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
- all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements
You can report any side effects to Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full , including Boxed WARNING, for ELZONRIS to learn more.
The risk information provided here is not comprehensive. To learn more, talk about
ELZONRIS (tagraxofusp-erzs) with your healthcare provider or pharmacist. The FDA-approved product labeling can be found on this website.