Birch Triterpenes

Birch Triterpenes is a prescription medication used for the treatment of wounds in patients with junctional and dystrophic epidermolysis bullosa.

• Birch Triterpenes is available under the following different brand names: Filsuvez.

Common side effects of Birch Triterpenes include:

• application site reactions, such as pain and itchy skin

Serious side effects of Birch Triterpenes include:

• red itchy bumps (hives) 
• skin rash 
• redness
• itching

Rare side effects of Birch Triterpenes include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical gel

• 10% supplied in 25-mL sterile tubes

Epidermolysis bullosa

Adult dosage

• Apply a 1 mm layer to the affected wound surface only
• Do not rub in gel; cover a wound with a sterile non-adhesive wound dressing
• Alternatively, apply the gel directly to the dressing so that the topical gel is in direct contact with the wound
• Reapply to cleansed wounds with wound dressing changes until the wound is healed
• If a treated wound is infected, discontinue treatment until the infection has resolved
• Also, see Administration

Pediatric dosage

• Children younger than 6 months: Safety and efficacy not established
• Children aged 6 months and older
  • Apply a 1 mm layer to the affected wound surface only
  • Do not rub in gel; cover the wound with a sterile non-adhesive wound dressing
  • Alternatively, apply the gel directly to the dressing so that the topical gel is in direct contact with the wound
  • Reapply to cleansed wounds with wound dressing changes until the wound is healed
  • If the treated wound is infected, discontinue treatment until the infection has resolved

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Birch Triterpenes has no noted severe interactions with any other drugs
• Birch Triterpenes has no noted serious interactions with any other drugs
• Birch Triterpenes has no noted moderate interactions with any other drugs
• Birch Triterpenes has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Birch Triterpenes?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Birch Triterpenes?”

Cautions

• Hypersensitivity
  • Local hypersensitivity and skin reactions reported, including urticaria and dermatitis
  • If signs and symptoms of local or systemic hypersensitivity occur, discontinue immediately and initiate appropriate therapy

Pregnancy and Lactation

• Data are unavailable regarding use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Systemic absorption in humans is low following topical administration and maternal use is not expected to result in fetal drug exposure
• Lactation
  • Data are unavailable regarding the presence of birch Triterpenes or metabolites in human milk, its effects on breastfed infants, or milk production
  • No effects on breastfed infants are anticipated since systemic exposure would be low