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Vyjuvek Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Carton—1 (susp vial + excipient gel vial)
Manufacturer
Generic Availability
NO
Mechanism of Action
Upon topical application to the wounds, Vyjuvek can transduce both keratinocytes and fibroblasts. Following its entry into the cells, the vector genome is deposited in the nucleus. Once in the nucleus, transcription of the encoded human COL7A1 is initiated. The resulting transcripts allow for production and secretion of COL7 by the cell in its mature form. These COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils. The anchoring fibrils hold the epidermis and dermis together and are essential for maintaining the integrity of the skin.
Vyjuvek Indications
Indications
Treatment of wounds in dystrophic epidermolysis bullosa (DEB) with mutations in the collagen type VII alpha 1 chain (COL7A1) gene in patients aged ≥6mos.
Vyjuvek Dosage and Administration
Adults and Children
For topical use only. <6mos: not established. 6mos–<3yrs: Apply 1.6X109 plaque forming units (PFU)/week (0.8mL/week). ≥3yrs: Apply 3.2X109 PFU/week (1.6mL/week). Apply to wounds until closed before treating new wound(s).
Vyjuvek Contraindications
Not Applicable
Vyjuvek Boxed Warnings
Not Applicable
Vyjuvek Warnings/Precautions
Warnings/Precautions
Avoid direct contact with treated wounds and dressings for ~24hrs post-treatment. Flush with clean water for ≥15mins if accidental exposure occurs. Advise females of reproductive potential to use effective contraception during therapy. Pregnancy. Nursing mothers.
Vyjuvek Pharmacokinetics
See Literature
Vyjuvek Interactions
Not Applicable
Vyjuvek Adverse Reactions
Adverse Reactions
Itching, chills, redness, rash, cough, runny nose.
Vyjuvek Clinical Trials
See Literature
Vyjuvek Note
Not Applicable
Vyjuvek Patient Counseling
See Literature
