Isavuconazonium side effects

What does the patient leaflet say about side effects?

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

CRESEMBA may cause serious side effects, including: • liver problems. Liver problems can happen in some people taking CRESEMBA. Some people who also have other serious medical problems may get severe liver problems which can lead to hepatitis, gallbladder problems, liver failure or death. Your or your child’s healthcare provider should do blood tests to check your liver before you start and while you are taking CRESEMBA. Call your or your child’s healthcare provider right away if you have any of the following symptoms of liver problems: o itchy skin o nausea or vomiting o yellowing of your eyes o feeling very tired o flu-like symptoms • infusion reactions. Infusion reactions can happen in people receiving CRESEMBA intravenously. If an infusion reaction happens, your or your child’s infusion will be stopped. […]

What does the label list?

From the label: adverse reactions

The most frequently reported adverse reactions among CRESEMBA-treated patients were nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (16%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%).

Table 3. Selected Adverse Reactions with Rates of 5% or Greater in CRESEMBA-treated Patients in Trial 1

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 are discussed in more detail in other sections of the labeling: • Hepatic Adverse Drug Reactions [see Warnings and Precautions ( 5.1 )] • Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 )] • Adult Patients: The most frequent adverse reactions in adult patients were nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, and back pain. ( 6.1 ) • Pediatric Patients: The most frequent adverse reactions in pediatric patients were diarrhea, abdominal pain, vomiting, elevated liver chemistry tests, rash, nausea, pruritus, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of CRESEMBA cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adult Patients A total of 403 adult patients were exposed to CRESEMBA in two clinical trials.

What do FAERS reports show?

3,649 reports list isavuconazonium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 739 are coded as a death and 1,183 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 18 reactions below, 10 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.

Reports received each year

• 250
• 575
• 238
• 269
• 269
• 208
• 249
• 253
• 363
• 517
• 401

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The 25 most reported reactions

• Off Label Use (a use or a product term, not a reaction)1,060
• Death (an outcome recorded in the report)327
• Nausea (named in the label)175
• Drug Ineffective (a use or a product term, not a reaction)151
• Febrile Neutropenia149
• Pyrexia142
• Pneumonia137
• Condition Aggravated (a use or a product term, not a reaction)126
• Fatigue (named in the label)118
• Diarrhoea (named in the label)108
• Dyspnoea (named in the label)104
• Drug Interaction (a use or a product term, not a reaction)98
• Vomiting (named in the label)91
• Disease Progression (a use or a product term, not a reaction)88
• Acute Kidney Injury86
• Product Use In Unapproved Indication (a use or a product term, not a reaction)85
• Platelet Count Decreased71
• Infection (named in the label)68
• Aspergillus Infection67
• Decreased Appetite (named in the label)66
• Headache (named in the label)66
• Neutropenia65
• Sepsis65
• Rash (named in the label)62
• Cough (named in the label)59

What next?

Isavuconazonium: the full record

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