Alvaiz

Pronunciation: al-VAYZ
Generic name: eltrombopag
Dosage form: oral tablet
Drug class: Platelet-stimulating agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 30, 2023.

What is Alvaiz?

Alvaiz (eltrombopag) is an oral thrombopoietin (TPO) receptor agonist that may be used to treat:

low blood platelet counts (thrombocytopenia) due to persistent or chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough in adults and children aged 6 years and older
thrombocytopenia due to chronic hepatitis C virus (HCV) infection in adults before and during treatment with interferon when the degree of thrombocytopenia prevents the initiation or continued administration of interferon-based treatment
severe aplastic anemia (SAA) in adults when other medicines to treat SAA have not worked well enough.

Alvaiz works by interacting with the TPO receptor and initiating a signaling cascade that stimulates the proliferation and differentiation of megakaryocytes – these are the bone marrow cells that give rise to blood platelets. This leads to increased platelet production. Alvaiz is used to try to raise platelet counts to lower your risk for bleeding but is not used to make platelet counts normal.

Severe aplastic anemia is a rare and serious blood disorder where the bone marrow fails to produce enough blood cells. This leads to symptoms like fatigue, difficulty breathing, infections, and abnormal bruising. In the past, it was often fatal due to complications from the lack of blood cell production.

Warnings

May increase the risk of severe and potentially life-threatening liver toxicity. Your healthcare provider will monitor your liver function before and during treatment and adjust or discontinue treatment as necessary. The risk of liver damage is increased when Alvaiz is used in combination with interferon and ribavirin. It is unknown if Alvaiz is safe and effective when used with other antiviral medicines to treat chronic hepatitis C.

Not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS) due to an increased risk of progression to acute myeloid leukemia, or in people with low platelet counts caused by certain other medical conditions or diseases.

This may increase the risk of thrombotic events and complications. Your healthcare provider will monitor your platelet counts regularly but venous and arterial events have been reported at low and normal platelet counts. The risk is further increased in patients with risk factors for thromboembolism, such as Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, or chronic liver disease. To reduce the risk, do not attempt to normalize platelet counts.

May increase the risk for cataracts or worsen existing cataracts.

It is not known if Alvaiz is safe and effective in children with low blood platelet counts due to chronic hepatitis C, whose severe aplastic anemia (SAA) has not improved after previous treatments, or who are younger than 6 years with persistent or chronic ITP.

Before taking

Before taking Alvaiz, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have a precancerous condition called MDS or a blood cancer
have or had a blood clot
have a history of cataracts
have had surgery to remove your spleen (splenectomy)
have bleeding problems
are of East-Asian or Southeast-Asian ancestry. You may need a lower dose
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

It is not known if Alvaiz will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment. Your doctor may conduct a pregnancy test before treatment. Females who can become pregnant should use effective birth control (contraception) during treatment with Alvaiz and for at least 7 days after stopping treatment. Talk to your healthcare provider about birth control methods that may be right for you during this time.

You should not breastfeed during your treatment with Alvaiz. Talk to your healthcare provider about the best way to feed your baby during this time.

How should I take Alvaiz?

Take it exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you what dosage of Alvaiz to take.

Swallow the tablets whole. Do not split, chew, or crush them, and do not mix with food or liquids.
Tell your healthcare provider if you or your child are not able to swallow the tablets whole. You will need to take a different medicine.
Alvaiz is not substitutable with other eltrombopag products on a milligram per-milligram basis.
Take Alvaiz without food or with food that is low in calcium (contains (≤ 50 mg).
Take at least 2 hours before or 4 hours after eating calcium-rich foods, such as dairy products, calcium-fortified juices, certain fruits and vegetables, and mineral supplements.
Do not take more than 1 dose in 1 day.
Do not stop taking Alvaiz without talking with your healthcare provider first. Do not change your dose or schedule for taking it unless your healthcare provider tells you to change it.

