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Promacta (eltrombopag) is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body. Eltrombopag can lower the risk of bleeding by increasing platelets in your blood.
Promacta is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. This medicine is for use in adults and children who are at least 1 year old, after other medicines have been tried without success.
Promacta is also used to prevent bleeding in adults with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).
Promacta is also used together with other medications to treat severe aplastic anemia in adults and children who are at least 2 years old.
Promacta is not a cure for ITP and it will not make your platelet counts normal if you have this condition.
Before you take Promacta tell your doctor if you have kidney disease, blood cancer, a bone marrow disorder, high platelet levels, liver problems (if you are not being treated for hepatitis C), a history of cataracts or blood clot, if your spleen has been removed, or if you are of East Asian descent. Also tell your doctor about all other medications you use.
Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Promacta.
If you have chronic hepatitis C, taking Promacta with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
After you stop taking this medicine, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking this medicine. Your blood will need to be tested weekly during this time.
Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
You should not use Promacta if you are allergic to eltrombopag.
Tell your doctor if you have ever had:
a blood clot;
liver disease (unless you are being treated for hepatitis C);
kidney disease;
myelodysplastic syndrome (also called "preleukemia");
cataracts;
surgery to remove your spleen; or
if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).
If you have myelodysplastic syndrome, taking Promacta can increase your risk of developing leukemia (a blood cancer that can be fatal). Talk with your doctor if you have concerns about this risk.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of eltrombopag on the baby.
You should not breast-feed while using this medicine.
Take Promacta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal.
Do not take Promacta with dairy products or calcium-fortified juice.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Mix the oral suspension powder only with water. Use a new dosing syringe each time you mix the medicine, to measure the water and to give the correct dose.
Swallow the tablet whole and do not crush, chew, or break it.
You will need frequent blood tests to check your liver function. Your eyes may also need to be checked for signs of cataract formation.
Eltrombopag doses are sometimes based on weight in children. Your child's dose needs may change if the child gains or loses weight.
If you take Promacta with medication to treat chronic hepatitis C, tell your doctor if you stop using any of your hepatitis medications.
Taking Promacta long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.
It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. After mixing Promacta oral suspension, store the liquid at room temperature and use it within 30 minutes.
After you stop taking Promacta, your risk of bleeding or bruising may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking this medicine. Your blood will need to be tested weekly during this time.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or 2 hours after you take Promacta.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Get emergency medical help if you have signs of an allergic reaction to Promacta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
You could develop a blood clot if your platelet count gets too high while you are using Promacta. Call your doctor or get emergency medical help if you have:
signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot in the stomach - severe stomach pain, vomiting, diarrhea;
signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
Call your doctor at once if you have:
vision changes, tunnel vision, eye pain, or seeing halos around lights;
flu symptoms such as fever, chills, cough, sore throat, headache, body aches, tired feeling;
increased or frequent need to urinate, pain or burning when you urinate;
low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
liver problems - confusion, nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Promacta side effects may include:
nausea, vomiting, diarrhea, stomach pain, loss of appetite;
cold symptoms such as stuffy nose, sneezing, cough, sore throat;
fever, flu symptoms, anemia;
mouth pain, tooth pain;
muscle pain, back pain, headache;
swelling in your feet or ankles;
feeling weak or tired;
sleep problems (insomnia);
itching, tingling, or burning under your skin;
skin rash;
hair loss; or
abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Some medicines can make Promacta much less effective when taken at the same time. If you take any of the following medicines, take your Promacta dose 2 hours before or 4 hours after you take the other medicine.
an antacid; or
vitamin or mineral supplements that contain aluminum, calcium, iron, magnesium, selenium, or zinc.
Tell your doctor about all your other medicines, especially:
a blood thinner - warfarin, Coumadin, Jantoven; or
cholesterol medication - atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
This list is not complete. Other drugs may interact with eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Promacta only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Promacta (www.drugs.com/promacta.html).
Note: This document contains side effect information about eltrombopag. Some of the dosage forms listed on this page may not apply to the brand name Promacta.
More frequent side effects include: cataract. See below for a comprehensive list of adverse effects.
Applies to eltrombopag: oral tablet
Oral route (Powder for Suspension; Tablet)
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.
Along with its needed effects, eltrombopag (the active ingredient contained in Promacta) 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 while taking eltrombopag:
More common
Less common
Some side effects of eltrombopag 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
Less common
Incidence not known
Applies to eltrombopag: oral powder for reconstitution, oral tablet
The most common side effects reported in ITP patients have included nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, urinary tract infection, oropharyngeal pain, increased AST, pharyngitis, back pain, influenza, paresthesia, and rash.
The most common side effects reported in thrombocytopenic patients with chronic hepatitis C have included anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia, and peripheral edema.
Common (1% to 10%): Deep vein thrombosis, edema, palpitations, prolonged QT interval on ECG, thrombotic/thromboembolic events
Uncommon (0.1% to 1%): Acute myocardial infarction, cardiovascular disorder, chest pain, cyanosis, embolism, flushing, hematoma, hot flush, hypertension, sinus tachycardia, superficial thrombophlebitis, tachycardia
Very common (10% or more): Total bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN) (76%), ALT or AST greater than 3 x ULN with total bilirubin greater than 1.5 x ULN (44%), ALT or AST greater than 3 x ULN with total bilirubin greater than 2 x ULN (33%), ALT increased (32%), ALT common terminology criteria for adverse events (CTCAE) grade 3 increase (26%), AST increased (20%), blood bilirubin increased (20%), AST CTCAE grade 3 increase (15%), bilirubin CTCAE grade 3 increase (12%)
Common (1% to 10%): Abnormal hepatic function, ascites, hepatic failure, hyperbilirubinemia, increased blood alkaline phosphatase, jaundice, portal vein thrombosis, drug-induced liver injury, CTCAE grade 4 increase, AST CTCAE grade 4 increase, bilirubin CTCAE grade 4 increase
Uncommon (0.1% to 1%): Cholestasis, hepatic lesion, hepatitis
In clinical trials, hepatic decompensation (ascites, hepatic encephalopathy, variceal hemorrhage, spontaneous bacterial peritonitis) was reported more commonly in chronic HCV patients with cirrhosis treated with eltrombopag compared to placebo.
