Birch Triterpenes Topical
Brand Name(s): Filsuvez®WHY is this medicine prescribed?
Birch triterpenes is used for treatment of wounds associated with certain types of epidermolysis bullosa(condition that causes blistering of the skin) in adults and children 6 months of age or older. Birch triterpenes is in a class of medications called botanicals. How it works to help epidermolysis bullosa is not well understood.
HOW should this medicine be used?
Burch triterpenes comes as a gel to apply to the skin. It is usually applied with every dressing change until the wound heals.
Wash hands before and after applying birch triterpenes or wear gloves when applying. Apply a generous (approximately 1 mm) layer of gel directly to the wound and then cover with clean bandage or apply it directly to the bandage to place on the wound.
Each tube is meant to only be used once. After opening, apply gel immediately and throw away any remaining amount and the tube.
If a wound become infected during treatment with birch triterpenes, stop treatment until the infection resolves.
Avoid contact with birch triterpenes and eyes or mucous membranes (example - mouth, vagina, or anus). If contact does occur, flush area with water.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using birch triterpenes,
- tell your doctor and pharmacist if you are allergic to birch triterpenes, any other medications, or any of the ingredients in birch triterpenes gel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using birch triterpenes, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using birch triterpenes.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue with your regular bandage change schedule. Do not apply extra gel to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Birch triterpenes may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- itching and pain at the application site
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- hives, rash, redness or itching
Birch triterpenes may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Each tube is intended for single use. Any unused portion and tube should be thrown away after each application.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
If someone swallows birch triterpenes, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 20, 2024.