Alvaiz for Immune Thrombocytopenia: What You Need to Know
If you have chronic immune thrombocytopenia (ITP), your immune system attacks your platelets, the blood cells that help your blood clot. Low platelet counts can lead to easy bruising, small red or purple spots on your skin, and, in some cases, more serious bleeding. Many people manage ITP well with treatments such as steroids or immune globulins, but for those who don’t respond well enough, other options are needed.
Alvaiz (eltrombopag) is one of those options. It’s a thrombopoietin (TPO) receptor agonist, a type of medicine that tells your body to make more platelets. Eltrombopag was first approved by the FDA in 2008 as a treatment for ITP. Alvaiz is a newer eltrombopag product, approved by the FDA in late 2023. It uses a different salt form (eltrombopag choline) compared to the original product, so its tablet strengths and dosing look a little different, even though it works the same way in the body.
This article covers how Alvaiz works for ITP, who it’s approved for, how to take it, what clinical studies found, and how to get help with the cost. You may also be interested in reading about Alvaiz side effects and Alvaiz drug interactions in their own articles.
How Does Alvaiz Work for Immune Thrombocytopenia?
In ITP, your immune system makes antibodies that target your own platelets. This causes two problems: your body destroys platelets faster than normal, and your bone marrow doesn’t always keep up by making enough new ones.
Alvaiz works on the second half of that problem. Platelets are made by cells in your bone marrow called megakaryocytes. Alvaiz attaches to a receptor on these cells called the TPO receptor (also known as cMpl), which is the same receptor your body’s natural thrombopoietin hormone uses. This turns on a signal inside the megakaryocytes that tells them to grow, mature, and release more platelets into your bloodstream. Alvaiz doesn’t fix the underlying immune attack on your platelets. Instead, it helps your body outpace that destruction by making more platelets to begin with.
Is Alvaiz Right for Me?
Alvaiz is approved for the treatment of thrombocytopenia (low platelet count) in adults and children (6 years and older) who have persistent or chronic ITP and who haven’t had a good enough response to corticosteroids, immunoglobulins, or having their spleen removed (splenectomy). Alvaiz should only be used in people with ITP whose platelet count and overall condition put them at increased risk for bleeding. Persistent ITP generally means the condition has lasted 3-12 months, and chronic ITP means it has lasted longer than 12 months.
Alvaiz isn’t approved to treat myelodysplastic syndrome (MDS), a different bone marrow condition, even though MDS can also cause low platelet counts. Alvaiz also isn’t approved for children younger than 6 years. Alvaiz tablets must be swallowed whole and can’t be split, crushed, or dissolved, so they aren’t an option for younger children who can’t swallow a tablet. Your health care provider will look at your ITP history, including how long you’ve had it, which treatments you’ve already tried, whether you’ve had a splenectomy, and how much your low platelet count is affecting your daily life and bleeding risk, before deciding if Alvaiz makes sense for you.
How Do I Take Alvaiz?
Most adults and children who are 6 years and older will likely start at 36 mg once a day. Your health care provider may start you at a lower dose if you’re of East Asian or Southeast Asian ancestry or you have liver problems, as eltrombopag can build up to higher levels in these groups. From there, your provider will adjust your dose based on regular blood tests, aiming to keep your platelet count at a safe level, generally at least 50,000 per microliter, without exceeding 54 mg per day.
Take Alvaiz on an empty stomach or with a meal that’s low in calcium (50 mg or less). Take it at least two hours before or four hours after antacids, calcium supplements, multivitamins with minerals, or calcium-rich foods such as dairy because these can significantly lower how much of the medicine your body absorbs. Swallow the tablet whole; don’t split, chew, or crush it. You can read more about why this timing matters and other medicines and supplements to watch for in the Alvaiz drug interactions article.
Alvaiz isn’t interchangeable with other eltrombopag products. Don’t switch between Alvaiz and a different eltrombopag brand or generic unless your health care provider tells you to and adjusts your dose. Don’t stop taking Alvaiz or change your dose on your own, even if your platelet count looks good because ITP symptoms and bleeding risk can come back within a couple of weeks of stopping.