Very common (10% or more): Anemia
Common (1% to 10%): Decreased hemoglobin, decreased neutrophil count, decreased white blood cell count, hemolytic anemia, increased INR, lymphopenia, prolonged activated partial thromboplastin time
Uncommon (0.1% to 1%): Anisocytosis, eosinophilia, increased hemoglobin, increased band neutrophil count, increased platelet cell counts, leukocytosis, myelocytosis, presence of myelocytes, thrombocytopenia
Frequency not reported: Thrombotic microangiopathy
In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.
Very common (10% or more): Diarrhea, nausea
Common (1% to 10%): Abdominal discomfort, abdominal distension, abdominal pain, aphthous stomatitis, constipation, dry mouth, dyspepsia, dysgeusia, esophageal varices hemorrhage, esophageal varices, gastritis, gastroenteritis,stomatitis, gastroesophageal reflux disease, hemorrhoids, toothache, upper abdominal pain, vomiting
Uncommon (0.1% to 1%): Abdominal tenderness, discolored feces, flatulence, food poisoning, frequent bowel movements, gingival bleeding, glossodynia, hematemesis, hemorrhoids, mouth hemorrhage, oral discomfort
Very common (10% or more): Pruritus, rash, alopecia
Common (1% to 10%): Dry skin, eczema, erythema, generalized pruritus, hyperhidrosis, night sweats, pruritic rash, skin lesion, skin discoloration including hyperpigmentation
Uncommon (0.1% to 1%): Cold sweat, contusion, dermatosis, ecchymosis, inflammation of wound, melanosis, petechia, pigmentation disorder, skin exfoliation, swelling face, sunburn, urticaria
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, leukocyturia, nocturia, proteinuria
Uncommon (0.1% to 1%): Hypersensitivity
Very common (10% or more): Influenza-like illness
Common (1% to 10%): Influenza, oral herpes
Very common (10% or more): Decreased appetite
Common (1% to 10%): Abnormal loss of weight, decreased blood albumin, hyperglycemia, increased blood glucose
Uncommon (0.1% to 10%): Gout, hypocalcemia, hypokalemia, increased appetite, increased blood albumin, increased blood uric acid, increased total protein, increased weight
Very common (10% or more): Pain in extremity, myalgia, muscle spasm, arthralgia
Common (1% to 10%): Back pain, bone pain, musculoskeletal pain
Uncommon (0.1% to 1%): Muscular weakness, sensation of heaviness
Very common (10% or more): Headache, dizziness
Common (1% to 10%): Hepatic encephalopathy, lethargy, memory impairment, paresthesia
Uncommon (0.1% to 1%): Balance disorder, cerebral infarction, dysesthesia, hemiparesis, hypoesthesia, migraine, migraine with aura, peripheral neuropathy, peripheral sensory neuropathy, somnolence, speech disorder, toxic neuropathy, tremor, vascular headache
Very common (10% or more): Cataract developed or worsened (up to 11%)
Common (1% to 10%): Dry eye, ocular icterus, retinal exudates, retinal hemorrhage
Uncommon (0.1% to 1%): Abnormal visual acuity tests, astigmatism, blepharitis, blurred vision, conjunctival hemorrhage, cortical cataract, eye pain, increased lacrimation, keratoconjunctivitis sicca, lenticular opacities, retinal hemorrhage, retinal pigment epitheliopathy, reduced visual acuity, visual impairment,
Common (1% to 10%): Malignant hepatic neoplasm
Uncommon (0.1% to 1%): Rectosigmoid cancer
Very common (10% or more): Insomnia
Common (1% to 10%): Agitation, anxiety, confusional state, depression, disturbance in attention, sleep disorder
Uncommon (0.1% to 1%): Altered mood, apathy, tearfulness
Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, increased urine pH, increased urine protein/creatinine ratio, lupus nephritis, renal failure
Very common (10% or more): Cough (up to 23%), upper respiratory tract infection (up to 17%), nasopharyngitis (up to 12%), rhinorrhea (up to 12%)
Common (1% to 10%): Bronchitis, dyspnea, exertional dyspnea, oropharyngeal pain, pharyngitis, productive cough, pulmonary embolism, upper respiratory tract infection, rhinitis, oropharyngeal pain
Uncommon (0.1% to 1%): Epistaxis, nasal discomfort, oropharyngeal blistering, pneumonia, pulmonary infarction, sinusitis, sinus disorder, sleep apnea syndrome, tonsillitis
Very common (10% or more): Asthenia, chills, fatigue, pyrexia, peripheral edema, clonal cytogenetic evolution, new cytogenetic abnormality, complex changes in chromosome 7
Common (1% to 10%): Chest discomfort, irritability, malaise, non-cardiac chest pain, pain, loss of chromosome 7, chromosomal aberrations, deletion of chromosome 13
Uncommon (0.1% to 1%): Ear pain, feeling hot, feeling jittery, ill-defined disorder, mucosal inflammation, pyrexia, sensation of foreign body, vertigo, vessel puncture site hemorrhage, features of dysplasia with hypercellularity concerning for potential development of myelodysplastic syndrome
Common (1% to 10%): Injection site rash/pruritus, injection site reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Promacta (www.drugs.com/promacta.html).
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