Prescription medicine
Tividenofusp alfa Brand names: Avlayah
Tividenofusp alfa (Avlayah) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the tividenofusp alfa FDA label on DailyMed (effective March 20, 2026); every tividenofusp alfa label on DailyMed.
Highlights of the record
FDA label of March 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with enzyme replacement therapies, including AVLAYAH, have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue AVLAYAH and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageAVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
Forms and strengths
- 150 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is tividenofusp alfa used for?
From the label: indications and usageAVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome. […]
FDA pharmacologic class: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme.
Source: FDA drug label (AVLAYAH), Denali Therapeutics Inc., effective March 20, 2026 (SPL set 014d92c1-b643-4680-8ca6-f0b3307da915), via openFDA; the full label on DailyMed
Is there a generic for tividenofusp alfa (Avlayah)?
No generic tividenofusp alfa is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tividenofusp alfa label say about other medicines?
The tividenofusp alfa label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | boxed warning | … anaphylaxis) occurs, discontinue AVLAYAH and immediately initiate appropriate medical treatment, including use of epinephrine. |
Source: FDA drug label (AVLAYAH), Denali Therapeutics Inc., effective March 20, 2026 (SPL set 014d92c1-b643-4680-8ca6-f0b3307da915), via openFDA; the full label on DailyMed
What next?
- Other hydrolytic lysosomal glycosaminoglycan-specific enzymes
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other