Laronidase

Laronidase is an enzyme used to treat some of the symptoms of a genetic condition called Hurler syndrome (also called mucopolysaccharidosis I).

• Laronidase is available under the following different brand names: Aldurazyme

Common side effects of Laronidase include:

• cold symptoms (runny or stuffy nose, sore throat, sneezing)
• cough
• mild skin rash
• numbness or tingling
• overactive reflexes
• injection site reactions (pain, redness, swelling, or other irritation)

Serious side effects of Laronidase include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• rapid breathing
• shortness of breath
• wheezing
• chest tightness
• lightheadedness (even while lying down)
• fast or slow heartbeats
• sweating
• cold or clammy skin
• pale skin

Rare side effects of Laronidase include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 2.9 mg/5 mL

Mucopolysaccharidosis I

Adult dosage

• 0.58 mg/kg IV (3 to 4 hours infusion) every week; may administer total volume 100 mL if body weight under 20 kg or 250 mL if body weight above 20 kg
• Initial infusion rate 10 mcg/kg/hr; may increase every 15 min during 1st hour, as tolerated, to a maximum of 200 mcg/kg/hr

Pediatric dosage

• Children younger than 5 years
  • Safety & efficacy not established
• Children aged 5 years and older
  • Children weighing less than 20 kg: 0.58 mg/kg IV (3 to 4 hours infusion) every week; total volume 100 mL
  • Children weighing 20 kg and more: As in adults; 0.58 mg/kg IV (3 to 4 hours infusion) every week; total volume 250 mL
  • Initial infusion rate 10 mcg/kg/hr; may increase every 15min during 1st hour, as tolerated, to a maximum of 200 mcg/kg/hr

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Laronidase has no noted severe interactions with any other drugs
• Laronidase has no noted serious interactions with any other drugs
• Laronidase has no noted moderate interactions with any other drugs
• Laronidase has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Laronidase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Laronidase?”

Cautions

• Consider registration in the MPS I Registry, www.MPSIregistry.com or 1-800-745-4447
• Consider delaying treatment in patients with acute febrile/respiratory illness; may increase risk of infusion-related reactions; premedication with antihistamines and antipyretics recommended; decrease infusion rate temporarily; manage reactions by administering additional antipyretics and antihistamines
• Use caution in patients with fluid overloads or in conditions where fluid restriction is indicated; exacerbation of such conditions may occur during infusions
• Not indicated for central nervous system manifestations of the disorder
• Use caution in patients with sleep apnea; apnea treatment options should be readily available during infusion or with the use of sedating antihistamines including supplemental oxygen and continuous positive airway pressure

Pregnancy and Lactation

• An MPS I Registry has been established and pregnant women with MPS I should be encouraged to enroll; for more information, visit www.registrynxt.com or call 1-800-745-4447 ext. 15500
• Available data from published case reports and postmarketing experience in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse pregnancy outcomes for both mother and fetus
• Lactation
  • Data are not available on the presence of laronidase in human milk or the effects on milk production
  • No adverse effects have been reported in breastfed infants in a few postmarketing cases of laronidase use in lactating women