For U.S. Healthcare
Professionals Only
ELITEK is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

ELITEK is the Only Agent Proven to Maintain Normal Uric Acid Levels in Significantly More Patients vs allopurinol

graph showing plasma uric response rate during the 3 to 7 day post baseline period (primary endpoint).
13%missing uric acid samples were the only reason for nonresponse in the ELITEK arm.1

15% missing samples for ELITEK- allopurinol1

19% missing samples for allopurinol1

The uric acid failure status in those patients is unknown.

ELITEK Was Validated in a Pivotal Trial to Protect Patients From Rising Uric Acid Levels1

Study Design: randomized, multicenter, open-label study in patients with leukemia, lymphoma, and/or solid tumor malignancies at risk for hyperuricemia and TLS.1

Patients were eligible for the study if they were either at high risk or potential (intermediate) risk for TLS1

82%
of patients were nonhyperuricemic (uric acid levels >7.5 mg/dL) at baseline.2
18%
of patients were hyperuricemic (uric acid levels >7.5 mg/dL) at baseline.2

3 Study Arms: patients in Arm A received ELITEK for 5 days (n=92). Patients in Arm B received ELITEK from day 1 through day 3 followed by oral allopurinol from day 3 through day 5 (overlap on day 3: ELITEK and allopurinol administered approximately 12 hours apart) (n=92). Patients in Arm C received oral allopurinol for 5 days (n=91).1

Primary Endpoint: response rate defined as percentage of patients with plasma uric acid levels maintained at ≤7.5 mg/dL between day 3 and day 7, after initiation of antihyperuricemic treatment.1

Treating your patients with ELITEK prior to initiating anticancer treatments may protect against elevated uric acid levels.1

PRIOR TO INITIATION OF ANTI-CANCER TREATMENT,

96% of Patients Receiving ELITEK Achieved Uric Acid Levels ≤2 mg/dL at 4 Hours After the First Dose1

graph showing patients' uric acid levels after receiving ELITEK® within 4 hours of the first dose on days 1 through 7.

* Plasma uric acid AUC from day 1 through day 7 was significantly lower for ELITEK and ELITEK + allopurinol

• ELITEK monotherapy and ELITEK + allopurinol reduced uric acid levels by 88% by hour 4 vs allopurinol monotherapy uric acid reduction of 14%2

POST ANTI-CANCER TREATMENT INITIATION,

ELITEK Sustained Uric Acid Levels ≤7.5 mg/dL in Significantly More Patients vs allopurinol1

Plasma uric acid response rate graph showing patients sustained uric acid levels after receiving ELITEK®.
13%missing uric acid samples were the only reason for nonresponse in the ELITEK arm.1

15% missing samples for ELITEK- allopurinol1

19% missing samples for allopurinol1

The uric acid failure status in those
patients is unknown.

ELITEK Sustained Control of Uric Acid Levels in Patients Measured1

Post day 5 hyperuricemic treatment graph showing patients sustained controlled uric acid levels after receiving ELITEK®.

The ELITEK, ELITEK + allopurinol, and allopurinol arms had 13%, 15%, and 19% missing uric acid samples respectively. The uric acid failure status in those patients is unknown.

ELITEK Has a Proven Safety Profile1

chart showing the ELITEK® safety profile

*Events were reported and graded according to NCI-CTC Version 3.0 and presented as preferred terms MedDRA version 10.1.

• Overall incidence of adverse reactions ≥10% in any ELITEK arm and the difference between any ELITEK arm vs the allopurinol arm ≥5%.1

Weight-based Dosing Provides Reliability and Control

In pivotal trial of ELITEK in adults, cytoreductive therapy was initiated between 4 and 24 hours after the first dose of antihyperuricemic treatment.

chart showing the ELITEK® dose profile vs Allopurinol

The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days.1

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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.

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IMPORTANT SAFETY INFORMATION

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 frequently observed ARs (incidence ≥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/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 ARs regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with 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 greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

Please see full prescribing information, including boxed WARNING.

References

1. ELITEK [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2017. 2. Cortes J, Moore JO, Maziarz RT, et al. Control of plasma uric acid in adults at risk for tumor lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone—results of a multicenter phase III study. J Clin Oncol. 2010;28(27):4207-4213. 3. Zyloprim [prescribing information]. San Diego, CA: Prometheus Laboratories; 2003. 4. Aloprim [prescribing information]. Rockford, IL: Mylan Institutional LLC; 2014.