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Alvaiz
eltrombopag
Black Box Warnings .
Hepatic Decompensation Risk
use w/ interferon and ribavirin may incr. risk of hepatic decompensation in chronic hepatitis C pts
Hepatotoxicity
incr. risk of severe and potentially life-threatening hepatotoxicity; in pts w/ persistent or chronic ITP, chronic HCV-associated thrombocytopenia, and refractory severe aplastic anemia, monitor ALT, AST, bilirubin at baseline, q2wk during dose adjustments until stable dose established, then qmo; if bilirubin elevated, perform fractionation and repeat LFTs w/in 3-5 days, if abnormalities confirmed, monitor LFTs qwk until resolved or stabilized; in pts w/ baseline normal liver function, D/C tx if ALT >3x ULN; in pts w/ baseline elevated ALT/AST, D/C tx if ALT >3x baseline or >5x ULN (whichever is lower) and are progressively increasing, persistent >4wk, or accompanied by incr. direct bilirubin or clinical s/sx of hepatic injury/hepatic decompensation
Adult Dosing .
Dosage forms: TAB: 9 mg, 18 mg, 36 mg, 54 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ other eltrombopag products; do not substitute on a mg to mg basis
ITP, persistent or chronic
- [36-54 mg PO qd]
- Start: 36 mg PO qd; Max: 54 mg/day; Info: for pts w/ risk of bleeding who had insufficient response to corticosteroids, immunoglobulins, or splenectomy; give on empty stomach or w/ low calcium meal, give 2h before or 4h after calcium-rich foods; do not cut/crush/chew tab; use lowest effective dose to maintain Plt >50,000; see pkg insert for dose adjustments; D/C if no incr. in Plt after 4wk at max dose; start 18 mg PO qd in pts of East/Southeast Asian ancestry (risk of incr. drug levels)
thrombocytopenia, chronic hepatitis C-associated
- [18-72 mg PO qd]
- Start: 18 mg PO qd; Max: 72 mg/day; Info: give on empty stomach or w/ low calcium meal, give 2h before or 4h after calcium-rich foods; do not cut/crush/chew tab; incr. dose q2wk to the lowest effective dose to maintain Plt necessary to initiate and maintain interferon-based antiviral tx; see pkg insert for dose adjustments; D/C when antiviral tx D/C
aplastic anemia, refractory severe
- [36-108 mg PO qd]
- Start: 36 mg PO qd; Max: 108 mg; Info: give on empty stomach or w/ low calcium meal, give 2h before or 4h after calcium-rich foods; do not cut/crush/chew tab; incr. dose q2wk to the lowest effective dose to maintain Plt >50,000; see pkg insert for dose adjustments; D/C if no hematologic response after 16wk; start 18 mg PO qd in pts of East/Southeast Asian ancestry (risk of incr. drug levels)
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [persistent or chronic ITP]
- Child-Pugh Class A, B, or C: start 18 mg qd; start 9 mg qd in pts of East/Southeast Asian ancestry (risk of incr. drug levels); Info: may incr. dose no more frequently than q3wk
- [chronic hepatitis C-associated thrombocytopenia]
- hepatic impairment: no adjustment
- [severe aplastic anemia]
- Child-Pugh Class A, B, or C: start 18 mg qd
Peds Dosing .
- Dosage forms: TAB: 9 mg, 18 mg, 36 mg, 54 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ other eltrombopag products; do not substitute on a mg to mg basis
ITP, persistent or chronic
- [6 yo and older]
- Dose: 36-54 mg PO qd; Start: 36 mg PO qd; Max: 54 mg/day; Info: for pts w/ risk of bleeding who had insufficient response to corticosteroids, immunoglobulins, or splenectomy; give on empty stomach or w/ low calcium meal, give 2h before or 4h after calcium-rich foods; do not cut/crush/chew tab; use lowest effective dose to maintain Plt >50,000; see pkg insert for dose adjustments; D/C if no incr. in Plt after 4wk at max dose; start 18 mg PO qd in pts of East/Southeast Asian ancestry (risk of incr. drug levels)
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: start 18 mg qd; start 9 mg qd in pts of East/Southeast Asian ancestry (risk of incr. drug levels); Info: may incr. dose no more frequently than q3wk