Patient Leaflet Updated 01-Feb-2024 | SANOFI
Nexviadyme 100 mg powder for concentrate for solution for infusion
Nexviadyme 100 mg
powder for concentrate for solution for infusion
avalglucosidase alfa
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▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Nexviadyme is and what it is used for
2. What you need to know before you are given Nexviadyme
3. How Nexviadyme is given
4. Possible side effects
5. How to store Nexviadyme
6. Contents of the pack and other information
Nexviadyme contains an enzyme called avalglucosidase alfa – it is a copy of the natural enzyme called acid alpha-glucosidase (GAA) that is lacking in people with Pompe disease.
Nexviadyme is used to treat people of all ages who have Pompe disease.
People with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA). This enzyme helps control levels of glycogen (a type of carbohydrate) in the body. Glycogen provides the body with energy, but in Pompe disease high levels of glycogen build up in different muscles and damages them. The medicine replaces the missing enzyme so that the body can reduce the build-up of glycogen.
If you have had life-threatening allergic (hypersensitive) reactions to avalglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and these reactions occurred again after stopping and restarting the medicine.
Talk to your doctor or pharmacist or nurse before using Nexviadyme
Speak to your doctor immediately if treatment with Nexviadyme causes:
Also tell your doctor if you have swelling in your legs or widespread swelling of your body. Your doctor will decide if your Nexviadyme infusion should stop and the doctor will give you appropriate medical treatment. Your doctor will also decide if you can continue receiving avalglucosidase alfa.
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is no information about the use of Nexviadyme in pregnant women. You must not receive Nexviadyme during pregnancy unless your doctor specifically recommends it. You and your doctor should decide if you can use Nexviadyme if you are breast-feeding.
Nexviadyme may have a minor effect on the ability to drive and use machines. Because dizziness, low blood pressure and sleepiness can occur as infusion-associated reactions, this may affect the ability to drive and use machines on the day of the infusion.
Nexviadyme will be given to you under the supervision of a health care professional who is experienced in the treatment of Pompe disease.
You may be given other medicines before you receive Nexviadyme, to reduce some side effects. Such medicines include an antihistamine, a steroid and a medicine (such as paracetamol) to reduce fever.
The dose of Nexviadyme is based on your weight and will be given to you once every 2 weeks.
Home infusion
Your doctor may consider that you can have home infusion of Nexviadyme if it is safe and convenient to do so. If you get any side effects during an infusion of Nexviadyme, your home infusion staff member may stop the infusion and start appropriate medical treatment.
Instructions for proper use
Nexviadyme is given through a drip into a vein (intravenous infusion). It is supplied to the healthcare professional as a powder to mix with sterile water and further dilute with glucose before infusing it.
Excessive infusion rate of Nexviadyme may result in hot flush.
If you have missed an infusion, please contact your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Speak to your doctor if you wish to stop Nexviadyme treatment. The symptoms of your disease may worsen if you stop treatment.
Side effects mainly occur while patients are being given Nexviadyme infusion or shortly afterwards. You must tell your doctor immediately if you get an infusion-associated reaction or an allergic reaction. Your doctor may give you medicines before your infusion to prevent these reactions.
Infusion-associated reactions
Mostly infusion-associated reactions are mild or moderate. Symptoms of infusion-associated reaction include:
Allergic reactions
Allergic reactions may include symptoms such as:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
The reported side effects seen in children and adolescents were similar to those seen in adults.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Unopened vials:
Store in a refrigerator (2°C - 8°C).
Reconstituted solution:
After reconstitution, immediate use for dilution is recommended. The reconstituted solution can be stored up to 24 hours when refrigerated at 2°C to 8°C.
Diluted solution:
After dilution, immediate use is recommended. The diluted solution can be stored for 24 hours at 2°C to 8°C followed by 9 hours at room temperature (up to 25°C).
Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is avalglucosidase alfa. One vial contains 100 mg of avalglucosidase alfa. After reconstitution, the solution contains 10 mg of avalglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg/ml to 4 mg/ml.
The other ingredients are
Avalglucosidase alfa is a powder for concentrate for solution for infusion in a vial (100 mg/vial). Each pack contains 1, 5, 10, or 25 vials. Not all pack sizes may be marketed.
The powder is white to pale yellow. After reconstitution it is a clear, colourless to pale yellow solution. The reconstituted solution must be further diluted.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor, nurse or pharmacist.
This leaflet was last revised in December 2023.
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