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Promacta

Generic Name: 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

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Uses For Promacta

Eltrombopag is used to treat low blood platelet counts (thrombocytopenia) in patients with a blood disorder called chronic immune (idiopathic) thrombocytopenic purpura (ITP). This medicine 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 this medicine.

Before Using Promacta

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 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

Using this medicine 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 this medicine 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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Calcium Rich Food
Dairy Food

Proper Use of Promacta

Take this medicine 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.

This medicine 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 this medicine 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 this medicine 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 this medicine. 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 Promacta

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

Eltrombopag may cause serious liver problems. Stop taking this medicine 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 this medicine.

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 this medicine.

Using this medicine 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 this medicine without checking with your doctor first. Stopping this medicine 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.

Promacta 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.

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