What should I know before starting ELZONRIS?
Before you begin treatment
- You will receive medicines about an hour before each ELZONRIS treatment to help reduce possible side effects of ELZONRIS. Talk to your treatment team if you have questions about these medicines
- Your treatment team will take your blood for routine tests before each dose. This will also help them see how your blood, liver, and kidneys are working during treatment
- Your treatment team will also check your weight and vital signs before each dose. Vital signs are blood pressure, heart rate, temperature, and breathing rate
Tell your treatment team about:
During treatment with ELZONRIS
Through a needle in your vein (IV infusion)
Each dose will take 15 minutes
Your dose of ELZONRIS is based on your weight
Each cycle of ELZONRIS treatment is 21 days
You will receive ELZONRIS daily on days 1 to 5 of each treatment cycle. Your healthcare provider may decide to extend this dosing period up to day 10 of the treatment cycle.
- Your healthcare provider may delay a dose if your blood test or vital signs show that it would be safer to wait. They may also decide if it is safer to skip a dose
- You will have at least 11 days without treatment
Your doctor will then decide if and when you may receive another 21-day cycle of treatment.
You will receive your first cycle of treatment in the hospital.
- Your treatment team will monitor your reaction to ELZONRIS for 24 hours after the last dose of cycle 1
Treatment cycle 2 and all additional treatment cycles may be in the hospital or at an outpatient clinic.
- Your treatment team should observe you for 4 hours after each dose
Keep all of your medical appointments
As with any medicine, it is important to follow the schedule set by your healthcare provider. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
Get emergency medical help immediately if you develop any of the following symptoms
- Fast weight gain
- Swelling of your face, arms, hands, legs, or feet
- Shortness of breath
- Low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)
Watching your weight
Your weight gives your treatment team important information during your treatment. Fast weight gain can be a sign of capillary leak syndrome (CLS), a serious side effect.
- Weigh yourself daily, and write down your weight every day
- Weigh yourself at the same time every morning, without clothes, with the scale on a hard surface
About ELZONRIS® (tagraxofusp-erzs)
ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.
IMPORTANT SAFETY INFORMATION
ELZONRIS can cause serious side effects, including:
Capillary Leak Syndrome (CLS). ELZONRIS can cause fluid to leak from small blood vessels into your body's tissues. This is called “Capillary Leak Syndrome.” CLS can quickly cause you to have symptoms that may become life-threatening or fatal (ie, lead to death). Get emergency medical help immediately if you develop any of the following symptoms:
- fast weight gain
- swelling of your face, arms, hands, legs, or feet
- shortness of breath or difficulty breathing
- low blood pressure (dizziness or lightheadedness, headache, feeling tired, or shortness of breath)
Your healthcare provider will check your weight and test your blood before you receive each dose of ELZONRIS and as needed during treatment.
- Hypersensitivity reactions may occur with ELZONRIS. Symptoms may include rash, itching (pruritus), wheezing, or swelling in your face, including around your eyes and/or in and around your mouth
- Liver damage is usually detected through blood tests. Symptoms may include feeling tired (fatigue), loss of appetite, yellowing of your skin or the whites of your eyes (jaundice), or upper right abdominal pain or discomfort
Your healthcare provider will periodically test your blood while you are on ELZONRIS to check for liver damage.
Contact your healthcare provider immediately if you have any of these symptoms.
Getting medical treatment right away may help keep these problems from becoming more serious.
If you have any side effects during treatment with ELZONRIS, your healthcare provider may hold your treatment for a period of time or completely stop your treatment with ELZONRIS.
The most common side effects of ELZONRIS include CLS, nausea, feeling tired (fatigue), swelling in your legs or feet, fever, and weight gain.
These are not all of the possible side effects of ELZONRIS. If any new side effects start or an existing one gets worse, contact your healthcare provider immediately. For more information, talk to your treatment team.
Be sure to tell your treatment team about:
- all of your medical conditions, including if you
are pregnant or plan to become pregnant. ELZONRIS may harm your unborn baby
- If you are a female who can become pregnant, you should use effective birth control during ELZONRIS treatment and for at least 1 week after the last dose
- Tell your healthcare provider right away if you become pregnant during treatment with ELZONRIS
- are breastfeeding or plan to breastfeed. It is not known if ELZONRIS passes into breast milk. You and your healthcare provider should decide if you will receive ELZONRIS or breastfeed. You should not do both
- are pregnant or plan to become pregnant. ELZONRIS may harm your unborn baby
- all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements
Please see full Prescribing Information, including Boxed WARNING, for ELZONRIS to learn more.