eltrombopag

el-TROM-boe-pag

Oral route(Tablet)

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 .

Commonly used brand name(s)

In the U.S.

• Promacta

Available Dosage Forms:

• Tablet

Therapeutic Class: Hematopoietic

Uses For eltrombopag

Eltrombopag is used to treat thrombocytopenia (low platelets in the blood) in patients with a blood disorder called chronic idiopathic thrombocytopenic purpura (ITP). eltrombopag is used after a splenectomy (surgery to remove the spleen) and other medicines, such as steroids or immunoglobulin, have not worked well enough. Platelets help clot the blood, so a person with thrombocytopenia may have bleeding problems. Eltrombopag works by stimulating the bone marrow to produce more platelets.

eltrombopag is available only with your doctor's prescription.

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 or an adjustment in the dose for patients receiving eltrombopag.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking eltrombopag, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 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


• Doxorubicin


• 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:

• Antiphospholipid syndrome or


• ATIII deficiency or


• Factor V Leiden (blood clotting disorder) or


• Liver disease, severe—Use with caution. May increase risk for blood clotting problems (e.g., thromboembolism).

• 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.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine 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.

Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of eltrombopag.

eltrombopag comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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) that contain aluminum, calcium, iron, magnesium, selenium, or zinc, take these at least 4 hours before or 4 hours after 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 thrombocytopenia:
    
    • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 75 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of eltrombopag, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 will be needed while you are using eltrombopag.

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.

Using eltrombopag for a long time may cause changes in your bone marrow. These changes may lead to a serious condition called bone marrow fibrosis, where your body produces less blood cells. Your doctor will check for this unwanted effect.

Blood clotting problems may occur while you are using eltrombopag. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or shortness of breath and pain in your chest.

Do not stop taking eltrombopag without checking first with your doctor. Your doctor will check your platelet levels and progress when you stop taking the medicine.

eltrombopag may cause cataracts or make them worse. Check with your doctor right away if you have blurred vision, difficulty in reading, or any other change in vision while you are taking eltrombopag. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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:

More common

• Body aches or pain


• chills


• cough


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness


• yellow eyes or skin

Less common

• Black, tarry stools


• bladder pain


• 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


• cloudy urine


• congestion


• decreased vision


• diarrhea


• difficult, burning, or painful urination


• dryness or soreness of the throat


• frequent urge to urinate


• general feeling of discomfort or illness


• hoarseness


• joint pain


• large, flat, or blue or purplish patches in the skin


• longer or heavier menstrual periods


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nausea


• pinpoint red spots on the skin


• redness of the eye


• shivering


• sweating


• tender, swollen glands in the neck


• trouble with sleeping


• trouble with swallowing


• unusual bleeding or bruising


• voice changes


• vomiting

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:

Less common

• Acid or sour stomach


• back pain


• belching


• bone pain


• difficulty with moving


• dry mouth


• hair loss or thinning of the hair


• heartburn


• indigestion


• muscle aching or cramping


• muscle pains or stiffness


• rash


• stomach discomfort, upset, or pain


• swollen joints

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.

See also: eltrombopag side effects (in more detail)

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More eltrombopag resources

• Eltrombopag Side Effects (in more detail)
• Eltrombopag Dosage
• Eltrombopag Use in Pregnancy & Breastfeeding
• Eltrombopag Drug Interactions
• Eltrombopag Support Group
• 1 Review for Eltrombopag - Add your own review/rating

• Eltrombopag Professional Patient Advice (Wolters Kluwer)


• Eltrombopag Monograph (AHFS DI)


• Eltrombopag MedFacts Consumer Leaflet (Wolters Kluwer)


• Promacta Prescribing Information (FDA)


• Promacta Consumer Overview

Compare eltrombopag with other medications

• Idiopathic Thrombocytopenic Purpura
• Thrombocytopenia Idiopathic