Description
Vestronidase alfa-vjbk injection is used to treat Mucopolysaccharidosis VII (MPS VII) or Sly syndrome.
Sly syndrome is a disorder caused by the lack of an enzyme called beta-glucuronidase (GUS), which causes an abnormal build-up of toxic materials in the cells. Vestronidase alfa-vjbk acts by replacing the GUS enzyme and helps reduce the amount of toxic materials in the blood.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vestronidase alfa-vjbk injection in children. Safety and efficacy have been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of vestronidase alfa-vjbk injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for at least 4 hours.
Your doctor may want you to stay around for at least 60 minutes after receiving this medicine to check for serious unwanted effects.
You may be given other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before receiving this medicine to prevent unwanted effects.
Precautions
It is very important that your doctor check your progress to make sure that this medicine is working properly and to check for unwanted effects.
This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Rare
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- pale skin, pain, or redness at the injection site
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- tightness in the chest
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Fever with seizures
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Rare
- Diarrhea
- swelling at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20406772
