Lesfal 250 mg – Injectable Phosphatidylcholine for Liver Therapy

Lesfal is a prescription injectable medicinal product containing
phosphatidylcholine from soybeans. Each 5 ml ampoule contains
250 mg of phosphatidylcholine, corresponding to a concentration of
50 mg/ml.

Phosphatidylcholine is a major component of biological cell membranes and belongs to the group of essential phospholipids used in hepatology. Lesfal is classified as a hepatotropic medicinal product and is intended for slow intravenous administration in adults and adolescents from 12 years of age.

According to the official Farmak prescribing information, the phospholipids contained in Lesfal are structurally similar to endogenous membrane phospholipids and contain a high proportion of polyunsaturated fatty acids. They participate in membrane structure, lipid and lipoprotein metabolism, and physiological processes associated with hepatocyte function and regeneration.

Product Information

• Product: Lesfal
• Active substance: Phosphatidylcholine from soybeans
• Concentration: 50 mg/ml
• Amount per ampoule: 250 mg / 5 ml
• Pharmaceutical form: Solution for injection
• Package: 5 ampoules × 5 ml
• Route of administration: Intravenous
• Pharmacotherapeutic group: Hepatotropic preparations
• ATC group: A05BA
• Manufacturer: Farmak, Ukraine
• Prescription status: Prescription medicine

Composition of Lesfal 250 mg

According to the official manufacturer information, 1 ml of Lesfal contains 50 mg of phosphatidylcholine from soybeans.

Each 5 ml ampoule therefore provides:

• 250 mg phosphatidylcholine from soybeans
• Benzyl alcohol
• Deoxycholic acid
• Sodium chloride
• Sodium hydroxide
• Riboflavin (E101)
• Water for injection

The solution is described by the manufacturer as a clear yellow injectable solution.

How Phosphatidylcholine Works in the Liver

Cell membranes of hepatocytes contain large amounts of phospholipids. Liver diseases can be accompanied by structural changes in these membranes and alterations in membrane-associated enzymes, receptors and metabolic processes.

The phospholipids contained in Lesfal are chemically similar to naturally occurring phospholipids but contain a high proportion of polyunsaturated fatty acids. According to the official pharmacological description, these molecules can be incorporated into cellular membrane structures and participate in the restoration of damaged liver tissue.

Their polyunsaturated fatty-acid chains influence the physical properties of phospholipid membranes, including membrane fluidity and the activity of membrane-associated enzymes.

Phosphatidylcholine and Lipid Metabolism

Phospholipids also participate in lipoprotein metabolism. According to the official Lesfal prescribing information, they influence disturbed lipid metabolism by modifying the transport of neutral fats and cholesterol.

The manufacturer describes an increased capacity of high-density lipoproteins (HDL) to bind cholesterol and transport lipids for further metabolism and oxidation.

During phospholipid excretion through the biliary system, the lithogenic index of bile may decrease and bile becomes more stable.

Medical Indications

The officially registered indications for Lesfal include several acute and chronic liver disorders as well as selected conditions in which phosphatidylcholine is used as part of combined treatment.

• Non-alcoholic steatohepatitis
• Alcoholic steatohepatitis
• Acute hepatitis of different etiologies
• Chronic hepatitis of different etiologies
• Liver cirrhosis
• Preoperative treatment before surgery involving the liver or biliary tract
• Postoperative treatment following liver or biliary surgery
• Pregnancy toxicosis as an indication listed in the registered product information
• Psoriasis as part of a combined treatment protocol
• Radiation syndrome

Lesfal and Fatty Liver Disease

Essential phospholipids have been studied extensively in patients with fatty liver disease, including metabolic dysfunction-associated steatotic liver disease (MASLD, previously NAFLD).

A 2026 multicenter, randomized, double-blind, placebo-controlled Phase IV trial investigated essential phospholipids in patients with MASLD and associated metabolic conditions such as type 2 diabetes, hyperlipidemia or obesity.

After six months, essential phospholipid treatment produced a statistically significant reduction in hepatic steatosis measured by Controlled Attenuation Parameter (CAP) compared with placebo. Improvements were also reported in fatigue scores and HbA1c.

