Is Beremagene geperpavec approved by the FDA?
Beremagene geperpavec topical, marketed under the brand name Vyjuvek, is an FDA-approved medication for treating wounds caused by dystrophic epidermolysis bullosa (DEB) in individuals aged six months and older. The FDA granted approval for this innovative treatment on May 19, 2023.
What is Beremagene Geperpavec Topical?
Beremagene geperpavec topical is a topical gel classified under miscellaneous topical agents. It is specifically designed to treat wounds associated with dystrophic epidermolysis bullosa, a rare genetic condition that causes the skin to be fragile and blister easily.
Usage and Dosage
- Dosage Form: Topical gel (svdt)
- Administration:
- Beremagene geperpavec topical is applied once a week by a healthcare provider.
- The healthcare provider will determine the number of treatments needed and will handle the application of the medicine.
- Follow up with your doctor for wound dressing changes and care.
Side Effects
Common side effects of beremagene geperpavec topical may include:
- Itching
- Chills
- Redness or rash
- Cough or runny nose
Serious allergic reactions, such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat, require immediate medical attention.
Warnings and Precautions
- Inform your doctor about any other medications or medical conditions you have.
- Use birth control during treatment and inform your doctor if you become pregnant.
- Consult your doctor to determine if it is safe to breastfeed while using this medication.
Treatment Considerations
- Avoid touching treated wounds and dressings for 24 hours after treatment.
- Prevent contact between treated wounds and untreated areas or other people. Rinse with water for at least 15 minutes if accidental exposure occurs.
Storage and Handling
Beremagene geperpavec topical is administered in a clinical or home setting by a healthcare provider. Proper storage and handling instructions will be provided by the healthcare professional.
Drug Interactions
- Inform your doctor about all other medications you are using, including prescription, over-the-counter medicines, vitamins, and herbal products, as they may interact with beremagene geperpavec topical.
Conclusion
Beremagene geperpavec topical (Vyjuvek) is an FDA-approved medication for the treatment of wounds caused by dystrophic epidermolysis bullosa. Approved on May 19, 2023, this topical gel provides a significant advancement in the management of this rare genetic condition. As always, follow your healthcare provider's instructions and report any side effects or concerns during treatment.
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