Description
Eltrombopag is used to treat thrombocytopenia (low platelets in the blood) in patients with a blood disorder called chronic immune thrombocytopenia (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) and other medicines (eg, steroids or immunoglobulin) have not worked well enough. Eltrombopag is also used to treat thrombocytopenia in patients with chronic hepatitis C, along with interferon treatment. 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 used together with standard immunosuppressive treatment for the first-line treatment of severe aplastic anemia (SAA) in adults and children 2 years of age and older. It is also used to treat SAA in patients who have received other medicines that did not work well.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Powder for Suspension
Before Using
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
Alvaiz™: Appropriate studies have not been performed on the relationship of age to the effects of eltrombopag for the treatment of ITP in children younger than 6 years of age and for the treatment of chronic hepatitis C and severe aplastic anemia in children. Safety and efficacy have not been established.
Promacta®: Safety and efficacy have not been established to treat ITP in children younger than 1 year of age, or in children with thrombocytopenia associated with chronic hepatitis C or severe aplastic anemia.
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 liver problems, which may require caution and an adjustment in the dose for patients receiving eltrombopag.
Breastfeeding
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.
Drug Interactions
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.
- Elagolix
- Grazoprevir
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.
- Alpelisib
- Aluminum
- Atogepant
- Atorvastatin
- Axitinib
- Bosentan
- Calcium
- Cerivastatin
- Docetaxel
- Eluxadoline
- Exemestane
- Fexofenadine
- Fluvastatin
- Glecaprevir
- Glyburide
- Irinotecan
- Iron
- Letermovir
- Lovastatin
- Magnesium
- Methotrexate
- Momelotinib
- Nateglinide
- Paclitaxel
- Paritaprevir
- Pexidartinib
- Pitavastatin
- Pixantrone
- Pravastatin
- Repaglinide
- Resmetirom
- Revefenacin
- Rosuvastatin
- Seladelpar
- Selenium
- Selexipag
- Simvastatin
- Sofosbuvir
- Sulfasalazine
- Sunitinib
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.
- Lopinavir
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 (eg, thromboembolism).
- Bleeding problems or
- Bone marrow problems (eg, myelodysplastic syndrome) 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
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 and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine without a meal or with a meal low in calcium (50 milligrams or less).
If you are taking antacids, multivitamins that contain aluminum, calcium, iron, magnesium, selenium, or zinc, or other products high in calcium (more than 50 milligrams of calcium including dairy products, juices, and certain fruits and vegetables), 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 cold water only. Do not use hot water to mix it.
- After mixing, take it within 30 minutes. If it comes in contact with your skin, wash it right away with soap and water.
- Use the dosing syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.
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 first-line treatment of severe aplastic anemia:
- For oral dosage forms (Promacta® suspension or tablets):
- Adults and children 12 years of age and older—At first, 150 milligrams (mg) once a day for 6 months. Some patients may start at a lower dose. Your doctor may adjust your dose as needed.
- Children 6 to 11 years of age—At first, 75 mg once a day for 6 months. Some patients may start at a lower dose. Your doctor may adjust your dose as needed.
- Children 2 to 5 years of age—Dose is based on weight and must be determined by your doctor. At first, 2.5 milligram per kilogram (mg/kg) of body weight once a day for 6 months. Some patients may start at a lower dose. Your doctor may adjust your dose as needed.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage forms (Promacta® suspension or tablets):
- For refractory severe aplastic anemia:
- For oral dosage forms (Promacta® suspension or tablets):
- Adults—At first, 50 milligrams (mg) once a day. Some patients may start at a lower dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (Alvaiz™ tablets):
- Adults—At first, 36 milligrams (mg) once a day. Some patients may start at a lower dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 108 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage forms (Promacta® suspension or tablets):
- For thrombocytopenia with ITP:
- For oral dosage forms (Promacta® suspension or tablets):
- 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 as 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 as 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 oral dosage form (Alvaiz™ tablets):
- Adults and children 6 years of age and older—At first, 36 milligrams (mg) once a day. Some patients may start at a lower dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 54 mg per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For oral dosage forms (Promacta® suspension or tablets):
- For thrombocytopenia with chronic hepatitis C:
- For oral dosage forms (Promacta® suspension or tablets):
- Adults—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (Alvaiz™ tablets):
- Adults—At first, 18 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage forms (Promacta® suspension or tablets):
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.
Throw away any unused liquid within 30 minutes of mixing it.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests will be needed while you are using this medicine.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 7 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Eltrombopag may cause or increase the risk for serious liver problems. Check with your doctor right away if you or your child start having nausea or vomiting, dark urine, light-colored stools, right upper stomach pain, unusual tiredness, or yellow eyes or skin while using this medicine.
This medicine may increased risk for blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia). Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Blood clotting problems may occur while you or your child are using this medicine. Check with your doctor right away if you or your child have pain, swelling, or tenderness in your leg, or pain in your chest.
Do not stop using this medicine without checking first with your doctor. Your doctor will check your platelet levels and progress before you stop using the medicine.
This medicine may cause cataracts or make them worse. Check with your doctor right away if you or your child have blurred vision, difficulty in reading, or any other change in vision while using this medicine. Your doctor may want your eyes 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
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
- fever
- headache
- loss of voice
- pain in the chest, groin, or legs, especially the calves
- pale skin
- rapid weight gain
- runny nose
- severe, sudden headache
- slurred speech
- sore throat
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- tingling of the hands or feet
- trouble breathing with exertion
- unusual tiredness or weakness
- unusual weight gain or loss
- yellow eyes or skin
Less common
- Bladder pain
- blindness
- blurred or decreased vision
- bruising
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- diarrhea
- general feeling of discomfort or illness
- hoarseness
- joint pain
- 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 sleeping
- trouble swallowing
- voice changes
- vomiting
Incidence not known
- Bone pain
- chest pain
- lower back or side pain
- painful or difficult urination
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- 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
- Decreased appetite
- difficulty with moving
- hair loss or thinning of the hair
- itching skin
- lack or loss of strength
- muscle cramps or stiffness
- swollen joints
Less common
- Back pain
- belching
- bone pain
- darkening of the skin
- 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.
CON-XXXXXXXX
