Tretinoin is indicated in combination with arsenic trioxide or chemotherapy for the treatment of patients with acute promyelocytic leukaemia (APL) which is newly diagnosed, relapsed or refractory to chemotherapy.
Combination of tretinoin with chemotherapy or arsenic trioxide is known to be effective and to induce very high rates of haematologic remission in patients with genetically confirmed APL, i.e. patients whose blasts harbor the t(15;17) by karyotyping or FISH or the PML-RARa fusion as detected by PCR. Thus, genetic confirmation of diagnosis is mandatory. Combination treatment with arsenic trioxide has been shown an effective treatment option in patients with newly diagnosed low-to-intermediate risk APL. However, because APL is characterized by high risk of early haemorrhagic death, current recommendations dictate that early treatment with tretinoin is started as soon as possible upon morphologic suspicion only.
For the selection of treatment strategy the relapse risk – indicated by pre-therapeutic white blood cell count (WBC) and platelet count (Sanz score) with high-risk (WBC>10 × 10^9^/L), intermediate risk (WBC≤10 × 109/L, platelet count ≤40 × 109/L), and low risk (WBC≤10x109/L, platelet count >40 × 109/L) - should be taken into consideration.
For this indication, competent medicine agencies globally authorize below treatments:
45 - 45 mg per m² of body surface area (BSA)
From 22.5 To 22.5 mg per m² of body surface area (BSA) 2 time(s) per day every day
For all therapy phases a total daily dose of 45 mg/m² body surface divided in two equal doses is recommended for oral administration to adult and elderly APL patients. This is approximately 8 capsules per adult dose.
It is recommended to take the capsules with a meal or shortly thereafter.
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