How Was Alvaiz Studied for Immune Thrombocytopenia?
The active ingredient in Alvaiz, eltrombopag, has been studied in adults and children with persistent or chronic ITP in many randomized, double-blind, placebo-controlled trials. In a double-blind, placebo-controlled study, some participants get the real medicine and some get a placebo (a look-alike tablet with no active medicine in it). Neither the participants nor the study team knows who’s getting which one until the study ends. This design helps researchers see how much of an effect is really coming from the medicine itself.
In adults, the main studies were two shorter, six-week studies and a six-month study called RAISE.
The first of the two shorter studies was an early dose-finding study that enrolled 118 adults with relapsed or refractory chronic ITP and a platelet count under 30,000 per microliter. Participants were randomly assigned to eltrombopag 30 mg, 50 mg, or 75 mg once daily or to a placebo for up to six weeks. At the start of the study, participants had a median age of 50 years, and about 6 in 10 were women. About 80% were White, about 18% Asian, and 2% Black; less than 1% were of mixed race.
A larger follow-up study was built on those results. A total of 114 adults with the same eligibility criteria were randomly assigned, in a 2:1 ratio, to eltrombopag 50 mg once daily (with the option to increase to 75 mg after three weeks, if needed) or a placebo for up to six weeks. At the start of that study, participants had a median age of 48 years, and about 6 in 10 were women. About 74% were White, less than 1% were Black, and about 25% belonged to other races.
RAISE enrolled 197 adults who had ITP for more than six months and a platelet count under 30,000 per microliter and who had already tried and not had a good enough response to at least one prior ITP treatment. Participants were randomly assigned in a 2:1 ratio to take eltrombopag 50 mg once daily or a placebo for six months, with dose adjustments allowed along the way. At the start of the study, participants were, on average, in their late 40s to early 50s. About 7 in 10 were women. About 74% of the participants were White, about 17% were Asian, and the remaining participants belonged to other races.
In children aged 1-17 years with persistent or chronic ITP, eltrombopag was studied in a phase 2 trial called PETIT and a larger phase 3 trial called PETIT2; both were randomized, multicenter, and placebo-controlled. These trials studied the original eltrombopag formulation, which is also available as an oral suspension for younger children who can’t swallow a tablet. Alvaiz is a tablet-only product, and it is approved only for children aged 6 and older who can swallow it whole, so the results below from children younger than 6 years don’t apply to Alvaiz specifically.
PETIT2 enrolled 92 children with chronic ITP and a platelet count under 30,000 per microliter who hadn’t responded well enough to at least one prior treatment. Participants were randomly assigned, in a 2:1 ratio, to eltrombopag or a placebo for 13 weeks, with starting doses based on their age, weight, and ancestry. About 33% of the participants were identified in the study as East Asian or Southeast Asian; the rest were grouped under a broader category that included White, Arab or North African, Black, and mixed-race children.
What Are the Main Benefits of Alvaiz Based on Studies?
In the early dose-finding study, the goal was to see how many adults reached a platelet count of at least 50,000 per microliter by day 43. That happened in 28% of people taking eltrombopag 30 mg, 70% of those taking 50 mg, and 81% of those taking 75 mg, compared with 11% of people taking the placebo. In the larger follow-up study, 59% of people taking eltrombopag 50 mg (with the option to move up to 75 mg) reached that same platelet goal by day 43, compared with 16% of people taking the placebo, meaning people taking eltrombopag were roughly 9-10 times more likely to reach a safe platelet count than those on the placebo.
In RAISE, the goal was to see how often adults kept a platelet count in a safe range (50,000-400,000 per microliter) over the six-month study. Overall, 79% of people taking eltrombopag reached that range at least once during the study, compared with 28% of people taking the placebo. People taking eltrombopag were about eight times more likely to reach a safe platelet range than those taking the placebo. Among the people who completed the full six months, 60% of those on eltrombopag had a sustained response (a safe platelet count for most of the last eight weeks without needing rescue treatment), compared with 10% of those on the placebo.
