vilobelimab

Action and Spectrum

Actions and Spectrum: vilobelimab, also known as IFX-1, is a monoclonal antibody currently under investigation for its potential use in treating various inflammatory and autoimmune conditions. Its mechanism of action involves selectively targeting and inhibiting the activity of complement factor C5a, a protein that is part of the complement system, an essential component of the immune system. The complement system is a complex cascade of proteins that plays a critical role in the immune response by helping to recognize and eliminate pathogens, such as bacteria and

viruses, and promoting inflammation. However, excessive or dysregulated activation of the complement system can also contribute to the pathogenesis of various inflammatory and autoimmune diseases, including conditions such as rheumatoid arthritis and lupus. vilobelimab works by specifically binding to C5a and inhibiting its activity, thereby preventing its pro-inflammatory effects. By blocking C5a, vilobelimab is believed to help reduce inflammation and tissue damage associated with various inflammatory and autoimmune conditions. The spectrum of activity of vilobelimab is primarily focused on its inhibitory effect on the complement system by explicitly targeting C5a. This makes it valuable for treating conditions where complement dysregulation, specifically C5a-mediated inflammation, is believed to play a role. However, further research and clinical trials are needed to determine the full spectrum of activity and potential therapeutic applications of vilobelimab.

Drug Interaction

Adverse Reaction

Frequency not defined

>10%

Sepsis (21.7%)

Pulmonary embolism (10.9%)

Pneumonia (31.4%)

Delirium (12.6%)

1-10%

Pneumothorax (8%)

Herpes simplex (6.3%)

Bronchopulmonary aspergillosis (5.7%)

Urinary tract infection (5.1%)

Thrombocytopenia (4.6%)

Respiratory tract infection (4%)

Constipation (3.4%)

Hypertension (9.1%)

Deep vein thrombosis (6.3%)

Enterococcal infection (5.7%)

Hepatic enzyme increased (5.1%)

Hypoxia (4.6%)

Pneumomediastinum (4.6%)

Supraventricular tachycardia (4%)

Rash (3.4%)

Reporting Required

With this therapy, serious and unanticipated side effects that haven’t been recorded before could happen. Mandatory reporting of all significant adverse events and medication errors that may be drug-related is the responsibility of prescribers and the provider’s designee within seven calendar days of the event’s occurrence.

Death or a life-threatening adverse event, medical or surgical intervention to avert these outcomes, hospitalization, a handicap, or a congenital disability are all considered severe adverse events. Inpatient hospitalization or an extension of a current hospitalization, persistent or significant disability, or a considerable interruption of ability to carry out daily activities; or an abnormality present at birth or congenital

Black Box Warning

Black box warning:

None

Contraindication / Caution

Contraindications/caution:

Contraindications:

None

Caution:

• Allergic reactions: As with any medication, vilobelimab may cause allergic reactions in some individuals. Signs of an allergic reaction may include difficulty breathing, rash, itching, swelling, or severe dizziness. If you experience any of these symptoms, seek immediate medical attention.
• Infections: vilobelimab may suppress the immune system, increasing the risk of infections. It is essential to monitor for signs of infections, such as fever, chills, cough, sore throat, or unusual discharge, and promptly report any symptoms to your healthcare provider.
• Interactions with other medications: vilobelimab may interact with your medications. To avoid potential drug interactions, it is essential to inform your healthcare provider about all the medications you are taking, including prescription, over the counter, and herbal supplements.
• Monitoring for adverse effects: vilobelimab is a newer medication, and its long-term safety profile is still being evaluated. Your healthcare provider may need to monitor you closely for potential adverse effects while taking vilobelimab.
• Pre-existing medical conditions: If you have any pre-existing medical conditions, such as liver or kidney disease, or a history of infections, it is essential to inform your healthcare provider before starting vilobelimab, as it may require particular caution or monitoring.

• Pregnancy and breast-feeding: The safety of vilobelimab during pregnancy and breastfeeding is not well-established, and it should be used with caution in these populations.

Children and elderly: The safety and effectiveness of vilobelimab in children and elderly populations have not been established, and it should be used with caution in these age groups.

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available

Lactation: Excretion of the drug in human breast milk is unknown

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 available 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: There is no data available for the drug under this category

Pharmacology

Pharmacology:

vilobelimab, also known as IFX-1, is a monoclonal antibody that targets and inhibits complement factor C5a, a component of the complement system, a part of the immune system involved in inflammation and immune response. vilobelimab binds explicitly to C5a and prevents its interaction with its receptor, C5aR, thereby inhibiting the downstream effects of C5a activation.

