Updated Guidance
VYJUVEK is now approved for use from birth, can be applied by a caregiver or patient at-home, has an increased weekly volume, & has the flexibility of being removed at your next dressing change.
VYJUVEK is a topical gel indicated for the treatment of wounds in adult and pediatric patients (from birth) with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
WARNINGS AND PRECAUTIONS
Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following treatment. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.
Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.
Dispose all materials (e.g., vial, syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.
ADVERSE REACTIONSThe most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
VYJUVEK is a topical gel indicated for the treatment of wounds in adult and pediatric patients (from birth) with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
WARNINGS AND PRECAUTIONS
Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following treatment. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.
Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.
Dispose all materials (e.g., vial, syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.
ADVERSE REACTIONSThe most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
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