birch triterpenes

Action and Spectrum

Actions and Spectrum: 

Actions: 

The mechanism of action by which Filsuvez treats wounds associated with epidermolysis bullosa remains unknown. In a phase III EASE trial, which was vehicle-controlled, randomized, and double-blind and involved patients with EB, birch bark extract demonstrated a notable increase in the number of patients achieving complete closure of target wounds within 45 days. Furthermore, it exhibited good tolerability in the study. 

Spectrum: 

Patients aged six months and older experiencing partial thickness wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa are now eligible for treatment with birch triterpenes (Filsuvez) topical gel following its approval by the FDA. This approval marks birch triterpenes as the first sanctioned treatment for wounds linked to junctional epidermolysis bullosa, a rare and moderate-to-severe form of epidermolysis bullosa that initiates blistering in infancy.

The application of birch triterpenes can be seamlessly incorporated into existing home treatment regimens, being topically applied to wounds during each dressing change. This hereditary skin condition often leads to intense pain and limited mobility. The topical gel comprises a dry extract from birch bark species containing naturally occurring triterpenes like betulinic acid, betulin, lupeol, erythrodiol, and oleanolic acid, as stated in a news release by Chiesi Global Rare Diseases. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Hives 

Redness 

Itching 

Skin rash 

Pain 

Black Box Warning

Black Box Warning:  

Cease immediately and commence suitable therapy if there are indications or symptoms of local or systemic hypersensitivity. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 
• Skin rash 
• Hives 
• Itching 
• redness 

Cautions 

• Renal impairment 
• Hypersensitivity 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

It expedites the process of wound closure by influencing various stages of wound healing. In vitro and ex-vivo examinations have indicated that birch triterpenes regulate immune-inflammatory mediators, crucial components in the inflammatory phase of wound healing. The development of a new skin barrier entails the migration, proliferation, and adhesion of new skin cells (keratinocytes) to form the outer layer of the skin, known as the epidermis. Birch triterpenes facilitate the differentiation of these cells, thereby enhancing the overall wound-healing process.  

Pharmacodynamics: 

An extract containing abundant betulin derived from birch bark is utilized for the treatment of wounds associated with epidermolysis bullosa, and the specific mechanism of action remains unidentified. 

Pharmacokinetics: 

Absorption 

Peak plasma concentration (betulin) on day 90: 207 ng/mL (children) ; 33 ng/mL (adults);  

Distribution 

Protein-bound is 99.1% 

Metabolism 

Metabolism of botulin byb cytochrome P450 3A 

Adminstartion

Administration: 

Follow your healthcare provider’s instructions precisely when using Filsuvez (birch triterpenes). The tube is designated for a single use. Once opened, promptly apply the gel and discard any remaining gel and the tube after usage. Prior to application, cleanse your hands or wear gloves. 

Cleanse wounds according to your healthcare provider’s instructions before application. Apply a 1 mm layer to the affected wound surface or directly onto the dressing during each dressing change. Avoid rubbing in the gel. Continue application until the wound achieves healing. Wash hands after application. 

If the wounds being treated with Filsuvez become infected, cease treatment and consult your healthcare provider. Signs of infection may include increased pain, warmth, swelling, redness, or discharge of yellow or greenish fluid (pus) from the wound. 

Do not use Filsuvez near the eyes or other mucous membrane areas, such as the vagina, mouth, or anus. In case of contact with the mucous membrane or eyes, rinse immediately with clean water and contact your healthcare provider if any discomfort occurs. Check the tube’s expiration date and refrain from using it if it has passed. Seek instructions from your pharmacist or healthcare provider. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: birch triterpenes 

Pronounced: burch try-ter-peenz 

Why do we use birch triterpenes? 

Birch triterpenes, including compounds such as betulinic acid and betulin, are derived from the bark of birch trees, specifically Betula pendula and Betula pubescens. Extensive research has explored their potential therapeutic properties, leading to their application in various contexts. These triterpenes showcase noteworthy attributes: 

Firstly, their anti-inflammatory effects make birch triterpenes promising for conditions associated with inflammation. Additionally, studies indicate potential antiviral properties, especially against specific viruses. The antioxidant activity of birch triterpenes contributes to their ability to combat oxidative stress and mitigate cellular damage caused by free radicals. 

Moreover, research points towards potential anticancer effects, particularly with compounds like betulinic acid, demonstrating promise in inhibiting cancer cell growth. The antimicrobial activity of birch triterpenes adds to their potential in addressing various infections. In the realm of skincare, birch triterpenes find application due to their anti-inflammatory and antioxidant characteristics. These properties make them beneficial for promoting skin health and addressing conditions such as eczema. 

Furthermore, studies suggest that birch triterpenes play a role in wound healing, potentially expediting the recovery process. While birch triterpenes exhibit significant potential in various therapeutic areas, ongoing research is crucial for a comprehensive understanding of their efficacy and safety across diverse medical applications. Consulting healthcare professionals is advisable before incorporating birch triterpenes into therapeutic practices.