Teva’s ALVAIZ (eltrombopag tablets)

What is ALVAIZ?

Teva’s ALVAIZ is a thrombopoietin receptor agonist (TPO-RA), and the first eltrombopag pharmaceutical alternative to the brand innovator Promacta®* (eltrombopag) tablets. ALVAIZ was approved as a New Drug Application (NDA) through the 505(b)(2) pathway using Promacta as the reference listed drug (RLD). Learn more here.

The dose of ALVAIZ is not the same as other eltrombopag products. Do not change between ALVAIZ and other eltrombopag products unless advised by a healthcare provider. 

ALVAIZ is indicated for:

• the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
  • ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
• the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
  • ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
• the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndromes (MDS). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Teva’s ALVAIZ may cause serious side effects, including:

• Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). ALVAIZ is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive ALVAIZ, you have an increased risk that your MDS condition may worsen and become a blood cancer called AML. If your MDS worsens to become AML, you may have an increased risk of death from AML.
• 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. Your risk of getting a blood clot may also be increased during treatment with ALVAIZ 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.
• New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts can happen in people taking ALVAIZ. Your healthcare provider will check your eyes before and during your treatment with ALVAIZ. Tell your healthcare provider about any changes in your eyesight while taking ALVAIZ.

The most common side effects of ALVAIZ in adults and children include: low red blood cell count (anemia), nausea, fever, abnormal liver function tests, cough, tiredness, headache, and diarrhea. Laboratory tests may show abnormal changes to the cells in your bone marrow.

Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase increased, cough, fatigue, headache, and diarrhea.

*Promacta is a registered trademark of Novartis Pharma AG

References