Vestronidase alfa-vjbk (Intravenous)

Vestronidase alfa-vjbk injection is used to treat Mucopolysaccharidosis VII (MPS VII) or Sly syndrome.

Sly syndrome is a condition caused by not having enough of an enzyme called beta-glucuronidase (GUS), which leads to a harmful build-up of toxic materials in the cells. Vestronidase alfa-vjbk works by replacing the GUS enzyme and helps lower the amount of toxic materials in the blood.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor monitors your progress to ensure that this medicine is working effectively and to identify any unwanted effects.

This medicine may cause a serious allergic reaction known as anaphylaxis. This can be life-threatening and needs immediate medical attention. Inform your doctor right away if you experience a rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after using this medicine.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as those to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any pediatric-specific problems that would limit the usefulness of vestronidase alfa-vjbk injection in children. Its safety and effectiveness have been established.

Geriatric

Studies have not been done to explore how age affects the effects of vestronidase alfa-vjbk injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. However, in some cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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.

In the U.S.

• Mepsevii

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vestronidase Alfa

Find detailed information on biosimilars for this medication.

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.