Nexviazyme (Avalglucosidase Alfa)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Nexviazyme Used For?
Nexviazyme is a specialized medicine that replaces a missing or deficient enzyme in people with Pompe disease, a rare genetic condition.
Primary Uses
Nexviazyme is used to treat Pompe disease in patients one year of age and older. Pompe disease is a rare genetic condition where the body lacks or has low levels of an important enzyme.
How It Works
Nexviazyme contains avalglucosidase alfa, an artificial enzyme that replaces the natural acid alfa-glucosidase enzyme that is missing or reduced in Pompe disease. This enzyme helps the body control levels of glycogen (a type of carbohydrate).
Good to know: This is a new medicine with additional monitoring to quickly identify any new safety information.
How to Take Nexviazyme
Nexviazyme is given as an intravenous infusion (drip into a vein) by your doctor or nurse at a hospital or clinic.
Dosage Instructions
The recommended dose is 20 mg/kg of body weight, given every other week. The infusion takes approximately 4 hours for people with late-onset Pompe disease and approximately 6 hours for children with infantile-onset Pompe disease. You may be given medicines before the infusion to prevent allergic reactions.
What If You Miss a Dose?
It is very important to attend all your appointments to ensure your treatment works properly. If you miss an appointment, call your doctor or nurse as soon as possible to reschedule. Your healthcare team will decide how to continue your treatment.
Important: Never stop your treatment with Nexviazyme unless you have discussed it with your doctor first.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- headache
- dizziness
- cough
- difficulty breathing
- nausea
- diarrhea
- vomiting
- itchy skin
- hives
- rash
- redness of skin
- muscle spasms
- muscle aches
- pain in arm or leg
- fatigue
- chills
- chest discomfort
- pain
- injection site pain
- swollen eyelid and/or face
- feeling cold
- flu-like symptoms
Seek immediate medical attention if you experience:
- fast heart beat
- chest discomfort
- increased or decreased blood pressure
- difficulty breathing or swallowing
- low blood oxygen
- severe rash
- redness on palms and feet
- skin discoloration
- itchy palms and feet
- headache
- fever
- flushing
- dizziness
- tremor (shaking)
- nausea
- swollen lower lip and tongue
Important Warnings
There are important safety considerations to discuss with your doctor before starting Nexviazyme treatment.
Who Should Not Take Nexviazyme
Do not use Nexviazyme if you have had a severe life-threatening allergic reaction to avalglucosidase alfa or any ingredients in this medicine, and these reactions occurred again after stopping and restarting the medicine.
Medical Conditions to Discuss
Tell your doctor if you have any other medical conditions or take any medicines for other conditions. Always check the ingredients to make sure you can use this medicine safely.
Pregnancy and Breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant, as there is no experience with Nexviazyme use in pregnant women. Talk to your doctor if you are breastfeeding or intend to breastfeed.
Drug Interactions
Some medicines may interfere with Nexviazyme and affect how it works.
- Tell your doctor about all medicines, vitamins, or supplements you are taking
- Check with your doctor if you are unsure about what medicines might affect Nexviazyme
Alcohol & Driving
Take special care when driving or operating machinery after receiving Nexviazyme.
Alcohol
No specific alcohol warnings were mentioned in the source material.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Nexviazyme affects you. Take care when driving shortly after infusion, as you may experience dizziness, low blood pressure, and tiredness.
Storage
Nexviazyme will be stored at the hospital or clinic in a refrigerator. The medicine can be stored up to 24 hours when refrigerated at 2°C to 8°C, and diluted product can be stored up to 24 hours when refrigerated at 2°C to 8°C and up to 9 hours (including infusion time) when stored at room temperature. Keep it where young children cannot reach it.
Overdose Information
Faster infusion of Nexviazyme may result in infusion-related side effects. If you experience any unusual reactions, tell your doctor or nurse immediately. Your healthcare team is trained to calculate the correct dose and will treat and monitor any side effects if too much medicine is given.
Frequently Asked Questions
Nexviazyme is given every other week as an intravenous infusion at a hospital or clinic.
The infusion takes approximately 4 hours for people with late-onset Pompe disease and approximately 6 hours for children with infantile-onset Pompe disease.
If you are tolerating your infusions well, your doctor may consider home infusion after careful consideration of the risks and benefits.
Tell your doctor or nurse immediately if you experience any symptoms during or after the infusion. They may stop the infusion and provide appropriate medical treatment.
You may be given medicines before the infusion to prevent or reduce allergic reactions, such as antihistamines, corticosteroids, or medicines to reduce fever.
Always remind any doctor, dentist, or pharmacist you visit that you are using Nexviazyme, as this information is important for your care.
Your doctor may recommend blood tests to monitor your body’s response to Nexviazyme and ensure it is working effectively for your condition.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.