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tretinoin
generic
Black Box Warnings .
Appropriate Use
weigh benefit vs. known adverse effects; admin. only by physician experienced in acute leukemia tx in adequate medical facility to manage complications
Retinoic Acid-APL Syndrome
occurs in 1st month of tx, possible after 1st dose; occurs in 25% of pts; incl. fever, dyspnea, acute resp. distress, weight gain, pulmonary infiltrates on x-ray, pleural and pericardial effusion, edema, and hepatic, renal, and multi-organ failure; may also incl. impaired myocardial contractility, episodic hypotension, and leukocytosis; at 1st signs give dexamethasone 10 mg IV q12h x3 days or until sx resolve; cont. tretinoin tx in most pts, but may hold tx if mod-severe retinoic acid-APL syndrome
Leukocytosis
rapidly evolving leukocytosis assoc. w/ high risk of life-threatening complications occurs in 40% of pts, incr. risk if baseline WBC >5000; start high-dose steroids immediately if retinoic acid-APL syndrome s/sx also present; addition of chemotherapy can decr. incidence of retinoic acid-APL syndrome if baseline WBC >5000 or baseline leukopenia w/ rapid incr. in WBC count on tretinoin tx; see pkg insert for chemo timing based on WBC count
Teratogen
high risk of severe fetal deformities; fully inform pregnant women or those of child-bearing potential of fetal risk, contraception failure risk, must use 2 reliable forms of contraception during and x1mo after D/C tx; must have negative pregnancy test <1wk prior to tx start, or if unable to delay may start tx w/ 2 reliable forms of contraception; cont. pregnancy testing and contraception counseling qmo during tx
Adult Dosing .
Dosage forms: CAP: 10 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
APL, relapsed or refractory
- [22.5 mg/m^2/dose PO bid]
- Info: for induction tx; D/C 30 days after remission or give up to 90 days; concomitant differentiation syndrome prophylaxis recommended for pts w/ WBC >10,000
APL, newly diagnosed (off-label)
- [induction tx]
- Dose: 22.5 mg/m^2/dose PO bid up to 60 days; Info: for low-risk dz; use w/ arsenic trioxide; concomitant differentiation syndrome prophylaxis recommended for pts w/ WBC >10,000
- [consolidation tx]
- Dose: 22.5 mg/m^2/dose PO bid on days 1-14, 29-42 of 56-day cycle x3 cycles, then on days 1-14 of 56-day cycle for cycle 4; Info: for low-risk dz; use w/ arsenic trioxide
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: CAP: 10 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
APL, relapsed or refractory
- [1 yo and older]
- Dose: 22.5 mg/m^2/dose PO bid; Info: for induction tx; D/C 30 days after remission or give up to 90 days; concomitant differentiation syndrome prophylaxis recommended for pts w/ WBC >10,000
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]