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Treatment Name: Eltrombopag (Promacta®)

Eltrombopag (Promacta®) is a Treatment Regimen for Immune Thrombocytopenic Purpura (ITP)

How does eltrombopag (Promacta®) work?
It is designed to increase platelets in your bloodstream by stimulating the cells in your bone marrow that make them.

Goals of therapy:
When the platelet count is less than 30 k/μL, patients are at risk for spontaneous (sudden) bleeding and excessive bleeding from an injury, such as a fall.

Eltrombopag (Promacta®) is taken to increase platelets in the blood stream when platelets are low. By increasing the platelet count to a goal of usually 50 k/μL or higher, the risk for bleeding and bruising (both spontaneous and injury-induced) is decreased. Although eltrombopag may increase platelets into a favorable "target” range, it is not taken with the goal of "normalizing" the platelet count.

Eltrombopag may be used for patients with chronic ITP that have low platelet counts if the following treatments do not work: dexamethasone, prednisone, or immune globulin, or for patients with low platelets after spleen removal.

Eltrombopag (Promacta®) is only available as a prescription drug.

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Schedule

  • Usual Eltrombopag (Promacta®) starting daily dose: one 50 mg oral tablet by mouth
  • It is VERY important to take the tablet(s) with water only, or on an empty stomach. Food may decrease the amount absorbed and therefore lessen its effectiveness
  • Food should be avoided for one hour before and two hours after each tablet

In clinical studies, the platelet count usually begins to rise 7 to 14 days after starting therapy, and decreases over 7 to 14 days after stopping eltrombopag. If the initial dose is ineffective, your doctor may recommend increasing the dose of eltrombopag, usually after a period of 2 or more weeks.

Eltrombopag (Promacta®) is normally taken at home. It is usually taken until it no longer works, unacceptable side effects are experienced, or the ITP goes into remission from other therapies such as dexamethasone or rituximab.

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Side Effects

In clinical studies, the most common side effects of treatment with Promacta® are shown here:

  • Mild to moderate headache, (15%)
  • Upper respiratory tract infection*, (7%)
  • Nose bleed [epistaxis], (6%)
  • Rash, (4%)
  • Fatigue, (4%)
  • Constipation, (4%)
  • Anemia [low red blood cells], (4%)
  • Pain in extremity such as arm or leg, (3%)
  • Water retention/swelling [peripheral edema], (3%)
  • Dry mouth, (2%)
  • Diarrhea, (1%)
  • Abdominal swelling/distention, (1%)
  • Joint pain, (1%)

*Upper respiratory tract infection may be related to the use of corticosteroids such as dexamethasone or prednisone, rather than eltrombopag.

In the clinical study referenced above, no patient (0 out of 68 patients) stopped taking (discontinued) due to unacceptable side effects of Promacta.

Hair loss or thinning is NOT an expected adverse effect from taking Promacta. If hair loss occurs, reasons other than eltrombopag (Promacta) therapy should be explored. In clinical trials, 2% of patients reported some loss of hair.

Side effect videos Side Effect Videos
BleedingBleedingFatigue Fatigue ConstipationConstipationAnemiaAnemiaDiarrheaDiarrhea

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, once weekly until stable platelet counts are achieved, then once monthly thereafter. If you are actively bleeding or bruising, the platelet count may be checked more regularly, such as once daily, until the bleeding resolves. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), liver function tests (LFT's), plus any others your doctor may order. Rarely, eltrombopag was associated with hepatic impairment (liver problems) in clinical studies which typically began 3 months after starting eltrombopag. Although liver laboratory values such as the AST, ALT and bilirubin may increase, they usually will decrease when eltrombopag therapy is stopped.

How often is imaging needed?
Imaging is not typically needed to monitor response or side effects from this drug.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue eltrombopag (Promacta) as planned, reduce the dose, or delay the next dose until a certain side effect goes away. The maximum recommended dose of eltrombopag for chronic ITP is 75 mg by mouth Once Daily. Patients with abnormal liver tests, a history of chronic hepatitis C, or other liver disease may receive a lower initital dose of eltrombopag.

If bleeding does not resolve after taking the maximum dose once daily for at least two weeks (without food and other medications), and no drug interactions are discovered by your pharmacist, a discussion with your doctor should take place. Do not suddenly stop taking eltrombopag without talking with your doctor first. Call your doctor or health care professional if you have questions about the dose or if you think you are having an insufficient response.

