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