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Promacta 50mg Tablet
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Indications & Clinical Uses
- Promacta 50 mg tablets contain eltrombopag, a thrombopoietin-receptor agonist that raises platelet counts by stimulating the bone marrow to make more platelets.
- It is used in adults and children aged 1 year and older for chronic immune thrombocytopenia (ITP) that has not responded well enough to previous treatments such as corticosteroids, immunoglobulins or splenectomy.
- It is also used, together with interferon-based antiviral therapy, to manage low platelet counts in adults with chronic hepatitis C so that antiviral treatment can begin or continue, and, together with standard immunosuppressive therapy, as a first-line treatment for severe aplastic anaemia in patients aged 2 years and older, as well as for severe aplastic anaemia that has not responded to earlier immunosuppressive treatment.
- Promacta is prescribed and monitored by a specialist and taken as tablets at home; it is not used for low platelet counts caused by myelodysplastic syndrome.
Side Effects
- Promacta carries a boxed warning for hepatotoxicity: it can cause serious, sometimes fatal, liver injury, and in people with chronic hepatitis C, combining Promacta with interferon and ribavirin can increase the risk of hepatic decompensation.
- Liver blood tests must be checked before starting and regularly during treatment.
- Very common side effects (affecting more than 1 in 10 people) across the approved uses include anaemia, nausea, fever, raised liver enzymes, cough, tiredness, headache and diarrhoea; nasopharyngitis and urinary tract infection are also common.
- Report new or worsening yellowing of the skin or eyes, dark urine, unusual tiredness, right-sided abdominal pain, or unexplained bruising or bleeding to your healthcare provider straight away, since these can signal liver injury or a clotting problem.
- Seek urgent medical help for signs of a blood clot, such as sudden leg swelling, chest pain or breathlessness.
Precautions & Warnings
- Before and during treatment with Promacta, your healthcare provider will check liver function tests and a full blood count, and will adjust or stop the dose if results are abnormal or if platelet counts rise too high.
- Promacta is not recommended if you have significant liver impairment unless the specific benefit outweighs the risk, and treatment for hepatitis C or aplastic anaemia requires close specialist monitoring, including regular eye checks for cataracts in aplastic anaemia.
- Because of a risk to the fetus seen in animal studies, women who could become pregnant should use effective contraception during treatment and for at least seven days afterwards, and should tell their healthcare provider if they are pregnant, planning pregnancy or breastfeeding.
- Follow the prescribed schedule exactly, and do not stop Promacta suddenly without medical advice, as platelet counts can fall sharply after discontinuation, increasing bleeding risk.
Avoid Interactions
- Promacta must not be taken within 4 hours of antacids, calcium-rich foods such as dairy products, or mineral supplements containing iron, calcium, zinc, selenium, magnesium or aluminium, since these reduce absorption of eltrombopag and can make it less effective; take Promacta at least 2 hours before or 4 hours after these products.
- Eltrombopag can raise blood levels of drugs transported by the OATP1B1 or BCRP pathways, including some statins such as rosuvastatin, increasing the risk of side effects like muscle pain; your healthcare provider may need to lower the statin dose.
- Eltrombopag does not require dose adjustment with the HIV protease inhibitors lopinavir/ritonavir.
- Always tell your prescriber and pharmacist about every medicine, supplement and antacid you use, including over-the-counter products, so interactions can be checked before you start or continue Promacta.
References
Frequently Asked Questions
Promacta (eltrombopag) 50 mg tablets raise low platelet counts in chronic immune thrombocytopenia (ITP) in adults and children aged 1 and over, in chronic hepatitis C to allow antiviral treatment, and in severe aplastic anaemia alongside immunosuppressive therapy. Your specialist checks your platelet count regularly and adjusts your dose accordingly.
Take Promacta tablets once daily by mouth, at least one hour before or two hours after a meal. Swallow the tablet whole with water; do not crush it into food or drink. Your prescriber sets the exact dose and may adjust it based on your platelet count and liver tests.
Promacta carries a boxed warning for serious liver injury (hepatotoxicity), and combining it with interferon and ribavirin in hepatitis C raises the risk of liver decompensation. Common effects include nausea, headache, fatigue and raised liver enzymes. Tell your healthcare provider immediately about yellowing skin or eyes, dark urine, or unusual bruising.
Avoid taking antacids, calcium supplements or dairy products within 4 hours of Promacta, as they reduce its absorption. Eltrombopag can raise levels of some statins, so tell your prescriber about all medicines and supplements you use. Do not stop Promacta suddenly without medical advice.
Your healthcare provider will check liver function tests and a full blood count before starting Promacta and regularly during treatment, since eltrombopag can affect the liver and platelet levels. If you are being treated for aplastic anaemia, you will also have regular eye examinations to check for cataracts.
Promacta is not recommended during pregnancy because animal studies showed harm to the fetus; women who could become pregnant should use effective contraception during treatment and for 7 days after stopping. It is approved for chronic ITP in children aged 1 and older, and for severe aplastic anaemia in children aged 2 and older.
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