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ChemoExperts Tips

  • Do not abruptly stop eltrombopag therapy before discussing with your doctor. This could cause your platelet count to drop to a dangerously low level and may increase the risk of bleeding
  • Tablets should be taken at least two hours before or four hours after any medicines (prescription or over-the-counter) or foods such as dairy that contain calcium, magnesium, aluminum, selenium, zinc, or iron. If you are not sure which medicines or foods that may contain these ingredients, ask your pharmacist!
  • If you are taking the oral suspension eltrombopag (liquid form), remember to mix it with cool water, not hot water. Take the oral suspension on an empty stomach within 30 minutes of preparing the dose
  • A pharmacist should ALWAYS review your ENTIRE medication list to ensure that drug interactions are prevented or managed appropriately. For example, eltrombopag may interact with commonly taken cholesterol medicines known as statins (atorvastatin, pravastatin, simvastatin). A statin dose reduction may be recommended when starting eltrombopag
  • Although rare, call your doctor immediately if the following adverse effects occur: yellowing of whites of eyes or skin (jaundice), unusual looking urine, right upper stomach pain, confusion, or swelling of stomach area (abdominal distention)
  • A baseline eye exam is recommended as cataracts are seen in roughly 5% of patients
  • Clinical trials may exist for ITP. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
  • If you are looking for patient assistance or co-pay coverage for eltrombopag (Promacta®), we have provided links that may help

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Eltrombopag (Promacta®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Eltrombopag (Promacta®). Depending upon your income, they may be able to help cover the cost of:

  • Eltrombo­pag

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Eltrombopag (Promacta®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Eltrombopag (Promacta®)

Individual Drug Label Information

Eltrombo­pag (Promacta®)

  • Eltrombopag is available as an oral tablet available in 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg strengths
  • Eltrombopag is also available as a liquid oral suspension
  • The bottle of eltrombopag may contain a little bag that absorbs moisture and keeps the medicine dry. This bag is known as a desiccant pack. If the desiccant pack is in your bottle, do not remove it.
  • Eltrombopag may increase the risk of potentially life-threatening liver damage
  • Eltrombopag should be taken without food, one hour before or 2 hours after a meal. Eltrombopag may be taken with water
  • Food decreases absorption so it is best to take on an empty stomach to avoid a decrease in effectiveness
  • If you miss a dose, wait until the next scheduled eltrombopag dose before taking. Do not take two doses in one day
  • Eltrombopag should be stored at room temperature, between 68°F and 77°F, but may be exposed to as low as 59°F and as high as 86°F. Eltrombopag should be dispensed in the original bottle Dosage adjustments may be required for patients with liver problems. A lower starting dose (example 25 mg) is usually recommended
  • Eltrombopag dosage adjustments may be required for patients of East Asian Ancestry. A lower starting dose (example 12.5 mg) is usually recommended
  • May interact with “statins,” medications taken for HIV, cyclosporine, foods such as dairy products, and over-the-counter antacids or supplements. Talk to your pharmacist for tips on making sure eltrombopag does not interact with your other medicines
  • Eltrombopag may not be safe during pregnancy or breast-feeding. It is not known if eltrombopag is excreted into human breast milk. If you are taking eltrombopag and wish to become pregnant, talk to your doctor or pharmacist about the potential risks and benefits of continuing treatment with eltrombopag 
General side effects from eltrombopag (Promacta)
  • Nausea
  • Headache
  • Diarrhea
  • Upper airway infection, such as sinus infection
  • Vomiting
  • Higher liver enzyme levels in blood (example: ALT or AST)
  • Fatigue
  • Muscle pain
  • Urinary tract infection
  • Sore throat
  • Back pain
  • Rash
  • Cataracts
  • Blood clots
  • Flu-like symptoms (headache, fever, cough, sore throat, body aches)
  • High bilirubin in blood (may cause yellow skin or eyes)
  • Click on the eltrombopag (Promacta®) package insert below for reported side effects, possible drug interactions, and other eltrombopag prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue BleedingBleedingConstipationConstipationPainPainBlood ClotsBlood Clots

See DailyMed package insert.

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References

Bussel JB, Cheng G, Saleh MN, et al. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007;357:2237-2247.

Created: November 16, 2016 Updated: June 5, 2018

What is Immune Thrombocytopenic Purpura (ITP)?

A disorder where platelets decrease in number due to decreased production in the bone marrow and increased destruction in the blood. This can lead to an increased risk of spontaneous bruising or bleeding (without injury), especially when the platelet count drops below 30,000 cells per microliter of blood.

