Frequently Asked Questions
What is ALVAIZ?
Teva’s ALVAIZ is a thrombopoietin receptor agonist, and the first eltrombopag pharmaceutical alternative to the brand innovator Promacta®* (eltrombopag) tablets.
What is ALVAIZ indicated for?
Teva’s ALVAIZ is indicated for: 01
- 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.
What important information should one know about ALVAIZ?
ALVAIZ may cause serious side effects, including: 01
Liver problems:
- If you have chronic hepatitis C virus and take ALVAIZ with interferon and ribavirin treatment, ALVAIZ 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.
- ALVAIZ may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking ALVAIZ and during your treatment. Your healthcare provider may stop your treatment with ALVAIZ if you have changes in your liver function blood tests.
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
- confusion
- unusual tiredness
- swelling of the stomach area (abdomen)
Why did Teva pursue the NDA 505(b)(2) pathway rather than the ANDA pathway for ALVAIZ?
Drugs submitted to the FDA on an ANDA pathway must show that the proposed generic product is the same as the innovator product (reference listed drug) with respect to certain conditions, including the active ingredient(s). Teva’s formulation of ALVAIZ contains a different salt from what is contained in Promacta tablets. Since the two products contain different salts of the active ingredient, Teva was required to file the application using the 505(b)(2) pathway.
What are the NDC numbers and available tablet strengths for ALVAIZ?
ALVAIZ is available in the following strengths and sizes: 01
Strength |
How Supplied |
NDC |
|---|---|---|
| 9 mg | 30 Tablets/Bottle | 00480-3273-56 |
| 18 mg | 30 Tablets/Bottle | 00480-3274-56 |
| 36 mg | 30 Tablets/Bottle | 00480-3275-56 |
| 54 mg | 30 Tablets/Bottle | 00480-3276-56 |
What is Immune Thrombocytopenia (ITP)?
ITP is a blood disorder characterized by low blood platelet counts, purpura, and bleeding episodes caused by antiplatelet autoantibodies. ITP may result in severe and unpredictable bleeding. ITP may be caused by autoimmune disorders, infections, pregnancy, certain medication use, or an unknown cause. Learn more here. 0203
Is ALVAIZ bioequivalent to Promacta Tablets?
Is ALVAIZ a generic version of Promacta Tablets?
No. ALVAIZ is the first eltrombopag pharmaceutical alternative to the brand innovator, Promacta Tablets. Currently there is no generic version of Promacta in the market.
How should ALVAIZ be stored?
Store ALVAIZ tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep ALVAIZ in the bottle given to you. Keep ALVAIZ and all medicines out of the reach of children. 01
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
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ALVAIZ [Prescribing Information]. Parsippany, NJ: Teva Pharmaceuticals; 2023.
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Justiz Vaillant AA, Gupta N. ITP – Immune Thrombocytopenic Purpura. StatPearls. 2023 Jan. Updated May 6, 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK537240/
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Idiopathic Thrombocytopenic Purpura. Johns Hopkins Medicine. Accessed July 5, 2023. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/idiopathic-thrombocytopenic-purpura.
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Data on File. [Clinical Summary]