Remission, right where you belong
Remission or complete remission means that all signs of cancer have disappeared in response to treatment, but there may be some skin abnormalities that remain.
CLINICAL TRIAL RESULTS
DECNUPAZ helped many people with BPDCN achieve remission, without the need for a hospital stay for infusion*
*For full treatment experience information, such as premedication and monitoring information, see How DECNUPAZ Is Given.
To better understand the clinical trial results with DECNUPAZ, first consider these general terms relating to BPDCN. Remission or complete remission means that all signs of cancer have disappeared in response to treatment, but there may be some skin abnormalities that remain.
A clinical trial that included a variety of BPDCN patients
In the clinical trial, DECNUPAZ was given to 84 people living with BPDCN:
33 people received DECNUPAZ as a first treatment†
- 22 were newly diagnosed with BPDCN as their first and only blood cancer
- 11 were newly diagnosed with BPDCN but also have another or previously had another blood cancer
51 people either relapsed after a previous treatment or did not respond to previous treatment such as chemotherapy or another targeted therapy‡
†With no central nervous system involvement.
‡Can include people with BPDCN with central nervous system involvement that was previously treated.
In the clinical trial, the majority of people reached remission when DECNUPAZ was used as their first treatment
In all people who received DECNUPAZ as their first treatment for BPDCN
70%
(23 out of 33 people)
achieved complete remission
Of the people who achieved complete remission, half were estimated to still remain in remission for at least 9.7 months
49% (16 out of 33 people) achieved complete remission with no skin abnormalities remaining
21% (7 out of 33 people) achieved complete remission with some skin abnormalities remaining
~
4
out
of
10
(13 out of 33 people)
people went on to receive a stem cell transplant after DECNUPAZ treatment
DECNUPAZ helped some people with BPDCN who relapsed after a previous treatment or did not respond to previous treatment achieve remission
In all people with previously treated BPDCN
16%
(8 out of 51 people)
achieved complete remission
Of the people who achieved complete remission, half were estimated to still remain in remission for at least 9.2 months
14% (7 out of 51 people) achieved complete remission with no skin abnormalities remaining
2% (1 out of 51 people) achieved complete remission with some skin abnormalities remaining
12%
(6 out of 51 people)
went on to receive a stem cell transplant after DECNUPAZ treatment
SIDE EFFECTS & MANAGEMENT
What to know about side effects
It is important to pay attention to how you feel and talk to your healthcare team right away about any discomfort or change in the way you are feeling, especially if having symptoms.
DECNUPAZ can cause serious side effects, including:
Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver) that can be severe, life-threatening, or may lead to death
Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including:
- yellowing of the skin or eyes
- pain in your stomach (abdomen)
- fast weight gain
- swelling of your stomach
- dark urine
Your healthcare provider will check you for liver problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also delay or stop treatment with DECNUPAZ if you have severe liver problems.
Infusion-related reactions (IRR)
DECNUPAZ can cause serious, life-threatening infusion-related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion of DECNUPAZ to help reduce infusion-related reactions. Your healthcare provider will check you for symptoms of infusion-related reactions during your infusion and for at least four hours or longer if needed, after your first infusion, and for at least one hour after each of your next infusions. Tell your healthcare provider right away if you develop signs or symptoms of infusion-related reactions, including:
Fluid retention (edema)
DECNUPAZ can cause your body to hold too much fluid during treatment. Your healthcare provider may prescribe water pills (diuretic) if you develop edema. Tell your healthcare provider if you develop new or worsening edema, including:
- swelling of your ankles or legs
- shortness of breath or difficulty breathing
- unusual weight gain
Sulfite allergic reactions
DECNUPAZ contains sodium metabisulfite, a sulfite that may cause severe, life-threatening allergic reactions in some people. Sulfite allergic reactions are more common in people with asthma than in people without asthma. Get medical help right away if you develop hives; itching; rash; swelling of the eyes, tongue, or lips; chest pain; or trouble breathing or swallowing.
Getting medical treatment right away is important. Your healthcare provider will check you for these problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, delay, or completely stop treatment with DECNUPAZ if you have severe side effects.
Most common side effects include:
- Fluid retention (edema)
- Bleeding
- Feeling tired
- Infusion-related reactions
- Muscle, bone, and joint pain
- Nausea
- Diarrhea
Most common severe abnormal laboratory test results with DECNUPAZ include:
- Decreased white blood cell counts
- Decreased red blood cell counts
- Decreased platelet counts
- Increased blood sugar level
These are not all of the possible side effects of DECNUPAZ. Call your healthcare provider for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.
Your guide to treatment and caring for a loved one
Whether you are beginning treatment yourself or supporting someone who is, you can learn more about treatment and what it means for you with these brochures.
Patient Brochure
If you are starting DECNUPAZ, this brochure will guide you through what to expect and help you feel supported every step of the way.
Caregiver Brochure
If you are caring for a loved one starting DECNUPAZ, this brochure will help you understand your role, find support, and care for yourself as you care for your loved one.
BPDCN=blastic plasmacytoid dendritic cell neoplasm