Adalimumab is a human monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease by blocking tumor necrosis factor-alpha (TNF-α). It was discovered in 1993 and approved by the FDA in 2008. Adalimumab works by binding to TNF-α molecules in the blood and tissues to block their interaction with cell surface receptors and lyse TNF-expressing cells, reducing inflammation. Clinical trials demonstrated its efficacy in treating psoriasis and other conditions. While common side effects include pain, nausea and fatigue, it poses risks like severe infections and cancer with long term use.
Adalimumab is a human monoclonal antibody that targets and blocks TNF-alpha, a protein involved in inflammatory and immune responses. It is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and other immune-mediated inflammatory diseases. Adalimumab works by binding to TNF-alpha in the blood and tissues to prevent it from activating immune cells and causing inflammation. It has been shown to effectively reduce symptoms and disease activity in clinical trials for various conditions. Like other TNF blockers, it carries risks of infections and rare cases of cancer with long-term use.
Clinical use & devleopment of adalimumab—lwLeo Williams
This document discusses adalimumab (Humira), a monoclonal antibody drug used to treat autoimmune disorders by blocking tumor necrosis factor alpha (TNFα). It first describes TNFα's role in normal immune function and elevated levels in autoimmune diseases. It then explains how adalimumab was developed using phage display to select antibodies that bind TNFα. The document outlines adalimumab's approval history, clinical indications, dosage, side effects, manufacturing process, and mechanism of action in blocking TNFα signaling and reducing inflammation.
This case report describes a 54-year old woman with severe plaque psoriasis who did not respond to various treatments including PUVA, cyclosporine, and methotrexate. She was started on adalimumab with an initial dose of 80 mg followed by 40 mg one week later and 40 mg every other week, which resulted in an improvement in her psoriasis. However, she did not have a complete response, so methotrexate 5 mg weekly was added to her treatment regimen. The combination of adalimumab and methotrexate proved to be safe and effective for her, with her psoriasis well controlled on this combination therapy.
Adalimumab (Humira) is a fully human monoclonal antibody that binds to tumor necrosis factor alpha (TNFα) to reduce inflammation. It is used to treat several autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Adalimumab works by blocking the interaction of TNFα with cell surface TNF receptors. Potential side effects include headache, nausea, and rash. It requires a prescription and is generally safe to take with other medications.
Remicade, also known as Infliximab, is a prescription drug administered via intravenous infusion to treat immune system diseases like Crohn's disease, rheumatoid arthritis, and ulcerative colitis. It works by binding to and blocking tumor necrosis factor alpha, which contributes to inflammation. Common side effects include stomach/chest pain and infections, while serious risks include tuberculosis, cancer, and heart failure. The drug requires careful dosage and administration in a medical setting due to its potential side effects.
Metronidazole, general presentation.. by patroba jonathan in tapsa sjutsjut tapsa
This document discusses the pharmacist of the week program designed by TAPSA-SJUT to educate pharmacy students about pharmacy practice through presentations and discussions. Metronidazole is presented on as today's pharmaceutical product. Metronidazole is an antibacterial and antiprotozoal agent used to treat anaerobe infections, C. difficile, H. pylori, bacterial vaginosis, trichomonas vaginitis, amebiasis, and giardiasis. It works by inhibiting nucleic acid synthesis in microbial cells. Common side effects include nausea, seizures, and liver problems. It can interact with alcohol and some other drugs. Missing a dose may reduce its effectiveness. Accidental
This document discusses the chemical metronidazole, including its molecular formula, structure, alternative names, history of development and uses. Metronidazole is a synthetic antibiotic and antiprotozoal agent used to treat various infections caused by anaerobic bacteria and protozoa. It works by being selectively reduced inside anaerobic cells and binding to DNA. Common side effects include nausea and neurological symptoms. The document compares metronidazole to other drugs for specific conditions, finding ciprofloxacin and vancomycin more effective than metronidazole for some infections. Metronidazole is recommended for completing the prescribed dosage to avoid antibiotic resistance.
