C1 inhibitor human

Action and Spectrum

Drug Interaction

Adverse Reaction

Frequency not defined 

Cinryze 

Sinusitis 

URI 

Headache 

Rash 

pre-eclampsia 

Rare HAE attacks 

Rare stroke 

Berinert 

Vomiting 

Dysgeusia 

Nausea 

Diarrhea 

Headache 

muscle spasms 

abdominal pain 

laryngospasm 

laryngeal edema 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

C1 inhibitor human, also known as C1 esterase inhibitor, is a medication used to treat hereditary angioedema (HAE) and other conditions. While I don’t have access to specific prescribing information or updates beyond my September 2021 knowledge cutoff, I can provide some general contraindications that may be associated with C1 inhibitor human. However, it’s crucial to consult the latest prescribing information, healthcare professionals, or updated drug databases for the most accurate and current contraindications. Some potential contraindications may include: 

• Hypersensitivity: C1 inhibitor human may be contraindicated in individuals with known hypersensitivity/allergic reaction to C1 inhibitor human or any of its components. Allergic reactions can range from mild-severe and may require immediate medical attention. 
• Allergy to rabbits or rabbit-derived products: C1 inhibitor human is typically derived from human plasma, but specific manufacturing processes may involve rabbit materials. Therefore, individuals with a known allergy to rabbits or rabbit-derived products may be contraindicated to C1 inhibitor human. 
• Active infection or systemic sepsis: C1 inhibitor human may not be recommended in individuals with active infections or systemic sepsis due to the potential risk of exacerbating the infection. The decision to use C1 inhibitor human in these situations should be made in consultation with healthcare professionals. 
• Pregnancy and breastfeeding: Safety and efficacy of C1 inhibitor human during pregnancy and breastfeeding have not been well-established. In such cases, healthcare professionals may need to carefully weigh the potential risks and also benefits before prescribing or administering C1 inhibitor human. 

Caution 

C1 inhibitor human, also known as C1 esterase inhibitor, is a medication used to treat hereditary angioedema (HAE) and other conditions. While I don’t have access to specific prescribing information or updates beyond my September 2021 knowledge cut off, I can provide some general cautions that may be associated with C1 inhibitor humans. However, it’s crucial to consult the latest prescribing information, healthcare professionals, or updated drug databases for the most accurate and current cautions. Some potential cautions may include: 

• Thrombotic events: C1 inhibitor humans may be associated with a potential risk of thrombotic events (formation of blood clots). Individuals with a history of thrombotic events, such as deep vein thrombosis or pulmonary embolism, may require careful monitoring and consideration of the risks versus benefits before initiating C1 inhibitor human therapy. 
• Hypersensitivity reactions: Although hypersensitivity reactions to C1 inhibitor human are rare, they can occur. Close monitoring for any signs of allergic reactions, such as rash, itching, swelling, or difficulty breathing, is recommended. If an allergic reaction is suspected, immediate medical attention should be sought. 
• Viral transmission: C1 inhibitor human is derived from human plasma, and while extensive screening and purification processes are in place to lower the risk, there is a theoretical risk of viral transmission. This applies to all plasma-derived products. Healthcare professionals should follow appropriate guidelines and protocols to minimize this risk. 
• Interactions with other medications: C1 inhibitor human may potentially interact with other medications. It’s crucial to inform healthcare professionals about all the medications, including prescription, over-the-counter, and herbal supplements, being taken concurrently. They can evaluate potential interactions and adjust dosages if necessary. 
• Renal impairment: Individuals with renal impairment may require dose adjustments or close monitoring while receiving a C1 inhibitor human. It is crucial to consider the individual’s renal function and adjust the treatment plan accordingly. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned 

Lactation:   

Excreted into human milk is Not known. 

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 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: 

C1 inhibitor human, also known as C1 esterase inhibitor, is a glycoprotein that plays a crucial role in regulating the complement system and coagulation cascade. Here’s an overview of the pharmacology of C1 inhibitor human: 

• Inhibition of C1r and C1s: C1 inhibitor human binds to and inactivates the serine proteases C1r and C1s, which are components of the C1 complex. By inhibiting C1r and C1s, C1 inhibitor human prevents the activation of the classical pathway of the complement system, which helps regulate immune responses and inflammation. 
• Inhibition of coagulation factors: C1 inhibitor human also inhibits several coagulation factors, including factor XIa and factor XIIa. By inhibiting these factors, the C1 inhibitor human helps regulate the coagulation cascade and prevents excessive clot formation. 

