite 18 14
Influenza-like illness 18 16
Asthenia 16 13
Insomnia 16 15
Cough 15 12
Pruritus 15 13
Chills 14 9
Myalgia 12 10
Alopecia 10 6
Peripheral edema 10 5

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.

Severe Aplastic Anemia

In the single-arm, open-label trial, 43 patients with 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 8: Adverse Reactions ( ≥ 10%) from One Open-label Trial in Adults with Severe Aplastic Anemia

Adverse Reaction PROMACTA
(n = 43) (%)
Nausea 33
Fatigue 28
Cough 23
Diarrhea 21
Headache 21
Pain in extremity 19
Dyspnea 14
Pyrexia 14
Dizziness 14
Oropharyngeal pain 14
Febrile neutropenia 14
Abdominal pain 12
Ecchymosis 12
Muscle spasms 12
Transaminases increased 12
Arthralgia 12
Rhinorrhea 12

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.

Vascular Disorders

Thrombotic microangiopathy with acute renal failure.

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

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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