aviptadil 

Action and Spectrum

Actions and Spectrum: 

aviptadil is a synthetic form of a naturally occurring peptide called vasoactive intestinal polypeptide (VIP). It has been investigated for its potential therapeutic effects on various medical conditions. 

The main action of aviptadil is its ability to bind to VIP receptors, which are located throughout the body, including the cardiovascular, respiratory, gastrointestinal, and nervous systems. When aviptadil binds to these receptors, it can cause various physiological responses, such as vasodilation (widening of blood vessels), relaxation of smooth muscle, and stimulation of glandular secretions. 

aviptadil has been studied primarily for its effects on pulmonary arterial hypertension (PAH), characterized by high blood pressure in the lungs’ arteries. aviptadil has been shown to improve blood flow and reduce pulmonary arterial pressure in patients with PAH. 

Additionally, aviptadil has been investigated for its potential therapeutic effects on other medical conditions, including acute respiratory distress syndrome (ARDS), erectile dysfunction, and sepsis. 

In summary, the spectrum of aviptadil’s actions is primarily related to its ability to bind to VIP receptors throughout the body, resulting in various physiological responses that may have therapeutic effects on various medical conditions. 

Drug Interaction

Adverse Reaction

N/A 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

The contraindications may not yet be fully established. However, based on the known pharmacological effects of aviptadil, it may not be appropriate for use in specific individuals, such as those with: 

• Known hypersensitivity or allergic reactions to aviptadil or any of its components 
• Cardiovascular instability or severe hypotension (low blood pressure) 
• Active bleeding or recent history of bleeding 
• Severe liver impairment or dysfunction 
• Severe renal impairment or dysfunction 
• Severe coagulopathy (bleeding disorder) 
• Pregnancy/breastfeeding due to the potential risks to the developing fetus or infant. 

It is key to consult with a healthcare provider before starting any new medication/treatment and to inform them of any medical conditions, allergies, or medications being taken, as they can help determine whether aviptadil is appropriate for an individual’s specific situation. 

Caution 

As an investigational drug, aviptadil is still being studied for its safety and efficacy. While specific cautions may not yet be fully established, based on the known pharmacological effects of aviptadil, the following cautions should be considered: 

• Use in elderly individuals or those with impaired liver or kidney function may require careful monitoring and adjustment of dosing. 
• aviptadil may cause some individuals hypotension (low blood pressure). Caution should be exercised when using aviptadil in patients with a history of hypotension or those taking medications that can lower blood pressure. 
• aviptadil may increase the risk of bleeding, so it should be typically used cautiously in patients with a bleeding disorder or those taking medications that can increase bleeding risk, such as anticoagulants or antiplatelet agents. 
• As aviptadil is an investigational drug, whether it is safe/effective in children, pregnant or breastfeeding women is unknown. 

It is key to consult with a healthcare provider before starting any new medication/treatment and to inform them of any medical conditions, allergies, or medications being taken, as they can help determine whether aviptadil is appropriate for an individual’s specific situation. 

Pregnancy / Lactation

Pregnancy consideration:  

Category  

Breastfeeding warnings:  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/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 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: 

aviptadil is a synthetic peptide selective agonist for the vasoactive intestinal peptide (VIP) receptor. VIP is a neuropeptide with many physiological effects, including vasodilation, smooth muscle relaxation, and immune modulation. By binding to the VIP receptor, aviptadil produces similar effects, leading to vasodilation of blood vessels and improved blood flow to various organs and tissues. aviptadil has also been shown to have anti-inflammatory and immunomodulatory effects, which may be beneficial in treating conditions such as sepsis and acute respiratory distress syndrome (ARDS). 

Pharmacodynamics: 

Mechanism of action: It is a synthetic analog of vasoactive intestinal polypeptide with potent vasodilatory properties. 

VIP is a molecule that binds specifically to alveolar type II cells (ATII) within the lung alveolus. In clinical research, animal models of respiratory distress, acute lung injury, and inflammation it has been found to have anti-inflammatory/anti-cytokine properties. 

Furthermore, this substance stimulates ATII cells to produce surfactant, which is required to coat the lung lining and enable it to exchange oxygen with the blood. Respiratory failure and alveolar collapse, characteristic of COVID-19, occur due to a loss of surfactant. 

Pharmacokinetics: 

Absorption 

aviptadil is administered by intravenous (IV) infusion and rapidly distributed into the bloodstream after administration. 

Distribution 

The distribution of aviptadil in the body has yet to be extensively studied. However, it is known that aviptadil is a small peptide that can rapidly diffuse into tissues. 

Metabolism 

aviptadil is rapidly metabolized in the bloodstream by proteases, resulting in a short half-life of only a few minutes. The metabolites of aviptadil are primarily excreted through the kidneys. 

Elimination and Excretion 

The metabolites of aviptadil are primarily excreted through the kidneys. 

Adminstartion

Administration: 

As an investigational drug, the administration of aviptadil may vary depending on the specific indication and the clinical trial protocol. However, here are some common guidelines on the administration of aviptadil: 

• aviptadil is administered by intravenous (IV) infusion. 
• The dosage and duration of the infusion will depend on the indication being treated and the clinical trial protocol. The infusion may be given continuously or intermittently. 
• The infusion rate may be adjusted based on the patient’s response and tolerability, as well as their age, weight, and other factors. 
• aviptadil should only be administered by a healthcare professional trained in the proper technique for IV infusions and who can monitor the patient for any adverse reactions. 
• Before administration, the drug should be visually inspected for any particles or discoloration. If present, the drug should not be used. 
• The drug should be stored according to the manufacturer’s instructions, and any unused portions should be appropriately disposed of. 

Patient Information Leaflet