openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings and cautions
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. For precautions, Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of an accidental exposure through a splash to the eyes or mucous membranes, flush with clean water for at least 15 minutes.
warnings and cautions
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. For precautions, Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of an accidental exposure through a splash to the eyes or mucous membranes, flush with clean water for at least 15 minutes.
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. The median duration of exposure to VYJUVEK gel was 25 weeks. The most frequent adverse reactions (incidence >5%) observed in the study are summarized in Table 3. There were no discontinuations due to adverse reactions. Table 3 Adverse Reactions (incidence >5%) Following Treatment with VYJUVEK gel (n =31) Adverse Reactions Patients n (%) Itching 3 (10) Chills 3 (10) Redness 2 (6) Rash 2 (6) Cough 2 (6) Runny Nose 2 (6) In addition, the safety profile of VYJUVEK in two patients with autosomal recessive DEB (RDEB) of six and seven months of age, respectively, who received topical VYJUVEK gel weekly in an open-label study was similar to the safety profile of VYJUVEK observed in the randomized, intra-patient placebo‑controlled study described above.
adverse reactions
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. The median duration of exposure to VYJUVEK gel was 25 weeks. The most frequent adverse reactions (incidence >5%) observed in the study are summarized in Table 3. There were no discontinuations due to adverse reactions. Table 3 Adverse Reactions (incidence >5%) Following Treatment with VYJUVEK gel (n =31) Adverse Reactions Patients n (%) Itching 3 (10) Chills 3 (10) Redness 2 (6) Rash 2 (6) Cough 2 (6) Runny Nose 2 (6) In addition, the safety profile of VYJUVEK in two patients with autosomal recessive DEB (RDEB) of six and seven months of age, respectively, who received topical VYJUVEK gel weekly in an open-label study was similar to the safety profile of VYJUVEK observed in the randomized, intra-patient placebo‑controlled study described above.