Promacta (eltrombopag)
Also marketed as Revolade. An approved treatment for Aplastic Anemia.
The same compound appears under different names depending on the context. Here is how to identify Eltrombopag wherever you encounter it, plus the key facts at a glance.
- Generic name
- Eltrombopag
- Brand names
- Promacta, Revolade
- Development code
- SB-497115
- Drug class
- Small molecule TPO agonist
- Manufacturer
- Novartis (originally GlaxoSmithKline)
- How it's taken
- Eltrombopag is taken by mouth once a day, either without a meal or with a meal low in calcium.
A daily pill that stimulates the bone marrow to produce more blood cells. It is FDA-approved with standard immunosuppressive therapy as a first-line treatment for severe aplastic anemia in adults and children 2 years and older. It is also approved for severe aplastic anemia that has not responded well enough to immunosuppressive therapy.
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Where Eltrombopag fits
Used in severe aplastic anemia as add-on to immunosuppressive therapy to improve blood count recovery. Also approved for chronic immune thrombocytopenia and chronic hepatitis C-associated thrombocytopenia.
How Eltrombopag works
Eltrombopag turns on a specific switch in your bone marrow to tell it to make more blood cells, especially platelets. It mimics a natural signaling protein called thrombopoietin (TPO). By activating this switch, the drug helps your bone marrow wake up and start producing blood cells that it had stopped making.
Mechanism: Thrombopoietin receptor agonist that stimulates bone marrow
Side effects and safety
Eltrombopag has a boxed warning: it can cause severe, possibly life-threatening liver damage, so liver blood tests are needed before and during treatment. In people with hepatitis C taking interferon and ribavirin, it can raise the risk of liver failure. Common side effects include nausea, fatigue, cough, diarrhea, and headache. Some patients experienced muscle aches or dizziness. In trials, some patients developed new chromosome changes, though it's unclear if this was from the drug or the disease. Regular blood tests are important. The label also warns about blood clots (including clots in the portal vein of the liver, mainly in people with chronic liver disease) and cataracts (eye exams are needed before and during treatment). It also warns about interference with some lab tests such as bilirubin and creatinine. Eltrombopag is not for people with myelodysplastic syndromes (MDS), where a study found a higher risk of death and of progression to leukemia.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Eltrombopag
Eltrombopag is taken by mouth once a day, either without a meal or with a meal low in calcium. Take it at least 2 hours before or 4 hours after antacids, dairy and other calcium-rich foods, and mineral supplements such as iron, calcium, magnesium, or zinc, because these block absorption. When used with immunosuppressive therapy as a first treatment, it is taken for 6 months. When used after immunosuppressive therapy has not worked well enough, it is stopped if blood counts have not improved after 16 weeks, and continues while the patient is responding.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Oral thrombopoietin receptor agonist approved across multiple rare hematologic conditions. Specialty pricing reflects the orphan indications and biologic-like activity despite being a small molecule.
Help paying for Promacta
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Universal Co-pay Program: eligible patients with private insurance may pay $0 per month; Novartis pays up to $15,000 per calendar year.
For: private insurance · source - Insurance and case manager help
Novartis Patient Support can answer questions about paying for PROMACTA; call 1-800-282-7630.
The official page does not say who qualifies. Ask the program. · source
Good to know: Co-pay program not valid with Medicare, Medicaid or other government coverage; enroll at Copay.NovartisOncology.com or 1-877-577-7756. PROMACTA is not on the Novartis Patient Assistance Foundation's current medication list, and no free-drug program is described on the PROMACTA site.
Clinical trial results
FDA approved eltrombopag for severe aplastic anemia not responding to other treatments on August 26, 2014. It was first approved in 2008 for a different blood disorder. In a single-arm study of 43 patients, 17 (40%) had a blood count response assessed after 12 weeks.
Development history
Developed by GlaxoSmithKline, eltrombopag was originally approved for immune thrombocytopenia (low platelets) before being approved for aplastic anemia in 2014. It represents a new approach by stimulating bone marrow rather than suppressing the immune system.
Explore Aplastic Anemia trials
Other Aplastic Anemia treatments
Common questions about Eltrombopag
▸What is Eltrombopag (Promacta)?
