Filsuvez
Birch Bark Extract Gel for Epidermolysis Bullosa Wound Treatment
Quick Facts About Filsuvez
Key Takeaways About Filsuvez
- First approved treatment for EB wounds: Filsuvez is the first herbal medicine specifically approved by the European Medicines Agency (EMA) for wound treatment in epidermolysis bullosa, a rare genetic skin condition
- Natural active ingredient: Contains purified triterpenes from birch bark (betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid) that promote wound healing through anti-inflammatory mechanisms
- Extremely low systemic absorption: Because it is applied topically and absorption into the body is negligible, Filsuvez can be used during pregnancy and breastfeeding with minimal risk
- Single-use tubes only: Each tube must be discarded after opening, even if gel remains – a new tube is required for every dressing change to maintain sterility
- Safe for birch pollen allergy sufferers: Filsuvez does not contain birch pollen and can be used by individuals with birch pollen allergy
What Is Filsuvez and What Is It Used For?
Filsuvez is a topical herbal gel containing purified dry extract from birch bark. It is specifically developed and approved for the treatment of partial-thickness wounds in patients with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB), rare genetic conditions that cause the skin to blister and form chronic wounds.
Epidermolysis bullosa (EB) is a group of rare inherited skin disorders characterised by extreme fragility of the skin and mucous membranes. In patients with EB, the structural proteins that normally hold the layers of the skin together are defective or absent, which means that even minor friction or trauma can cause the skin to blister and tear. The subtypes targeted by Filsuvez – dystrophic EB (DEB) and junctional EB (JEB) – are among the most severe forms of the condition, often resulting in chronic, painful wounds that are slow to heal and prone to infection.
The active ingredient in Filsuvez is a refined, dry extract obtained from the outer bark of birch trees (Betula pendula Roth and Betula pubescens Ehrh., and hybrids of both species). This extract is rich in triterpenes, a group of naturally occurring compounds that have demonstrated significant wound-healing properties in preclinical and clinical research. The principal triterpenes present are betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid, which together constitute 84–95 mg per gram of gel.
Filsuvez promotes wound healing through several complementary mechanisms. The triterpenes exert anti-inflammatory effects, reducing the excessive inflammatory response that impairs healing in EB wounds. They also stimulate keratinocyte migration and proliferation, which are essential processes in the re-epithelialisation of wounded skin. Additionally, these compounds help to modulate the wound microenvironment, creating conditions more favourable for tissue repair and regeneration.
Filsuvez was approved by the European Medicines Agency (EMA) in 2022, making it the first medicine specifically approved for the treatment of wounds in epidermolysis bullosa. This approval was based on data from the pivotal EASE (Efficacy and Safety of Birch Bark Extract in EB) clinical trial, a randomised, double-blind, vehicle-controlled Phase III study that demonstrated statistically significant improvements in wound healing compared to placebo. The approval represented a major milestone for the EB patient community, which had previously had no specifically approved wound treatment available.
Filsuvez is classified as a herbal medicine rather than a conventional pharmaceutical drug. However, unlike many herbal products, it has undergone rigorous clinical testing including a Phase III randomised controlled trial. The gel formulation uses refined sunflower oil as the only excipient, and the product contains no water, preservatives, or fragrances, making it well-tolerated on the extremely sensitive skin of EB patients.
What Should You Know Before Using Filsuvez?
Before using Filsuvez, ensure you are not allergic to birch bark or any other ingredient in the gel. Report any signs of wound infection or allergic reaction to your doctor immediately. Filsuvez does not contain birch pollen and can be used by people with birch pollen allergy.
Contraindications
You should not use Filsuvez if:
- Allergy to birch bark or any other ingredient in the gel – the only other ingredient is refined sunflower oil. If you have ever had an allergic reaction to birch bark products, you must not use this medicine
There are no other absolute contraindications listed for Filsuvez. However, because the medicine is specifically designed for patients with epidermolysis bullosa, it should only be used under the guidance of a healthcare professional experienced in managing EB or rare skin conditions.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before using Filsuvez, and be aware of the following important precautions:
Allergic reactions: If you develop an allergic reaction while using Filsuvez, you must stop using the gel immediately and contact your doctor or nurse. Signs of an allergic reaction may include itching, swelling, and redness of the skin that is more pronounced in the area where the medicine was applied. Allergic reactions are listed as a common side effect of the medication.