Pharmacodynamics:

• Effect on complement system: vilobelimab inhibits the activity of C5a, a potent pro-inflammatory mediator that plays a role in the pathogenesis of several autoimmune and inflammatory conditions. By blocking C5a, vilobelimab may help to reduce the inflammatory response associated with C5a activation, potentially leading to decreased inflammation and immune-mediated tissue damage.
• Immunomodulatory effects: vilobelimab’s inhibition of C5a can modulate the immune response by reducing the recruitment and activation of immune cells, such as neutrophils and monocytes, at the site of inflammation. This can result in decreased production of pro-inflammatory cytokines and chemokines and may help to attenuate the immune response in certain inflammatory conditions.
• Clinical effects:The specific clinical effects of vilobelimab would depend on the condition being treated and the underlying pathophysiology. vilobelimab is currently being investigated for its potential use in various autoimmune and inflammatory conditions, including hidradenitis suppurativa and ANCA-associated vasculitis. Clinical studies are ongoing to evaluate the safety and efficacy of vilobelimab in these conditions and other potential indications.

Pharmacokinetics:

Absorption

vilobelimab is administered intravenously, typically as an infusion. As such, it is expected to be fully and immediately absorbed into the systemic circulation.

Distribution

The distribution of vilobelimab in the body is not fully characterized. As a monoclonal antibody, it is expected to have a relatively large volume of distribution, with the potential to distribute to various tissues and organs.

Metabolism

vilobelimab is a monoclonal antibody and is not expected to undergo significant metabolism in the body. Monoclonal antibodies are typically not metabolized into smaller molecules but instead are cleared from the body intact.

Elimination and Excretion

The exact excretion pathway of vilobelimab is not well-established. However, as a monoclonal antibody, it is expected to be eliminated primarily through proteolysis and clearance by the reticuloendothelial system, which includes organs such as the liver and spleen.

Adminstartion

Administration:

• Dosage:The prescribed healthcare provider will determine the recommended dosage and frequency of vilobelimab based on the specific condition being treated, patient characteristics, and other relevant factors.
• Infusion rate: vilobelimab is typically administered as an IV infusion over a specific duration, which may vary depending on the dosing regimen. The infusion rate may be adjusted based on the patient’s tolerability and any potential infusion-related reactions.
• Preparation:vilobelimab is typically supplied as a sterile solution for IV infusions in vials or pre-filled syringes. It should be prepared and administered according to the manufacturer’s instructions and in compliance with aseptic techniques.
• Monitoring:During and after the infusion of vilobelimab, the patient’s vital signs, including blood pressure, heart rate, and respiratory rate, may be monitored to detect any potential infusion-related reactions or adverse events. Additional monitoring, such as laboratory tests, may also be performed as clinically indicated.

Special considerations: vilobelimab may have specific considerations for special populations, such as patients with impaired renal or hepatic function, pregnant or breastfeeding individuals, or pediatric populations. Dosing adjustments or additional precautions may be necessary in these cases, and consultation with a qualified healthcare provider is recommended.

Patient Information Leaflet

Patient information leaflet

Generic Name: vilobelimab

Why do we use vilobelimab?

vilobelimab, also known as IFX-1, is a monoclonal antibody being investigated for its potential uses in various inflammatory and autoimmune diseases. Some of the potential uses of vilobelimab based on the ongoing clinical trials and preclinical studies:

• Bullous Pemphigoid: Bullous pemphigoid is a chronic autoimmune blistering skin disease. vilobelimab has been studied in clinical trials as a potential treatment for bullous pemphigoid, with promising results in early-phase studies showing improvement in disease activity and reduction in blistering.
• Rheumatoid Arthritis: Rheumatoid arthritis is a chronic inflammatory joint disease. vilobelimab has shown potential as an inhibitor of the complement system, which plays a role in the pathogenesis of rheumatoid arthritis. Clinical trials are ongoing to investigate the efficacy and safety of vilobelimab in treating rheumatoid arthritis.
• Hidradenitis Suppurativa: Hidradenitis suppurativa is a chronic inflammatory skin condition that affects hair follicles and sweat glands. vilobelimab has been studied in preclinical models and early-phase clinical trials as a potential treatment for hidradenitis suppurativa, with promising results in reducing inflammation and improving disease symptoms.

Pyoderma Gangrenosum: Pyoderma gangrenosum is a rare, ulcerative skin condition often associated with autoimmune diseases. vilobelimab has been studied in clinical trials as a potential treatment for pyoderma gangrenosum, with promising results in reducing inflammation and promoting wound healing.