Adalimumab is a human monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease by blocking tumor necrosis factor-alpha (TNF-α). It was discovered in 1993 and approved by the FDA in 2008. Adalimumab works by binding to TNF-α molecules in the blood and tissues to block their interaction with cell surface receptors and lyse TNF-expressing cells, reducing inflammation. Clinical trials demonstrated its efficacy in treating psoriasis and other conditions. While common side effects include pain, nausea and fatigue, it poses risks like severe infections and cancer with long term use.
Adalimumab is a human monoclonal antibody that targets and blocks TNF-alpha, a protein involved in inflammatory and immune responses. It is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and other immune-mediated inflammatory diseases. Adalimumab works by binding to TNF-alpha in the blood and tissues to prevent it from activating immune cells and causing inflammation. It has been shown to effectively reduce symptoms and disease activity in clinical trials for various conditions. Like other TNF blockers, it carries risks of infections and rare cases of cancer with long-term use.
Clinical use & devleopment of adalimumab—lwLeo Williams
This document discusses adalimumab (Humira), a monoclonal antibody drug used to treat autoimmune disorders by blocking tumor necrosis factor alpha (TNFα). It first describes TNFα's role in normal immune function and elevated levels in autoimmune diseases. It then explains how adalimumab was developed using phage display to select antibodies that bind TNFα. The document outlines adalimumab's approval history, clinical indications, dosage, side effects, manufacturing process, and mechanism of action in blocking TNFα signaling and reducing inflammation.
This case report describes a 54-year old woman with severe plaque psoriasis who did not respond to various treatments including PUVA, cyclosporine, and methotrexate. She was started on adalimumab with an initial dose of 80 mg followed by 40 mg one week later and 40 mg every other week, which resulted in an improvement in her psoriasis. However, she did not have a complete response, so methotrexate 5 mg weekly was added to her treatment regimen. The combination of adalimumab and methotrexate proved to be safe and effective for her, with her psoriasis well controlled on this combination therapy.
Adalimumab (Humira) is a fully human monoclonal antibody that binds to tumor necrosis factor alpha (TNFα) to reduce inflammation. It is used to treat several autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Adalimumab works by blocking the interaction of TNFα with cell surface TNF receptors. Potential side effects include headache, nausea, and rash. It requires a prescription and is generally safe to take with other medications.
Remicade, also known as Infliximab, is a prescription drug administered via intravenous infusion to treat immune system diseases like Crohn's disease, rheumatoid arthritis, and ulcerative colitis. It works by binding to and blocking tumor necrosis factor alpha, which contributes to inflammation. Common side effects include stomach/chest pain and infections, while serious risks include tuberculosis, cancer, and heart failure. The drug requires careful dosage and administration in a medical setting due to its potential side effects.
Metronidazole, general presentation.. by patroba jonathan in tapsa sjutsjut tapsa
This document discusses the pharmacist of the week program designed by TAPSA-SJUT to educate pharmacy students about pharmacy practice through presentations and discussions. Metronidazole is presented on as today's pharmaceutical product. Metronidazole is an antibacterial and antiprotozoal agent used to treat anaerobe infections, C. difficile, H. pylori, bacterial vaginosis, trichomonas vaginitis, amebiasis, and giardiasis. It works by inhibiting nucleic acid synthesis in microbial cells. Common side effects include nausea, seizures, and liver problems. It can interact with alcohol and some other drugs. Missing a dose may reduce its effectiveness. Accidental
This document discusses the chemical metronidazole, including its molecular formula, structure, alternative names, history of development and uses. Metronidazole is a synthetic antibiotic and antiprotozoal agent used to treat various infections caused by anaerobic bacteria and protozoa. It works by being selectively reduced inside anaerobic cells and binding to DNA. Common side effects include nausea and neurological symptoms. The document compares metronidazole to other drugs for specific conditions, finding ciprofloxacin and vancomycin more effective than metronidazole for some infections. Metronidazole is recommended for completing the prescribed dosage to avoid antibiotic resistance.
