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Drug overview for VYJUVEK (beremagene geperpavec-svdt):
Generic name: beremagene geperpavec-svdt
Drug class: Dermatological - Gene Therapy Agents
Therapeutic class: Dermatological
Beremagene geperpavec-svdt is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy.
No enhanced Uses information available for this drug.
Generic name: beremagene geperpavec-svdt
Drug class: Dermatological - Gene Therapy Agents
Therapeutic class: Dermatological
Beremagene geperpavec-svdt is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for VYJUVEK (beremagene geperpavec-svdt) have been approved by the FDA:
Indications:
Dystrophic epidermolysis bullosa
Professional Synonyms:
Epidermolysis bullosa dystrophica
Indications:
Dystrophic epidermolysis bullosa
Professional Synonyms:
Epidermolysis bullosa dystrophica
The following dosing information is available for VYJUVEK (beremagene geperpavec-svdt):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For topical application only. Beremagene geperpavec-svdt gel is applied topically to wound(s) once a week.
Prepare the gel at the pharmacy by mixing beremagene geperpavec-svdt biological suspension into the excipient gel for immediate use within 8 hours of application. Only a healthcare professional should apply the gel either at a healthcare professional setting (e.g., clinic) or the home setting. Individuals who are pregnant should not prepare or apply the gel and should avoid direct contact with the treated wounds or dressings from treated wounds.
The recommended dose of beremagene geperpavec-svdt gel is based on age (see Table 1).
Table 1: Maximum Weekly Dose by Age
Age Range Maximum Weekly Dose Maximum Weekly Volume (plaque forming units; (mL) PFU) 6 months to <3 years old 1.6x109 0.8 >= 3 years old 3.2x109
1.6
Maximum weekly volume is the volume after mixing beremagene geperpavec-svdt biological suspension with excipient gel.
Apply beremagene geperpavec-svdt gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1 cm-by-1 cm apart. The table below provides a reference on dose per approximate size of the wound.
Table 2: Dose per Approximate Size of Wound
Wound Area (cm2) Dose (PFU) Volume (mL) <20 4x108 0.2 20 to <40 8x108 0.4 40 to 60 1.2x109
0.6
For wound area over 60 cm2, recommend calculating the total dose based on this table until the maximum weekly dose is reached.
It may not be possible to apply the gel to all the wounds at each treatment visit. Apply 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 full prescribing information for instructions on preparation and handling, and administration.
For topical application only. Beremagene geperpavec-svdt gel is applied topically to wound(s) once a week.
Prepare the gel at the pharmacy by mixing beremagene geperpavec-svdt biological suspension into the excipient gel for immediate use within 8 hours of application. Only a healthcare professional should apply the gel either at a healthcare professional setting (e.g., clinic) or the home setting. Individuals who are pregnant should not prepare or apply the gel and should avoid direct contact with the treated wounds or dressings from treated wounds.
The recommended dose of beremagene geperpavec-svdt gel is based on age (see Table 1).
Table 1: Maximum Weekly Dose by Age
Age Range Maximum Weekly Dose Maximum Weekly Volume (plaque forming units; (mL) PFU) 6 months to <3 years old 1.6x109 0.8 >= 3 years old 3.2x109
1.6
Maximum weekly volume is the volume after mixing beremagene geperpavec-svdt biological suspension with excipient gel.
Apply beremagene geperpavec-svdt gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1 cm-by-1 cm apart. The table below provides a reference on dose per approximate size of the wound.
Table 2: Dose per Approximate Size of Wound
Wound Area (cm2) Dose (PFU) Volume (mL) <20 4x108 0.2 20 to <40 8x108 0.4 40 to 60 1.2x109
0.6
For wound area over 60 cm2, recommend calculating the total dose based on this table until the maximum weekly dose is reached.
It may not be possible to apply the gel to all the wounds at each treatment visit. Apply 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 full prescribing information for instructions on preparation and handling, and administration.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for VYJUVEK (beremagene geperpavec-svdt):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VYJUVEK (beremagene geperpavec-svdt):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for VYJUVEK (beremagene geperpavec-svdt):
Adverse reaction overview.
The most common adverse reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose.
The most common adverse reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose.
There are 0 severe adverse reactions.
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Chills Cough Erythema Pruritus of skin Rhinorrhea Skin rash |
None. |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for VYJUVEK (beremagene geperpavec-svdt):
The safety and effectiveness of beremagene geperpavec-svdt gel was studied in pediatric patients. The safety and efficacy findings in pediatric patients were similar to safety and efficacy findings in adult patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no data with beremagene geperpavec-svdt gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with beremagene geperpavec-svdt. 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.
If the patient becomes pregnant while being administered beremagene geperpavec-svdt 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 beremagene geperpavec gel.
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.
If the patient becomes pregnant while being administered beremagene geperpavec-svdt 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 beremagene geperpavec gel.
There is no information available on the presence of beremagene geperpavec in human milk, the effects on the breastfed infant, or the effects on milk production. Animal lactation studies have not been conducted with beremagene geperpavec-svdt. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for beremagene geperpavec and any potential adverse effects on the breastfed child from beremagene geperpavec or from the underlying maternal condition.
Clinical studies of beremagene geperpavec-svdt gel did not include geriatric patients 65 years of age and over.
The following prioritized warning is available for VYJUVEK (beremagene geperpavec-svdt):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VYJUVEK (beremagene geperpavec-svdt)'s list of indications:
| Dystrophic epidermolysis bullosa | |
| Q81.2 | Epidermolysis bullosa dystrophica |
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