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Aldurazyme is indicated for enzyme replacement therapy in patients diagnosed with α-L-iduronidase I-induced mucopolysaccharidosis I, for the treatment of non-neuropathy related manifestations of this disease.
What is Aldurazyme?
Aldurazyme with the active ingredient Laronidase, this is a medicine containing an enzyme that occurs naturally in the healthy human body. Laronidase helps replace an enzyme that is missing in some people due to a genetic disorder.
What is the effect of Aldurazyme? Aldurazyme is used to treat some symptoms of an inherited condition called Mucopolysaccharidosis, abbreviated MPS I. This condition is also known as Hurler syndrome, Hurler-Scheie syndrome, or Scheie syndrome.
MPS I is a metabolic disorder in which the patient's body lacks the necessary enzymes to break down certain substances, leading to a condition where these substances can accumulate in the body causing abnormal bone structures, changes in facial features, breathing problems, heart problems, decreased vision or hearing, changes in mental or physical abilities.
Aldurazyme may improve breathing and walking in patients with this condition but is not a cure for MPS I.
Warnings when using Aldurazyme
Before using Aldurazyme, tell your doctor if you have heart disease, kidney disease, lung disease, epilepsy, migraine or sleep apnea, use a positive pressure ventilator. continuous (CPAP).
Allergic reactions may occur during or shortly after the infusion of Aldurazyme . Tell your caregivers or get emergency medical help right away if you have any signs of a serious allergic reaction to Aldurazyme, such as sweating, chest discomfort, trouble breathing, pale skin, blue lips or fingernails, feeling faint.
Your doctor may also prescribe other medicines to help prevent an allergic reaction to Aldurazyme, but you should take all of the medicines on the prescription exactly as directed by your doctor.
Patients should not be treated with Aldurazyme if they are allergic to Laronidase.
Aldurazyme infusion may be delayed if the patient has a fever or cold symptoms.
Tell your doctor if you are pregnant or breast-feeding before using Aldurazyme. It is not known at this time whether Laronidase will harm an unborn baby. However, the symptoms of Mucopolysaccharidosis can get worse during pregnancy and can cause health problems for both mother and baby. The benefits of treating Mucopolysaccharidosis may outweigh any risks to the baby.
Your name may need to be listed on the MPS I Registry while you are taking Aldurazyme . The purpose of this registry is to monitor the progression of this disorder and the effects of Laronidase on long-term treatment of MPS I. The registry also monitors the effects of Laronidase on the baby if patients with Mucopolysaccharidosis who are pregnant or breast-feeding.
How is Aldurazyme used?
The route of administration of Aldurazyme is by intravenous administration by professionally trained medical personnel; Aldurazyme is usually given once a week; Before injecting Aldurazyme, the patient should inform the doctor if he or she has a fever or cold. Patients may need to be more stable before using this medicine; Aldurazyme requires a very slow intravenous infusion, which can last up to 4 hours; About 1 hour before the injection of Aldurazyme, the patient may be prescribed by the doctor to take some supportive drugs to prevent severe allergic reactions; After each injection of Aldurazyme, the patient should be closely monitored for at least 60 minutes to ensure there are no serious allergic reactions; Your doctor will need to check your Aldurazyme treatment progress on a regular basis, which can take a while (months to years) before you get the full benefits of Aldurazyme treatment. Continued injection of Aldurazyme should be according to the doctor's instructions, the patient should discuss when the symptoms do not improve or even get worse. Dosage information for Aldurazyme :
The recommended adult dose for Mucopolysaccharidosis Type I is 0.58 mg/kg body weight intravenously once a week; Clinical studies did not include subjects 65 years of age or older, so it is not known whether the response to Aldurazyme in this group is different from that of younger patients; Aldurazyme is used to treat Hurler syndrome or Hurler-Scheie syndrome of Mucopolysaccharidosis I (MPS I) and for patients with Scheie syndrome who have moderate to severe symptoms. However, the risks and benefits of treatment in patients with mild Scheie syndrome have not been established; The recommended dose for children with type I mucopolysaccharidosis 6 months of age and older is 0.58 mg/kg body weight IV once a week.
What are the side effects of Aldurazyme?
Get emergency medical help if the patient has signs of an allergic reaction to Aldurazyme such as hives, difficulty breathing, swelling of the face, lips, tongue or throat... Allergic reactions may occur. occurs during or shortly after the infusion of Aldurazyme (up to 3 hours of injection). Patients should notify medical personnel or any signs of a serious allergic reaction, such as:
Rapid breathing, or feeling short of breath; Wheeze; Chest tightness; Signs of fainting, even while lying down; Fast or slow heart rate; Sweating, chills, or rough skin; pale skin; Blue-violet lips or fingernails. Some other common side effects of Aldurazyme may include:
Fever, chills; Cold symptoms such as stuffy nose, sneezing, sore throat; Hypertension; feeling hot, red, numb, or tingling; Fast heart beat ; Excessive reflexes; Pain, swelling, burning or irritation around the Aldurazyme injection site. Aldurazyme is indicated for enzyme replacement therapy in patients diagnosed with α-L-iduronidase I-induced mucopolysaccharidosis I, for the treatment of non-neuropathological manifestations of this disease. To ensure effective treatment and avoid side effects, users need to strictly follow the instructions of the doctor.
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