VYJUVEK- vyjuvek
Krystal Biotech, Inc.
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MEDICATION GUIDE
VYJUVEK (Vye-JOO-vek) Gel
(beremagene geperpavec-svdt)
biological suspension mixed with gel, for topical use
| What is the most important information I should know about VYJUVEK Gel?
…The VYJUVEK® biological suspension must be mixed with the gel at the pharmacy prior to use. …VYJUVEK gel should be applied by a healthcare professional (HCP) or by a patient/caregiver either at a healthcare professional setting (e.g., clinical) or a home setting. |
| What is VYJUVEK Gel?
…VYJUVEK gel is a prescription medicine for the treatment of wounds (topical use only), in adult and pediatric patients who have dominant or recessive dystrophic epidermolysis bullosa. |
| Who should not take VYJUVEK Gel?
… 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. |
| Before taking VYJUVEK Gel, tell your healthcare provider about all of your medical conditions, including if you:
… are pregnant or plan to become pregnant. It is not known if VYJUVEK gel will harm your unborn baby. …are breast feeding or plan to breast feed. It is not known if VYJUVEK gel passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
| How should I take VYJUVEK Gel?
…See the Instructions For Use for detailed instructions. …Use VYJUVEK exactly as your healthcare providers tells you to and do not use past the expiration date. If you have questions, reach out to your provider or the pharmacy for further instructions. |
| What should I avoid while taking VYJUVEK Gel?
…Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following VYJUVEK gel application. …Individuals should wear protective gloves when assisting with changing wound dressings and handling the disposal of the dressings. |
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What are the possible side effects of VYJUVEK Gel?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| How should I store VYJUVEK Gel?
…See the Instructions For Use for detailed instructions. …VYJUVEK gel syringes may remain at room temperature (20° to 25°C (68° to 77°F)) for up to 8 hours prior to application. 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). …Follow expiration information provided by the pharmacy. If you have any questions, reach out to the pharmacy for additional information. |
| General information about the safe and effective use of VYJUVEK Gel
…Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VYJUVEK gel for a condition for which it was not prescribed. Do not give VYJUVEK gel to other people, even if they have the same symptoms that you have. It may harm them. …You can ask your pharmacist or healthcare provider for information about VYJUVEK gel that is written for health professionals. |
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What are the ingredients in VYJUVEK Gel?
Inactive ingredients: glycerol, sodium chloride, sodium phosphate dibasic, potassium chloride, potassium phosphate monobasic, hydroxypropyl methylcellulose, and tromethamine Manufactured by: Krystal Biotech, Inc.
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| This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 09/2025 |