6.3 Immunosuppressants, Biologics, Monoclonal Antibodies, and Biosimilar Drugs

3 min readjune 18, 2024

, , and are powerful tools in managing various health conditions. These drugs work by modulating the , helping to prevent , treat , and fight cancer.

Understanding how these medications work is crucial for nurses. From assessing infection risks to educating patients on side effects, nurses play a vital role in ensuring safe and effective treatment with these complex drugs.

Immunosuppressants, Biologics, and Monoclonal Antibodies

Types of immune system modulators

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  • Immunosuppressants suppress or reduce the strength of the body's immune system, used to prevent rejection in (kidney, liver, heart) and treat autoimmune diseases (, , )
  • are drugs derived from living organisms or containing components of living organisms, used to treat various conditions including autoimmune diseases (, ), cancer (, ), and diabetes ()
  • are a type of biologic drug consisting of laboratory-produced designed to target specific , used to treat autoimmune diseases (), cancer (, ), and inflammatory disorders (asthma, )
  • are biologic products highly similar to an already approved biologic drug (reference product) with no clinically meaningful differences in safety, purity, and potency, offering more affordable treatment options for patients

Mechanisms of immunomodulating drugs

  • Immunosuppressants work by inhibiting and proliferation, suppressing (, ), and preventing the migration of immune cells to sites of
  • Monoclonal antibodies target specific antigens on cells, leading to cell death (), inhibition of cell growth and proliferation, or neutralization of inflammatory mediators (TNF-α, )
  • Biologics can have various mechanisms depending on the specific drug, such as replacing deficient proteins (insulin for diabetes), stimulating the production of blood cells ( for ), or modulating immune responses ( for )

The immune system and its components

  • The immune system is a complex network of cells, tissues, and organs that work together to defend the body against harmful pathogens and foreign substances
  • Antibodies are proteins produced by B cells that recognize and bind to specific antigens, helping to neutralize or destroy them
  • Antigens are substances (usually proteins) on the surface of cells, viruses, fungi, or bacteria that trigger an immune response
  • are small proteins released by cells that play a crucial role in cell signaling and regulating immune responses
  • Inflammation is a protective response of the body to injury or infection, characterized by redness, swelling, heat, and pain
  • Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and tissue damage

Nursing care for immunosuppressant patients

  • Assess for signs of infection by monitoring vital signs (temperature, heart rate, respiratory rate), observing for localized signs (redness, swelling, drainage), and promptly reporting any concerns
  • Monitor for drug-specific side effects through regular assessment of liver and kidney function (, , ), monitoring complete blood count () to detect hematologic abnormalities (anemia, , )
  • Implement infection prevention measures by encouraging good hand hygiene, educating patients on avoiding crowded places and sick contacts, and ensuring patients receive recommended vaccinations (influenza, pneumococcal)
  • Administer medications as prescribed, double-checking dosages and administration routes, and monitoring for (fever, chills, rash) during monoclonal antibody therapy

Patient education for immunomodulating therapies

  • Emphasize the importance of medication adherence by explaining the role of immunomodulating drugs in managing their condition and discussing the consequences of non-adherence (organ rejection, disease flare-ups)
  • Teach patients to recognize signs of infection such as fever, chills, persistent cough, or painful urination, and instruct them to report any signs promptly to their healthcare provider
  • Educate patients on potential side effects (gastrointestinal disturbances, fatigue, headache) and when to seek medical attention, providing written information and encouraging the use of a symptom diary
  • Stress the importance of regular follow-up appointments to monitor drug levels, assess organ function, and adjust treatment plans as needed, encouraging patients to keep all scheduled appointments and communicate any concerns

Key Terms to Review (77)

