Alveofact (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Lyomark Pharma, GmbH (Germany)

Manufactured By

BAG Health Care GmbH (Germany)

Solvent Manufacturer

IDT Biologika, GmbH (Germany)

ATC Code

R07AA02 (Natural phospholipids)

Active Substance

Bovactant (BAN)

Dosage Form

Alveofact

Lyophilisate for preparation of suspension for endotracheal administration 50 mg: vial 1 pc. in set with solvent (syringe 1.2 ml), needle for prep. susp., syringe adapter, vial holder

Dosage Form, Packaging, and Composition

Vials (1) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the prevention and treatment of neonatal respiratory distress syndrome

Pharmacotherapeutic Group

Surfactant

Pharmacological Action

Pulmonary surfactant replenishes the deficiency of endogenous pulmonary surfactant with exogenous surfactant. It coats the inner surface of the alveoli; reduces surface tension in the lungs, stabilizes the alveoli, preventing their collapse at the end of the expiratory phase, promotes adequate gas exchange maintained throughout the entire respiratory cycle. It is evenly distributed in the lungs and spreads over the alveolar surface.

In premature newborns, it restores the level of oxygenation, which requires a reduction in the concentration of inhaled oxygen in the gas mixture; reduces the level of mortality and respiratory diseases. The use of surfactant significantly reduces the severity of respiratory distress syndrome.

Pharmacokinetics

In experimental studies, T_1/2 is about 30 hours. The metabolism of Alveofact occurs in the same way as the metabolism of natural surfactant.

However, the route and rate of metabolism, as well as the degradation of organic molecules, are influenced by the degree of lung immaturity. The drug is almost completely utilized in the lungs and does not accumulate in the body.

Indications

• Prevention of respiratory distress syndrome in premature infants with a gestational age of less than 27-28 weeks;
• Treatment of respiratory distress syndrome. Premature newborns with signs of RDS (clinical manifestations: Silverman score more than 7 points; radiological manifestations: white lung/oxygen dependency level more than 40%);
• Neonatal asphyxia. Apgar score less than 3 points. Typically, premature infants (gestational age 32-34 weeks) (clinical manifestations: blood pressure instability, oxygen dependency more than 40%, radiological manifestations: shock lung);
• Massive meconium aspiration. After thorough sanitation of the tracheobronchial tree, if the degree of oxygen dependency is more than 65%.

ICD codes

Dosage Regimen

Endotracheal administration in intubated children on artificial lung ventilation (ALV) with continuous monitoring of heart rate, arterial blood oxygen concentration or oxygen saturation. Treatment should be started as early as possible, after diagnosis of RDS.

Prevention. One dose of 1.2 ml of Alveofact^® per 1 kg of body weight is recommended, which is administered within 1 hour after birth. If necessary, the administration is repeated another 3 times at intervals of 12-24 hours – a total of 4 single doses.

In case of deterioration of ventilation parameters and the occurrence of life-threatening indications, the time interval between doses may be shortened under medical supervision.

Emergency therapy. One dose of 1.2 ml of Alveofact^® per 1 kg of body weight is recommended immediately upon the onset of clinical symptoms and/or radiological changes that correspond to the development of RDS, or when the required oxygen fraction exceeds 40% (FiO₂>0.4).

If necessary, the administration is repeated another 3 times at intervals of 12-24 hours – a total of 4 single doses. If life-threatening conditions persist, the time interval between doses may be shortened under medical supervision, however, the 2nd dose should be administered no earlier than 30-60 minutes after the first administration.

Treatment with Alveofact^® is carried out only by intratracheal instillation.

Administration technique

1. Correct position of the endotracheal tube (1 cm above the bifurcation), correct size of the endotracheal tube.
2. Control suction from the tracheobronchial tree.
3. Insert a catheter into the endotracheal tube to a depth that determines its exit from the endotracheal tube by 1 cm.
4. Position the patient on the left side.
5. Administer the drug into the catheter as a bolus at a dose of 1.2 ml/kg, then draw air into the syringe and inject it into the catheter, ensuring complete entry of the drug into the tracheobronchial tree.
6. Manually (using a Penlon bag, Cardiff, etc.) perform 5 respiratory movements and begin ALV – respiratory rate above 60/min and expiratory time of at least 0.6 sec.
7. For uniform distribution of Alveofact, the patient can be carefully turned to the right-left side for several minutes.
8. If possible, avoid routine suction from the tracheobronchial tree for 6-8 hours.
9. Continuous monitoring of blood gases. Avoid hyperoxia (PO₂ not more than 60 mm Hg, SaO₂ not more than 95%, best effect if at FiO₂ 0.25 SaO₂ not more than 95-96%).
10. Upon achieving stabilization of blood gases at FiO₂ 0.4, select ALV parameters (Pin, Tin, Tech, Flow) sufficient for the specific situation.
11. If the condition begins to deteriorate within the next 4-6 hours, i.e., the patient requires FiO₂ more than 0.4, the issue of repeated surfactant administration should be decided based on X-ray data and blood gas parameters.
12. Perform manipulations strictly under aseptic conditions.

Adverse Reactions

Anaphylactoid reaction; transient tracheal or bronchial obstruction, which is eliminated by increasing respiratory pressure for 30-60 seconds; in children with intrapartum respiratory tract infection, sputum production may increase due to activation of mucociliary clearance.

Contraindications

• Multiple malformations;
• Malformations incompatible with life;
• Intestinal atresia;
• Severe birth trauma of the central nervous system;
• Hypothermia less than 36°C (96.8°F).

Pediatric Use

Use according to indications only in a hospital setting by doctors experienced in the treatment and resuscitation of premature infants.

Special Precautions

The drug should be used only in a hospital setting by doctors experienced in the treatment and resuscitation of premature infants.

Before starting treatment, it is necessary to correct acidosis, hypotension, anemia, hypoglycemia and hypothermia.

Overdose

No cases of overdose have been reported to date. Nevertheless, in case of overdose and only in the presence of clear clinical manifestations (related to respiration, ventilation or oxygenation), the maximum possible aspiration of the suspended contents from the lungs should be performed and therapy aimed at maintaining water-electrolyte balance should be carried out.

Drug Interactions

Not established.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.