Alert

elosulfase alfa

Pronunciation: EE loe SUL face AL fa

Brand: Vimizim

What is the most important information I should know about elosulfase alfa?

An allergic reaction may occur during or shortly after infusion of this medicine. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as chest discomfort, cough, trouble breathing, vomiting, skin rash or redness, pale skin, blue lips or fingernails, and feeling like you might pass out.

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.

You will be watched closely after receiving elosulfase alfa, to make sure you do not have an allergic reaction.

What is elosulfase alfa?

Elosulfase alfa contains an enzyme that occurs naturally in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Elosulfase alfa helps replace this missing enzyme in such people.

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 natural substances. 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.

Elosulfase alfa may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for MPS IVA.

Elosulfase alfa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving elosulfase alfa?

Your elosulfase alfa infusion may be delayed if you have a fever or cold symptoms.

Tell your doctor if you have ever had:

  • breathing problems; or
  • sleep apnea, and you use a continuous positive airway pressure (CPAP) machine.

Tell your doctor if you are pregnant or breastfeeding.

It is not known whether elosulfase alfa will harm an unborn baby. However, MPS symptoms can get worse during pregnancy and may cause medical problems in both mother and baby. The benefit of treating MPS may outweigh any risks to the baby.

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 elosulfase alfa has on long-term treatment of Morquio A syndrome. The registry also tracks the effects of elosulfase alfa on a baby if you are pregnant or breastfeeding.

How is elosulfase alfa given?

Elosulfase alfa is given as an infusion into a vein. A healthcare provider will give you this injection.

Elosulfase alfa must be given slowly, and the infusion can take up to 4 hours or longer to complete.

Elosulfase alfa is usually given once per week. Follow your doctor's instructions.

Elosulfase alfa doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

About 30 to 60 minutes before each injection, you will be given other medications to help prevent a serious allergic reaction.

You will be watched closely after receiving elosulfase alfa, to make sure you do not have an allergic reaction.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your elosulfase alfa 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 receiving elosulfase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of elosulfase alfa?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction may occur during or shortly after infusion of this medicine (up to 3 hours later). Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as:

  • feeling like you might pass out, even while lying down;
  • cough, chest discomfort, feeling short of breath;
  • skin rash or redness, sudden warmth or tingly feeling;
  • nausea, vomiting;
  • pale skin; or
  • blue lips or fingernails.

Common side effects of elosulfase alfa may include:

  • nausea, vomiting, stomach pain;
  • headache;
  • fever, chills; or
  • feeling tired.

Even though it may not be a side effect of elosulfase alfa, 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:

  • back pain;
  • loss of movement in any part of your body; or
  • loss of bowel or bladder control.

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 elosulfase alfa?

Other drugs may affect elosulfase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about elosulfase alfa.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2020 Cerner Multum, Inc. Version: 3.01. Revision date: 12/11/2019.

Your use of the content provided in this service indicates that you have read, understood and agree to the End-User License Agreement, which can be accessed by End-User License Agreement, which can be accessed by clicking on this link.

Related Locations

Top