In PETIT2, the main goal was the proportion of children who reached a platelet count of at least 50,000 per microliter for six or more of the last eight weeks of the 13-week study, without needing rescue treatment. That happened in 40% of children taking eltrombopag, compared with 3% of children taking the placebo. Results were similar across the three age groups studied (1-5 years, 6-11 years, and 12-17 years).
Your results may differ from what was seen in clinical studies.
Are There Additional Benefits Based on Studies?
Beyond raising platelet counts, studies also looked at bleeding and quality of life, which are often what matter most day to day.
In the larger follow-up study described above, significantly fewer people taking eltrombopag had bleeding symptoms by day 43 than people taking placebo (39% vs. 60%), and people taking eltrombopag had lower odds of any bleeding at any point during the six-week study. No episodes of clinically significant bleeding occurred in people taking eltrombopag whose platelet count reached at least 50,000 per microliter.
In RAISE, the number of people with any bleeding symptoms (using the World Health Organization, or WHO, bleeding scale) dropped by roughly half within two weeks of starting eltrombopag and stayed lower throughout the six-month study. People taking eltrombopag also had significantly lower odds of any bleeding and of more serious bleeding compared with people on the placebo. A separate analysis pooling five eltrombopag studies in adults with chronic ITP, including RAISE and the extension study EXTEND, found the same pattern: bleeding rates fell within about two weeks of starting treatment and stayed lower for as long as people continued treatment.
Roughly 6 in 10 adults in RAISE who were also taking another ITP medicine at the start of the study, such as a corticosteroid, were able to reduce or stop that medicine while on eltrombopag, compared with about 3 in 10 people on the placebo.
In PETIT2, the share of children with any WHO-graded bleeding dropped from 71% at the start of the study to 37% at the end of the 13-week double-blind period among those taking eltrombopag, compared with a smaller drop (from 69% to 55%) among those on the placebo.
Your results may differ from what was seen in clinical studies.
How Fast Does Alvaiz Work?
Platelet counts generally start to rise within about a week of starting Alvaiz, with the biggest increase usually seen around two weeks. Everyone’s response is different, so it may take some dose adjustments over the first few weeks before you and your health care provider find the dose that works best for you.
Is There Longer-Term Data on Alvaiz?
Because ITP is often a long-term condition, researchers also studied how eltrombopag performs over years, not just months. Adults who completed one of the earlier eltrombopag studies could enroll in EXTEND, an open-label extension study (meaning everyone knew they were getting the real medicine). EXTEND followed 302 adults for a median of about 2.4 years, with some participants treated for close to nine years. At the start of EXTEND, 79% of participants were White, 15% were Asian, 4% were Indigenous American or Alaska Native, and 1% were Black.
In EXTEND, median platelet counts reached at least 50,000 per microliter by two weeks and generally stayed there for years. Overall, 86% of participants reached a platelet count of at least 50,000 per microliter at least once, and just over half of those who responded kept a continuous response for 25 weeks or longer. Bleeding symptoms dropped from 57% of participants at the start of EXTEND to 16% at one year, and about a third of those taking another ITP medicine at the start were able to permanently stop at least one of those medicines.
Your results may differ from what was seen in clinical studies.
What Kind of Health Care Provider Prescribes Alvaiz?
Alvaiz for ITP is typically prescribed and monitored by a hematologist, a doctor who specializes in blood disorders, though your primary care provider may be involved in coordinating your care. You’ll need regular blood tests, including complete blood counts and liver function tests, throughout treatment, so plan to keep those appointments.
Is There Cost Assistance Available for Alvaiz?
Cost can be a real barrier to starting or staying on a specialty medicine such as Alvaiz. Teva, the drugmaker of Alvaiz, offers a copay savings program for eligible people with insurance, as well as a separate patient assistance program through the Teva Cares Foundation for people who meet certain income and insurance requirements. Ask your health care provider’s office or pharmacist about these options, or visit Alvaiz’s official website or the Teva Cares Foundation to check your eligibility.