Wound infection: Infection is a serious complication that can occur during the wound healing process, particularly in patients with EB whose skin barrier function is already compromised. Signs of wound infection include yellow or greenish discharge (pus) from the wound, and surrounding skin that becomes red, warm, swollen, or increasingly painful. If you develop a wound infection, you may need to stop using Filsuvez temporarily while the infection is treated with appropriate therapy. Your doctor or nurse will advise you on when it is safe to resume Filsuvez treatment once the infection has resolved.
Skin cancer risk: Patients with epidermolysis bullosa, particularly severe forms such as recessive dystrophic EB, have an inherently elevated risk of developing a type of skin cancer called squamous cell carcinoma (SCC). This risk is associated with the chronic wound inflammation characteristic of EB, not with Filsuvez itself. However, if you are diagnosed with skin cancer while using Filsuvez, you should inform your doctor and discontinue use of the gel on the affected area of skin.
Eye contact: Avoid getting Filsuvez in your eyes. If accidental eye contact occurs, rinse your eyes thoroughly with clean water. If discomfort persists, seek advice from your doctor or nurse.
Birch pollen allergy: Filsuvez does not contain birch pollen and can therefore be safely used by people who have a birch pollen allergy. The extract is derived from birch bark and contains triterpenes, which are chemically distinct from the allergenic proteins found in birch pollen.
Use in Children
Filsuvez can be used in children from 6 months of age. The application method and dosing are the same as for adults – a thick layer (approximately 1 mm) should be applied to the wound at each dressing change. The safety and efficacy of Filsuvez in children under 6 months of age have not been established, and therefore the gel should not be used in this age group.
Pregnancy and Breastfeeding
No specific studies have been conducted on the effects of Filsuvez in pregnant women. However, because systemic absorption of the medicine is extremely low following topical application, the risk to the foetus is considered negligible. Filsuvez can be used during pregnancy.
It is not known whether the components of Filsuvez pass into breast milk. Again, because systemic absorption is extremely low, the risk to the nursing infant is considered negligible. Filsuvez can be used during breastfeeding, provided that it is not applied to the chest area to avoid direct exposure of the infant to the gel during feeding.
Due to the very low systemic absorption of Filsuvez, it is not expected to have any effect on fertility in either men or women.
Driving and Operating Machinery
Filsuvez has no effect on the ability to drive or operate machinery. Because the gel is applied topically and has negligible systemic absorption, it does not cause any central nervous system effects such as drowsiness or dizziness.
Drug Interactions
There is no specific information available about how Filsuvez may interact with other medicines applied to the skin, taken orally, or given by injection. As a precaution, you should not apply other products to the wound at the same time as you apply Filsuvez. If you need to use more than one product on your wounds, speak to your doctor or nurse for guidance on appropriate timing and application.
Always tell your doctor, pharmacist, or nurse about all medicines you are currently using, have recently used, or might plan to use, including those that do not require a prescription.
| Precaution | Details | Action Required |
|---|---|---|
| Birch bark allergy | Do not use if allergic to birch bark or sunflower oil | Do not use Filsuvez |
| Wound infection | Pus, redness, warmth, swelling, or increasing pain | Stop use, seek medical advice |
| Allergic reaction | Itching, swelling, redness at application site | Stop use immediately, contact doctor |
| Skin cancer | EB patients have elevated SCC risk | Discontinue on affected area, inform doctor |
| Eye contact | Gel should not contact eyes | Rinse with water; seek help if discomfort persists |
| Children under 6 months | Safety and efficacy not established | Do not use |
What Is the Correct Dosage of Filsuvez?
Filsuvez gel should be applied in a thick layer (approximately 1 mm) to the cleaned wound at every dressing change. It can be applied directly to the wound or to a sterile non-adhesive dressing. Each tube is single-use and must be discarded after opening.
Always use Filsuvez exactly as your doctor, pharmacist, or nurse has instructed. If you are unsure about any aspect of the application, consult your healthcare team for clarification. The following guidelines apply to both adults and children (from 6 months of age).
How to Apply
Before applying Filsuvez, gently clean the wound according to your healthcare provider's instructions. You can apply the gel using one of two methods:
Method 1 – Direct application to the wound:
- Apply: Squeeze a thick layer (approximately 1 mm) of Filsuvez gel directly onto the wound surface
- Spread: Using a clean hand or wearing a glove, spread the gel generously so that it covers the entire wound. Do not rub the gel into the wound
- Cover: Place a sterile non-adhesive dressing over the wound to protect it
Method 2 – Application to the dressing:
- Apply: Squeeze a thick layer (approximately 1 mm) of Filsuvez gel onto a sterile non-adhesive dressing
- Spread: Using a clean hand or wearing a glove, spread the gel over the part of the dressing that will come into direct contact with the wound
- Place: Position the dressing with the gel-coated side directly against the wound surface
Apply fresh gel each time you change your dressing. Continue treatment until the wound has healed, or as directed by your healthcare provider.
