April 19, 2016



Class: Supportive Care

Generic Name: eltrombopag

Trade Name: Promacta®

How is this drug used? Promacta is used to treat thrombocytopenia (low platelet counts) in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. It is also used to treat thrombocytopenia in patients with chronic hepatitis C to allow for interferon-based therapy whose degree of thrombocytopenia prevents initiation of therapy, and also for patients with severe aplastic anemia who have had insufficient response to to immunosuppressive therapy.

Promacta should only be used for chronic ITP patients whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Promacta should not be used to normalize platelet levels.

What is the mechanism of action? Promacta increases the number of platelets.

How is Promacta given (administered)? Promacta is given orally (by mouth). Doses differ depending on indication and other factors.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Promacta. Patients may undergo blood tests, physical examinations, or other measures to assess side effects and response to therapy. Promacta can cause liver problems in some patients, and liver function will be assessed before and during treatment with Promacta.

What are potentially serious side effects of Promacta?

  • Liver problems.
  • Recurrence of thrombocytopenia and risk of bleeding shortly after stopping Promacta.
  • Blood clots (these can be fatal if they travel to the lungs or cause heart attacks or strokes).
  • New or worsened cataracts.

What are the most common side effects of Promacta?

In patients with ITP:

  • Nausea
  • Diarrhea
  • Upper respiratory tract infection
  • Vomiting
  • Muscles aches
  • Urinary tract infections
  • Pain or swelling in throat or mouth
  • Abnormal liver function tests
  • Abnormal skin sensations such as tingling, itching, or burning
  • Back pain
  • Flu-like symptoms
  • Rash

In patients with hepatitis C:

  • Anemia
  • Fever
  • Fatigue
  • Headache
  • Nausea
  • Diarrhea
  • Decreased appetite
  • Flu-like illness
  • Insomnia
  • Cough
  • Profound weakness; loss of strength
  • Itching
  • Chills
  • Muscle aches
  • Hair loss
  • Swelling in lower limbs

In patients with severe aplastic anemia:

  • Nausea
  • Fatigue
  • Cough
  • Diarrhea
  • Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

Because of the risk of liver problems and other side effects, access to Promacta is limited to physicians, pharmacists, and patients who are registered in a program designed to monitor safety and encourage appropriate use.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Follow your doctor’s instructions and inform the doctor of any side effects.
  • Do not miss appointments with your doctor or the lab.
  • Avoid situations that may increase your risk of bleeding.

Are there any special precautions patients should be aware of before starting treatment?

  • For patients with chronic ITP, objective is to achieve and maintain a platelet count necessary to reduce the risk for bleeding.
  • For patients with chronic hepatitis C, objective is to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin.
  • Patients should inform their physician of any other medication they are taking. This includes prescription and over-the-counter medications, vitamins, and herbal products.
  • Patients should be advised of possible liver failure and abnormalities.
  • Patients should inform their physician about all medical conditions, including liver or kidney problems, history of blood clots, history of cataracts, surgery to remove spleen (splenectomy), bone marrow problems, or bleeding problems.
  • Advise patients to have eye examination before therapy as a baseline for signs and symptoms of cataracts during therapy.
  • Advise patients that risk of bleeding may occur upon discontinuation of Promacta, especially if patients are on anti-clotting or antiplatelet agents.
  • Advise patients the importance of proper dosage and dosage scheduling and the problems that may be associated with improper dosage. Patients of East Asian ancestry require less of initial dose.
  • Advise patients to take Promacta at least 2 hours before or 4 hours after foods, mineral supplements, and antacids which contain polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.
  • Patients’ liver function needs to be monitored before and during therapy.

When should patients notify their physician?  Tell your doctor if you experience any unusual symptoms. Some side effects require immediate medical treatment. Tell your doctor if you experience any bruising or bleeding that happens while you take Promacta or after you stop Promacta. Tell your doctor if you take more than the recommended amount of Promacta. Tell your doctor if you experience symptoms of liver problems (such as jaundice, unusual darkening of the urine, unusual tiredness, or pain the right upper stomach area), cataracts (such as changes in vision), or blood clots (symptoms of a blood clot in the leg include pain, swelling, or tenderness in the leg).

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Copyright © 2016 CancerConnect Last updated 04/16.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.  We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.


The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Drug Dictionary, E, Supportive, Uncategorized