Vimizim (elosulfase alfa) is used to treat some of the symptoms of a genetic condition called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis) IV (4) type A, or MPS IV A, also called Morquio A syndrome.
MPS IVA 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.
Vimizim may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for MPS IVA.
Vimizim may also be used for purposes not listed in this medication guide.
Important information
Some side effects may occur during the Vimizim infusion, or up to several days afterward. Tell your caregiver right away if you feel dizzy, itchy, nauseated, light-headed, or if you have chest pain, tightness in your throat, pale skin, blue lips, diarrhea, or vomiting.
You may be more likely to have a reaction to elosulfase alfa if you have a breathing disorder, or if you are sick with a fever at the time of your infusion.
Your breathing, blood pressure, and other vital signs will be watched closely during and after the infusion, so your caregivers can quickly treat any serious side effects that occur.
Before taking this medicine
You should not receive Vimizim if you are allergic to elosulfase alfa.
To make sure this medicine is safe for you, tell your doctor if you have:
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asthma or any other lung problems;
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sleep apnea (breathing stops during sleep); or
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any current illness, especially if you have a fever.
Your name may need to be listed on a Morquio A Registry while you are using this medicine. The purpose of this registry is to track the progression of this disorder and the effects that Vimizim has on long-term treatment of Morquio A syndrome.
FDA pregnancy category C. It is not known whether Vimizim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether elosulfase alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Vimizim?
Vimizim is injected into a vein through an IV. You will most likely receive this injection in a clinic or hospital setting.
Vimizim must be given slowly through an IV infusion, and can take up to 4 hours or longer to complete.
Vimizim is usually given once per week. Follow your doctor"s instructions.
If a child is using this medicine, tell your doctor if the child has any changes in weight. Elosulfase alfa doses are based on body weight.
Your doctor may also prescribe other medications to help prevent an allergic reaction to elosulfase alfa. Take all of your medications as directed.
Your doctor will need to check your progress while you are using Vimizim.
Vimizim dosing information
Usual Adult Dose for Mucopolysaccharidosis Type IV:
2 mg/kg via IV infusion once a week
Comments:
-Should be infused over 3.5 to 4.5 hours, depending on infusion volume
-Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes before starting the infusion.
Use: For patients with mucopolysaccharidosis IVA (MPS IVA; Morquio A syndrome)
Usual Pediatric Dose for Mucopolysaccharidosis Type IV:
5 years or older: 2 mg/kg via IV infusion once a week
Comments:
-Should be infused over 3.5 to 4.5 hours, depending on infusion volume
-Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes before starting the infusion.
Use: For patients with MPS IVA
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Vimizim injection.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while taking Vimizim?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Vimizim side effects
Some side effects may occur during the Vimizim infusion, or up to several days afterward. Tell your caregiver right away if you feel dizzy, itchy, nauseated, light-headed, or if you have chest pain, tightness in your throat, pale skin, blue lips, diarrhea, or vomiting.
Get emergency medical help if you have any of these signs of an allergic reaction to Vimizim: hives; cough, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
It may still be possible for you to receive a Vimizim infusion even after you have had a reaction to it. There are other medications that can be given to you before your infusion to help prevent symptoms of a reaction.
Common Vimizim side effects include:
Even though it may not be a side effect of Vimizim, increased pressure on the spinal cord is a complication of MPS IVA that may occur while you are using this medicine. Tell your doctor right away if you have any symptoms of spinal cord compression:
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.
See also: Side effects (in more detail)
What other drugs will affect Vimizim?
Other drugs may interact with elosulfase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
