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 »
Elaprase Consumer (continued)
SIDE EFFECTS: Headache, nausea, abdominal pain, tiredness, dizziness, or painful menstrual periods may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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 this rare but serious side effect occurs: severe lower abdominal pain (especially 3 to 5 weeks after taking ulipristal).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your 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: 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 pregnant, tell your doctor immediately.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Elaprase Patient Information Including Side Effects
Brand Names: Elaprase
Generic Name: idursulfase (Pronunciation: EYE dur SUL fase)
- What is idursulfase (Elaprase)?
- What are the possible side effects of idursulfase (Elaprase)?
- What is the most important information I should know about idursulfase (Elaprase)?
- What should I discuss with my health care provider before receiving idursulfase (Elaprase)?
- How is idursulfase given (Elaprase)?
- What happens if I miss a dose (Elaprase)?
- What happens if I overdose (Elaprase)?
- What should I avoid while receiving idursulfase (Elaprase)?
- What other drugs will affect idursulfase (Elaprase)?
- Where can I get more information?
What is idursulfase (Elaprase)?
Idursulfase is used to treat some of the symptoms of a genetic condition called Hunter's syndrome. Hunter syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).
Hunter syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision loss, and changes in mental or physical abilities.
Idursulfase may improve walking ability in people with this condition. However, this medication is not a cure for Hunter syndrome.
Idursulfase may also be used for purposes not listed in this medication guide.
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 at once if you have any of these serious side effects:
- worsened asthma;
- uneven heartbeats;
- blue lips or fingernails;
- fever;
- vision problems; or
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
- joint pain;
- pain in your arms or legs;
- headache;
- itching, mild skin rash; or
- weakness.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about idursulfase (Elaprase)?
Idursulfase may improve walking ability in people with Hunter syndrome. However, idursulfase is not a cure for this condition.
Some people receiving an 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.
You may be more likely to have a reaction to idursulfase if you have a breathing disorder. Tell your doctor if you have asthma or other lung disease.
Your name may need to be listed on a Hunter Outcome Survey while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that idursulfase has on long-term treatment of Hunter syndrome.
- Elaprase
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