Elzonris

Last updated on RxList: 1/2/2019
Elzonris Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/2/2019

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. Common side effects of Elzonris include:

Administer Elzonris intravenously at a dose of 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle. Elzonris may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Elzonris; it may harm a fetus. Because of the potential for serious adverse reactions in breastfed children, breastfeeding is not recommended while using Elzonris and for 1 week after the last dose.

Our Elzonris (tagraxofusp-erzs) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow
Elzonris Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; mouth sores; sudden warmth or tingly feeling; difficult breathing; swelling of your face, lips, tongue, or throat.

Capillary leak syndrome is a serious side effect of tagraxofusp. Call your doctor right away if you have a stuffy or runny nose followed by:

  • tiredness or dizziness;
  • thirst;
  • decreased urination;
  • trouble breathing; and
  • sudden swelling or weight gain.

Common side effects may include:

  • capillary leak syndrome;
  • nausea;
  • tiredness;
  • swelling in your hands or feet;
  • fever; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Elzonris (Tagraxofusp-erzs Injection)

Elzonris Professional Information

SIDE EFFECTS

The following serious adverse drug reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety of ELZONRIS was assessed in a single-arm clinical trial that included 94 adults with newly-diagnosed or relapsed/refractory myeloid malignancies, including 58 with BPDCN, treated with ELZONRIS 12 mcg/kg daily for 5 days of a 21-day cycle. The overall median number of cycles administered was 2 (range, 1-43), and 4 in patients with BPDCN (range, 1-43).

Two (2%) patients had fatal adverse reaction, both capillary leak syndrome. Overall, 10 (11%) patients discontinued treatment with ELZONRIS due to an adverse reaction; the most common adverse reactions resulting in treatment discontinuation were hepatic toxicities and CLS.

Table 3 summarizes the common (≥10%) adverse reactions with ELZONRIS in patients with myeloid malignancies. The rate of any given adverse reaction or lab abnormality was derived from all the reported events of that type.

Table 3: Adverse Reactions in ≥10% of Patients Receiving 12 mcg/kg of ELZONRIS

  N=94
All Grades % Grade ≥ 3 %
Vascular disorders
Capillary leak syndrome1 55 9
Hypotension 29 9
Hypertension 15 6
Gastrointestinal disorders
Nausea 49 0
Constipation 23 0
Vomiting 21 0
Diarrhea 20 0
General disorders and administration site conditions
Fatigue 45 7
Peripheral edema 43 1
Pyrexia 43 0
Chills 29 1
Investigations
Weight increase 31 0
Nervous system disorders
Headache 29 0
Dizziness 20 0
Metabolism and nutrition disorders
Decreased appetite 24 0
Blood and lymphatic system disorders
Febrile neutropenia 20 18
Musculoskeletal and connective tissue disorders
Back pain 20 2
Pain in extremity 10 2
Respiratory, thoracic and mediastinal disorders
Dyspnea 19 2
Cough 14 0
Epistaxis 14 1
Oropharyngeal pain 12 0
Psychiatric disorders
Insomnia 17 0
Anxiety 15 0
Confusional state 11 0
Cardiac disorders
Tachycardia 17 0
Skin and subcutaneous tissue disorders
Petechiae 10 0
Pruritus 10 0
Renal and urinary disorders
Hematuria 10 0
1 Capillary leak syndrome defined as any event reported as CLS during treatment with ELZONRIS or the occurrence of at least 2 of the following CLS manifestations within 7 days of each other: hypoalbuminemia (including albumin value less than 3.0 g/dL), edema (including weight increase of 5 kg or more), hypotension (including systolic blood pressure less than 90 mmHg).

Table 4 summarizes the clinically-important laboratory abnormalities that occurred in ≥10% patients with myeloid malignancies treated with ELZONRIS.

Table 4: Selected Laboratory Abnormalities in Patients Receiving 12 mcg/kg of ELZONRIS

  Treatment-Emergent Laboratory Abnormalities
All Grades % Grade ≥ 3 %
Hematology
Platelets decrease 67 53
Hemoglobin decrease 60 35
Neutrophils decrease 37 31
Chemistry
Glucose increase 87 20
ALT increase 82 30
AST increase 79 37
Albumin decrease 77 0
Calcium decrease 57 2
Sodium decrease 50 10
Potassium decrease 39 4
Phosphate decrease 30 11
Creatinine increase 27 0
Alkaline phosphatase increase 26 1
Potassium increase 21 2
Magnesium decrease 20 0
Magnesium increase 14 3
Bilirubin increase 14 0
Glucose decrease 11 0
Sodium increase 10 0

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ELZONRIS with the incidences of antibodies to other products may be misleading.

Immune response to ELZONRIS was evaluated by assessment of serum binding reactivity against ELZONRIS (anti-drug antibodies; ADA) and neutralizing antibodies by inhibition of functional activity. Immune response to ELZONRIS was assessed using two immunoassays. The first assay detected reactivity directed against ELZONRIS (ADA), and the second assay detected reactivity against the interleukin-3 (IL-3) portion of ELZONRIS. Two cell-based assays were used to investigate the presence of neutralizing antibodies by inhibition of a cell-based functional activity.

The presence of ADA had a clinically significant effect on the pharmacokinetics of tagraxofusp-erzs [see CLINICAL PHARMACOLOGY]. In 130 patients treated with ELZONRIS in 4 clinical trials:

  • 96% (115/120) of patients evaluable for the presence of pre-existing ADA at baseline before treatment were confirmed positive with 21% being positive for the presence of neutralizing antibodies. The high prevalence of ADA at baseline was anticipated due to diphtheria immunization.
  • 99% (107/108) of patients evaluable for treatment-emergent ADA tested positive with most patients showing an increase in ADA titer by the end of Cycle 2 of ELZONRIS.
  • 85% (86/101) of ADA-positive patients evaluable for the presence of neutralizing antibodies were neutralizing antibody-positive.
  • 68% (73/108) of patients evaluable for treatment-emergent anti-IL-3 antibodies tested positive with most patients testing positive by Cycle 3 of ELZONRIS.

Read the entire FDA prescribing information for Elzonris (Tagraxofusp-erzs Injection)

© Elzonris Patient Information is supplied by Cerner Multum, Inc. and Elzonris Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors