Nexviazyme
- Generic Name: avalglucosidase alfa-ngpt for injection
- Brand Name: Nexviazyme
Nexviazyme (Avalglucosidase Alfa-ngpt for Injection) side effects drug center
Nexviazyme Side Effects Center
What Is Nexviazyme?
Nexviazyme (avalglucosidase alfa-ngpt) is a hydrolytic lysosomal glycogen-specific enzyme used to treat patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency).
What Are Side Effects of Nexviazyme?
Side effects of Nexviazyme include:
- headache,
- fatigue,
- diarrhea,
- nausea,
- joint pain,
- dizziness,
- muscle aches,
- itching,
- vomiting,
- shortness of breath,
- skin redness,
- numbness and tingling, and
- hives.
Dosage for Nexviazyme
Nexviazyme is administered as intravenous infusion. For patients weighing 30 kg or more, the recommended dosage of Nexviazyme is 20 mg/kg (of actual body weight) every two weeks. For patients weighing less than 30 kg, the recommended dosage of Nexviazyme is 40 mg/kg (of actual body weight) every two weeks.
Nexviazyme In Children
The safety and effectiveness of Nexviazyme for the treatment of late-onset Pompe disease have been established in pediatric patients 1 year of age and older.
The safety and effectiveness of Nexviazyme have not been established in pediatric patients younger than 1 year of age.
What Drugs, Substances, or Supplements Interact with Nexviazyme?
Nexviazyme may interact with other medicines.
Tell your doctor all medications and supplements you use.
Nexviazyme During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Nexviazyme; it is unknown how it could affect a fetus. The continuation of treatment for Pompe disease during pregnancy should be individualized to the pregnant woman. Untreated Pompe disease may result in worsening disease symptoms in pregnant women. It is unknown if Nexviazyme passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Nexviazyme (avalglucosidase alfa-ngpt) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Nexviazyme Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions Including Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Infusion-Associated Reactions (IARs) [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions From Clinical Trials In The Pompe Disease Population
The pooled safety analysis from 4 clinical trials (mean exposure of 26 months, up to 85 months of treatment) included a total of 141 NEXVIAZYME-treated patients (118 adult and 23 pediatric patients) [see Clinical Studies].
Serious adverse reactions reported in 2 or more NEXVIAZYME-treated patients were respiratory distress, chills, and pyrexia. Serious adverse events were similar across both adult and pediatric populations.
A total of 5 NEXVIAZYME-treated patients in clinical trials permanently discontinued NEXVIAZYME due to adverse reactions, including 2 of these patients who discontinued the treatment because of a serious adverse reaction.
The most frequently reported adverse reactions (>5%) in the pooled safety population were headache, diarrhea, nausea, fatigue, arthralgia, myalgia, dizziness, rash, vomiting, pyrexia, abdominal pain, pruritus, erythema, abdominal pain upper, chills, cough, urticaria, dyspnea, hypertension, and hypotension.
IARs were reported in 48 (34%) NEXVIAZYME-treated patients. IARs reported in more than 1 patient included chills, cough, diarrhea, erythema, fatigue, headache, influenza-like illness, nausea, ocular hyperemia, pain in extremity, pruritus, rash, rash erythematous, tachycardia, urticaria, vomiting, chest discomfort, dizziness, hyperhidrosis, lip swelling, oxygen saturation decreased, pain, palmar erythema, swollen tongue, abdominal pain upper, burning sensation, eyelid edema, feeling cold, flushing, respiratory distress, throat irritation, and tremor [see v].
Adverse Reactions From Clinical Trials In Late-Onset Pompe Disease (LOPD)
In Study 1, 100 patients aged 16 to 78 years of age with LOPD (naive to enzyme replacement therapy) were treated with either 20 mg/kg of NEXVIAZYME (n=51) or 20 mg/kg of alglucosidase alfa (n=49) given every other week as an intravenous infusion for 49 weeks followed by an open-label extension period [see Clinical Studies].
During the double-blind active-controlled period of 49 weeks, serious adverse reactions were reported in 1 (2%) patient treated with NEXVIAZYME and in 3 (6%) patients treated with alglucosidase alfa. The most frequently reported adverse reactions in (>5%) NEXVIAZYME-treated patients were headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
IARs were reported in 13 (25%) of the NEXVIAZYME-treated patients. IARs reported in more than 1 patient on NEXVIAZYME were mild to moderate and included headache, diarrhea, pruritus, urticaria, and rash. None of them were severe IARs. IARs were reported in 16 (33%) patients treated with alglucosidase alfa. IARs reported in more than 1 patient on alglucosidase alfa were mild to severe and included dizziness, flushing, dyspnea, nausea, pruritis, rash, erythema, chills, and feeling hot. Severe IARs were reported in 2 patients treated with alglucosidase alfa.