Adalimumab: Adalimumab is a monoclonal antibody used as an immunosuppressant to treat autoimmune conditions like rheumatoid arthritis and psoriasis. It works by inhibiting tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation.
Adaptive immune system: The adaptive immune system is a specialized part of the immune system that targets specific pathogens with high precision. It has memory capabilities, allowing it to respond more effectively upon subsequent exposures to the same pathogen.
Anemia: Anemia is a condition characterized by a decrease in the number or quality of red blood cells, leading to a reduced ability to transport oxygen throughout the body. This can have significant implications in various medical contexts, including intravenous fluid therapy, total parenteral nutrition, blood products, immunosuppressants, chemotherapeutic drugs, biologic response modifiers, and oxygenation and gas exchange.
Antibodies: Antibodies are specialized proteins produced by the immune system to recognize and neutralize foreign substances, such as bacteria, viruses, and toxins. They are a critical component of the adaptive immune response, playing a central role in the body's defense against disease and infection across various topics in pharmacology and immunology.
Antigens: Antigens are any substances that can trigger an immune response by stimulating the production of antibodies. They are typically foreign molecules or structures that the body recognizes as potentially harmful, initiating a cascade of immune reactions to neutralize or eliminate them.
Apoptosis: Apoptosis is the process of programmed cell death that occurs in multicellular organisms. It is a crucial mechanism for maintaining cellular health and homeostasis.
Apoptosis: Apoptosis is a form of programmed cell death that occurs in multicellular organisms. It is a tightly regulated process that plays a crucial role in various biological contexts, including immunosuppression, cancer therapy, and the development and maintenance of healthy tissues.
Atopic Dermatitis: Atopic dermatitis, also known as eczema, is a chronic, inflammatory skin condition characterized by dry, itchy, and inflamed skin. It is often associated with a personal or family history of allergic conditions, such as asthma or hay fever, and is believed to be the result of a complex interplay between genetic and environmental factors.
Autoimmune Diseases: Autoimmune diseases are a group of disorders in which the body's immune system mistakenly attacks and damages its own healthy tissues and cells. This inappropriate immune response can lead to a wide range of chronic and debilitating conditions affecting various parts of the body.
Autoimmune disorders: Autoimmune disorders are conditions in which the immune system mistakenly attacks the body's own tissues. These disorders can lead to chronic inflammation and damage to various organs.
Avastin: Avastin, also known as Bevacizumab, is a monoclonal antibody that inhibits angiogenesis by blocking vascular endothelial growth factor (VEGF). It is commonly used in the treatment of various cancers and certain eye diseases.
Azathioprine: Azathioprine is an immunosuppressive medication commonly used to prevent organ rejection in transplant patients and to treat autoimmune diseases. It works by inhibiting the synthesis of DNA, RNA, and proteins, thereby suppressing the immune response.
Basal insulin dosing: Basal insulin dosing involves the administration of long-acting insulin to maintain blood glucose levels within a target range during fasting periods, typically over 24 hours. It is essential for managing diabetes mellitus, particularly Type 1 diabetes.
Bevacizumab: Bevacizumab is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), reducing blood vessel growth in tumors. It is commonly used in the treatment of various cancers and certain eye diseases.
Biologic drugs: Biologic drugs are medications derived from living organisms or contain components of living organisms. They are used to treat various diseases by targeting specific parts of the immune system.
Biologics: Biologics are complex drugs derived from living organisms, used to treat various medical conditions. They include proteins, nucleic acids, or cells that mimic natural substances in the body.
Biologics: Biologics are a class of drugs derived from living organisms, such as proteins, antibodies, or other biological substances. They are designed to target specific molecules or processes in the body, often used to treat complex diseases like autoimmune disorders, cancer, and infectious diseases.
Biosimilar drugs: Biosimilar drugs are biologic medical products highly similar to already approved reference biologics, with no clinically meaningful differences in safety, purity, or potency. They are used to treat various conditions, including immune system and inflammatory disorders.
Biosimilar Drugs: Biosimilar drugs are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biological product, known as the reference product. They are designed to mimic the safety, purity, and efficacy of the original biologic drug, providing a more affordable alternative for patients.
Blood urea nitrogen (BUN): Blood urea nitrogen (BUN) is a measure of the amount of urea nitrogen in the blood, a waste product formed in the liver from protein metabolism. Elevated BUN levels can indicate impaired kidney function or fluid imbalance.
Bortezomib: Bortezomib is a proteasome inhibitor used primarily as an anti-cancer drug to treat multiple myeloma and mantle cell lymphoma. It works by inhibiting the proteasome, leading to cancer cell death.
