Arsenic Trioxide Phebra 1mg/ml
Concentrate for Solution for Infusion

Overview

  • Arsenic Trioxide Phebra is indicated for the treatment of low-intermediate risk acute promyelocytic leukaemia or APML (For full details please read the SmPC) .1  
  • Arsenic Trioxide Phebra is presented in a vial (10ml) which is made up as an infusion to be given intravenously.1
  • The active ingredient, arsenic trioxide, targets the specific genetic mutation that causes APML, killing the leukaemia cells that cause APML2
  • Arsenic trioxide-based treatment has been shown to be at least as effective as chemotherapy-based treatment in treating APML, but arsenic trioxide based treatment does not cause neutropenia and other toxicities associated with chemotherapy.3,4
  • The routine use of arsenic trioxide in combination with all-trans retinoic acid (ATRA) have made APML one of the most curable forms of acute leukaemia.4
  • Arsenic Trioxide Phebra is the first generic arsenic trioxide product in the UK5, and importantly the first arsenic trioxide product in a vial. At NHS/list price it is £220 per pack cheaper than the ampoule equivalent.6

Acute Promyelocytic Leukaemia (APML)

APML is a rare aggressive subtype of acute myeloid leukaemia, caused by a genetic mutation and characterized by a chromosomal translocation involving the retinoic acid receptor alpha gene (RAR-α), which leads to an abnormal accumulation of immature granulocytes called promyelocytes2 and a highly abnormal haematological status.2

APML is now highly curable4 with arsenic trioxide based therapy proven to offer 97% event free survival after 2 years.7

Arsenic trioxide’s true innovation lies in offering a chemotherapy-free treatment option to newly-diagnosed low-to intermediate-risk APML patients, allowing them to avoid short- and long-term toxicity associated with chemotherapy.3

NICE Guidance on Arsenic Trioxide and APML

The new standard approach to treating newly diagnosed patients with low-to-intermediate risk APML is to use all-trans retinoic acid (ATRA) in combination with arsenic trioxide (ATO), avoiding the use of traditional cytotoxic chemotherapy.4

  • NICE has recommended arsenic trioxide3 for inducing remission and consolidation in APML in adults with;
    • untreated, low-to-intermediate risk disease when given with ATRA.
    • relapsed or refractory disease, after a retinoid and chemotherapy.
  • ATRA with an anthracycline-based chemotherapy (usually idarubicin, a combination known as AIDA), has high toxicity compared to arsenic trioxide and ATRA.3,4,7
  • Clinical trial evidence shows that low-to-intermediate risk patients have superior outcomes when treated with ATRA plus ATO compared to AIDA.3,4,7

AIDA - all-trans retinoic acid and idarubicin

Arsenic Trioxide Phebra 1mg/ml Concentrate for Solution for Infusion Overview

Arsenic Trioxide Phebra is indicated1 for the induction of remission and consolidation in adult patients with:

  • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APML) (white blood cell count, ≤10 x 103/μl) in combination with all-trans retinoic acid (ATRA)
  • Relapsed/refractory acute promyelocytic leukaemia (APML); previous treatment should have included a retinoid and chemotherapy

Arsenic Trioxide Phebra is;

  • The first arsenic trioxide product available in a vial presentation
  • The only vial 1mg/ml presentation with licensed in-use stability of up to 72 hours at 2°C-8°C when made into an infusion bag
  • The only arsenic trioxide product with licensed in-use stability of up to 48 hours at 15°C-30°C when made into an infusion bag
© Flexipharm Austrading Ltd 2019
Date of Preparation: March 2020
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