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Elitek

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Elitek

Elitek Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Elitek (rasburicase) is used to treat increased levels of uric acid caused by the breakdown of tumors during treatment for some types of cancer. It increases the rate at which uric acid is broken down in the body. Common side effects include vomiting, nausea, headache, stomach pain, constipation, diarrhea, mouth sores/ulcers or rash.

The recommended dose of Elitek is 0.2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days. Other drugs may interact with Elitek. Tell your doctor all prescription or over-the-counter medicines or supplements you use. You may require a dosage adjustment or special monitoring if you are taking other medications. Elitek should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Breastfeeding is not recommended while using this drug.

Our Elitek (rasburicase) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Elitek in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain or tightness, difficult breathing; fainting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • change in your mental state;
  • headache, tired feeling, dizziness;
  • blue colored lips;
  • feeling short of breath;
  • feeling like you might pass out;
  • fast, slow, or uneven heart rate;
  • seizure (convulsions);
  • white patches or sores inside your mouth or on your lips; or
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • anxiety;
  • fever, sore throat;
  • mild rash; or
  • swelling in your hands or feet.

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 Elitek (Rasburicase) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Elitek Overview - Patient Information: Side Effects

SIDE EFFECTS: Also see the Warnings section.

Vomiting, nausea, headache, stomach pain, constipation, diarrhea, mouth sores/ulcers or rash may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent sore throat, fever, chills.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: chest pain, trouble breathing, severe dizziness, weakness, yellowing eyes and skin, dark urine, blue or gray skin color.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Elitek (Rasburicase)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Elitek FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information:

Clinical Trials

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.

The data below reflect exposure to Elitek (rasburicase) in 265 pediatric and 82 adult patients enrolled in one active-controlled trial (Study 1), two uncontrolled trials (Studies 2 and 3), and an uncontrolled safety trial (n=82). Additional data were obtained from an expanded access program of 356 patients, for whom data collection was limited to serious adverse reactions. Among these 703 patients 63% were male, the median age was 10 years (range 10 days to 88 years), 73% were Caucasian, 9% African, 4% Asian, and 14% other/unknown.

Among the 347 patients for whom all adverse reactions regardless of severity were assessed, the most frequently observed adverse reactions (incidence ≥ 10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%). In Study 1, an active control study, the following adverse reactions occurred more frequently in Elitek (rasburicase) -treated subjects than allopurinol-treated subjects: vomiting, fever, nausea, diarrhea, and headache. Although the incidence of rash was similar in the two arms, severe rash was reported only in one Elitek (rasburicase) -treated patient.

Further studies, including one-active controlled study (Study 4) and four supportive studies, have been conducted in adult patients. In these studies, Elitek (rasburicase) was administered to a total of 434 adult patients [58% male, 42% female; median age 56 years (range 18 years to 89 years); 52% Caucasian, 7% African, 14% Asian, 28% other/unknown].

Of these 434 patients, 275 adult patients with leukemia, lymphoma, or solid tumor malignancies at risk for hyperuricemia and tumor lysis syndrome (TLS) were randomized in an open label trial receiving either Elitek (rasburicase) alone, Elitek (rasburicase) in combination with allopurinol, or allopurinol alone (Study 4).

A drug-related adverse reaction in Study 4 of any grade was experienced in 4.3% of Elitek (rasburicase) -treated patients, 5.4% of Elitek (rasburicase) /allopurinol-treated patients, and 1.1% of allopurinol-treated patients.

Table 1 presents the per patient incidence of adverse reactions by study arm in Study 4.

Table 1 - per patient incidence of selected adverse reactions by study arm in Study 4

Adverse Reaction* Elitek
(n=92)
Elitek/Allopurinol
(n=92)
Allopurinol
(n=91)
All Grades % Grades 3,4 % All Grades % Grades 3,4 % All Grades % Grades 3,4 %
Nausea 57.6 1.1 60.9 1.1 54.9 2.2
Peripheral edema 50 2.2 43.5 3.3 42.9 6.6
Vomiting 38 1.1 37 0 30.8 1.1
Anxiety 23.9 3.3 17.4 0 17.6 0
Abdominal pain 21.7 3.3 33.7 4.3 25.3 2.2
Hypophosphatemia 17.4 4.3 22.8 6.5 16.5 6.6
Hyperbilirubinemia 16.3 3.3 14.1 2.2 7.7 4.4
Pharyngolaryngeal pain 14.1 1.1 20.7 0 9.9 0
Sepsis 12 5.4 7.6 6.5 4.4 4.4
Fluid overload 12 0 6.5 0 3.3 1.1
Increased alanine aminotransferase 10.9 3.3 27.2 4.3 17.6 2.2
Hyperphosphatemia 9.8 0 15.2 0 8.8 1.1
*Events were reported and graded according to NCI-CTC version 3.0 and presented as preferred terms MedDRA version 10.1.
*Overall incidence ≥ 10% in any Elitek (rasburicase) arm and the difference between any Elitek (rasburicase) arm versus the allopurinol arm ≥ 5%.

Hypersensitivity reactions occurred in 4.3% of Elitek (rasburicase) -treated patients and 1.1% of Elitek (rasburicase) /allopurinol-treated patients in Study 4. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash.

The following serious adverse reactions occurred at a difference in incidence of ≥ 2% in patients receiving rasburicase compared to patients receiving allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

The incidence of anaphylaxis, hemolysis, and methemoglobinemia was less than 1% of the 887 rasburicase-treated patients entered on these clinical trials.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Elitek (rasburicase) can elicit anti-product antibodies that bind to rasburicase and in some instances inhibit the activity of rasburicase in vitro [see Boxed Warning, WARNINGS AND PRECAUTIONS].

In clinical trials of pediatric patients with hematologic malignancies, 24/218 patients tested (11%) developed antibodies by day 28 following Elitek (rasburicase) administration as assessed by qualitative ELISA.

Using quasi-quantitative immunoassays in rasburicase na´ve adult patients with hematological malignancies, 47/260 (18%) patients were positive for anti-rasburicase immunoglobulin G (IgG), 21/260 (8%) patients were positive for anti-rasburicase neutralizing IgG, and 16/260 (6%) patients were positive for anti-rasburicase immunoglobulin E (IgE) from day 14 to 24 months after 5 daily doses of Elitek (rasburicase) .

The incidence of antibody responses detected is highly dependent on the sensitivity and specificity of the assay, which have not been fully evaluated. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including serum sampling, timing and methodology, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Elitek (rasburicase) with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Elitek (Rasburicase) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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