Naxitamab side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of DANYELZA?

DANYELZA may cause serious side effects, including: See " What is the most important information I should know about DANYELZA? " Swelling of the heart (myocarditis). Myocarditis has happened in adolescents ages 12 to 18 within days of receiving DANYELZA. Tell your healthcare provider if you get any signs or symptoms of myocarditis, including: chest pain shortness of breath irregular heartbeat or feel like your heart is racing High blood pressure (hypertension). High blood pressure is common in people who receive DANYELZA. Your blood pressure will be monitored during your DANYELZA infusion, and at least each day on Days 1 to 8 of each DANYELZA treatment cycle. […]

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥25%) are infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability ( 6.1 ).

Table 6. Adverse Reactions (>10%) in Patients with Refractory or Relapsed High-Risk Neuroblastoma in Bone or Bone Marrow Who Received DANYELZA with GM-CSF in Study 12-230

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are also described elsewhere in the labeling: Serious Infusion-Related Reactions [see Warnings and Precautions (5.1) ] Neurotoxicity [see Warnings and Precautions (5.2) ] Myocarditis [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Orthostatic Hypotension [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥25%) are infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability ( 6.1 ). The most common Grade 3 or 4 laboratory abnormalities (≥5%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc., Inc, at + 1-877-377-3784 , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

What do FAERS reports show?

241 reports list naxitamab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 84 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Hypotension (named in the label)65
• Pain63
• Hypertension (named in the label)33
• Off Label Use (a use or a product term, not a reaction)29
• Urticaria (named in the label)29
• Rash (named in the label)26
• Pyrexia (named in the label)23
• Bronchospasm (named in the label)17
• Oxygen Saturation Decreased17
• Hypoxia (named in the label)15
• Tachycardia (named in the label)15
• Abdominal Pain (named in the label)14
• Vomiting (named in the label)13
• Cough (named in the label)12
• Anaphylactic Reaction (named in the label)11
• Febrile Neutropenia11
• Dyspnoea (named in the label)10
• Hypersensitivity10
• Myelosuppression9
• Posterior Reversible Encephalopathy Syndrome9
• Anaphylactic Shock8
• Drug Ineffective (a use or a product term, not a reaction)8
• Neuroblastoma Recurrent8
• Nausea (named in the label)7
• Product Use In Unapproved Indication (a use or a product term, not a reaction)7

What next?

Naxitamab: the full record

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