Ruxolitinib is an oral inhibitor of JAK1 and JAK2 that is effective for treating polycythemia vera in patients who have an inadequate response or intolerance to hydroxyurea. It reduces hematocrit and spleen size while improving symptoms. In clinical trials, ruxolitinib provided durable control of hematocrit without phlebotomy and significantly reduced spleen volume compared to best available therapies. The most common side effects were mild and included headache, diarrhea, and fatigue.
Flagyl is used to treat bacterial infections of the vagina, stomach, skin, joints, and respiratory tract. This medication will not treat a vaginal yeast infection.
Metronidazole 500mg tablets smpc taj pharmaceuticalsTaj Pharma
This document provides information on Metronidazole 500mg Tablets, including:
- Indications for use in treating various anaerobic bacterial and protozoal infections
- Posology details for different conditions and populations (adults, children, hepatic impairment etc.)
- Contraindications such as pregnancy in first trimester and known hypersensitivity
- Warnings regarding interactions with alcohol, lithium, anticoagulants and potential side effects
- Extensive dosing guidelines for multiple therapeutic areas and populations
Metronidazole ( Treatment for Trichomoniasis )Sufi Zukiya
This document discusses the drug metronidazole, including its structure, mechanism of action, indications, side effects, dosing, and drug interactions. Metronidazole is an antibacterial and antiprotozoal medication commonly used to treat anaerobic bacterial infections and parasites. It works by inhibiting nucleic acid synthesis in anaerobic cells. Common uses include treating bacterial vaginosis, trichomoniasis, C. difficile infections, and giardiasis. Side effects include nausea, vomiting, and neurological effects. Care should be taken with alcohol and other drug interactions.
In this presentation, mainly I concentrated on Metronidazole, which is an anti-biotic; and talking about it's pharmacokinetics, drug indication, contraindication, adverse drug reactions and taking the drug during pregnancy and lactation, finally I hope you enjoy it as much as I DID, SALAAM.
Laboratory offering TDM for Immunosuppressive Drugs needs to understands their pharmacodynamics & clinical applications so that the results value add in the patient care
Metronidazole is an antibiotic used to treat various anaerobic bacterial and protozoal infections. It works by disrupting the DNA of anaerobic bacteria and protozoa. Common uses include treating Clostridium difficile infections, bacterial vaginosis, amebiasis, giardiasis, and certain anaerobic bacterial infections. Common side effects include nausea, vomiting, and metallic taste. It should not be taken with alcohol.
This study aimed to evaluate the efficacy of oral montelukast in acute asthma exacerbation. It was a randomized, double-blind, placebo-controlled trial conducted in a tertiary care hospital over 2 years. Patients presenting with acute asthma exacerbation were randomized to receive standard therapy with either montelukast or placebo. The primary outcomes of lung function, duration of hospital stay, and secondary outcomes showed no significant differences between the montelukast and placebo groups. The study concluded that montelukast provided no added benefit over standard therapy alone for acute asthma exacerbation. Larger multicenter trials are still needed.
Ustekinumab therapy efficacy in psoriasis patients previously treated with bi...wolass
This document summarizes a study on the efficacy of ustekinumab therapy in psoriasis patients previously treated with biologic drugs. It provides details on 39 patients treated with ustekinumab, including their demographics, comorbidities, PASI scores over time, and adverse events. The results showed that ustekinumab effectively reduced PASI scores and achieved therapeutic goals for most patients. Adverse events were generally mild. Patients who had previously used other biologics had lower PASI reduction initially but still saw benefits from ustekinumab over time.
Apremilast is a small molecule inhibitor of phosphodiesterase 4 approved for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. It works by downregulating inflammatory immune mediators. Pharmacokinetically, it has good oral bioavailability and undergoes extensive metabolism. Clinical trials showed apremilast improved signs and symptoms of psoriasis and psoriatic arthritis over both short and long term use. The most common side effects are diarrhea, upper respiratory tract infection, and nausea. Apremilast is approved in Europe and the US for patients with psoriasis or psoriatic arthritis with inadequate response or intolerance to other systemic therapies.
