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.
Available Dosage Forms:
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.
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:
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.
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.
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.
|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.|
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.
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.
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.
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.
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:
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.
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.
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.
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
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
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.
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