Each tube of Filsuvez is a sterile, single-use product. Once a tube has been opened, the gel must be used immediately and the tube discarded – even if gel remains inside. A new, sealed tube must be used at every dressing change. This is essential to prevent contamination and maintain the sterility of the gel.
Dosage for Adults and Children
The dosage is the same for all age groups from 6 months of age onward. There is no need to adjust the dose based on age, weight, or wound size beyond applying a sufficient amount to cover the wound completely with a layer approximately 1 mm thick. Your doctor will determine the duration of treatment based on wound healing progress.
Adults and children (≥ 6 months)
Dose: Apply a thick layer (~1 mm) to the wound at each dressing change
Route: Topical (on the wound)
Frequency: At every dressing change
Duration: Until wound heals (as directed by your doctor)
Children under 6 months
Not recommended. Safety and efficacy have not been established in this age group.
Missed Dose
If you forget to apply Filsuvez at a scheduled dressing change, simply apply it at the next planned dressing change and continue with your usual routine. Do not apply extra gel to make up for a missed application.
Overdose
Filsuvez is applied topically, and systemic absorption is extremely low. This means that overdose is very unlikely, even when the gel is applied to large wound areas over an extended period. If you accidentally apply more gel than recommended, simply remove the excess and apply a fresh dressing. No specific overdose treatment is required.
Stopping Treatment
Filsuvez should be used according to your healthcare provider's instructions. Do not stop using the gel without first consulting your doctor, pharmacist, or nurse, as premature discontinuation may delay wound healing.
Filsuvez is not intended for internal use. Avoid contact with the eyes, mouth, or nostrils. If accidental contact occurs, rinse the affected area immediately with clean water.
What Are the Side Effects of Filsuvez?
Like all medicines, Filsuvez can cause side effects, although not everybody gets them. The most common side effect is wound complications (affecting more than 1 in 10 users), which include increased wound size, wound reopening, and wound pain. Common side effects include wound infection and allergic reactions.
The side effects of Filsuvez have been characterised through clinical trials in patients with epidermolysis bullosa. It is important to note that many of the reported side effects overlap with symptoms that are inherent to the underlying condition itself, as EB naturally involves ongoing wound complications and healing difficulties. Your healthcare team can help you distinguish between effects related to the medicine and those related to your condition.
If you experience any of the side effects listed below, particularly wound infection or allergic reaction, inform your doctor, pharmacist, or nurse promptly. Early recognition and management of these complications can prevent more serious outcomes.
Very Common
May affect more than 1 in 10 people
- Wound complications (increased wound size, wound reopening, wound pain)
Common
May affect up to 1 in 10 people
- Wound infection
- Allergic reaction (hypersensitivity)
- Itchy skin (pruritus)
- Pain and itching at the application site
- Complications during wound healing
Uncommon
May affect up to 1 in 100 people
- Wound discharge (exudation)
- Skin irritation (dermatitis)
- Itchy skin rash
- Purple-coloured skin rash (purpura)
- Pain at or around the wound site
When to Seek Medical Help
You should contact your doctor or nurse immediately if you notice any of the following:
- Signs of wound infection: yellow or greenish discharge (pus), increasing redness, warmth, swelling, or worsening pain around the wound
- Signs of allergic reaction: significant itching, swelling, or redness that is more severe than usual, particularly at or near the application site
- New skin changes: unusual lumps, non-healing ulcers, or other changes on or near the wound that could indicate squamous cell carcinoma, which EB patients are at higher risk for
It is important to report any suspected side effects to your healthcare provider. Ongoing monitoring of side effects after a medicine has been approved helps regulatory authorities to continuously assess the benefit-risk balance. Patients and healthcare professionals can report suspected adverse reactions through their national pharmacovigilance agency.
Wound complications are listed as the most common side effect of Filsuvez, but it is important to understand that these events occur very frequently in EB patients regardless of treatment. The EASE clinical trial showed that Filsuvez actually improved overall wound closure rates compared to placebo. The reporting of wound complications as a side effect reflects the regulatory requirement to document all adverse events during clinical trials, even those that may be related to the underlying disease rather than the treatment itself.
How Should You Store Filsuvez?
