What is the most important information I should know about laronidase?
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.
What is laronidase?
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 should I discuss with my healthcare provider before receiving laronidase?
You should not use laronidase if you are allergic to it.
To make sure laronidase is safe for you, tell your doctor if you have any of these other conditions:
- fever or cold symptoms (cough, sore throat, chest congestion, sinus pain, runny or stuffy nose, sneezing);
- heart disease;
- kidney disease;
- asthma or other lung disease;
- epilepsy or other seizure disorder;
- migraine headaches; or
- if you have sleep apnea and you use a continuous positive airway pressure (CPAP) machine.
You may be encouraged to join 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 MPS I.
FDA pregnancy category B. Laronidase is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of laronidase on the baby.
It is not known whether laronidase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use laronidase?
Laronidase is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.
The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.
Laronidase is usually given once per week. Follow your doctor's instructions very carefully.
Tell your doctor if you have been sick with a fever, head cold, chest cold. You may need to wait until you get better before receiving your dose of laronidase.
Your doctor may also prescribe other medications to help prevent an allergic reaction to laronidase. Take all of your medications as directed.
Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
What happens if I miss a dose?
Contact your doctor if you miss an appointment for your laronidase injection.
What happens if I overdose?
Since laronidase is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving laronidase?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects 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, 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.
What other drugs will affect laronidase?
There may be other drugs that can interact with laronidase. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your doctor or pharmacist can provide more information about laronidase.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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