Vyjuvek (beremagene geperpavec or beremagene geperpavec-svdt) is a topical gel that's used to treat wounds on the skin of people ages 6 months and older with a rare genetic problem called dystrophic epidermolysis bullosa (DEB). It's a type of gene therapy that helps skin cells make a certain protein that seals wounds and strengthens skin. Vyjuvek is applied onto the wounds once per week by a healthcare provider. Side effects include itching and chills.
There's a gene in your body called COL7A1 that normally gives your skin cells instructions on how to make a protein called COL7 (or type VII collagen). This collagen protein helps strengthen and support your skin.
But people with dystrophic epidermolysis bullosa (DEB) have abnormal versions (mutations) of the COL7A1 gene. This causes your skin cells to not make enough COL7 proteins that work properly, which can lead to skin problems and wounds.
Vyjuvek is a type of gene therapy. When you apply it to your skin, it delivers normal copies of the COL7A1 gene to your skin cells. This allows your skin cells to make functional COL7 protein that can help close skin wounds and make healthy skin.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
In a small clinical study, 71% of dystrophic epidermolysis bullosa wounds completely healed after 3 months of treatment with Vyjuvek. Another 3 months later, 67% of the wounds that were treated with the medication were completely healed.
Yes, Vyjuvek is a gene therapy. Gene therapy medications are used to treat genetic conditions by replacing abnormal or missing genes in your cells with working genes. Once the working gene gets into your cells, your cells use the gene as a blueprint to make proteins that work properly. Some people with dystrophic epidermolysis bullosa (DEB) don't make enough of a collagen protein called COL7 because they have an abnormal COL7A1 gene. Vyjuvek is a gel that's applied onto the skin wounds of people with this type of DEB. The medication delivers a working COL7A1 gene to the skin cells so they can make COL7 and seal open skin wounds.
No, Vyjuvek can only be given by a healthcare provider because the medication has special storage, preparation, and administration requirements. When you first start treatment, your provider will apply Vyjuvek onto your skin wounds at their office or clinic. But it's also possible to get treated with Vyjuvek at home with a healthcare provider there to apply the medication onto your skin wounds. Ask your provider whether this is an option for you.
It's not known whether Vyjuvek is safe for you if you're pregnant because it hasn't been studied. If you're pregnant, you shouldn't prepare or apply Vyjuvek. You also should avoid direct contact with treated wounds or dressings from treated wounds. The manufacturer recommends that you should use birth control during treatment if you're able to get pregnant. Talk to your provider if you're pregnant or thinking of getting pregnant.
It's not known whether Vyjuvek is safe for you or your baby while you're breastfeeding because it hasn't been studied. Talk to your provider if you're currently breastfeeding.
Vyjuvek can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Vyjuvek won't work on healthy parts of your skin. But it's still important to be careful to avoid accidentally getting the medication onto other parts of your body. Don't scratch or touch wounds or their dressings for at least 24 hours after you get each Vyjuvek treatment. Additionally, make sure to wear protective gloves when you're handling or changing wound dressings. If you accidentally get Vyjuvek in your eyes, mouth, or nose, flush the area with clean water for at least 15 minutes. Get medical help if you have any side effects like burning, stinging, or tingling in an area of your body that was exposed to Vyjuvek.
Your Vyjuvek dose will depend on the size of your wound(s). Your healthcare provider will help apply the medication onto your wound(s).