What is the most important information I should know about vestronidase 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 sweating, trouble breathing, pale skin, blue lips or fingernails, and feeling like you might pass out.
What is vestronidase alfa?
Vestronidase alfa contains an enzyme that occurs naturally in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Vestronidase alfa helps replace this missing enzyme in such people.
Vestronidase alfa is used to treat some of the symptoms of a genetic condition called mucopolysaccharidosis VII (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis Seven) or MPS VII, also called Sly syndrome.
MPS VII 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.
Vestronidase alfa may improve walking ability in people with this condition. However, this medication is not a cure for MPS VII.
Vestronidase alfa may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving vestronidase alfa?
You should not receive vestronidase alfa if you are allergic to it.
To make sure vestronidase alfa is safe for you, tell your doctor if you have ever had:
- a lung disease or breathing problems.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether vestronidase alfa passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
How is vestronidase alfa given?
Vestronidase alfa is injected into a vein through an IV. A healthcare provider will give you this injection.
This medicine is usually given once every 2 weeks.
Vestronidase alfa must be given slowly, and the IV infusion can take up to 4 hours to complete.
About 30 to 60 minutes before each injection, you will be given other medications to help prevent a serious allergic reaction.
Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vestronidase alfa is injected.
You will be watched closely for at least 60 minutes after receiving vestronidase 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 vestronidase alfa injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving vestronidase alfa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of vestronidase 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. 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;
- sweating, cold or clammy skin;
- feeling short of breath;
- pale skin; or
- blue lips or fingernails.
Common side effects may include:
- diarrhea;
- swelling in your hands or feet;
- rash, itching; or
- swelling or irritation around the IV needle.
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 vestronidase alfa?
Other drugs may interact with vestronidase 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.
Where can I get more information?
Your doctor or pharmacist can provide more information about vestronidase 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 1996-2018 Cerner Multum, Inc. Version: 1.01. Revision date: 12/5/2017.