Dosage

Usual dosage for persistent or chronic ITP: 36 mg orally once daily for adults and children 6 years and older. Maximum dosage: 54mg/day.
- Reduce dosage in people with liver disease or East-/Southeast-Asian ancestry.
- Adjust dosage to maintain a platelet count greater than or equal to 50 x 109 /L.
Usual dosage for chronic Hepatitis C-associated thrombocytopenia: is 18 mg orally once daily for all patients. Maximum dosage: 72 mg/day.
- Adjust to achieve the target platelet count required to initiate antiviral therapy.
Usual dosage for refractory severe aplastic anemia: is 36 mg orally once daily. Maximum dosage: 108 mg/day.
- Reduce dosage in people with liver disease or East-/Southeast-Asian ancestry.
- Adjust dosage to maintain a platelet count greater than or equal to 50 x 109 /L.

What happens if I overdose?

If you take too much Alvaiz, you may have a higher risk of serious side effects. Call your healthcare provider right away.

What should I avoid while taking Alvaiz?

Avoid situations and medicines that may increase your risk of bleeding during treatment with Alvaiz.

What are the side effects of Alvaiz?

Alvaiz may cause serious side effects, including:

Liver problems, which may be severe and life-threatening. If you have chronic hepatitis C virus and take Alvaiz with interferon and ribavirin treatment, it may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking Alvaiz. Your healthcare provider will do blood tests to check your liver function before you start taking Alvaiz and during your treatment. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
- yellowing of the skin or the whites of the eyes (jaundice)
- right upper stomach area (abdomen) pain
- unusual darkening of the urine or confusion
- unusual tiredness or swelling of the stomach area (abdomen).
Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). Alvaiz should not be used in people with MDS
High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with Alvaiz, or even if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Alvaiz if your platelet counts get too high.
- Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg.
- People with chronic liver disease may be at risk for a type of blood clot in the stomach area (abdomen). Tell your healthcare provider right away if you have stomach-area (abdomen) pain, nausea, vomiting, or diarrhea as these may be symptoms of this type of blood clot.
- Tell your healthcare provider about any bruising or bleeding that happens during treatment and after you stop taking Alvaiz.
If you have SAA, your healthcare provider may do tests to monitor your bone marrow during treatment.
New or worsened cataracts (a clouding of the lens in the eye) can happen in people taking Alvaiz.
- Your healthcare provider will check your eyes before and during your treatment.
- Tell your healthcare provider about any changes in your eyesight.

The most common side effects of Alvaiz in adults affecting 20% of more people include:

low red blood cell count (anemia)
cough
nausea
tiredness
fever
headache
abnormal liver function tests
diarrhea
fatigue.

Laboratory tests may show abnormal changes to the cells in your bone marrow.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Alvaiz. For more information, ask your healthcare provider or pharmacist. You may report side effects to Teva at 1-888-832-2872 FDA at 1-800-FDA-1088.

What other drugs will affect Alvaiz?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Alvaiz may affect the way certain medicines work.

Tell your healthcare provider if you take:

certain medicines used to treat high cholesterol called “statins”
a blood thinner medicine

Certain medicines may keep Alvaiz from working correctly. Take it at least 2 hours before or 4 hours after taking these products:

antacid medicine used to treat stomach ulcers or heartburn
multivitamins or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc which may be found in mineral supplements.

Ask your healthcare provider if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C) in the original container.

Keep out of the reach of children.

Ingredients

Active: eltrombopag choline

Inactive:

Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide
Coating (9mg tablets): FD&C Blue No. 1 aluminum lake, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
Coating (18 mg tablets): Hypromellose 2910, polyethylene glycol 4000, talc, and titanium dioxide.
Coating (36 mg tablets): Iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
Coating (54 mg tablets): FD&C Red #40 aluminum lake, hypromellose 2910, iron oxide yellow, polyethylene glycol 400, and titanium dioxide.

Available as 9 mg, 18 mg, 36 mg, and 54 mg tablets.