A daily pill that stimulates the bone marrow to produce more blood cells. It is FDA-approved with standard immunosuppressive therapy as a first-line treatment for severe aplastic anemia in adults and children 2 years and older. It is also approved for severe aplastic anemia that has not responded well enough to immunosuppressive therapy.
▸How does Eltrombopag work?
Eltrombopag turns on a specific switch in your bone marrow to tell it to make more blood cells, especially platelets. It mimics a natural signaling protein called thrombopoietin (TPO). By activating this switch, the drug helps your bone marrow wake up and start producing blood cells that it had stopped making.
▸What are the side effects of Eltrombopag?
Eltrombopag has a boxed warning: it can cause severe, possibly life-threatening liver damage, so liver blood tests are needed before and during treatment. In people with hepatitis C taking interferon and ribavirin, it can raise the risk of liver failure. Common side effects include nausea, fatigue, cough, diarrhea, and headache. Some patients experienced muscle aches or dizziness. In trials, some patients developed new chromosome changes, though it's unclear if this was from the drug or the disease. Regular blood tests are important. The label also warns about blood clots (including clots in the portal vein of the liver, mainly in people with chronic liver disease) and cataracts (eye exams are needed before and during treatment). It also warns about interference with some lab tests such as bilirubin and creatinine. Eltrombopag is not for people with myelodysplastic syndromes (MDS), where a study found a higher risk of death and of progression to leukemia.
▸How is Eltrombopag taken?
Eltrombopag is taken by mouth once a day, either without a meal or with a meal low in calcium. Take it at least 2 hours before or 4 hours after antacids, dairy and other calcium-rich foods, and mineral supplements such as iron, calcium, magnesium, or zinc, because these block absorption. When used with immunosuppressive therapy as a first treatment, it is taken for 6 months. When used after immunosuppressive therapy has not worked well enough, it is stopped if blood counts have not improved after 16 weeks, and continues while the patient is responding.
▸Is Eltrombopag FDA approved?
Yes, Eltrombopag (Promacta) is FDA approved (2008) for the treatment of Aplastic Anemia.
▸How much does Promacta cost, and is there patient assistance?
Novartis does not publish a price, and privately insured patients may pay $0 a month with its co-pay help.
Co-pay help: eligible privately insured patients may pay $0 a month for Promacta, with Novartis paying up to $15,000 per calendar year, per product.
Not eligible: Medicare, Medicaid and any other federal or state health care program.
Enroll: Copay.NovartisOncology.com or 1-877-577-7756. Novartis Patient Support is 1-800-282-7630.
Generic: the FDA has approved generic eltrombopag from several companies. The Novartis offer is for Promacta, so ask your pharmacist which version your plan covers.
▸How does eltrombopag help in aplastic anemia?
Eltrombopag stimulates the thrombopoietin receptor on bone marrow stem cells, promoting the growth of blood-forming cells. In severe aplastic anemia, it helps restore blood cell production by boosting the depleted bone marrow.
▸Is eltrombopag used alone or in combination?
For severe aplastic anemia, eltrombopag is typically used in combination with immunosuppressive therapy (antithymocyte globulin and cyclosporine). This combination has shown improved response rates compared to immunosuppression alone.
▸When was eltrombopag approved for aplastic anemia?
Eltrombopag (Promacta) was approved in August 2014 for severe aplastic anemia that has not responded well enough to immunosuppressive therapy, and in November 2018 for first-line use together with standard immunosuppressive therapy in people 2 years and older. It was originally developed for immune thrombocytopenic purpura (ITP) and was later found to benefit aplastic anemia patients.
▸How is eltrombopag taken?
Eltrombopag is taken orally as a tablet once daily. It can be taken without a meal or with a meal low in calcium. Take it at least 2 hours before or 4 hours after antacids, calcium-rich foods such as dairy, and mineral supplements.
▸What monitoring is needed?
Regular blood count monitoring is essential to track response and detect any blood count abnormalities. Liver function tests are also required, as liver enzyme elevations can occur.
▸Is generic eltrombopag available?
Yes. Generic eltrombopag tablets from several companies are sold in the US. The brand is Promacta (Revolade in some countries), made by Novartis. Ask your pharmacist or insurer which version your plan covers.