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Alvaiz Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—14, 180
Manufacturer
Generic Availability
NO
Mechanism of Action
Eltrombopag is a molecule thrombopoietin (TPO)-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
Alvaiz Indications
Indications
Severe aplastic anemia in adults who have had insufficient response to immunosuppressive therapy.
Limitations of Use
Not indicated for the treatment of myelodysplastic syndromes (MDS).
Alvaiz Dosage and Administration
Adult
Swallow whole. Use lowest dose to achieve and maintain hematologic response. Take without a meal or with a meal low in calcium (≤50mg). Initially 36mg once daily. East-/Southeast-Asian ancestry or hepatic impairment: initially 18mg once daily. Adjust dose by 36mg increments every 2 weeks as needed to maintain platelet count ≥50×109/L; max 108mg/day. Monitoring, dose adjustment, and discontinuation: see full labeling.
Children
Not established.
Alvaiz Contraindications
Not Applicable
Alvaiz Boxed Warnings
Boxed Warning
Risk for hepatic decompensation in patients with chronic hepatitis C. Risk of hepatotoxicity.
Alvaiz Warnings/Precautions
Warnings/Precautions
Not substitutable with other eltrombopag products on a milligram per milligram basis. Increased risk of hepatic decompensation in patients with chronic hepatitis C in combination with interferon and ribavirin; discontinue Alvaiz if antiviral therapy is discontinued. Increased risk of severe hepatotoxicity; monitor liver function prior to initiation, every 2 weeks during dose adjustments, and monthly after stabilized; discontinue if ALT ≥3×ULN in those with normal liver function or ≥3× baseline (or >5×ULN, whichever is lower) in those with pre-treatment transaminase elevations and are progressive or persistent for ≥4 weeks, or if occurs with increased bilirubin, or symptoms/evidence of hepatic injury/decompensation; reinitiate therapy if benefit outweighs risk; if restarted, monitor carefully. Increased risk of death and progression of MDS to acute myeloid leukemia. Increased risk of thromboembolism in those with risk factors (eg, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, chronic liver disease); do not use to normalize platelet counts. Do baseline eye exam; monitor for cataracts. Asian ancestry. Advise females of reproductive potential to use effective contraception during and for ≥7 days after stopping treatment. Pregnancy. Nursing mothers: not recommended.
Alvaiz Pharmacokinetics
Distribution
Plasma protein bound: >99%.
Elimination
Fecal (59%); renal (31%). Half-life: ~21–32 hours (in healthy subjects); and 26–35 hours (in patients with ITP).
Alvaiz Interactions
Interactions
Potentiates substrates of OATP1B1 (eg, most statins, bosentan, ezetimibe, glyburide, olmesartan, valsartan, repaglinide, rifampin) or BCRP (eg, imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, sulfasalazine, topotecan); monitor and consider reducing their doses. Separate dosing by at least 2hrs before or 4hrs after food/drugs containing polyvalent cations (eg, Fe+2, Ca+2, Al+3, Mg+2, Se+2, Zn+2).
Alvaiz Adverse Reactions
Adverse Reactions
Anemia, nausea, pyrexia, increased ALT, cough, fatigue, headache, diarrhea; hepatotoxicity, thrombotic/thromboembolic complications, cataracts.
Alvaiz Clinical Trials
See Literature
Alvaiz Note
Not Applicable
Alvaiz Patient Counseling
See Literature
Alvaiz Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—14, 180
Manufacturer
Generic Availability
NO
Mechanism of Action
Eltrombopag is a molecule thrombopoietin (TPO)-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
Alvaiz Indications
Indications
Thrombocytopenia in adult and pediatric patients ≥6years with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Should be used only in ITP patients whose degree of thrombocytopenia and clinical condition increase the risk of bleeding. Thrombocytopenia in adults with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy. Should be used only in chronic hepatitis C patients whose degree of thrombocytopenia prevents starting or limiting ability to maintain interferon-based therapy.
Limitations of Use
Not indicated for the treatment of myelodysplastic syndromes (MDS). Safety and efficacy not established in combination with direct-acting antiviral agents without interferon for chronic hepatitis C infection.
Alvaiz Dosage and Administration
Adults and Children
Swallow whole. Use lowest dose to achieve and maintain hematologic response. Take without a meal or with a meal low in calcium (≤50mg). ITP: <6yrs: not established; ≥6yrs: initially 36mg once daily. East-/Southeast-Asian ancestry or hepatic impairment: initially 18mg once daily. East-/Southeast-Asian ancestry with hepatic impairment: consider initiating at 9mg once daily. Adjust dose to maintain platelet count ≥50×109/L; max 54mg daily. Chronic hepatitis C-associated thrombocytopenia: initially 18mg once daily. Adjust dose by 18mg increments every 2 weeks as needed to achieve target platelet counts; max 72mg/day. Monitoring, dose adjustment, and discontinuation: see full labeling.
Alvaiz Contraindications
Not Applicable
Alvaiz Boxed Warnings
Boxed Warning
Risk for hepatic decompensation in patients with chronic hepatitis C. Risk of hepatotoxicity.
Alvaiz Warnings/Precautions
Warnings/Precautions
Not substitutable with other eltrombopag products on a milligram per milligram basis. Increased risk of hepatic decompensation in patients with chronic hepatitis C in combination with interferon and ribavirin; discontinue Alvaiz if antiviral therapy is discontinued. Increased risk of severe hepatotoxicity; monitor liver function prior to initiation, every 2 weeks during dose adjustments, and monthly after stabilized; discontinue if ALT ≥3×ULN in those with normal liver function or ≥3× baseline (or >5×ULN, whichever is lower) in those with pre-treatment transaminase elevations and are progressive or persistent for ≥4 weeks, or if occurs with increased bilirubin, or symptoms/evidence of hepatic injury/decompensation; reinitiate therapy if benefit outweighs risk; if restarted, monitor carefully. Increased risk of death and progression of MDS to acute myeloid leukemia. Increased risk of thromboembolism in those with risk factors (eg, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, chronic liver disease); do not use to normalize platelet counts. Do baseline eye exam; monitor for cataracts. Asian ancestry. Advise females of reproductive potential to use effective contraception during and for ≥7 days after stopping treatment. Pregnancy. Nursing mothers: not recommended.
Alvaiz Pharmacokinetics
Distribution
Plasma protein bound: >99%.
Elimination
Fecal (59%); renal (31%). Half-life: ~21–32 hours (in healthy subjects); and 26–35 hours (in patients with ITP).
Alvaiz Interactions
Interactions
Potentiates substrates of OATP1B1 (eg, most statins, bosentan, ezetimibe, glyburide, olmesartan, valsartan, repaglinide, rifampin) or BCRP (eg, imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, sulfasalazine, topotecan); monitor and consider reducing their doses. Separate dosing by at least 2hrs before or 4hrs after food/drugs containing polyvalent cations (eg, Fe+2, Ca+2, Al+3, Mg+2, Se+2, Zn+2).
Alvaiz Adverse Reactions
Adverse Reactions
Anemia, nausea, pyrexia, increased ALT, cough, fatigue, headache, diarrhea; hepatotoxicity, thrombotic/thromboembolic complications, cataracts.
Alvaiz Clinical Trials
See Literature
Alvaiz Note
Not Applicable
Alvaiz Patient Counseling
See Literature
