Aldurazyme

DRUG DESCRIPTION

ALDURAZYME® (laronidase) is a polymorphic variant of the human enzyme, ?-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. ?-L-iduronidase (glycosaminoglycan ?-L-iduronohydrolase, EC 3.2.1.76) is a lysosomal hydrolase that catalyses the hydrolysis of terminal ?-L-iduronic acid residues of dermatan sulfate and heparan sulfate.

Laronidase is a glycoprotein with a molecular weight of approximately 83 kD. The predicted amino acid sequence of the recombinant form, as well as the nucleotide sequence that encodes it, are identical to a polymorphic form of human ?-L-iduronidase. The recombinant protein is comprised of 628 amino acids after cleavage of the N-terminus and contains 6 N-linked oligosaccharide modification sites. Two oligosaccharide chains terminate in mannose-6-phosphate sugars. ALDURAZYME (laronidase) has a specific activity of approximately 172 U/mg.

ALDURAZYME (laronidase) , for intravenous infusion, is supplied as a sterile, nonpyrogenic, colorless to pale yellow, clear to slightly opalescent solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP, containing 0.1% Albumin (Human). The solution in each vial contains a nominal laronidase concentration of 0.58 mg/mL and a pH of approximately 5.5. The extractable volume of 5.0 mL from each vial provides 2.9 mg laronidase, 43.9 mg sodium chloride, 63.5 mg sodium phosphate monobasic monohydrate, 10.7 mg sodium phosphate dibasic heptahydrate, and 0.05 mg polysorbate 80. ALDURAZYME (laronidase) does not contain preservatives; vials are for single use only.

What are the possible side effects of laronidase (Aldurazyme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Less serious side effects may include:

  • runny or stuffy nose, sore throat,...

Read All Potential Side Effects and See Pictures of Aldurazyme »


Aldurazyme Patient Information Including Side Effects

Brand Names: Aldurazyme

Generic Name: laronidase (Pronunciation: lah RAH nih daze)

  • What is laronidase (Aldurazyme)?
  • What are the possible side effects of laronidase (Aldurazyme)?
  • What is the most important information I should know about laronidase (Aldurazyme)?
  • What should I discuss with my healthcare provider before receiving laronidase (Aldurazyme)?
  • How should I use laronidase (Aldurazyme)?
  • What happens if I miss a dose (Aldurazyme)?
  • What happens if I overdose (Aldurazyme)?
  • What should I avoid while receiving laronidase (Aldurazyme)?
  • What other drugs will affect laronidase (Aldurazyme)?
  • Where can I get more information?

What is laronidase (Aldurazyme)?

Laronidase is used to treat some of the symptoms of a genetic condition called Hurler syndrome. Hurler syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Hurler 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 or hearing loss, and changes in mental or physical abilities.

Laronidase may improve breathing and walking ability in people with this condition. However, this medication is not a cure for Hurler syndrome.

Laronidase may also be used for other purposes not listed in this medication guide.

What are the possible side effects of laronidase (Aldurazyme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • mild skin rash;
  • numbness or tingling; or
  • pain, redness, swelling, or other irritation where the medicine was injected.

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 laronidase (Aldurazyme)?

Laronidase may improve breathing and walking ability in people with Hurler syndrome. However, laronidase is not a cure for this condition.

Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that laronidase has on long-term treatment of Hurler syndrome.

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