Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc.
at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
6.1 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.
The safety data described in this section reflects exposure to VYJUVEK gel in a randomized, intra-patient placebo‑controlled study.
A total of 31 patients with dystrophic epidermolysis bullosa (DEB), including 30 patients with autosomal recessive DEB and one patient with autosomal dominant DEB received topical administration of VYJUVEK gel to their wounds.
The age of the patients ranged from 1 year to 44 years (mean age 17 years).
Of the 31 patients, 19 (61%) were pediatric patients (less than 17 years of age), and 11 (36%) were females.
Each patient received weekly topical application of VYJUVEK gel at one or more wound sites and placebo at a matching wound site as an intra-subject comparator.
5 WARNINGS AND PRECAUTIONS Accidental Exposure to VYJUVEK: Avoid direct contact with treated wounds and dressings of treated wounds until the next dressing change, following application.
Clean the affected area if accidental exposure occurs.
(5.1) 5.1 Accidental Exposure to VYJUVEK Accidental exposure to VYJUVEK may occur to close contacts and caregivers.
VYJUVEK is a genetically modified, herpes-simplex virus type 1 vector-based, replication-deficient, non-integrating gene therapy.
VYJUVEK will not replicate in the patient’s cells and does not integrate into the patient cells’ native genetic material.
Like all medications, Vyjuvek can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: