ALVAIZ 54 mg/1

Eltrombopag · TABLET, FILM COATED · Teva Pharmaceuticals, Inc.

No Recall History

Plain English

ALVAIZ is a tablet, film coated containing eltrombopag at 54 mg/1, taken oral. Manufactured by Teva Pharmaceuticals, Inc..

Key Facts

Brand Name: ALVAIZ
Generic Name: Eltrombopag
NDC Code (Product): 0480-3276
Manufacturer: Teva Pharmaceuticals, Inc.
Strength: 54 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA216774
Marketing Start: 02/13/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective493 reports

off label use416 reports

platelet count decreased365 reports

product use in unapproved indication241 reports

thrombocytopenia233 reports

therapy non-responder200 reports

pneumonia135 reports

death129 reports

immune thrombocytopenia124 reports

pyrexia124 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ALVAIZ is a thrombopoietin receptor agonist 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. ( 1.1 ) 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. ( 1.2 ) for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3 ) Limitations of Use: ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without inter…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ALVAIZ is not substitutable with other eltrombopag products on a milligram per milligram basis. ( 2.1 ) Take ALVAIZ without a meal or with a meal low in calcium (≤ 50 mg). Take ALVAIZ at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements. ( 2.4 , 7.1 , 12.3 ) Persistent or Chronic ITP: Initiate ALVAIZ at 36 mg orally once daily for most adult and pediatric patients 6 years and older. Dose reductions are needed for patients with hepatic impairment and some patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L. Do not exceed 54 mg per day. ( 2.1 , 8.6 , 8.7 ) Chronic Hepatitis C-associated Thrombocytopenia: Initiate ALVAIZ at 18 mg orally once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 72 mg. ( 2.2 ) Refractory Severe Aplastic Anemia: Initiate ALVAIZ at 36 mg orally once daily. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain pl…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Polyvalent Cations (Chelation) Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium, and zinc) in foods, mineral supplements, and antacids. Take ALVAIZ at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, dairy products, and mineral supplements to avoid significant reduction in absorption of ALVAIZ due to chelation [see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 )] . 7.2 Transporters Use caution when concomitantly administering ALVAIZ and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 or BCRP and consider reduction of the dose of these drugs, if appropriate. In clinical tria…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions associated with ALVAIZ are described in other sections. Hepatic Decompensation in Patients with Chronic Hepatitis C [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia [see Warnings and Precautions ( 5.3 )] Thrombotic/Thromboembolic Complications [see Warnings and Precautions ( 5.4 )] Cataracts [see Warnings and Precautions ( 5.5 )] Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase increased, cough, fatigue, headache, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ALVAIZ has been establis…

Frequently Asked Questions

What is ALVAIZ used for?

ALVAIZ contains Eltrombopag. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is ALVAIZ a controlled substance?

ALVAIZ is not classified as a controlled substance by the DEA.

What is the generic name for ALVAIZ?

The generic name for ALVAIZ is Eltrombopag. There are 11 other brand versions of Eltrombopag.

What is the NDC code for ALVAIZ 54 mg/1?

The NDC (National Drug Code) for ALVAIZ 54 mg/1 is 0480-3276, listed by Teva Pharmaceuticals, Inc..

Product NDC

0480-3276

Package NDC

0480-3276-56

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