All-trans retinoic acid (Tretinoin)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ATRA |
|---|---|
| Type | Drug |
| Aliases | ATRAAll-trans retinoic acidTretinoinVesanoidТретиноїн (ATRA) |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-APL |
| Sources | SRC-APL0406-LOCOCO-2013 SRC-ELN-APL-2019 SRC-NCCN-AML-2025 |
Drug Facts
| Class | Retinoid (vitamin A derivative); differentiation agent |
|---|---|
| Mechanism | Binds retinoic-acid receptor α (RARα) and degrades the PML-RARα fusion oncoprotein in APL → forces blast differentiation rather than killing. Cornerstone of every APL induction regimen. |
| Typical dosing | APL: 45 mg/m²/day PO divided BID until complete remission (typically ~30-50 days). Continue per consolidation/maintenance protocol. Initiate IMMEDIATELY at clinical APL suspicion (don't wait for cytogenetic confirmation) — mortality from bleeding > from leukemia in first 7 days. |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- Differentiation syndrome (formerly RA-syndrome) — fever, dyspnea, weight gain, pulmonary infiltrates, hypotension; potentially fatal; treat with dexamethasone 10 mg IV BID
- Leukocytosis — high WBC at diagnosis predicts higher DS risk; prophylactic steroids if WBC >5K (low-risk) or >10K (high-risk)
- Teratogenicity — pregnancy must be excluded
Notes
Initiate ATRA at clinical APL suspicion based on smear findings + DIC pattern, BEFORE PML-RARα confirmation — early death from bleeding is the dominant APL mortality. Differentiation-syndrome prophylaxis with dexamethasone 10 mg IV BID for high-risk (WBC >10K) or rising WBC. Pregnancy-test gating + 2 forms of contraception mandatory.
Used By
Regimens
REG-ATRA-ATO-APL- ATRA + Arsenic Trioxide (APL low/intermediate-risk) — APL0406 / LO-CoCo scheduleREG-ATRA-ATO-APL-SALVAGE- ATRA + ATO salvage for R/R APL post front-lineREG-ATRA-ATO-IDA-APL- ATRA + ATO + Idarubicin (APL high-risk) — modified APL0406 / AIDA-styleREG-GEMTUZUMAB-APL- Gemtuzumab ozogamicin for relapsed APL with maintenance