Breast Cancer: Breast cancer is a type of cancer that originates in the breast tissue, typically in the milk ducts or lobules. It is a complex and heterogeneous disease that can have various molecular subtypes and clinical presentations, making it an important consideration in the context of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs.
BUN: BUN, or Blood Urea Nitrogen, is a measure of the amount of nitrogen in the blood that comes from the waste product urea. It is an important indicator of kidney function and can provide valuable insights into various medical conditions and drug therapies.
CBC: CBC, or Complete Blood Count, is a common laboratory test that provides a comprehensive overview of an individual's blood composition. It is a crucial diagnostic tool used across various medical specialties, including immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs.
Cellcept: Cellcept, generic name mycophenolate mofetil, is an immunosuppressant medication primarily used to prevent organ rejection after transplants. It works by inhibiting the proliferation of T and B lymphocytes.
Colorectal Cancer: Colorectal cancer is a type of cancer that originates in the colon or rectum, which are part of the large intestine. It is a significant health concern that can be influenced by various factors, including immunosuppression, biologics, monoclonal antibodies, and biosimilar drugs, as well as the use of laxatives and stool softeners.
Creatinine: Creatinine is a waste product generated from the breakdown of creatine, a molecule found in muscle tissue. It is primarily filtered out of the bloodstream by the kidneys and excreted in urine, making it an important biomarker for evaluating kidney function.
Crohn's Disease: Crohn's disease is a type of inflammatory bowel disease (IBD) that causes chronic inflammation and irritation in the digestive tract. It can affect any part of the gastrointestinal system, from the mouth to the anus, but most commonly occurs in the last part of the small intestine (the ileum) and the beginning of the colon. Crohn's disease is a lifelong condition that can have significant impacts on a person's quality of life, and it is often treated with a combination of medications, dietary changes, and sometimes surgery. Understanding Crohn's disease is important in the context of topics like immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs, as well as the anatomy and function of the small and large intestines.
Cytokine Production: Cytokine production refers to the process by which various cells in the body, such as immune cells, release small signaling proteins called cytokines. These cytokines play a crucial role in regulating immune responses, inflammation, and other physiological processes, making them an important factor in the context of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs.
Cytokines: Cytokines are small signaling proteins secreted by various cells in the body, particularly immune cells, that play a crucial role in regulating the immune response, inflammation, and other physiological processes. They act as chemical messengers, allowing cells to communicate with each other and coordinate their activities.
Decadron: Decadron is a brand name for dexamethasone, a potent glucocorticoid used to reduce inflammation and suppress the immune system. It is commonly used in treating various conditions, including autoimmune diseases, cancer, and adrenal insufficiency.
Enbrel: Enbrel (etanercept) is a biologic medication used to treat autoimmune conditions by inhibiting tumor necrosis factor (TNF). It is commonly prescribed for conditions such as rheumatoid arthritis and psoriasis.
Erythropoietin: Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidneys that stimulates the production of red blood cells (erythrocytes) in the bone marrow. It plays a crucial role in the regulation of erythropoiesis, the process of red blood cell formation, and is closely connected to the topics of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs, as well as the renal system.
Erythropoietin production: Erythropoietin production is the process by which the kidneys produce erythropoietin, a hormone that stimulates red blood cell formation in the bone marrow. This production is crucial for maintaining adequate oxygen levels in tissues.
Etanercept: Etanercept is a biologic medication that acts as a tumor necrosis factor (TNF) inhibitor, used primarily to treat autoimmune diseases such as rheumatoid arthritis and psoriasis. It works by binding to TNF, preventing it from interacting with its receptors and thereby reducing inflammation.
Glucocorticoids: Glucocorticoids are a class of corticosteroids that play a critical role in regulating metabolism, immune response, and inflammation. They are produced naturally in the adrenal cortex and can also be synthetically manufactured for medical use.
Heparin-induced thrombocytopenia (HIT): Heparin-induced thrombocytopenia (HIT) is a serious immune-mediated adverse reaction to heparin therapy characterized by a significant reduction in platelet count. This condition can lead to a paradoxical increase in the risk of thrombosis despite low platelet levels.
Humira: Humira (adalimumab) is a biologic medication used to reduce inflammation by inhibiting tumor necrosis factor-alpha (TNF-alpha). It is commonly prescribed for autoimmune conditions such as rheumatoid arthritis and psoriasis.
IL-2: IL-2, or Interleukin-2, is a cytokine produced primarily by activated T cells that plays a crucial role in regulating the immune response. This key term is particularly relevant in the context of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs, as it is involved in various immunological processes and therapeutic interventions.
