Vyjuvek

FDA Drug Information • Also known as: Vyjuvek

Brand Names: Vyjuvek
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

Description

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. VYJUVEK is an opalescent yellow to colorless biological suspension following thaw from its frozen state. Each 1 mL VYJUVEK vial contains 5×10 9 PFU/mL of VYJUVEK in a solution of 100.0 mL/L Glycerol, 8.0 mg/mL Sodium Chloride, 2.16 mg/mL Sodium Phosphate Dibasic, 0.2 mg/mL Potassium Chloride, 0.2 mg/mL Potassium Phosphate Monobasic. The excipient gel is a clear viscous solution, following thaw from its frozen state. Each 1.5 mL Excipient Gel vial contains 44 mg/mL Hydroxypropyl Methylcellulose in a solution of 0.91 mg/mL Tromethamine, 9.0 mg/mL Sodium Chloride, 0.726 mg/mL Sodium Phosphate Dibasic, 0.21 mg/mL Potassium Phosphate Monobasic. VYJUVEK biological suspension is mixed into excipient gel prior to administration. After mixing, VYJUVEK gel consists of 5×10 9 PFU in a volume of 2.5 mL. Neither VYJUVEK biological suspension nor the excipient gel contains preservatives.

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)

Dosage and Administration

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. Table 1 Maximum Weekly Dose of VYJUVEK by Age 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 unit; mL=milliliter *Maximum weekly volume is the volume after mixing VYJUVEK biological suspension with excipient gel. It may not be possible to apply VYJUVEK gel to all the wounds at each treatment visit. Apply VYJUVEK gel to wounds until they are closed before selecting new wound(s) to treat. Prioritize weekly treatment to previously treated wounds if they re-open. [ see Administration (2.3) ] If a dose is missed, apply VYJUVEK gel as soon as possible and resume weekly dosing thereafter. 2.2 Preparation Important Preparation Instructions Prepare VYJUVEK gel at the pharmacy by mixing the VYJUVEK biological suspension into the excipient gel for immediate use. [see Storage and Handling ( 16.2 )] The VYJUVEK gel prepared at the pharmacy, should be applied by a healthcare professional (HCP), patient, or caregiver either at a healthcare professional setting (e.g., clinic) or at a home setting. Individuals who are pregnant should not prepare or apply VYJUVEK gel and should avoid direct contact with the treated wounds or dressings from treated wounds [see Accidental Exposure to VYJUVEK ( 5.1 )]. Below is the list of supplies needed for VYJUVEK gel preparation: One (1) carton containing one (1) VYJUVEK biological suspension vial and one (1) excipient gel vial (Figure 1) Two (2) 18-gauge needles Two (2) to four (4) 1 mL administration syringes One (1) 3 mL preparation syringe Two (2) to four (4) syringe caps Protective gloves 70% isopropyl alcohol pads Biohazard container Labels for administration syringes Virucidal agent for clean-up Follow the steps below for VYJUVEK gel preparation. PREPARE THE PREPARATION SYRINGE 1. Wash hands and put on protective gloves. 2. Remove both vials from the carton and thaw the VYJUVEK biological suspension vial and the excipient gel vial at room temperature for AT LEAST 20 minutes (Figure 1). Figure 1 Carton containing the VYJUVEK biological suspension vial and excipient gel vial Note: Visually inspect the vials to ensure both are in liquid form and completely thawed. Excipient gel is more viscous and will take longer...

Side Effects (Adverse Reactions)

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. 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.

Drug Interactions

7 DRUG INTERACTIONS No drug interaction studies have been performed.

Contraindications

4 CONTRAINDICATIONS None. None. (4)

Pregnancy and Breastfeeding

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. Clinical Considerations If the patient becomes pregnant while being administered VYJUVEK gel, the patient should be apprised of the potential hazards to the fetus and neonate. Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with VYJUVEK gel.

How Supplied

16 HOW SUPPLIED/ STORAGE AND HANDLING 16.1 How Supplied Each carton of VYJUVEK (NDC 82194-510-02) contains one single-dose vial of VYJUVEK biological suspension and one single-dose vial of excipient gel. VYJUVEK biological suspension (inner NDC 82194-501-01), green cap, is supplied as a 1 mL extractable volume in a single-use, single-dose vial containing 5×10 9 PFU/mL. Excipient gel (inner NDC 82194-001-01), blue cap, is supplied as a 1.5 mL fill volume in a separate single-use, single-dose vial. 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. Administration syringes containing the VYJUVEK gel may remain at room temperature (20 to 25°C (68° to 77°F)) for up to 8 hours prior to application. If immediate use is not possible, administration syringes can be kept in an appropriate insulated or temperature regulated secondary container for up to 48 hours at 2° to 8°C (35.6° to 46.4°F). Discard material if it falls out of the parameters described above. VYJUVEK is a replication deficient HSV-1-based gene therapy. See Dosage and Administration (2) for appropriate handling, preparation, application, and disposal of materials. Follow universal biohazard precautions for handling. 16.1 How Supplied Each carton of VYJUVEK (NDC 82194-510-02) contains one single-dose vial of VYJUVEK biological suspension and one single-dose vial of excipient gel. VYJUVEK biological suspension (inner NDC 82194-501-01), green cap, is supplied as a 1 mL extractable volume in a single-use, single-dose vial containing 5×10 9 PFU/mL. Excipient gel (inner NDC 82194-001-01), blue cap, is supplied as a 1.5 mL fill volume in a separate single-use, single-dose vial.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.