"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
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, also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis), or MPS I. Forms of MPS I include Hurler syndrome, Hurler-Scheie syndrome, and Scheie syndrome."
MPS I 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 MPS I.
Laronidase may also be used for purposes not listed in this medication guide.
What are the possible side effects of laronidase (Aldurazyme)?
Some people receiving a laronidase 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, pale skin, or trouble breathing when laronidase is injected.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing; slow heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- chest pain;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- fever, chills, rapid heart rate; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- mild skin rash;
- overactive reflexes;
- numbness or tingling;
- cold symptoms such as runny or stuffy nose, sneezing, sore throat; 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Aldurazyme (laronidase) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about laronidase (Aldurazyme)?
You should not use laronidase if you are allergic to it.
Before you receive laronidase, tell your doctor if you have heart disease, kidney disease, lung disease, seizures, migraine headaches, or sleep apnea.
Tell your doctor if you have been sick with a fever, head cold, or chest cold. You may need to wait until you get better before receiving your dose of laronidase.
Some people receiving a laronidase 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 doctor may also prescribe other medications to help prevent an allergic reaction to laronidase. Take all of your medications as directed.
Additional Aldurazyme Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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