Vestronidase Alfa-vjbk

Vestronidase Alfa-vjbk is a recombinant human lysosomal beta glucuronidase indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

• Vestronidase Alfa-vjbk is available under the following different brand names: Mepsevii

Common side effects of Vestronidase Alfa-vjbk include:

• infusion site leakage or swelling
• diarrhea
• rash
• severe allergic reaction (anaphylaxis)
• swelling of the extremities
• itching

Serious side effects of Vestronidase Alfa-vjbk include:

• difficulty breathing
• fast heartbeat
• rash
• hives
• swelling of the face or tongue 
• tightness in the throat
• dizziness
• feeling confused 
• nausea
• diarrhea 
• stomach pain

Rare side effects of Vestronidase Alfa-vjbk include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, IV solution

• 2 mg/mL (10 mg/5 mL single-dose vial)

MPS VII

Adult and Pediatric dosage

• Premedication 30-60 minutes before IV infusions with a nonsedating antihistamine with or without an antipyretic medication is recommended

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Vestronidase Alfa-vjbk has severe interactions with no other drugs
• Vestronidase Alfa-vjbk has serious interactions with no other drugs
• Vestronidase Alfa-vjbk has moderate interactions with no other drugs
• Vestronidase Alfa-vjbk has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vestronidase Alfa-vjbk?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vestronidase Alfa-vjbk?”

Cautions

• Anaphylaxis was reported in the clinical program; reactions occurred during infusion and were observed as early as the first dose; manifestations included respiratory distress, cyanosis, decreased oxygen saturation, and hypotension; administer under the supervision of a healthcare professional with experience managing anaphylaxis

Pregnancy and Lactation

• No data are available regarding use in pregnant women
• When administered to pregnant rats and rabbits during organogenesis, vestronidase Alfa-vjbk showed no maternal toxicity or adverse developmental outcomes at doses causing maternal serum exposures up to 1.6 and 10 times, respectively for rats and rabbits, the exposure at the recommended human dose
• Lactation
  • Unknown if present in either human or animal milk; the effects on the breastfed infant or the effects on milk production