Generic Name: eltrombopag (Oral route)
In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity; hepatic function should be monitored and therapy discontinued if necessary .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
- Powder for Suspension
Therapeutic Class: Hematopoietic
Uses For Promacta
Eltrombopag is used to treat thrombocytopenia (low platelets in the blood) in adults and children 1 year of age and older 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.
Eltrombopag is also used to treat severe aplastic anemia (SAA) in patients who have received other medicines to treat SAA, when those medications did not work well.
This medicine is available only with your doctor's prescription.
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:
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.
Safety and efficacy have not been established to treat ITP in children younger than 1 years of age, or in children with thrombocytopenia associated with chronic hepatitis C or with severe aplastic anemia.
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 liver problems, which may require caution or an adjustment in the dose for 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.
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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
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.
- Doxorubicin Hydrochloride Liposome
- Penicillin G
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
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 (eg, thromboembolism).
- Bleeding problems or
- Blood clots, history of 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 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.
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 2 hours after eltrombopag.
Swallow the tablet whole. Do not crush, break, or chew it. Do not mix it with food or liquids.
If you are using the oral suspension:
- Mix the powder with water only. Do not use hot water to mix it.
- After mixing, take it immediately.
- Use the dosing syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.
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 forms (suspension or tablets):
- For severe aplastic anemia:
- Adults—At first, 50 milligrams (mg) once a day. Some patients may start at a lower dose. Your doctor may adjust your dose if needed. However, the dose is usually not more than 150 mg per day.
- Children—Use and dose must be determined by your doctor.
- For thrombocytopenia with ITP:
- Adults and children 6 years of age and older—At first, 50 milligrams (mg) once a day. Some patients may start at a lower dose. Your doctor may adjust your dose if needed. However, the dose is usually not more than 75 mg per day.
- Children 1 to 5 years of age—At first, 25 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 younger than 1 year of age—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.
- For severe aplastic anemia:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Throw away any unused liquid within 30 minutes of mixing it.
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 will be needed while you are using this medicine.
Eltrombopag may cause or increase the risk for 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.
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.
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:More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- chills or fever
- difficulty with breathing
- loss of voice
- pale skin
- rapid weight gain
- runny nose
- sore throat
- tingling of the hands or feet
- troubled breathing with exertion
- unusual tiredness or weakness
- unusual weight gain or loss
- yellow eyes or skin
- Bladder pain
- blurred or decreased vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- general feeling of discomfort or illness
- joint pain
- lower back or side pain
- muscle aches and pains
- pinpoint red spots on the skin
- redness of the eye
- tender, swollen glands in the neck
- trouble sleeping
- trouble swallowing
- voice changes
- Chest pain
- pain, redness, or swelling in the legs or arms
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
- Acid or sour stomach
- back pain
- bone pain
- dry mouth
- 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.
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- Drug class: platelet-stimulating agents