Active Substance: eltrombopag olamine
Common Name: eltrombopag
ATC Code: B02BX05
Marketing Authorisation Holder: Novartis Europharm Limited
Active Substance: eltrombopag olamine
Status: Authorised
Authorisation Date: 2010-03-11
Therapeutic Area: Purpura, Thrombocytopenic, Idiopathic
Pharmacotherapeutic Group: Antihaemorrhagics
Therapeutic indication
Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).
Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
What is Revolade and what is it used for?
Revolade is a medicine that is used for the treatment of:
- long-term immune (idiopathic) thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys the platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding. Revolade is used in patients aged 1 year and above who do not respond to treatment with medicines such as corticosteroids or immunoglobulins;
- thrombocytopenia in adult patients with chronic (long-term) hepatitis C, a disease of the liver caused by infection with the hepatitis C virus, when the severity of thrombocytopenia is preventing antiviral therapy;
- acquired severe aplastic anaemia (a disease in which the bone marrow does not make enough blood cells or platelets) in adult patients. Revolade is used in patients who did not respond to or had received multiple courses of immunosuppressive therapy (medicines that lower the body’s immune defences) and cannot receive haematopoietic (blood) stem cell transplantation.
Revolade contains the active substance eltrombopag.
How is Revolade used?
Revolade is available as tablets (12.5, 25, 50 and 75 mg) and as a powder (25 mg) to prepare a suspension (a liquid to be taken by mouth). The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating blood diseases or chronic hepatitis C and its complications.
The dose depends on the patient’s age and the disease Revolade is being used to treat; it is adjusted as needed to maintain the appropriate platelet level. For ITP and aplastic anaemia, a lower starting dose may be needed in patients of East Asian descent (such as Chinese, Japanese, Korean or Taiwanese).
Patients should not take any antacids, dairy products or mineral supplements in the four hours before and in the two hours after taking Revolade. For more information, see the package leaflet.
How does Revolade work?
In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets by attaching to certain targets in the bone marrow. The active substance in Revolade, eltrombopag, attaches to and stimulates the same receptors as thrombopoietin. This leads to an increased production of platelets, improving platelet counts.
What benefits of Revolade have been shown in studies?
For the treatment of chronic ITP in adults, Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 patients who had previously been treated, but the treatments had not worked or the disease had come back.
Revolade was shown to be more effective than placebo: in the first study, 59% of the patients who took Revolade (43 out of 73) achieved a platelet count of at least 50,000 per microlitre (a platelet level considered adequate to prevent the risk of bleeding complications) after six weeks (the main measure of effectiveness), compared with 16% of those who took placebo (6 out of 37). In the second study, patients taking Revolade were around eight times more likely than those taking placebo to reach the target platelet count of between 50,000 and 400,000 per microlitre during the six months of treatment.
In children with chronic ITP, Revolade was shown to be more effective than placebo in one main study involving a total of 92 children between 1 and 17 years of age who had previously received treatment for ITP. This study lasted 13 weeks and looked at the proportion of patients whose platelet count had increased to at least 50,000 per microlitre for at least 6 out of 8 weeks, between week 5 to 12 of the study in the absence of rescue medication. This occurred in around 40% of those taking Revolade (25 out of 63) compared with around 3% (1 out of 29) of those who took placebo. The study had also an extension phase, in which all patients received Revolade. This showed that Revolade was also effective at maintaining adequate levels of platelets in the long term.
For the treatment of thrombocytopenia associated with hepatitis C, two main studies involving a total of 1,441 adults were carried out. These compared Revolade with placebo for allowing the starting and maintenance of antiviral treatment in patients with hepatitis C whose platelet count was initially too low to allow starting such treatment (less than 75,000 per microlitre). In both studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 6 months after the end of treatment.
In these two studies, a higher proportion of patients who took Revolade tested negative for hepatitis C, compared with those who took placebo (23% versus 14% in the first study, and 19% versus 13% in the second study).
