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Elitek Side Effects

Generic Name: rasburicase

Note: This page contains information about the side effects of rasburicase. Some of the dosage forms included on this document 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

In addition to its needed effects, some unwanted effects may be caused by rasburicase (the active ingredient contained in Elitek). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking rasburicase, check with your doctor or nurse immediately:

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

Minor Side Effects

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

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%): Hypersensitivity reactions (rashes and urticaria)
Uncommon (0.1% to 1%): Severe hypersensitivity reactions
Rare (less than 0.1%): Anaphylaxis[Ref]

Immunologic

Very common (10% or more): Anti-rasburicase (the active ingredient contained in Elitek) antibodies, 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): Vomiting (up to 61%), nausea (up to 57.6%), 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%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)
Postmarketing reports: Convulsion, 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: Supraventricular arrhythmias, ischemic coronary artery disorders[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]

References

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

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

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

Not all side effects for Elitek may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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