Essential Phospholipids in Metabolic Dysfunction-Associated Steatotic Liver Disease – Randomized Phase IV Trial, Liver International, 2026

Clinical Research on Essential Phospholipids

A systematic review and network meta-analysis published in 2020 examined clinical studies of essential phospholipids in adults with NAFLD associated with type 2 diabetes and/or obesity.

In the direct analysis of randomized controlled trials, essential phospholipids added to antidiabetic treatment were associated with greater reductions in ALT, triglycerides and total cholesterol compared with antidiabetic treatment alone. The analysis also found a higher overall rate of clinical improvement.

Essential phospholipids for NAFLD associated with metabolic syndrome – Systematic Review and Network Meta-Analysis

Another randomized clinical study included 324 patients with NAFLD, including patients with type 2 diabetes and mixed hyperlipidemia. Treatment with essential phospholipids was associated with significant improvements in ALT and AST, while ultrasound and liver-stiffness measurements also showed improvement in a proportion of patients.

Essential phospholipids as a supportive adjunct in patients with NAFLD – Arab Journal of Gastroenterology

These studies investigated essential phospholipid and phosphatidylcholine preparations as a pharmacological class. The exact formulations and routes of administration used in clinical studies were not necessarily identical to the injectable Lesfal 250 mg formulation.

Dosage and Intravenous Administration

According to the official Lesfal prescribing information, the medicine is intended for
slow intravenous administration only.

• Adults and adolescents from 12 years: 5–10 ml intravenously per day
• Severe conditions: 10–20 ml per day
• Up to 10 ml may be administered at one time
• Intravenous treatment is generally used for up to 10 days

Since each 5 ml ampoule contains 250 mg of phosphatidylcholine, 5–10 ml corresponds to 250–500 mg of phosphatidylcholine.

The manufacturer recommends supporting or continuing parenteral treatment as early as possible with an oral phosphatidylcholine-containing preparation. The total treatment course described in the official information is generally 3–6 months.

Dilution and Compatibility

Lesfal must not be diluted with electrolyte-containing solutions.

The following solutions must not be used for dilution:

• 0.9% sodium chloride solution
• Ringer’s solution
• Other electrolyte solutions

If dilution is required and the patient’s own blood cannot be used, the official prescribing information lists electrolyte-free solutions such as:

• 5% glucose solution
• 10% glucose solution
• 5% xylitol solution

The recommended dilution ratio is 1:1. Only a clear solution should be administered.

Lesfal should not be mixed in the same syringe with other medicinal products.

Intramuscular Administration

Lesfal must not be administered intramuscularly. The official manufacturer information specifically states that intramuscular injection may cause local irritation.

The approved route of administration is slow intravenous injection or intravenous infusion according to the prescribing information.

Lesfal in Psoriasis Treatment

The official Lesfal information includes a specific combined protocol for psoriasis.

Treatment begins with oral phosphatidylcholine for two weeks. This is followed by
10 intravenous injections of 5 ml together with PUVA therapy.

After completion of the injection course, oral phosphatidylcholine is resumed and continued for approximately two months according to the registered prescribing information.

Contraindications

Lesfal is contraindicated in patients with hypersensitivity to any component of the preparation.

The injectable solution contains benzyl alcohol and must not be administered to newborn or premature infants.

The medicine is intended for adults and children from 12 years of age with an approximate body weight of at least 43 kg.

Pregnancy and Breastfeeding

Although pregnancy toxicosis appears among the registered indications, the current official prescribing information states that Lesfal is
not recommended during pregnancy or breastfeeding because clinical data in pregnant patients are limited and the formulation contains benzyl alcohol, which can cross the placental barrier.

Possible Side Effects

According to the manufacturer, Lesfal is generally associated with a limited number of reported adverse reactions.

• Diarrhea may occur when higher doses are used
• Hypersensitivity reactions may occur in isolated cases
• Skin rash
• Itching
• Urticaria
• Reactions at the injection site

Sodium and Benzyl Alcohol Content

Lesfal contains benzyl alcohol and approximately 0.1 mmol of sodium per ml.