Store Filsuvez below 30°C (86°F), out of the sight and reach of children. Each tube is a single-use product – once opened, use immediately and discard the tube even if gel remains.
Proper storage of Filsuvez is essential to maintain the quality, sterility, and effectiveness of the gel. Follow these storage guidelines carefully:
- Temperature: Store at no more than 30°C (86°F). Do not freeze the gel. Keep the tubes in their outer carton to protect from light and physical damage
- Keep out of reach: Store the gel where children cannot see or reach it, even though the tamper-evident seal provides some protection against accidental use
- Expiry date: Do not use Filsuvez after the expiry date printed on the carton and the tube (marked “EXP”). The expiry date refers to the last day of the month indicated
- Single-use only: Once a tube has been opened, the gel must be used immediately. Discard the tube after a single use, even if gel remains. Use a new, sealed tube for each dressing change
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps to protect the environment
| Parameter | Requirement |
|---|---|
| Storage temperature | Below 30°C (86°F) |
| After opening | Use immediately, discard tube after single use |
| Protection | Keep in outer carton; keep out of reach of children |
| Tube size | 23.4 g per tube (available in packs of 1, 10, or 30) |
What Does Filsuvez Contain?
Filsuvez contains birch bark dry extract as its active substance (100 mg per gram of gel) and refined sunflower oil as the only inactive ingredient. The gel is a colourless to slightly yellow, opalescent, non-aqueous formulation supplied in single-use aluminium tubes.
Active Ingredient
Each gram of Filsuvez gel contains 100 mg of dry extract (as a refined dry extract) from the bark of Betula pendula Roth, Betula pubescens Ehrh., and hybrids of both birch species. This corresponds to 0.5–1.0 g of birch bark per gram of gel.
The therapeutically relevant components of the extract are triterpenes, which constitute 84–95 mg per gram of gel. These triterpenes are calculated as the sum of five key compounds:
- Betulin – the most abundant triterpene, a lupane-type pentacyclic triterpenoid with documented anti-inflammatory and wound-healing properties
- Betulinic acid – a pentacyclic lupane-type triterpenoid with anti-inflammatory, antimicrobial, and anti-tumour activity in preclinical studies
- Erythrodiol – an oleanane-type triterpene with antioxidant properties
- Lupeol – a pentacyclic triterpenoid with anti-inflammatory and wound-healing effects demonstrated in experimental models
- Oleanolic acid – a widely studied triterpene with anti-inflammatory, antioxidant, and hepatoprotective properties
The extraction solvent used is n-heptane, a non-polar organic solvent that selectively extracts the lipophilic triterpene compounds from the birch bark while leaving behind water-soluble and polar components, including allergenic proteins found in birch pollen.
Inactive Ingredient
The only inactive ingredient (excipient) in Filsuvez is refined sunflower oil. This serves as the gel vehicle, creating the opalescent, non-aqueous gel formulation that allows the triterpenes to be evenly distributed and easily applied to wound surfaces. The simplicity of the formulation – with just one excipient and no water, preservatives, fragrances, or colouring agents – is a deliberate design choice to minimise the risk of irritation on the extremely sensitive skin of EB patients.
Appearance and Packaging
Filsuvez gel is a colourless to slightly yellow, opalescent, non-aqueous gel. It is packaged in white, collapsible aluminium tubes. Each tube is sealed with a tamper-evident aluminium membrane and capped with a white polypropylene screw cap. The tubes are packed in an outer cardboard carton.
Filsuvez is available in the following pack sizes:
- 1 tube of 23.4 g gel
- 10 tubes of 23.4 g gel
- 30 tubes of 23.4 g gel
Not all pack sizes may be marketed in all countries.
Manufacturer
Filsuvez is manufactured by Amryt GmbH (Streiflingsweg 11, 75223 Niefern-Öschelbronn, Germany) and the marketing authorisation is held by Chiesi Farmaceutici S.p.A. (Via Palermo 26/A, 43122 Parma, Italy). For further information about Filsuvez, including full prescribing information, you can consult the European Medicines Agency (EMA) website.
Frequently Asked Questions About Filsuvez
Filsuvez is a topical herbal gel containing a purified dry extract from birch bark, rich in triterpenes. It is specifically approved for the treatment of partial-thickness wounds in patients with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB), which are rare genetic skin conditions that cause extreme skin fragility, blistering, and chronic wounds. Filsuvez promotes wound healing through anti-inflammatory mechanisms and by stimulating skin cell regeneration.