For the treatment of severe aplastic anaemia, Revolade was studied in 43 patients and it was not compared with any other medicine. The main measure of effectiveness was the number of patients who responded to Revolade (whose platelet, red or white blood cell count remained above pre-set levels) after 12 or 16 weeks of treatment.
In this study, 40% of patients (17 out of 43) responded to treatment after 12 weeks, and 65% of responders (11 out of 17) either had a platelet count increase of at least 20,000 per microliter or had a platelet count that was stable without need for blood transfusions. Preliminary data from a supportive study are consistent with the result of the main study, with 46% of patients responding to treatment after 12 weeks.
What are the risks associated with Revolade?
The most common side effects with Revolade in adults with chronic ITP and hepatitis C (seen in more than 1 patient in 10) are headache, anaemia (low red blood cell counts), decreased appetite, insomnia (difficulty sleeping), cough, nausea (feeling sick), diarrhoea, pruritus (itching), alopecia (hair loss), myalgia (muscle pain), pyrexia (fever), fatigue (tiredness), influenza (flu)-like illness, asthenia (weakness), chills and peripheral oedema (swelling, especially of the ankles and feet). In addition, in children with ITP the most common side effects also included colds, nasopharyngitis (inflammation of the nose and throat), rhinitis (inflammation of the lining of the nose), pain in the belly or in the mouth and throat, toothache, rash, runny nose and abnormal blood levels of certain liver enzymes (AST).
In adults with severe aplastic anaemia the most common side effects included headache, dizziness, insomnia, cough, dyspnoea (difficulty breathing), pain in the belly or in the mouth and throat, nausea, diarrhoea, joint pain, muscle spasms, pain in limbs, fatigue, fever, ecchymosis (discoloration of the skin resulting from bleeding underneath), abnormal blood levels of certain liver enzymes and runny nose.
In patients with thrombocytopenia and advanced chronic hepatitis C who are treated with a medicine called interferon and Revolade liver problems and thromboembolic complications (problems with clots in blood vessels) are the most important serious side effects. In these patients Revolade should only be used if clinically indicated and patients should then be closely monitored. Bleeding can also come back after the medicine is stopped.
For the full list of restrictions and side effects with Revolade, see the package leaflet.
Why has Revolade been approved?
The European Medicines Agency decided that Revolade’s benefits are greater than its risks and recommended that it be given marketing authorisation.
What measures are being taken to ensure the safe and effective use of Revolade?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revolade have been included in the summary of product characteristics and the package leaflet.
Other information about Revolade
The European Commission granted a marketing authorisation valid throughout the European Union for Revolade on 11 March 2010.
For more information about treatment with Revolade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
FAQs
What are the benefits of Revolade? ›
Revolade is a medicine that is used for the treatment of: • primary immune thrombocytopenia (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding.
What are the common side effects of Revolade? ›The most common side effects of Revolade when used to treat adult patients with chronic ITP include headache, anemia, decreased appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and peripheral edema.
What are the side effects of Revolade 25 mg? ›In some cases, Revolade 25mg Tablet 7's can cause common side effects like nausea, diarrhoea, headache, muscle pain, tiredness, loss of appetite, fever, anaemia (lack of blood cells), cough and tingling numbness. These side effects are not familiar to everyone who take Revolade 25mg Tablet 7's and vary individually.
What is the effectiveness of Revolade? ›Revolade was shown to be more effective than placebo: in the first study, 59% of the patients who took Revolade (43 out of 73) achieved a platelet count of at least 50,000 per microlitre (a platelet level considered adequate to prevent the risk of bleeding complications) after six weeks (the main measure of ...
What does Revolade treat? ›Revolade is a medicine that is used for the treatment of: primary immune thrombocytopenia (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts in the blood (thrombocytopenia) and are at risk of bleeding.
How fast does Revolade work? ›It may take up to 2 weeks for patients to respond to eltrombopag.
How much does Revolade cost? ›| Drug/Comparator | Strength | Price ($) |
|---|---|---|
| Eltrombopag (Revolade)a | 25 mg | 62.50 |
| 50 mg | 125.00 |
Eltrombopag oral tablet is used for long-term treatment. It comes with serious risks if you don't take it as prescribed. If you stop taking the drug suddenly or don't take it at all: Your platelet counts may decrease. If your platelet level drops dangerously low, it can cause bleeding.
