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Important Safety Information
Prescribing Information

About AVLAYAH
Results with AVLAYAH
Patient Support
Resources
Connect with Patient Services

About AVLAYAH
Results with AVLAYAH
Patient Support
Resources
Connect with Patient Services

Important Safety Information
Prescribing Information

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Indications & Important Safety Information

WHAT IS AVLAYAH?

AVLAYAH is approved for the treatment of neurologic symptoms in pediatric patients weighing at least 5 kg with Hunter syndrome prior to advanced neurologic disease. This approval is based on a reduction of heparan sulfate (HS) in the cerebrospinal fluid (CSF) surrounding the brain and spinal cord. Studies are ongoing to confirm how well it works in improving clinical symptoms.

AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome.

AVLAYAH may cause serious side effects, including:
Hypersensitivity Reactions including Anaphylaxis. Life-threatening allergic reactions occurred both early in treatment and after many doses over time, including:

Fast heartbeat
Dizziness or fainting
Wheezing

Vomiting
Hives
Swelling of the lips and tongue

Notify your healthcare provider immediately if these symptoms occur. If a serious allergic reaction happens, your treatment will be stopped and emergency treatment will be given, including use of epinephrine.

Infusion-Associated Reactions (IARs). IARs occurred during or within 24 hours after receiving AVLAYAH, including:

Chills
Swelling
Low blood pressure (dizziness or fainting)
Fast heartbeat
Hives
Wheezing
Fever
Flushing or reddening of the skin

Rash
Cough
Diarrhea
Abdominal pain
Vomiting
Headache
Irritability
Small bumps on the skin

If you have an IAR, your doctor may slow down, pause, adjust your dose, or stop the infusion depending on how serious the reaction is. You may also be given medicine before infusions to help prevent these reactions. Patients with heart or lung problems may be at higher risk of serious complications from these reactions and will be monitored closely.

Anemia (Low Red Blood Cell Count) occurred during AVLAYAH treatment and may require periodic laboratory tests for hemoglobin. Contact your healthcare provider if you experience any symptoms (e.g., fatigue, pale skin) suggestive of anemia.

Membranous Nephropathy (kidney disorder that affects the filters that help remove wastes and fluids from the kidney) occurred in an AVLAYAH treated patient. Your doctor will monitor your kidney function during treatment.

The most common side effects (in 20% or more of patients):

Infusion-associated reactions
Upper respiratory infections
Ear infection
Fever
Anemia (low red blood cell count)
Cough
Vomiting
Diarrhea

Rash
COVID-19
Runny or congested nose
Falls
Headache
Skin injuries
Hives

Contact your healthcare provider right away if you experience any side effects. These are not all the possible side effects of AVLAYAH. You may report side effects to FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Denali Therapeutics at 1-833-ONE-DNLI (1-833-663-3654).

Please see the full Prescribing Information for additional Important Safety Information, including serious side effects.

Indications & Important Safety Information

WHAT IS AVLAYAH?

AVLAYAH is approved for the treatment of neurologic symptoms in pediatric patients weighing at least 5 kg with Hunter syndrome prior to advanced neurologic disease. This approval is based on a reduction of heparan sulfate (HS) in the cerebrospinal fluid (CSF) surrounding the brain and spinal cord. Studies are ongoing to confirm how well it works in improving clinical symptoms.

AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome.

AVLAYAH may cause serious side effects, including:
Hypersensitivity Reactions including Anaphylaxis. Life-threatening allergic reactions occurred both early in treatment and after many doses over time, including:

Fast heartbeat
Dizziness or fainting
Wheezing

Vomiting
Hives
Swelling of the lips and tongue

Notify your healthcare provider immediately if these symptoms occur. If a serious allergic reaction happens, your treatment will be stopped and emergency treatment will be given, including use of epinephrine.

Infusion-Associated Reactions (IARs). IARs occurred during or within 24 hours after receiving AVLAYAH, including:

Chills
Swelling
Low blood pressure (dizziness or fainting)
Fast heartbeat
Hives
Wheezing
Fever
Flushing or reddening of the skin

Rash
Cough
Diarrhea
Abdominal pain
Vomiting
Headache
Irritability
Small bumps on the skin

If you have an IAR, your doctor may slow down, pause, adjust your dose, or stop the infusion depending on how serious the reaction is. You may also be given medicine before infusions to help prevent these reactions. Patients with heart or lung problems may be at higher risk of serious complications from these reactions and will be monitored closely.

Anemia (Low Red Blood Cell Count) occurred during AVLAYAH treatment and may require periodic laboratory tests for hemoglobin. Contact your healthcare provider if you experience any symptoms (e.g., fatigue, pale skin) suggestive of anemia.

Membranous Nephropathy (kidney disorder that affects the filters that help remove wastes and fluids from the kidney) occurred in an AVLAYAH treated patient. Your doctor will monitor your kidney function during treatment.

The most common side effects (in 20% or more of patients):

Infusion-associated reactions
Upper respiratory infections
Ear infection
Fever
Anemia (low red blood cell count)
Cough
Vomiting
Diarrhea

Rash
COVID-19
Runny or congested nose
Falls
Headache
Skin injuries
Hives

Contact your healthcare provider right away if you experience any side effects. These are not all the possible side effects of AVLAYAH. You may report side effects to FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Denali Therapeutics at 1-833-ONE-DNLI (1-833-663-3654).

Please see the full Prescribing Information for additional Important Safety Information, including serious side effects.

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C-US-TDA-00013 03/2026

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