immune globulin intravenous, human-stwk

Action and Spectrum

Actions and Spectrum: 

Actions: 

ALYGLO (immune globulin intravenous, human-stwk) provides a wide range of IgG antibodies that neutralise the poisons and pathogens, both bacterial and viral. In PI, the mode of action has not been completely explained. 

Spectrum: 

ALYGLO (immune globulin intravenous)(human-stwk) is a 10% liquid immune globulin designed for intravenous injection. It is indicated for PI (primary humoral immunodeficiency) in adults. This encompasses various conditions such as common variable immunodeficiency (CVID), the immunological humoral deficiency present in Wiskott-Aldrich syndrome, congenital agammaglobulinemia, severe combined immunodeficiency (SCID), and X-linked agammaglobulinemia. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Chest pain 

Pale or yellow colored skin 

Being unable to urinate 

Little or no urination 

Dark colored urine 

Confusion 

Heavy sweating 

Feeling very thirsty 

Hot and dry skin 

Fever 

Weakness 

Pain 

Rash 

Dizziness 

Diarrhea 

Abdominal discomfort 

Trouble breathing 

Rapid weight gain 

Arthralgia 

Cough 

Swelling 

Blue colored fingers, lips, or toes 

SOB 

Eye pain 

Fever with a severe headache 

Tachycardia 

Sweeling of leg 

Warmth of leg 

Numbness or weakness on one side 

Discoloration in leg or arm 

Increased sensitivity to light 

Black Box Warning

Black Box Warning: 

RENAL DYSFUNCTION, THROMBOSIS, and Acute renal failure: 

This compound carries a potential risk of thrombosis. Factors contributing to thrombosis include advancing years, hypercoagulable conditions, prolonged immobilization, presence of indwelling vascular catheters, a history of arterial or venous thrombosis, estrogen use, cardiovascular risk factors, and hyperviscosity. 

To mitigate thrombosis risk, administer this product at the lowest feasible dose and infusion rate for patients prone to thrombosis. 

Patients should be hydrated well before administration. 

Monitor at-risk patients for signs and symptoms of thrombosis and assess blood viscosity regularly. 

RENAL DYSFUNCTION, osmotic nephrosis, acute renal failure, and death are potential complications associated with IGIV (immune globulin intravenous) products in predisposed individuals. 

Renal dysfunction-predisposed patients include those with diabetes mellitus, age exceeding 65,  preexisting renal insufficiency,  sepsis, volume depletion, paraproteinemia, or people using medicines known to be nephrotoxic. 

Instances of renal dysfunction and acute renal failure are more frequent in patients receiving IGIV products containing sucrose; refer to the manufacturer’s product information for detailed guidance. 

For patients at risk of renal failure or dysfunction, administer at the lowest available concentration and the minimum feasible infusion rate. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 
• IgA defieciency 
• Anaphylactic reactions 
• Pediatrics below 6 

Cautions 

• Renal impairment 
• Thrombosis 
• Geriatrics 
• Pediatrics 
• Infection 
• Transfusion acute lung injury 
• Electrolyte imbalance 
• DM 
• Hemolysis 
• Increased viscosity of serum 
• Cardiovascular disorders 
• Blood clots 
• Aseptic meningitis syndrome 
• Paraproteinemia 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

Category C 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: C 

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: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

ALYGLO (immune globulin intravenous, human-stwk) provides a wide range of IgG antibodies that neutralise the poisons and pathogens, both bacterial and viral. In PI, the mode of action has not been completely explained. 

Pharmacodynamics: 

ALYGLO mostly consists of IgG, which reflects the IgG activity present in the donor population and has a wide range of antibodies against different pathogenic pathogens. The IgG subclass distribution of ALYGLO, which is made from pooled material, is comparable to that of native human plasma. Abnormally low IgG levels can be brought back to the normal level with a correct dose of IGIV.  

No standard pharmacodynamics studies were carried out. 

Pharmacokinetics: 

Limited data is available 

Adminstartion

Administration: 

Administration guidance: 

Continuous monitoring of vital signs during the infusion is recommended. In the event of adverse reactions, consider halting or reducing the infusion; if symptoms rapidly alleviate, cautiously resume the infusion at a decreased rate. 

Patients should be hydrated and not experiencing volume depletion. Exercise caution and administer the minimum feasible dose and rate in patients with potential risks of thrombosis or renal dysfunction. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: immune globulin intravenous, human-stwk 

Pronounced: ih-MYOON GLO-byoo-lin in-truh-VEE-nus, HYOOM-an – stwk 

Why do we use immune globulin intravenous, human-stwk? 

Immune globulin intravenous, human-stwk serves diverse purposes within the realm of the immune system, being a blood product enriched with antibodies sourced from human plasma. Its applications are manifold, catering to specific medical conditions and therapeutic needs. Firstly, it plays a crucial role in addressing immunodeficiency disorders, particularly in cases where the immune system fails to generate an adequate quantity of antibodies, leaving individuals vulnerable to infections. Additionally, immune globulin is employed in the treatment of autoimmune diseases, stepping in when the immune system erroneously targets the body’s own tissues. 

Furthermore, this intravenous product proves valuable in the prevention of infections, finding utility among individuals with compromised immune systems who require temporary protection against specific pathogens. As a form of post-exposure prophylaxis, it can be administered after contact with certain diseases, mitigating the severity or preventing the onset of infection. In the pediatric realm, immune globulin is a key component in treating Kawasaki disease, an inflammatory condition impacting blood vessels. 

Moreover, it finds application in managing Idiopathic Thrombocytopenic Purpura (ITP), a condition marked by reduced platelet counts. In neurological contexts, immune globulin contributes to the treatment of Guillain-Barré Syndrome, a disorder affecting peripheral nerves. Lastly, it is employed in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), offering therapeutic support for this condition affecting the peripheral nervous system. The multifaceted use of immune globulin intravenous, human-stwk underscores its significance in addressing various immune-related challenges and promoting overall health.