When is the best time to take Revolade? ›Take REVOLADE at least 2 hours before or at least 4 hours after antacids, dairy products or some mineral supplements such as iron, calcium, magnesium, aluminium, selenium and zinc. One way to avoid issues with these products would be to take them in the morning and REVOLADE in the evening.
How long can you take eltrombopag for? ›Interim results from this study showed that treatment with eltrombopag was safe, well-tolerated, and effective in maintaining platelet counts in the desired range for most of the 299 patients treated for up to 3 years. This final study report describes up to 8 years of continuous treatment with eltrombopag.
When should I stop eltrombopag? ›
Successful discontinuation of eltrombopag (SDOE) was defined as those patients who reached remission and maintained platelet counts ≥ 50x109/l for at least 6 months in absence of eltrombopag or any rescue therapies administered.
Is eltrombopag hazardous? ›Ecotoxical effects: · Remark: Very toxic for fish · Additional ecological information: · General notes: Water hazard class 3 (Self-assessment): extremely hazardous for water Do not allow product to reach ground water, water course or sewage system, even in small quantities.
What is the success rate of eltrombopag? ›A pooled analysis of both trials showed that 62% of the patients treated for six weeks with eltrombopag achieved a response compared to 24% of the placebo group. Response was defined as an increase in platelet count of at least 50 × 109/L. Bleeding risk was significantly lower with eltrombopag than with placebo [18].
What medicines increase platelets? ›Romiplostim is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
What type of drug is Revolade? ›Eltrombopag belongs to the class of medications called thrombopoietin receptor agonists. It is used to increase the number of platelets in the blood for adults and children with chronic (long-term) immune thrombocytopenia purpura (ITP).
What is the best treatment for ITP? ›- Steroids. Your doctor will likely start you on an oral corticosteroid, such as prednisone. ...
- Immune globulin. If corticosteroids don't help, your doctor may give you an injection of immune globulin. ...
- Drugs that boost platelet production. ...
- Other drugs.
The total duration of Eltrombopag treatment is 6 months. Initial Dose Regimen Initiate Eltrombopag at a dose of 50 mg once daily.
How do I stop Revolade? ›Don't stop taking Revolade without talking to your doctor. If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks. See also 'Bleeding or bruising after you stop treatment' in section 4.
What foods to avoid while taking eltrombopag? ›Too much calcium (more than 50 mg) stops PROMACTA from working properly. So you need to be careful to avoid eating calcium-rich foods such as dairy products (yogurt, cheese, milk, ice cream), calcium-fortified foods (some orange juice, dry cereal, and bread), and leafy green vegetables (spinach, collard greens).
Does ITP get worse with age? ›Does it get worse over time? No, unlike autoimmune diseases such as rheumatoid arthritis and multiple sclerosis it is not a progressive disease, but the risk of bleeding is present from the day the disease develops. ITP can go into temporary or permanent remission.
How long does it take for 50 mg of eltrombopag to increase platelet count? ›
Among patients who were receiving the two highest doses of eltrombopag, more than 80% had increased their platelet count by day 15: this increment allowed platelets to approach their normal range, and was seen in 88% and 81% of patients receiving a daily dose of 50 or 75 mg respectively, with the median platelet counts ...
How much is eltrombopag in USA? ›The retail price of $13188 is the lowest available at Capsule Pharmacy. No need for a GoodRx discount. Haven't found your pharmacy? Pay between $ 11,686 and $ 12,014 chevron_right at other pharmacies with this coupon.
Is Revolade the same as PROMACTA? ›Eltrombopag, sold under the brand name Promacta among others, is a medication used to treat thrombocytopenia (abnormally low platelet counts) and severe aplastic anemia. Eltrombopag is sold under the brand name Revolade outside the US and is marketed by Novartis.