Table 2 summarizes the adverse reactions that occurred in at least 3 NEXVIAZYME-treated patients (≥6%) in Study 1. Study 1 was not designed to demonstrate a statistically significant difference in the incidence of adverse reactions in the NEXVIAZYME and the alglucosidase alfa treatment groups.
Table 2: Adverse Reactions Reported in at Least 6% of NEXVIAZYME-Treated Patients with LOPD in Study 1
| Adverse Reaction | NEXVIAZYME (N=51) n (%) |
Alglucosidase Alfa (N=49) n (%) |
| Headache | 11 (22%) | 16 (33%) |
| Fatigue | 9 (18%) | 7 (14%) |
| Diarrhea | 6 (12%) | 8 (16%) |
| Nausea | 6 (12%) | 7 (14%) |
| Arthralgia | 5 (10%) | 8 (16%) |
| Dizziness | 5 (10%) | 4 (8%) |
| Myalgia | 5 (10%) | 7 (14%) |
| Pruritus | 4 (8%) | 4 (8%) |
| Vomiting | 4 (8%) | 3 (6%) |
| Dyspnea | 3 (6%) | 4 (8%) |
| Erythema | 3 (6%) | 3 (6%) |
| Paresthesia | 3 (6%) | 2 (4%) |
| Urticaria | 3 (6%) | 1 (2%) |
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other avalglucosidase alfa products may be misleading.
The incidence of anti-avalglucosidase alfa-ngpt antibodies (antidrug antibodies, ADA) in NEXVIAZYME-treated patients with Pompe disease is shown in Table 3. In NEXVIAZYME-treated patients (mean of 26 months, up to 85 months of treatment), the incidence of IAR was 62% (8/13) in those with an ADA peak titer ≥12,800, compared with incidences of 19% (8/43) in those with ADA peak titer <12,800 and 33% (1/3) in those who were ADA-negative [see WARNINGS AND PRECAUTIONS]. Increased incidence of hypersensitivity reactions was observed in patients with higher ADA titers (4/13, 31%) compared to lower ADA titers (2/14, 14%). In enzyme replacement therapy (ERT)-experienced adult patients, the occurrences of IARs and hypersensitivity reactions were higher in patients who developed ADA compared to patients who were ADA-negative. One (1) treatment-naive patient (ADA peak titer 3,200) and 2 treatment-experienced patients (ADA peak titers; 800 and 12,800, respectively) developed anaphylaxis [see WARNINGS AND PRECAUTIONS].
The median time to seroconversion was 8 weeks. No clear trend of ADA impact on pharmacokinetics was observed [see CLINICAL PHARMACOLOGY]. A trend toward decreased pharmacodynamic response as measured by percent change of urinary glucose tetrasaccharides from baseline was observed in patients with ADA peak titer ≥12,800. The development of ADA did not have an apparent impact on clinical efficacy.
ADA cross-reactivity studies showed that antibodies to avalglucosidase alfa-ngpt were cross-reactive to alglucosidase alfa.
Table 3: Incidence of Anti-Avalglucosidase Alfa-ngpt Antibodies in Patients with Pompe Disease
| NEXVIAZYME | ||||
| Treatment-Naive Patients Avalglucosidase alfa-ngpt ADA* (N=61)† |
Treatment-Experienced Patients Avalglucosidase alfa-ngpt ADA (N=74)‡ |
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| Adults/Pediatrics 20 mg/kg every two weeks (N=61)† |
Adults 20 mg/kg every two weeks (N=58) |
Pediatrics 20 mg/kg every two weeks (N=6) |
Pediatrics 40 mg/kg every two weeks (N=10) |
|
| n (%) | n (%) | n (%) | n (%) | |
| ADA at baseline | 2 (3%) | 43 (74%) | 1 (17%) | 1 (10%) |
| ADA after treatment | 58 (95%) | 32 (55%) | 1 (17%) | 5 (50%) |
| Neutralizing Antibody (NAb) | ||||
| Both NAb types | 13 (21%) | 3 (5%) | 0 | 0 |
| Inhibition of enzyme activity | 17 (28%) | 10 (18%) | 0 | 0 |
| Inhibition of enzyme cellular uptake | 24 (39%) | 12 (21%) | 0 | 1 (10%) |
| * Includes one pediatric patient † Treatment naive: only treated with avalglucosidase alfa-ngpt ‡ Treatment experienced: previously treated with alglucosidase alfa. Treatment-experienced patients received alglucosidase alfa treatment within a range of 0.9-9.9 years for adult patients and 0.5-11.7 years for pediatric patients before receiving NEXVIAZYME. |
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DRUG INTERACTIONS
No Information provided
Read the entire FDA prescribing information for Nexviazyme (Avalglucosidase Alfa-ngpt for Injection)
&Copy; Nexviazyme Patient Information is supplied by Cerner Multum, Inc. and Nexviazyme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.