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Elitek Side Effects

Generic Name: rasburicase

Note: This document contains side effect information about rasburicase. Some of the dosage forms listed on this page may not apply to the brand name Elitek.

In Summary

Common side effects of Elitek include: abdominal pain, fever, headache, nausea, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to rasburicase: intravenous powder for solution

Along with its needed effects, rasburicase (the active ingredient contained in Elitek) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking rasburicase:

More Common

  • Cracked lips
  • diarrhea
  • difficulty with swallowing
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth

Less Common

  • Abdominal or stomach pain
  • agitation
  • black or red, tarry, stools
  • bleeding gums
  • bluish color of the fingernails, lips, skin, palms, or nail beds
  • changes in skin color
  • changes in vision
  • chest pain or discomfort
  • chills
  • coma
  • confusion
  • convulsions (seizures)
  • cough
  • coughing that sometimes produces a pink, frothy sputum
  • coughing up blood
  • decreased urination
  • depression
  • dilated neck veins
  • dizziness
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • headache
  • hostility
  • increased menstrual flow or vaginal bleeding
  • increased sweating
  • increased thirst
  • irritability
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lightheadedness
  • lower back or side pain
  • muscle twitching
  • nausea
  • no blood pressure or pulse
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • painful or difficult urination
  • pains in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • paralysis
  • prolonged bleeding from cuts
  • red or dark brown urine
  • severe constipation
  • severe headaches of sudden onset
  • shortness of breath
  • skin rash
  • sneezing
  • sore throat
  • stopping of heart
  • stupor
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sunken eyes
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swollen glands
  • temporary blindness
  • thirst
  • tightness in the chest
  • troubled breathing
  • unconsciousness
  • unexplained or unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • wheezing
  • wrinkled skin

Rare

  • Back pain
  • hives
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • yellow eyes or skin

Some side effects of rasburicase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • feeling of warmth
  • feeling unusually cold
  • redness of the face, neck, arms, and occasionally, upper chest
  • shivering

For Healthcare Professionals

Applies to rasburicase: intravenous powder for injection

General

The most common adverse reactions reported included vomiting, nausea, pyrexia, peripheral edema, anxiety, headache, abdominal pain, constipation, and diarrhea. Since this drug is administered concomitantly with cytoreductive chemotherapy, the causality of adverse reactions is difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.[Ref]

Hematologic

Uncommon (0.1% to 1%): Hemolytic anemia, hemolysis, methemoglobinemia[Ref]

Hypersensitivity

Clinical manifestations of hypersensitivity have included arthralgia, injection site irritation, peripheral edema, urticaria, and rash.[Ref]

Common (1% to 10%): Allergy, allergic reactions, hypersensitivity reactions

Uncommon (0.1% to 1%): Severe hypersensitivity reactions

Rare (less than 0.1%): Anaphylaxis

Frequency not reported: Anaphylactic shock

Postmarketing reports: Anaphylaxis with potential fatal outcome[Ref]

Immunologic

Very common (10% or more): Anti-rasburicase (the active ingredient contained in Elitek) antibodies (up to 53%), sepsis (up to 12%)[Ref]

Anti-rasburicase antibodies were measured in 53% of healthy volunteers one month post last dose; most were no longer positive at 1 year. In clinical trials of pediatric patients with hematologic malignancies 11% (n=24/218) patients developed anti-rasburicase antibodies by day 28 following treatment. In adult trials, 18% (n=47/260) were positive for anti-rasburicase immunoglobulin G (IgG); 8% were positive for IgG and 6% were positive for IgE from day 14 to 24 months after 1 treatment course (5 daily doses).

All-grade sepsis was reported in 12%, 7.6%, and 4.4% of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Sepsis was grade 3, 4 in 5.4%, 6.5%, and 4.4%, respectively.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 57.6%), vomiting (up to 50%), abdominal pain (up to 21.7%), constipation (up to 20%), diarrhea (up to 20%), mucositis (up to 15%)

Frequency not reported: Abdominal and gastrointestinal infections[Ref]

All-grade nausea, vomiting, and abdominal pain were reported in 57.6%, 38% and 21.7%; 60.9%, 37% and 33.7%; 54.9%, 30.8% and 25.3%; of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Nausea, vomiting, and abdominal pain were grade 3, 4 in 1.1%, 1.1% and 3.3%; 1.1%, 0% and 4.3%; and 2.2%, 1.1%, and 2.2%, respectively.