Pharmacodynamics: 

Mechanism of action: C1 inhibitor human, also known as C1 esterase inhibitor, acts through its mechanism of action to regulate the complement system and coagulation cascade. Here is an overview of the mechanism of action of C1 inhibitor human: 

• Inhibition of C1r and C1s: C1 inhibitor human binds to and inactivates the serine proteases C1r and C1s, which are components of the C1 complex. The C1 complex initiates the classical pathway of the complement system. By inhibiting C1r and C1s, C1 inhibitor human prevents the activation of downstream complement components and subsequent immune responses and inflammatory reactions. 
• Regulation of the complement system: It is a part of the immune system that typically helps defend against pathogens. However, excessive or uncontrolled complement activation can lead to tissue damage and inflammation. C1 inhibitor human helps maintain the balance of the complement system by inhibiting the enzymatic activities of C1r and C1s, thus preventing the excessive activation of the classical pathway. 
• Inhibition of coagulation factors: C1 inhibitor human also inhibits several coagulation factors, including factor XIa and factor XIIa. By inhibiting these factors, C1 inhibitor human helps regulate the coagulation cascade and prevent excessive clot formation. This anti-coagulant effect may be beneficial in conditions with uncontrolled coagulation activation. 

Pharmacokinetics: 

Absorption 

C1 inhibitor human is administered intravenously (IV) as an infusion. As a result, it bypasses the absorption phase, directly entering the bloodstream. 

Distribution 

After IV administration, the C1 inhibitor human is distributed throughout the bloodstream and extravascular compartments. The exact distribution pattern may vary depending on vascular permeability and tissue characteristics. 

Metabolism 

The metabolism of C1 inhibitor in human occurs in various tissues, including the liver. The exact metabolic pathways and specific enzymes involved in the metabolism of C1 inhibitor human need to be better characterized. 

Elimination and Excretion 

C1 inhibitor human is primarily eliminated through proteolytic degradation in the liver and other tissues. The exact excretion routes and elimination half-life can vary between individuals and may be influenced by factors such as liver function and individual patient characteristics. 

Adminstartion

Administration: 

Intravenous administration 

C1 inhibitor human, or C1 esterase inhibitor, is administered through intravenous (IV) infusion. The specific dosing and administration instructions may vary depending on the indication and individual patient factors. Here are some general guidelines for the administration of C1 inhibitor human: 

• Preparation: C1 inhibitor human is supplied as a lyophilized powder for reconstitution. It should be reconstituted according to the instructions provided by the manufacturer/as directed by healthcare professionals. The reconstituted solution should be inspected for any particulate matter or discoloration before administration. 
• Administration route: C1 inhibitor human is administered intravenously. The medication is typically given as a slow infusion over a specified period. The exact infusion rate and duration may vary depending on the product and indication. 
• Dosage: The dosage of the C1 inhibitor human is determined based on factors like the patient’s weight and individual response. Healthcare professionals will determine the appropriate dosage for each patient and may adjust it as necessary. 
• Monitoring: During and after the infusion of the C1 inhibitor human, patients should be closely monitored for any adverse reactions or hypersensitivity symptoms. Vital signs, such as BP, heart rate, and respiratory rate, should be monitored regularly. 
• Reconstitution and handling: Following proper aseptic techniques when reconstituting and handling C1 inhibitor human is essential. This includes using sterile equipment and maintaining proper hygiene to minimize the risk of contamination. 
• Storage: C1 inhibitor human should be stored according to the manufacturer’s instructions. It is typically stored in a refrigerator, but some products may have different storage requirements. Always check the product label and package insert for specific storage instructions. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: C1 inhibitor human 

Pronounced: [ cee-won-in-HIB-i-ter-HYU-man ] 

Why do we use C1 inhibitor human? 

C1 inhibitor human, also known as C1 esterase inhibitor, is primarily used to treat hereditary angioedema (HAE), a genetic disorder characterized by recurrent episodes of swelling in various body parts. However, C1 inhibitor human has also been investigated for potential uses in other conditions. Here are the primary uses of C1 inhibitor human: 

• Hereditary angioedema (HAE): C1 inhibitor human is the mainstay of treatment for acute attacks and prophylaxis in patients with HAE. It helps prevent or reduce the severity and duration of HAE attacks by restoring the deficient or dysfunctional C1 inhibitor in the body. 
• Acute attacks of angioedema: C1 inhibitor human can treat acute angioedema attacks in HAE patients. It is administered during an attack to help alleviate swelling and associated symptoms, such as pain and discomfort. 
• Prophylaxis of angioedema attacks: C1 inhibitor human can also be used as a prophylactic therapy to prevent/reduce the frequency and severity of angioedema attacks in individuals with HAE. Prophylactic treatment is typically recommended in patients with frequent or severe attacks. 
• Other potential uses: C1 inhibitor human has been investigated for its potential use in other conditions, such as sepsis, ischemia-reperfusion injury, and organ transplantation. These investigations are based on the anti-inflammatory and anti-thrombotic properties of C1 inhibitor, but the efficacy and safety of these indications are still being studied. 

It’s important to note that the uses of C1 inhibitor human may vary depending on the country and regulatory approvals. The specific indications and recommended uses may be determined by healthcare professionals based on the individual patient’s condition and clinical guidelines.