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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.


ALVAIZ contains eltrombopag as eltrombopag choline, and Promacta contains eltrombopag as eltrombopag olamine 0102


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.

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

Hepatic Decompensation in Patients with Chronic Hepatitis C. In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation. 

Hepatotoxicity. ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity. 

Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia. In a clinical trial of patients with intermediate to high risk MDS with thrombocytopenia, an increased number of progressions from MDS to AML was observed compared to placebo. 

Thrombotic/Thromboembolic Complications may result from increases in platelet counts with ALVAIZ. Reported thrombotic/thromboembolic complications included both venous and arterial events and were observed at low and at normal platelet counts.  

Cataracts. In clinical trials, development or worsening of cataracts was reported in patients treated with eltrombopag. 

ADVERSE REACTIONS  

The following clinically significant adverse reactions associated with ALVAIZ are described above.  

  • Hepatic Decompensation in Patients with Chronic Hepatitis C 
  • Hepatotoxicity 
  • Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia 
  • Thrombotic/Thromboembolic Complications 
  • Cataracts 

Common adverse reactions associated with the use of ALVAIZ observed in placebo-controlled clinical trials in adults and pediatric patients include nausea, diarrhea, upper respiratory tract infection, nasopharyngitis, cough, anemia, pyrexia, and fatigue. 

USE IN SPECIFIC POPULATIONS  

Pregnancy and Lactation 

There is insufficient data in pregnant women to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Due to the potential for serious adverse reactions in a breastfed child from eltrombopag, breastfeeding is not recommended during treatment. 

Pediatric Use 

The safety and effectiveness of ALVAIZ have been established in pediatric patients 6 years and older with persistent or chronic ITP. The safety and effectiveness of ALVAIZ have not been established in pediatric patients less than 6 years of age with persistent or chronic ITP. The safety and effectiveness in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established. 

INDICATIONS AND USAGE 

Treatment of Thrombocytopenia in Patients with Persistent or Chronic Immune Thrombocytopenia 

ALVAIZ™ (eltrombopag tablets) are 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. 

Treatment of Thrombocytopenia in Patients with Hepatitis C Infection 

ALVAIZ is indicated for 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. 

Treatment of Severe Aplastic Anemia 

ALVAIZ is indicated for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 

Limitations of Use 
  • 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. 

Please see the full Prescribing Information, including Medication Guide and Boxed Warning. 

*Promacta is a registered trademark of Novartis Pharma AG

References

  1. Back to contents.

    ALVAIZ [Prescribing Information]. Parsippany, NJ: Teva Pharmaceuticals; 2023.

  2. Back to contents.

    Promacta [Prescribing Information]. East Hanover, NJ: Novartis; 2008.