Vyjuvek
Generic Name: vyjuvek
Brand Names:
Vyjuvek
11 DESCRIPTION VYJUVEK (beremagene geperpavec-svdt) is a suspension of an HSV-1 vector-based gene therapy, mixed with the supplied sterile excipient gel for topical application on wounds. VYJUVEK is a live, replication defective HSV-1-based vector that has been genetically modified to express the human type VII collagen (COL7) protein. The parental virus for VYJUVEK was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.
Overview
11 DESCRIPTION VYJUVEK (beremagene geperpavec-svdt) is a suspension of an HSV-1 vector-based gene therapy, mixed with the supplied sterile excipient gel for topical application on wounds. VYJUVEK is a live, replication defective HSV-1-based vector that has been genetically modified to express the human type VII collagen (COL7) protein. The parental virus for VYJUVEK was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.
Uses
1 INDICATIONS AND USAGE VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. (1)
Dosage
2 DOSAGE AND ADMINISTRATION For topical application only. Age Range Maximum Weekly Dose (PFU) Maximum Weekly Volume (mL)* <3 years old 2×10 9 1 ≥3 years old 4×10 9 2 PFU=plaque forming units; mL=milliliter *Maximum weekly volume after mixing VYJUVEK biological suspension with excipient gel Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart. (2.3) Apply VYJUVEK gel on wounds once a week. (2.1) See full prescribing information for instructions on preparation and handling, (2.2) and administration (2.3) . 2.1 Dose For topical application on wounds only. The recommended dose of VYJUVEK gel is based on age (Table 1). VYJUVEK gel is applied topically to wound(s) once a week.
Side Effects
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.
Interactions
7 DRUG INTERACTIONS No drug interaction studies have been performed.
Warnings
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. 4 CONTRAINDICATIONS None. None. (4)
Pregnancy
8.1 Pregnancy Risk Summary There are no data with VYJUVEK gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with VYJUVEK. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Storage
16.2 Storage and Handling Store the VYJUVEK carton in the pharmacy at -15°C to -25°C (5°F to -13°F). If a freezer is not available, the carton can be refrigerated in the pharmacy (2° to 8°C (35.6° to 46.4°F)) for up to 1 month. Prior to use, VYJUVEK requires mixing into excipient gel in the pharmacy.
Frequently Asked Questions
What is Vyjuvek used for?▼
1 INDICATIONS AND USAGE VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. (1)
What are the side effects of Vyjuvek?▼
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.
Can I take Vyjuvek during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data with VYJUVEK gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with VYJUVEK. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What are the important warnings for Vyjuvek?▼
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. 4 CONTRAINDICATIONS None. None. (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.