Generic Name: tagraxofusp-erzs
Trade Name: Elzonris®
For which conditions is Elzonris approved for? Elzonris is indicated for the treatment of adults and children 2 years or older with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and/or life-threatening side effects of capillary leak syndrome (CLS).
What is the mechanism of action? Elzonris works by causing cell death in CD123-expressing cells.
How is Elzonris typically given (administered)? Elzonris is administered intravenously on days 1 through 5, every 21 days.
How are patients typically monitored? During treatment with Elzonris, at a minimum your healthcare provider will do blood tests to check your blood counts and liver function tests as well as monitor you for signs or symptoms of CLS. Elzonris may harm an unborn baby. Do not breastfeed during treatment with Elzonris and for at least 1 week after the last dose of Elzonris.
What are the common (occur in 30% or more of patients) side effects of treatment with Elzonris?
- Capillary leak syndrome
- Peripheral edema
- Weight increase
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Elzonris and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions and tell your doctor if you or your partner are pregnant or are planning on becoming pregnant and if you are breastfeeding. Elzonris may cause serious side effects.
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When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. You should also contact your healthcare provider if you experience hypersensitivity reactions including rash, flushing, wheezing or swelling of the face.
ELZONRIS may cause severe or life-threatening side effects from CLS and it is important that you weigh yourself every day and call your healthcare provider right away if you experience any of the following symptoms:
· New or worsening swelling
· Weight gain
· Shortness of breath
· Hypotension after infusion
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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