IMPORTANT SAFETY
INFORMATION
AND INDICATION
IMPORTANT SAFETY INFORMATION
WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS
Hypersensitivity Reactions Including Anaphylaxis
If you are taking NEXVIAZYME, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis and severe hypersensitivity reactions may occur during and after NEXVIAZYME treatment. You should seek immediate medical care if signs and symptoms of anaphylaxis or hypersensitivity reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after NEXVIAZYME administration.
Infusion-Associated Reactions (IARs)
If you are taking NEXVIAZYME, you should know that severe IARs may occur during and after NEXVIAZYME treatment. If severe IARs occur during your NEXVIAZYME infusion, your doctor may decide to immediately discontinue the infusion and provide appropriate medical care. If you have an acute underlying illness at the time of NEXVIAZYME infusion you may be at greater risk for IARs. If you have advanced Pompe disease you may have compromised heart and breathing function, which may put you at a higher risk of severe complications from IARs.
Risk of Acute Cardiorespiratory Failure in Susceptible Patients
If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion. Your doctor may decide that close observation during NEXVIAZYME administration may be necessary.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis: Life-threatening hypersensitivity reactions, including anaphylaxis, were observed in NEXVIAZYME-treated patients. Some of the hypersensitivity reactions were related to the immune system. Symptoms of anaphylaxis may include difficulty breathing, chest discomfort, flushing/feeling hot, cough, redness of the skin, lip swelling, itching, swollen tongue, difficulty swallowing, and rash. Symptoms of severe hypersensitivity reactions may include difficulty breathing, redness of the skin, hives, swollen tongue, and rash. Your doctor may decide to give you antihistamine, anti-fever and/or steroid medications before your infusions.
Infusion-Associated Reactions (IARs): In clinical studies, IARs were observed during and/or within a few hours after the NEXVIAZYME infusion. Symptoms of IARs that required stopping the infusion included chest discomfort, cough, dizziness, redness of the skin, flushing/feeling hot, nausea, redness of the eye, and difficulty breathing. Your doctor may decide to give you antihistamine, anti-fever and/or steroid medications before your infusions to decrease the risk of IARs; however, IARs may still occur after receiving these medications.
Risk of Acute Cardiorespiratory Failure in Susceptible Patients: If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion, and your doctor may decide that close observation during and after NEXVIAZYME administration may be necessary.
ADVERSE REACTIONS
The most common adverse reactions (>5%) were headache, fatigue, diarrhea, nausea, joint pain, dizziness, muscle pain, itching, vomiting, shortness of breath, rash, “pins-and-needles” sensation, and hives.
INDICATION
NEXVIAZYME (avalglucosidase alfa-ngpt) is used for the treatment of patients 1 year of age and older with late-onset Pompe disease [lysosomal acid alpha-glucosidase (GAA) deficiency].
Please see full Prescribing Information for complete details, including Boxed WARNING.