POSSIBLE benefits
Complete remission may be possible with Revuforj
Revuforj was studied in the AUGMENT-101 clinical trial, which included both adult and pediatric patients with acute leukemia with a KMT2A translocation whose disease had come back or had not improved after previous treatment(s)
A total of 135 people were treated with Revuforj
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104 were adults (≥17 years old)
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31 were pediatric (<17 years old)
A specific dose of Revuforj was given based on the person’s body weight
All doses were taken by mouth 2x a day
People continued taking Revuforj until they experienced side effects or worsening of their leukemia
The study was designed to measure the safety and effectiveness of Revuforj
135 people were included in
the trial’s safety population
135
104
104 of the 135 people met the criteria
to be evaluated for effectiveness
The youngest person was ~1 year old
and the oldest was 79 years old
Remission is the main goal of AML and ALL treatment
~1 in 5 people achieved CR + CRh with Revuforj
In the clinical trial, 21% of people (22 out of 104) achieved complete remission (CR) or complete remission with a partial hematologic recovery (CRh).
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CR=signs of acute leukemia are gone, and blood cell counts are back to normal
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CRh=signs of acute leukemia are gone but some blood cell counts did not fully return to normal
1
MONTH
Of the 22 people who achieved CR + CRh:
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Some responded in as early as 1 month
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Half responded within the first 2 months of treatment (median time to CR + CRh was 1.9 months; range=0.9 to 5.6 months)
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Half stayed in remission for more than 6.4 months
Revuforj helped some people achieve complete remission
Actor portrayal.
Actor portrayal.
Potential for transplant with Revuforj
23
%
(24 out of 104)
of the people in the trial went on to receive a
stem cell transplant
following treatment with Revuforj
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Revuforj will not work for everyone. Individual results may vary.
Side effects
What are the possible side effects?
Revuforj may cause serious side effects, including differentiation syndrome
Differentiation syndrome is a serious but common condition that affects your blood cells, which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 3 days and up to 41 days after starting Revuforj. Tell any healthcare provider caring for you that you are taking a medicine that can cause differentiation syndrome.
Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with Revuforj:
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fever
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cough
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shortness of breath
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severe headache
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confusion
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dizziness or lightheadedness
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fast weight gain
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swelling of arms, legs, neck,
groin, or underarm area -
decreased urination
Revuforj may also cause changes in electrical activity of your heart, called “QT prolongation”
QT prolongation is a serious but common side effect that can cause irregular heartbeats that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with Revuforj.
Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or if you feel your heart beating irregularly or fast during treatment with Revuforj.
Revuforj can harm your unborn baby
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Revuforj.
Females who are able to become pregnant:
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your healthcare provider will perform a pregnancy test within 7 days before you start treatment with Revuforj
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you should use effective birth control (contraception) during treatment with Revuforj and for 4 months after the last dose of Revuforj
Males who have female partners who are able to become pregnant:
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you should use effective birth control during treatment with Revuforj and for 4 months after the last dose of Revuforj
It is not known if Revuforj passes into your breast milk. Do not breastfeed during your treatment with Revuforj or for 1 week after your last dose of Revuforj.
Revuforj may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.
Talk to your healthcare provider about birth control methods you can use during this time
The most common side effects of Revuforj include:
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bleeding (hemorrhage)
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nausea and vomiting
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muscle pain
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infections, including bacterial and
viral infections -
low white blood cell counts with fever
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diarrhea
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changes in liver function tests
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swelling in the arms and legs
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decreased appetite
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constipation
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tiredness
Check out our Revuforj Ready page to find tips for staying ahead of side effects.