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PATIENTS WITH NORMAL URIC ACID LEVELS MAY BE AT SIGNIFICANT RISK1

Relationship between uric acid level and development of TLS in patients with hematologic malignancies1*

Relationship between rising uric acid levels and incidence of TLS Relationship between rising uric acid levels and incidence of TLS

*Results from a retrospective analysis conducted to determine the relationship between uric acid levels and TLS in 1198 patients with a hematological malignancy who were admitted for inpatient chemotherapy.

Not all patients who are at risk for TLS have elevated uric acid levels before starting anticancer therapy2

Factors that put patients at increased risk of developing hyperuricemia and TLS include3-5:

  • Bulky disease
  • Elevated LDH
  • Lymph node involvement
  • Elevated creatinine levels
  • Bone marrow involvement
  • Elevated WBC count
  • Renal involvement or insufficiency

Certain anticancer agents have been associated with elevated uric acid or TLS6-20†

Ibrutinib Lenalidomide Bortezomib Carfilzomib
Brentuximab vedotin Ixazomib Cetuximab Doxorubicin HCl
Nilotinib Rituximab Dasatinib Omacetaxine
Pomalidomide Vincristine sulfate Thalidomide Bendamustine HCl
Imatinib Obinutuzumab Venetoclax Romidepsin
Ibrutinib
Brentuximab vedotin
Nilotinib
Pomalidomide
Imatinib
Lenalidomide
Ixazomib
Rituximab
Vincristine sulfate
Obinutuzumab
Bortezomib
Cetuximab
Dasatinib
Thalidomide
Venetoclax
Carfilzomib
Doxorubicin HCl
Omacetaxine
Bendamustine HCl
Romidepsin

LDH=lactate dehydrogenase; WBC=white blood cell.

This is not a comprehensive list of agents.

Components of the R-CHOP regimen.

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

  • Hypersensitivity Reactions: ELITEK can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.
  • Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.
  • Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.
  • Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.
  • Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions (ARs) regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most common ARs (≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).
  • Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with ELITEK alone and 1.1% of patients treated with the ELITEK plus oral allopurinol. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3‐4 ARs regardless of relationship to study drug in Study 4 (ELITEK alone; ELITEK plus oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.
  • The following serious ARs occurred with a difference in incidence of ≥2% in patients receiving ELITEK vs. oral allopurinol in Study 1 and Study 4: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

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