Filsuvez can be applied in two ways: either directly onto the cleaned wound in a thick layer (approximately 1 mm), then covered with a sterile non-adhesive dressing; or applied to a sterile non-adhesive dressing first, then placed on the wound with the gel-coated side touching the wound. Use a clean hand or glove to spread the gel. Do not rub it in. A new tube must be used for each dressing change, as opened tubes should be discarded immediately.
Yes. Filsuvez does not contain birch pollen. The gel contains only an extract from birch bark, which consists of triterpene compounds that are chemically entirely different from the allergenic proteins present in birch pollen. Therefore, individuals with birch pollen allergy can safely use Filsuvez. However, if you are allergic to birch bark itself or to sunflower oil (the only excipient), you should not use this medicine.
Yes, Filsuvez can be used during pregnancy and breastfeeding. Since the gel is applied topically and systemic absorption is extremely low, the risk to an unborn child or breastfed infant is considered negligible. During breastfeeding, Filsuvez should not be applied to the chest area to prevent direct contact between the gel and the infant during feeding. As always, discuss any concerns with your healthcare provider.
Each tube of Filsuvez is a sterile, single-use product. Once the tube's tamper-evident seal is broken, the sterility of the gel can no longer be guaranteed, and the gel could become contaminated with bacteria from the environment or the wound. For patients with epidermolysis bullosa, who are already at increased risk of wound infection due to their compromised skin barrier, maintaining sterility is critical. Using a fresh, sealed tube at each dressing change significantly reduces the risk of introducing infection.
Filsuvez was approved based on the EASE (Efficacy and Safety of Birch Bark Extract in Epidermolysis Bullosa) clinical trial, a Phase III, randomised, double-blind, vehicle-controlled study. The trial demonstrated statistically significant improvements in wound healing in patients treated with Filsuvez compared to the vehicle (placebo) gel. This was the first randomised controlled trial to show a treatment benefit for wound healing in epidermolysis bullosa, and it led to the first-ever EMA approval of a medicine specifically for EB wound treatment in 2022.
References
This article is based on peer-reviewed research, regulatory documents, and international clinical guidelines. All medical claims are supported by evidence level 1A wherever possible.
- European Medicines Agency (EMA). Filsuvez – European Public Assessment Report (EPAR). EMA/117923/2022. Available at: ema.europa.eu/en/medicines/human/EPAR/filsuvez
- Kern JS, Schwieger-Briel A, Jurić S, et al. Efficacy and safety of birch bark extract (Filsuvez) for wound treatment in epidermolysis bullosa: results of the phase III EASE study. British Journal of Dermatology. 2023;188(1):131–140. doi:10.1093/bjd/ljac034
- Has C, Bauer JW, Bodemer C, et al. Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility. British Journal of Dermatology. 2020;183(4):614–627. doi:10.1111/bjd.18921
- DEBRA International. Clinical Practice Guidelines for Wound Care in Epidermolysis Bullosa. Updated 2023. Available at: debra-international.org
- Ebeling S, Naumann K, Pollok S, et al. From a traditional medicinal plant to a rational drug: understanding the clinically proven wound healing efficacy of birch bark extract. PLoS ONE. 2014;9(1):e86147. doi:10.1371/journal.pone.0086147
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- European Medicines Agency (EMA). Filsuvez – Summary of Product Characteristics (SmPC). Last updated 2024.
- Frew JW, Martin LK, Murrell DF. Evidence-based treatments in epidermolysis bullosa: an updated Cochrane systematic review. Cochrane Database of Systematic Reviews. 2022. doi:10.1002/14651858
- Fine JD, Bruckner-Tuderman L, Eady RAJ, et al. Inherited epidermolysis bullosa: updated recommendations on diagnosis and classification. Journal of the American Academy of Dermatology. 2014;70(6):1103–1126. doi:10.1016/j.jaad.2014.01.903
- Goldschneider KR, Good J, Harber LC, et al. Pain management for epidermolysis bullosa: best care practice guidelines. BMC Medicine. 2014;12:178. doi:10.1186/s12916-014-0178-2
About Our Medical Team
This article was written and reviewed by our medical editorial team, which includes licensed specialist physicians in dermatology, clinical pharmacology, and rare skin diseases. Our team follows international clinical guidelines from the EMA, DEBRA International, and the WHO, ensuring that all information meets the highest standards of medical accuracy and evidence-based practice.
All claims are supported by peer-reviewed research and international clinical guidelines, with evidence graded according to the GRADE framework. We prioritise Level 1A evidence (systematic reviews and randomised controlled trials) wherever available.
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