IL-6: IL-6 (Interleukin-6) is a pro-inflammatory cytokine that plays a crucial role in the immune response, inflammation, and various disease processes. It is a key mediator of the body's reaction to infection, injury, and other forms of stress, making it a significant factor in the context of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs.
Immune System: The immune system is a complex network of cells, tissues, and organs that work together to defend the body against infections, diseases, and foreign invaders. It plays a crucial role in maintaining health and well-being by recognizing and eliminating threats, while also regulating the body's response to various stimuli.
Immunosuppressants: Immunosuppressants are a class of drugs that work by reducing or preventing the body's immune response. They are commonly used to prevent rejection of transplanted organs, treat autoimmune disorders, and manage certain inflammatory conditions.
Imuran: Imuran is an immunosuppressive medication primarily used to prevent organ rejection following transplants and to treat autoimmune diseases. It works by inhibiting the proliferation of immune cells that cause inflammation.
Inflammation: Inflammation is the body's natural immune response to various stimuli, such as pathogens, damaged cells, or irritants. It is a complex biological process that aims to remove harmful stimuli, initiate the healing process, and restore homeostasis. Inflammation is a key component in the understanding of immunity, immunosuppressants, corticosteroids, and other related pharmacological topics.
Inflammatory response: The inflammatory response is the body's immediate reaction to injury or infection, characterized by redness, heat, swelling, and pain. It involves a complex interaction of immune cells, signaling molecules, and blood vessels to eliminate the cause of injury and initiate tissue repair.
Infliximab: Infliximab is a monoclonal antibody used as an immunosuppressant to treat various inflammatory diseases. It works by inhibiting tumor necrosis factor-alpha (TNF-α), a substance in the body that causes inflammation.
Infusion Reactions: Infusion reactions are adverse events that can occur during the administration of certain medications, particularly biologics, monoclonal antibodies, and biosimilar drugs. These reactions are typically triggered by the body's immune response to the foreign proteins or molecules present in the infused medication.
Insulin: Insulin is a hormone produced by the pancreas that regulates blood sugar levels by facilitating the uptake and utilization of glucose by cells throughout the body. It plays a crucial role in maintaining homeostasis, managing electrolyte balance, and supporting various physiological processes, making it an essential consideration in drug administration, documentation, and the treatment of conditions like diabetes and weight management.
Interferon-β: Interferon-β is a type of protein produced by the body's cells in response to the presence of viruses, bacteria, or other pathogens. It is a key player in the body's immune system, helping to protect cells from viral infections and regulate various immune responses.
Leukemia: Leukemia is a type of cancer that originates in the bone marrow and leads to an overproduction of abnormal white blood cells. These abnormal cells crowd out normal blood cells, impeding their function.
Leukemia: Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the uncontrolled proliferation of abnormal white blood cells. This cancer is closely tied to the topics of immunosuppressants, biologics, monoclonal antibodies, biosimilar drugs, and the various phases of cancer therapy.
Leukopenia: Leukopenia is a condition characterized by a decrease in the number of white blood cells (leukocytes) in the body. This can result in a weakened immune system and increased susceptibility to infections.
LFTs: LFTs, or Liver Function Tests, are a group of blood tests that measure the levels of certain enzymes and proteins produced by the liver. These tests provide valuable information about the health and function of the liver, which is a crucial organ involved in various metabolic processes, including the metabolism and clearance of drugs and other substances.
Lupus: Lupus is an autoimmune disease where the body's immune system mistakenly attacks its own healthy tissues and organs. It is a chronic, inflammatory condition that can affect various parts of the body, including the skin, joints, and internal organs. Lupus is a key term in the context of immunosuppressants, biologics, monoclonal antibodies, biosimilar drugs, glucocorticoids, and mineralocorticoids, as these therapies are often used to manage the symptoms and complications of this complex disease.
Lymphoma: Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It is characterized by the abnormal growth and proliferation of lymphocytes, a type of white blood cell. Lymphoma can be classified into different subtypes based on the specific type of lymphocyte involved and the rate of disease progression.
Monoclonal antibodies: Monoclonal antibodies are laboratory-made molecules that can bind to specific targets, such as antigens on cancer cells. They are used in various therapies, including for cancer and autoimmune diseases.
Monoclonal Antibodies: Monoclonal antibodies are laboratory-produced immune system proteins that are designed to target specific antigens or molecules. They are created by cloning a unique white blood cell, allowing for the mass production of a single, highly specialized antibody that can recognize and bind to a particular target.
Multiple sclerosis: Multiple sclerosis (MS) is an autoimmune disease where the immune system attacks the protective myelin sheath covering nerve fibers, causing communication issues between the brain and the rest of the body. The disease can result in deterioration or permanent damage to nerves.
