Lyophilized Bacterial Lysates

Approved Indications:

• Prevention of Recurrent Respiratory Tract Infections (RTIs):
  Indicated to reduce the frequency and severity of recurrent upper and lower RTIs in both adults and children, including:
• Chronic bronchitis
• Recurrent pharyngitis, tonsillitis, sinusitis
• Otitis media
• Chronic obstructive pulmonary disease (COPD) exacerbations

Clinically Accepted Off-label Uses:

• Immunostimulation in At-Risk Populations:
  Used in individuals with impaired or immature immune systems (e.g., elderly, children) to strengthen host defense mechanisms.
• Adjunctive Therapy in Respiratory Allergies and Asthma:
  May be used to help reduce infection-related exacerbations in patients with asthma or allergic rhinitis.
• Supportive Therapy in Chronic Sinopulmonary Disorders:
  Used in diseases such as bronchiectasis or cystic fibrosis to prevent infection recurrence.

Adults:

• One capsule (7 mg) orally once daily, preferably in the morning before meals, for 10 consecutive days per month for 3 consecutive months.

Children (≥6 months):

• One sachet (3.5 mg) orally once daily for 10 consecutive days per month for 3 months. Contents may be mixed with water, juice, or milk before administration.

Elderly:

• Same as adult dosage. No specific adjustment required unless clinically indicated.

Renal Impairment:

• No dose adjustment required.

Hepatic Impairment:

• No dose adjustment required.

Route of Administration:

• Oral (capsules or sachets)

Duration of Treatment:

• Standard course: 3 months. Cycles may be repeated based on clinical need.

Lyophilized Bacterial Lysates contain inactivated components of multiple common respiratory pathogens. These lysates act by stimulating the immune system through the gut-associated lymphoid tissue (GALT), particularly Peyer's patches. They activate innate immune cells (macrophages, dendritic cells) and promote the maturation of adaptive immunity (T and B lymphocytes), enhancing the production of secretory IgA and other immune mediators. This leads to improved mucosal defense, reduced susceptibility to infections, and better immune memory to prevent recurrent infections.

As a non-systemic immunomodulator, conventional pharmacokinetic data are limited.

• Absorption: Not absorbed into systemic circulation; acts locally in the gut
• Distribution: N/A – acts via immune stimulation in gut-associated lymphoid tissue
• Metabolism: Broken down enzymatically in the gastrointestinal tract
• Excretion: Metabolized and eliminated as non-active protein fragments
• Onset of Action: Immune response begins within a few days; clinical benefit often evident after the first or second monthly cycle
• Duration of Action: Immune-modulating effects persist several weeks after each cycle

• Pregnancy:
• No official FDA pregnancy category assigned.
• Use only if clearly needed and prescribed by a physician. Safety data are limited. Avoid use during active pregnancy unless benefit outweighs risk.
• Lactation:
• No significant excretion into breast milk reported.
• Considered compatible with breastfeeding. Use with caution and under supervision.

• Primary Class: Immunostimulant
• Subclass: Oral bacterial lysate-based mucosal immune modulator

• Known hypersensitivity to any component of the bacterial lysates
• Active febrile illness or acute infection (delay treatment until resolution)
• Autoimmune disorders (use only under specialist supervision)
• Infants under 6 months of age (safety not established)

• Autoimmune Diseases:
  May trigger or exacerbate autoimmune reactions; use cautiously or avoid in active autoimmune conditions.
• Acute Infections:
  Do not initiate treatment during acute infections. Resume once the infection is controlled.
• Immunocompromised States:
  May have reduced efficacy in patients on immunosuppressive therapy.
• Hypersensitivity Reactions:
  Rare cases of allergic rash or bronchospasm have been reported.
• Monitoring:
  Regular monitoring of infection frequency and immune response is recommended during long-term or repeated use.

Common:

• Gastrointestinal: Nausea, abdominal discomfort
• Respiratory: Nasal congestion, sneezing
• Skin: Mild rash or pruritus
• General: Low-grade fever, fatigue

Uncommon:

• Headache
• Flu-like symptoms (usually self-limiting)

Rare but Serious:

• Hypersensitivity reactions, including rash or urticaria
• Bronchospasm
• Exacerbation of autoimmune disorders

Severity and Onset:

• Most adverse effects are mild, occur early in treatment, and resolve without intervention.

• Immunosuppressive Agents (e.g., corticosteroids, cytotoxic drugs):
  May reduce the immunostimulatory effect of the lysates.
• Live Vaccines:
  Caution is advised. Ideally, separate administration by several days.
• Antibiotics:
  No direct interaction, but concurrent antibiotic use during bacterial lysate therapy may obscure clinical benefit evaluation.

CYP Enzyme Involvement:

• No known involvement with cytochrome P450 enzymes. No hepatic enzyme inhibition or induction reported.

• European Respiratory Guidelines:
  Continue to support the use of bacterial lysates in reducing recurrent RTIs, especially in children and the elderly.
• Clinical Data:
  Studies confirm a reduction in the frequency of respiratory infections and antibiotic use in patients using lyophilized bacterial lysates.
• Antibiotic Stewardship:
  Recognized as an important adjunct to reduce antibiotic overuse in recurrent infection management.

• Temperature: Store below 25°C (77°F)
• Light and Humidity Protection: Keep in original packaging; protect from moisture and direct sunlight
• Handling Precautions:
• Do not use damaged or expired sachets/capsules
• Keep out of reach of children
• Reconstitution (if sachets used):
• Mix contents in a small amount of water, juice, or milk immediately before administration
• No refrigeration required