I  = Immune, ITP is caused by a disturbance in the immune system
T  = Thrombocytopenic, a medical term meaning low platelet count
P  = Purpura, a type of bleeding in the skin

ITP is NOT a cancer, but it is commonly managed by hematologists (blood doctors) who often treat blood cancers as well. ITP is an uncommon condition and may be caused by auto-immune disorders, infections, certain medications, or pregnancy. However, in many cases, a cause cannot be identified which gives rise to its other name-idiopathic (meaning “cause unknown”) thrombocytopenic purpura. Although ITP may spontaneously resolve, for some patients lifelong therapy may be needed.

The effectiveness of medications may depend upon the causes of ITP and the ability to remove these causes, or whether a splenectomy (removal of the spleen) has been performed, or is able to be performed.

Deciding on a treatment for ITP is in a way like buying, owning, and driving a car. Think about the following similarities to help you understand which treatment is right for you:

BUYING: "0 - 50 time" (0 to 50 k/µL platelets, instead of 0 - 60 m.p.h) is an important performance feature
Once the platelet count exceeds 50 k/µL, bleeding episodes are rare. Therefore, the time it takes to go from very few platelets to a platelet count over 50 k/µL matters. In general, steroids such as prednisone and dexamethasone have the fastest "0 - 50" time.

  • Although exceptions, the thrombopoeitin receptor agonists romiplostim and eltrombopag usually have a 0 - 50 k/µL platelet time of 1 - 2 weeks
  • Although exceptions, one-half of rituximab recipients have a 0 - 50 k/µL platelet time below 5.5 weeks, and the other half over 5.5 weeks. The response to rituximab is often unpredictable

OWNING: Warranty offered?
A 5-year bumper-to-bumper warranty helps us worry less about something breaking or going wrong with our vehicle after we buy it. Likewise, not all medications used for ITP have a long-lasting effect in keeping the platelet count above 50 k/µL.

  • When it works, rituximab can work for 1 - 2 years, but lasting responses beyond two years are rarer. The 5 year rituximab response rate is estimated at 20 - 25%. When the rituximab "warranty" runs out and platelets fall, patients with ITP that had a long lasting response to rituximab may respond to another course of therapy. Certain insurances require the platelet count to be less than 30 k/µL before it will be covered.
  • When they work, the thrombopoeitin receptor agonists romiplostim and eltrombopag generally have lasting effect beyond that of rituximab. The "warranty" period where the platelet count remains above 50 k/µL often lasts 2 years or longer

DRIVING: Cruise control optional?
The ability for a treatment to maintain the platelet count within the goal range is similar to setting the cruise control on a car.

  • Steroids are given in a pulse (example: dexamethasone daily for 4 consecutive days) or given daily for several weeks (example: prednisone), then decreased over several weeks and eventually discontinued a few months after it is started. As a result, when steroids are no longer taken there is a chance for ITP to relapse
  • Because eltrombopag and romiplostim are administered continuously, these medications have the highest likelihood of keeping the platelet count in the goal range for the long haul
  • Rituximab is typically given once weekly for 4 doses, and usually takes several weeks to determine if it is working (see above), therefore it is difficult to predict who will have a lasting response to this therapy
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is ITP?

A disorder where platelets decrease in number due to decreased production in the bone marrow and increased destruction in the blood. This can lead to an increased risk of spontaneous bruising or bleeding (without injury), especially when the platelet count drops below 20,000 cells per microliter of blood.

I  = Immune, ITP is caused by a disturbance in the immune system
T  = Thrombocytopenic, a medical term meaning low platelet count
P  = Purpura, a type of bleeding in the skin

ITP is NOT a cancer, but it is commonly managed by hematologists (blood doctors) who often treat blood cancers as well. ITP is an uncommon condition and may be caused by auto-immune disorders, infections, certain medications, or pregnancy. However, in many cases, a cause cannot be identified which gives rise to its other name-idiopathic (meaning “cause unknown”) thrombocytopenic purpura. Although ITP may spontaneously resolve, for some patients lifelong therapy may be needed. The effectiveness of medications may depend upon the causes of ITP and the ability to remove these causes, or whether a splenectomy has been performed, or is able to be performed.

What is k/μL ?

It is an abbreviation for thousand per microLiter, which is a measurement of quantity per volume unit of blood.

Patient assistance & copayment coverage for eltrombopag (Promacta)

If you are underinsured and need help with paying for eltrombopag (Promacta®), click the links on our Friends page to see if funding is available. Depending upon your income, they may be able to help cover the cost of:

  • Eltrombopag (Promacta®)

Note: Funding is not always available at the time you check, but may become available in the future. If funding is currently closed for the medications you are looking for, please check back another time. Proof of income may be required.