Multiple Sclerosis: Multiple sclerosis (MS) is an autoimmune disease that affects the central nervous system, causing damage to the protective myelin sheath around nerve fibers, leading to disruption of nerve impulse transmission. This chronic and often disabling condition is closely tied to the topics of immunosuppressants, biologics, monoclonal antibodies, biosimilar drugs, and the management of urinary dysfunction.
Mycophenolate: Mycophenolate is an immunosuppressant drug commonly used to prevent organ rejection in transplant patients. It works by inhibiting the proliferation of lymphocytes, which are crucial for the immune response.
Neulasta: Neulasta (pegfilgrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) used to stimulate the production of white blood cells. It is commonly administered to patients undergoing chemotherapy to reduce the risk of infection due to neutropenia.
Non-Hodgkin lymphoma: Non-Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, specifically in the lymphocytes. It differs from Hodgkin lymphoma by the absence of Reed-Sternberg cells.
Organ Rejection: Organ rejection is an immune system response that occurs when the body recognizes a transplanted organ as foreign and attempts to attack and destroy it. This is a common complication that can arise after an organ transplant procedure, as the recipient's immune system tries to identify and eliminate the transplanted organ as a threat.
Organ Transplantation: Organ transplantation is the surgical procedure of removing an organ from one individual (the donor) and placing it into the body of another individual (the recipient) to replace a damaged or non-functioning organ. This process is crucial in the context of immunosuppressants, biologics, monoclonal antibodies, and biosimilar drugs, as these pharmacological agents play a vital role in preventing rejection and maintaining the viability of the transplanted organ.
Pegfilgrastim: Pegfilgrastim is a long-acting form of filgrastim, a granulocyte colony-stimulating factor (G-CSF) that stimulates the production of neutrophils. It is used to decrease the incidence of infection in patients undergoing chemotherapy.
Psoriasis: Psoriasis is a chronic, inflammatory skin condition characterized by the rapid buildup of skin cells, leading to the formation of thick, scaly, and often itchy or painful patches on the skin. This autoimmune disorder is closely linked to the topics of immunosuppressants, biologics, monoclonal antibodies, biosimilar drugs, and other dermatologic condition drugs and topical anti-infectives for burns.
Remicade: Remicade (infliximab) is a monoclonal antibody used to treat autoimmune conditions by inhibiting tumor necrosis factor-alpha (TNF-α). It is commonly used for conditions like Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriasis.
Rheumatoid Arthritis: Rheumatoid arthritis is an autoimmune disorder that primarily affects the joints, causing inflammation, pain, and progressive damage. It is a chronic condition that can have significant impacts on a person's quality of life and overall health.
Rituxan: Rituxan is a monoclonal antibody used to treat certain autoimmune diseases and types of cancer, particularly non-Hodgkin's lymphoma and chronic lymphocytic leukemia. It works by targeting the CD20 protein on the surface of B cells, leading to their destruction.
Rituximab: Rituximab is a monoclonal antibody used to treat certain autoimmune diseases and types of cancer. It targets the CD20 protein on the surface of B cells, leading to their destruction.
Serum creatinine: Serum creatinine is a waste product found in the blood that comes from muscle metabolism. It is commonly used as an indicator of kidney function.
T-cell Activation: T-cell activation is the process by which T cells, a type of white blood cell crucial for the adaptive immune response, become stimulated and ready to carry out their effector functions. This activation is a critical step in the body's ability to mount an effective immune defense against pathogens and abnormal cells.
T-cell Proliferation: T-cell proliferation refers to the rapid increase in the number of T-cells, a type of white blood cell that plays a crucial role in the adaptive immune response. This process is essential for mounting an effective immune defense against pathogens and is a key mechanism of action for various immunomodulatory drugs.
Thrombocytopenia: Thrombocytopenia is a condition characterized by a low platelet count in the blood, which can lead to an increased risk of bleeding and bruising. This term is particularly relevant in the context of intravenous fluid therapy, total parenteral nutrition, blood products, immunosuppressants, chemotherapeutic drugs, and antiplatelet medications, as these treatments and therapies can directly impact platelet levels and function.
TNF-α: TNF-α, or Tumor Necrosis Factor alpha, is a pro-inflammatory cytokine that plays a crucial role in the body's immune response and inflammatory processes. This multifunctional protein is produced by various cells, including macrophages, T cells, and adipocytes, and is a key mediator in the regulation of immune cells, cell proliferation, differentiation, and apoptosis.
Ulcerative Colitis: Ulcerative colitis is a chronic inflammatory bowel disease that affects the large intestine, causing inflammation and ulceration of the inner lining of the colon. It is characterized by periods of flare-ups and remission, and can significantly impact a person's quality of life.
Velcade: Velcade (bortezomib) is a proteasome inhibitor used primarily in the treatment of multiple myeloma and mantle cell lymphoma. It interferes with the growth of cancer cells, ultimately leading to their destruction.
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