Elaprase (Idursulfase Solution) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

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Elaprase

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ELAPRASE™
(idursulfase) Solution for intravenous infusion

WARNING

Risk of anaphylaxis.

Life-threatening anaphylactic reactions have been observed in some patients during ELAPRASE (idursulfase solution) infusions. Therefore, appropriate medical support should be readily available when ELAPRASE (idursulfase solution) is administered. Biphasic anaphylactic reactions have also been observed after ELAPRASE (idursulfase solution) administration and patients who have experienced anaphylactic reactions may require prolonged observation. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.

DRUG DESCRIPTION

ELAPRASE is a formulation of idursulfase, a purified form of human iduronate-2-sulfatase, a lysosomal enzyme. Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans dermatan sulfate and heparan sulfate in the lysosomes of various cell types.

Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains eight asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent onthe post-translational modification of a specific cysteine to formylglycine. Idursulfase has a specific activity ranging from 41 to 77 U/mg of protein (one unit is defined as the amount of enzyme required to hydrolyze 1 µmole of heparin disaccharide substrate per hour under the specified assay conditions).

ELAPRASE (idursulfase solution) is intended for intravenous infusion and is supplied as a sterile, nonpyrogenic clear to slightly opalescent, colorless solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP. Each vial contains an extractable volume of 3.0 mL with an idursulfase concentration of 2.0 mg/mL at a pH of approximately 6, providing 6.0 mg idursulfase, 24.0 mg sodium chloride, 6.75 mg sodium phosphate monobasic monohydrate, 2.97 mg sodium phosphate dibasic heptahydrate, and 0.66 mg polysorbate 20. ELAPRASE (idursulfase solution) does not contain preservatives; vials are for single use only.

What are the possible side effects of idursulfase (Elaprase)?

Some people receiving a idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

Call your doctor...

Read All Potential Side Effects and See Pictures of Elaprase »

What are the precautions when taking idursulfase solution (Elaprase)?

Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; or to other progestins (such as levonorgestrel, norethindrone); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or suspected pregnancy, unexplained vaginal bleeding.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should not be used during pregnancy. If you become pregnant or think you may be...

Read All Potential Precautions of Elaprase »

Last reviewed on RxList: 11/28/2007
This monograph has been modified to include the generic and brand name in many instances.