Elitek

DRUG DESCRIPTION

Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically
modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase
was cloned from a strain of Aspergillus flavus.

Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek (rasburicase) is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution.

Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188).

Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).

What are the possible side effects of rasburicase (Elitek)?

In rare cases, the use of rasburicase has been associated with blood problems (methemoglobinemia, hemolytic reactions) and serious allergic reactions. Contact your doctor immediately if you develop swelling of the lips, tongue, or face; chest pain; shortness of breath; dizziness; hives; or bluish skin or lips. These may be symptoms of a serious reaction.

Other, less serious side effects may be more likely to occur. Continue to take rasburicase and talk to your doctor if you experience:

• diarrhea;


• abdominal...

Read All Potential Side Effects and See Pictures of Elitek »

What are the precautions when taking rasburicase (Elitek)?

Also see the Warnings section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you have: previous severe allergic reaction to this medication, certain metabolic conditions (e.g., G6PD deficiency), previous red blood cell damage (e.g., hemolysis, methemoglobinemia) with this medication.

Before using this medication, tell the doctor the medical history, especially of: kidney disease, dehydration.

Caution is...

Read All Potential Precautions of Elitek »

Elitek Consumer (continued)

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.

PRECAUTIONS: Also see the Warnings section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you have: previous severe allergic reaction to this medication, certain metabolic conditions (e.g., G6PD deficiency), previous red blood cell damage (e.g., hemolysis, methemoglobinemia) with this medication.

Before using this medication, tell the doctor the medical history, especially of: kidney disease, dehydration.

Caution is advised when using this drug in children less than 2 years old because they may be more sensitive to the side effects of the drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding is not recommended while using this drug.

Elitek Patient Information Including Side Effects

Brand Names: Elitek

Generic Name: rasburicase (Pronunciation: ras BUR ih kase)

• What is rasburicase (Elitek)?


• What are the possible side effects of rasburicase (Elitek)?


• What is the most important information I should know about rasburicase (Elitek)?


• What should I discuss with my healthcare provider before taking rasburicase (Elitek)?


• How should I take rasburicase (Elitek)?


• What happens if I miss a dose (Elitek)?


• What happens if I overdose (Elitek)?


• What should I avoid while taking rasburicase (Elitek)?


• What other drugs will affect rasburicase (Elitek)?


• Where can I get more information?

What is rasburicase (Elitek)?

Rasburicase increases the rate at which uric acid is broken down in the body.

Rasburicase is used to treat increased levels of uric acid caused by the breakdown of tumors during treatment for some types of cancer.

Rasburicase may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of rasburicase (Elitek)?

In rare cases, the use of rasburicase has been associated with blood problems (methemoglobinemia, hemolytic reactions) and serious allergic reactions. Contact your doctor immediately if you develop swelling of the lips, tongue, or face; chest pain; shortness of breath; dizziness; hives; or bluish skin or lips. These may be symptoms of a serious reaction.

Other, less serious side effects may be more likely to occur. Continue to take rasburicase and talk to your doctor if you experience:

• diarrhea;


• abdominal pain;


• nausea or vomiting;


• fever;


• rash;


• sores inside the mouth;


• headache, or


• constipation.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rasburicase (Elitek)?

Do not take rasburicase without first talking to your doctor if you have glucose 6-phosphate dehydrogenase (G6PD) deficiency. Rasburicase should not be used by people with this deficiency.

In rare cases, the use of rasburicase has been associated with blood problems (methemoglobinemia, hemolytic reactions) and serious allergic reactions. Contact your doctor immediately if you develop swelling of the lips, tongue, or face; chest pain; shortness of breath; dizziness; hives; or bluish skin or lips. These may be symptoms of a serious reaction.

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