Is eltrombopag a chemotherapy drug? ›Eltrombopag, is US Food and Drug Administration (FDA) approved for treatment of non-chemotherapy related disorders of low platelets like chronic immune thrombocytopenia (ITP).
What are the benefits of eltrombopag? ›Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.
What happens when you stop taking a biologic? ›Stopping biologics could make your arthritis flare. A relapse not only affects your quality of life, but could also lead to more joint-damaging inflammation, Ghosh says. If your symptoms haven't improved on your biologic, or if you're having side effects, you do have other options, Haberman says.
Is eltrombopag a steroid? ›Conclusion: Eltrombopag is effective as a rapidly acting corticosteroid sparing therapy for patients with ITP associated with SLE.
Can I take Revolade with food? ›REVOLADE may be taken with food containing little (< 50 mg) or preferably no calcium (see section 4.5 and section 5.2). Use the lowest dose of REVOLADE to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding.
What is the use of Revolade 25 mg tablet? ›Revolade 25mg Tablet is used to treat low platelet count due to chronic immune (idiopathic) thrombocytopenic purpura (ITP) or chronic hepatitis C virus (HCV) infection. It is also used to treat severe aplastic anemia.
Can eltrombopag cause back pain? ›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.
What is long term treatment for ITP? ›
Most of ITP patients respond to primary treatment such as glucocorticoids or IVIG, but a significant number of patients eventually require secondary treatment because the maintain of long-term responses are difficult. Such patients may consider medical therapy (TPO-RA, rituximab) or surgical option (splenectomy).
Can you take Revolade on an empty stomach? ›Take Revolade 50mg at the time of 1 hour before meals or 2 hours after meals. Should be taken on an empty stomach. Remember to use Revolade 50mg with products containing calcium, aluminum or magnesium because it can prevent the complete absorption of the drug. Initial dose: Revolade 50mg/time, 1 time per day.
What is the half life of Revolade? ›The plasma elimination half-life of eltrombopag is approximately 21-32 hours.
Do you have to wean off cilostazol? ›Can you just stop taking cilostazol? You shouldn't stop taking this medication without speaking with your healthcare provider first. If you just stop taking this medication, you might be at risk for blood clots and complications. Why shouldn't cilostazol be used in heart failure?
What is treatment free remission in ITP? ›treatment-free remission with Nplate®. This means their platelet counts reached and stayed above 50,000 so that they were able to stop any ITP treatment for at least 6 months. About half of adults achieved treatment-free remission by about 6 months with Nplate®.
Can you take Tylenol with PROMACTA? ›Interactions between your drugs
No interactions were found between Promacta and Tylenol. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.
Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
Is eltrombopag cytotoxic? ›Cytotoxic effect of Eltrombopag on AML cells is dependent on dose and serum concentration.
What chemical class is eltrombopag? ›It is a member of hydrazines, a member of pyrazoles and a member of benzoic acids.
How long does chronic ITP last? ›Chronic ITP lasts 6 months or longer and mostly affects adults. However, some teens and children do get this type of ITP. Chronic ITP affects women two to three times more often than it affects men.
Does Medicare Part D cover PROMACTA? ›
Do Medicare prescription drug plans cover Promacta? Yes. 100% of Medicare prescription drug plans cover this drug.
How long do people take PROMACTA? ›Aplastic anemia combination therapy
However, 87% (95% CI 75-100) of patients treated with Promacta once daily for the first 6 months of their treatment plan (cohort 3 Study US01T) had either a complete or partial response to Promacta + combination immunosuppressive therapy at 3 months.
What is even more interesting is that milk contains vitamin K, which is an essential vitamin in the blood clotting mechanism in our body. Furthermore, it is believed that regular consumption of milk may help in improving total blood platelet counts.
Which fruits increase platelets fast? ›- Papaya leaf. ...
- Wheatgrass. ...
- Pomegranate. ...
- Pumpkin. ...
- Vitamin C rich foods. ...
- Raisins. ...
- Brussel sprouts. ...
- Beetroot.
Even egg whites helps in boosting your platelet count as they contain albumin which is a vital protein found in the blood plasma.