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Eltrombopag (Oral route)

Pronunciation:

el-TROM-boe-pag

Brand Names:

  • Promacta

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation .

Classifications:

Therapeutic—

Hematopoietic

Uses of This Medicine:

Eltrombopag is used to treat thrombocytopenia (low platelets in the blood) in patients with a blood disorder called chronic idiopathic thrombocytopenic purpura (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) and other medicines, such as steroids or immunoglobulin, have not worked well enough. Eltrombopag is also used to treat thrombocytopenia in patients with chronic hepatitis C along with interferon therapy. 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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 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.

Other 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 this medicine, 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 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
  • Pixantrone
  • 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
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Fluvastatin
  • Levothyroxine
  • Lopinavir
  • Methotrexate
  • Nateglinide
  • Penicillin G
  • Pravastatin
  • Repaglinide
  • Rifampin
  • Rosuvastatin
  • Teriflunomide

Other interactions—

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
  • Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 or
  • Liver disease (including cirrhosis)—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 This Medicine:

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.

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

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

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) 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 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 thrombocytopenia with ITP:
      • 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.
    • For thrombocytopenia with chronic hepatitis C:
      • Adults—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 100 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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 This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed while you are using this medicine.

Eltrombopag may cause serious liver problems. 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.

Using this medicine 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 this medicine. 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 this medicine without checking first with your doctor. Your doctor will check your platelet levels and progress when you stop taking the medicine.

This medicine 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 this medicine. Your doctor may want your eyes to be 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.

Side Effects of This Medicine:

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
Bloating or swelling of the face, arms, hands, lower legs, or feet
body aches or pain
chills
cough
difficulty with breathing
ear congestion
fever
headache
loss of voice
nasal congestion
pale skin
rapid weight gain
runny nose
sneezing
sore throat
tingling of the hands or feet
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
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
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:

More common
Decreased appetite
difficulty with moving
hair loss or thinning of the hair
itching skin
lack or loss of strength
muscle aching or cramping
muscle pains or stiffness
swollen joints
Less common
Acid or sour stomach
back pain
belching
bone pain
dry mouth
heartburn
indigestion
rash
stomach discomfort, upset, or pain

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.


Last Updated: 4/4/2014

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