Abdominal and gastrointestinal infections occurred at a difference in incidence of 2% or more in patients receiving this drug compared to those receiving allopurinol in randomized studies.[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (up to 17.4%), fluid overload (up to 12%)

Common (1% to 10%): Hyperphosphatemia[Ref]

All-grade hypophosphatemia, fluid overload, and hyperphosphatemia were reported in 17.4%, 12%, and 9.8%; 22.8%, 6.5% and 15.2%; and 16.5%, 3.3%, and 8.8%; of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase alone (n=92); rasburicase in combination with allopurinol (n=92); or allopurinol alone (n=91). Hypophosphatemia, fluid overload, and hyperphosphatemia were grade 3, 4 in 4.3%, 0% and 0%; 6.5%, 0% and 0%; and 6.6%, 1.1%, and 1.1%, respectively.[Ref]

Dermatologic

Very Common (10% or more): Rash (up to 13%)

Common (1% to 10%): Urticaria[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)

Uncommon (0.1% to 1%): Convulsion

Postmarketing reports: Involuntary muscle contractions[Ref]

Hepatic

All-grade hyperbilirubinemia and increased alanine aminotransferase was reported in 16.3% and 10.9%; 14.1% and 27.2%; and 7.7% and 17.6%; of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase (the active ingredient contained in Elitek) alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Hyperbilirubinemia and increased alanine aminotransferase were grade 3, 4 in 3.3% and 3.3%; 2.2% and 4.3%; and 4.4%, and 2.2%; respectively.[Ref]

Very common (10% or more): Hyperbilirubinemia (up to 16.3%), increased alanine aminotransferase (up to 10.9%)[Ref]

Other

Very common (10% or more): Fever (up to 46%)[Ref]

Local

Frequency not reported: Injection site irritation[Ref]

Cardiovascular

All-grade peripheral edema was reported in 50%, 43.5%, and 42.9% of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase (the active ingredient contained in Elitek) alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Peripheral edema was grade 3, 4 in 2.2%, 3.3%, and 6.6%, respectively.

Supraventricular arrhythmias and ischemic coronary artery disorders occurred at a difference in incidence of 2% or more in patients receiving this drug compared to those receiving allopurinol in randomized studies.[Ref]

Very common (10% or more): Peripheral edema (up to 50%)

Uncommon (0.1% to 1%): Hypotension

Frequency not reported: Ischemic coronary artery disorders, supraventricular arrhythmias[Ref]

Respiratory

All-grade pharyngolaryngeal pain was reported in 14.1%, 20.7%, and 9.9% of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase (the active ingredient contained in Elitek) alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Pharyngolaryngeal pain was grade 3, 4 in 1.1%, 0%, and 0%, respectively.

Pulmonary hemorrhage and respiratory failure occurred at a difference in incidence of 2% or more in patients receiving this drug compared to those receiving allopurinol in randomized studies.[Ref]

Very common (10% or more): Pharyngolaryngeal pain (up to 14.1%)

Uncommon (0.1% to 1%): Bronchospasm

Rare (less than 0.1%): Rhinitis

Frequency not reported: Pulmonary hemorrhage, respiratory failure[Ref]

Psychiatric

All-grade anxiety was reported in 23.9%, 17.4%, and 17.6% of adult patients with leukemia, lymphoma, or solid tumor malignancies receiving rasburicase (the active ingredient contained in Elitek) alone (n=92), rasburicase in combination with allopurinol (n=92), or allopurinol alone (n=91). Anxiety was grade 3, 4 in 3.3%, 0%, and 0%, respectively.[Ref]

Very common (10% or more): Anxiety (up to 23.9%)[Ref]

Musculoskeletal

Frequency not reported: Arthralgia[Ref]

References

1. "Product Information. Elitek (rasburicase)." Sanofi Winthrop Pharmaceuticals, New York, NY.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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