A 10 ml dose contains approximately 1 mmol, or 25.8 mg, of sodium. This should be taken into account in patients following a sodium-controlled diet.

Storage

• Storage temperature: 2°C to 8°C
• Protect from light
• Keep out of reach of children
• Use only clear solution
• Shelf life: 3 years

Product Specifications

• Brand: Lesfal
• Active substance: Soybean phosphatidylcholine
• Strength: 50 mg/ml
• Amount per ampoule: 250 mg
• Ampoule volume: 5 ml
• Package: 5 ampoules
• Form: Injectable solution
• Administration: Slow intravenous injection / intravenous infusion
• Manufacturer: Farmak
• Registration number: UA/12317/01/01

Frequently Asked Questions about Lesfal

How much phosphatidylcholine is in one Lesfal ampoule?

One 5 ml ampoule contains 250 mg of soybean phosphatidylcholine. The concentration of the solution is 50 mg/ml.

What is Lesfal used for?

The registered indications include non-alcoholic and alcoholic steatohepatitis, acute and chronic hepatitis of different etiologies, liver cirrhosis, perioperative treatment in liver and biliary surgery, psoriasis, radiation syndrome and pregnancy toxicosis.

Can Lesfal be injected intramuscularly?

No. The manufacturer’s prescribing information states that Lesfal is intended only for intravenous administration. Intramuscular injection can cause local irritation.

Can Lesfal be diluted with normal saline?

No. Lesfal is incompatible with electrolyte solutions such as normal saline and Ringer’s solution. The official information specifies electrolyte-free solutions such as 5% or 10% glucose or 5% xylitol when dilution is required.

How is Lesfal administered?

The solution is administered slowly intravenously. The usual registered dose for adults and adolescents from 12 years of age is 5–10 ml per day. In severe conditions, 10–20 ml per day may be prescribed.

How much active substance does 10 ml of Lesfal contain?

Because Lesfal contains 50 mg of phosphatidylcholine per ml, 10 ml contains
500 mg of phosphatidylcholine.

How long can Lesfal treatment last?

The official prescribing information states that intravenous treatment is usually used for up to 10 days, while the complete treatment course, including oral phosphatidylcholine therapy, may last approximately 3–6 months.

Can Lesfal be used during pregnancy?

The current manufacturer’s information does not recommend Lesfal during pregnancy or breastfeeding because clinical data are limited and the injectable formulation contains benzyl alcohol.

Does Lesfal contain soy-derived phosphatidylcholine?

Yes. The active substance listed by the manufacturer is
phosphatidylcholine derived from soybeans.

How should Lesfal ampoules be stored?

The ampoules should be stored protected from light at a temperature between
2°C and 8°C.

Is Lesfal a prescription medicine?

Yes. Lesfal solution for injection is registered as a prescription medicinal product.

Scientific References

1. Stefan N, Hartleb M, Fan J, et al.
   Effect of Essential Phospholipids in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Phase 4 Clinical Trial.
   Liver International. 2026.
   PubMed: PMID 41889076
   
2. Dajani AI, Popovic B.
   Essential phospholipids for nonalcoholic fatty liver disease associated with metabolic syndrome: A systematic review and network meta-analysis.
   World Journal of Clinical Cases. 2020;8(21):5235–5249.
   PubMed: PMID 33269259
   
3. Dajani A, Abu Hammour A, Zakaria M, et al.
   Essential phospholipids as a supportive adjunct in the management of patients with NAFLD.
   Arab Journal of Gastroenterology. 2015;16(3-4):99–104.
   PubMed: PMID 26589371
   
4. Gundermann KJ, Kuenker A, Kuntz E, Droździk M.
   Essential phospholipids in fatty liver: a scientific update.
   Clinical and Experimental Gastroenterology. 2016.
   PubMed: PMID 27217791
   

Official Product Information

Farmak – Official Lesfal Prescribing Information

Medical notice: Lesfal is a prescription injectable medicinal product.
The information above is based on the manufacturer’s registered prescribing information and published scientific literature and does not replace individual medical advice or professional supervision.