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Drugs reference index «eltrombopag»

eltrombopag


eltrombopag (Oral route)

el-TROM-boe-pag

Oral routeTablet
  • Risk for Hepatotoxicity
  • Eltrombopag may cause hepatotoxicity:
    • Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. 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 the abnormality(ies) resolve, stabilize, or return to baseline levels.
    • Discontinue eltrombopag if ALT levels increase to equal to or greater than 3 times the upper limit of normal (ULN) and are:
      • progressive, or
      • persistent for 4 weeks or greater, or
      • accompanied by increased direct bilirubin, or
      • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
  • Because of the risk for hepatotoxicity and other risks, eltrombopag is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive eltrombopag. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA .

Eltrombopag may cause hepatotoxicity. Measure serum ALT, AST, and bilirubin before initiating eltrombopag, every 2 weeks during dose adjustment and monthly after dose is stable. Perform fractionation for elevated bilirubin. Repeat testing for abnormal serum liver values within 3 to 5 days. If abnormalities are confirmed, monitor serum liver tests weekly until abnormalities resolve, stabilize, or return to baseline levels. Discontinue eltrombopag if ALT levels increase to 3 times the upper ULN or greater and are: progressive, persistent for 4 weeks or more, accompanied by increased direct bilirubin, or accompanied by symptoms of liver injury or evidence for hepatic decompensation. Eltrombopag is available only through a restricted distribution program called PROMACTA CARES. To enroll, call 1-877-9-PROMACTA .

Commonly used brand name(s):

In the U.S.

  • Promacta

Available Dosage Forms:

  • Tablet

Uses For eltrombopag

Eltrombopag is used to treat low blood platelet counts (thrombocytopenia) in patients with a blood disorder called chronic immune (idiopathic) thrombocytopenic purpura (ITP). eltrombopag is used after a splenectomy (surgery to remove the spleen) and other medicines, such as steroids or immunoglobulins, have not worked well enough.

Eltrombopag is only available through a restricted access program. Doctors who are enrolled in the restricted program can write a prescription for eltrombopag.

Before Using eltrombopag

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For eltrombopag, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eltrombopag or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eltrombopag in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eltrombopag in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving eltrombopag.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using eltrombopag with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum
  • Calcium
  • Ciprofloxacin
  • Fluvoxamine
  • Gemfibrozil
  • Iron
  • Magnesium
  • Mexiletine
  • Propafenone
  • Selenium
  • Trimethoprim
  • Zileuton
  • Zinc

Using eltrombopag with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Fluvastatin
  • Levothyroxine
  • Methotrexate
  • Nateglinide
  • Penicillin G
  • Pravastatin
  • Repaglinide
  • Rifampin
  • Rosuvastatin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using eltrombopag with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use eltrombopag, or give you special instructions about the use of food, alcohol, or tobacco.

  • Calcium Rich Food
  • Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of eltrombopag. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Blood cancer or
  • Blood clots, history of or
  • Bone marrow problems (e.g., myelodysplastic syndrome) or
  • Cataracts, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. Effects may be increased because of the slower removal of eltrombopag from the body.

Proper Use of eltrombopag

Take eltrombopag only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

eltrombopag will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Your doctor will ask you to sign a form to show that you understand this information.

It is best to take eltrombopag on an empty stomach, or at least 1 hour before or 2 hours after a meal.

If you are taking antacids, multivitamins, or other products (such as dairy products or juices) containing aluminum, calcium, iron, magnesium, selenium, or zinc, take these at least 4 hours before or 4 hours after you take eltrombopag.

Dosing

The dose of eltrombopag will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of eltrombopag. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For lowering blood platelet counts:
      • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose depending on your condition. However, the dose is usually not more than 75 mg a day.
      • Children—Use and dose must be determined by your doctor.

Precautions While Using eltrombopag

It is very important that your doctor check your progress at regular visits to make sure eltrombopag is working properly. Blood tests may be needed to check for unwanted effects.

Eltrombopag may cause serious liver problems. Stop taking eltrombopag and check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, right upper stomach pain, unusual tiredness, or yellow eyes or skin while you are using eltrombopag.

Tell your doctor if you are of Asian descent, having either Filipino, Chinese, Japanese, Korean, or Taiwanese origin. You may need a lower dose of eltrombopag.

Using eltrombopag for a long time may cause changes in your bone marrow. These changes may lead to a severe condition called bone marrow fibrosis, wherein your body produce less blood cells.

Do not stop taking eltrombopag without checking with your doctor first. Stopping eltrombopag suddenly may cause the number of platelets, necessary for blood clotting, to become lower than before you started taking the medicine. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

eltrombopag Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Black, tarry stools
  • bleeding gums
  • blindness
  • blood in the urine or stools
  • bloody eye
  • blurred vision
  • bruising
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • decreased vision
  • large, flat, or blue or purplish patches in the skin
  • longer or heavier menstrual periods
  • pinpoint red spots on the skin
  • redness of the eye
  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Nausea
Less common
  • Acid or sour stomach
  • belching
  • difficulty in moving
  • heartburn
  • indigestion
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • stomach discomfort, upset, or pain
  • swollen joints
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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  • Eltrombopag Professional Patient Advice (Wolters Kluwer)
  • Eltrombopag MedFacts Consumer Leaflet (Wolters Kluwer)
  • Promacta Prescribing Information (FDA)
  • Promacta Consumer Overview

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