Anti protozoal and anti malarial drugsThiru Vinoth
Metronidazole is the prototype nitroimidazole anti-protozoal drug used to treat amoebiasis and other anaerobic bacterial infections. It is well absorbed orally and widely distributed throughout the body, with an elimination half-life of around 8 hours. Metronidazole's mechanism of action involves reduction of its nitro group by redox proteins in anaerobic organisms, which disrupts their energy metabolism. It is generally well tolerated but can cause adverse effects like nausea, metallic taste, and peripheral neuropathy with prolonged use. Metronidazole interacts with alcohol and some other drugs due to its metabolism.
Use of biologicals in rheumatoid arthritisILHAR HASHIM
- Biologicals are the newest class of drugs for treating rheumatoid arthritis (RA), developed using biotechnology. They target specific components of the immune system like cytokines such as tumor necrosis factor (TNF) and interleukins.
- RA is a chronic autoimmune disease that causes inflammation in the joints. While the exact causes are unknown, biologicals have become an important therapy when other disease-modifying antirheumatic drugs (DMARDs) like methotrexate fail. They can help reduce symptoms, slow joint damage, and improve quality of life.
- Major biological drugs for RA target TNF like adalimumab, etanercept, infliximab; IL-6 like
Adverse drug reactions attributed to genetic differences Ayesha Younas
Genetic differences between individuals can lead to variability in responses to drugs and adverse drug reactions. Some key points:
- About 30% of adverse drug reactions may be due to genetic polymorphisms affecting drug metabolism. Enzymes like CYP2D6 play an important role.
- Genes can impact how the body processes and breaks down drugs (pharmacokinetics) and how drugs interact with receptors (pharmacodynamics).
- Single nucleotide polymorphisms are variations in DNA sequences that can alter protein structure and drug responses. They have been linked to prolonged muscle relaxation after cholinergic drugs and hemolytic anemia from antimalarial drugs.
Pharmacogenomics aims to tailor drug therapy based on an individual's genetic makeup. Variations in genes encoding drug-metabolizing enzymes and transporters can impact drug response. This can increase risks of toxicities in poor metabolizers or reduce efficacy in ultra-rapid metabolizers. Regulatory agencies now provide dosing guidelines based on pharmacogenomic biomarkers. Understanding these genetic factors enhances drug development and allows for safer, more effective personalized medication.
Rachmat Gunadi Wachjudi was born in Garut, Indonesia in 1955. He received his medical education in Indonesia, obtaining degrees in general medicine, internal medicine, and rheumatology. He has worked as a rheumatology staff member at Dr. Hasan Sadikin Hospital. He is a member of several Indonesian medical organizations. The document provides biographical information about Rachmat Gunadi Wachjudi's education, career, and professional affiliations.
This document discusses tuberculosis categories, treatment, and diagnostic testing. It describes four categories of TB based on smear and x-ray results, HIV status, and other factors. Treatment involves multiple drug therapy including isoniazid, rifampin, pyrazinamide, and ethambutol over 2-4 months depending on the category. Diagnostics include sputum smear, culture, chest x-ray, and PPD skin test. Signs and symptoms, transmission, and other aspects of TB management are also covered.
Otezla is a drug created by Celgene Corporation to treat moderate to severe plaque psoriasis and psoriatic arthritis. It works by inhibiting the phosphodiesterase 4 enzyme, which reduces inflammation. Clinical studies showed patients experienced a reduction in symptoms and improvement in their conditions. Common side effects include diarrhea, nausea, and headache. Otezla provides an oral treatment option for these autoimmune disorders.
1) Remicade, Humira, Tysabri, and Cimzia are the main biologics approved for treating Crohn's disease.
2) Remicade and Humira have the longest history and largest safety databases, while Tysabri carries a risk of rare but serious side effects like PML.
3) The document provides brief summaries of each drug's mechanism of action, clinical trial results demonstrating efficacy in Crohn's, and safety profiles.
Ruxolitinib is an oral inhibitor of JAK1 and JAK2 that is effective for treating polycythemia vera in patients who have an inadequate response or intolerance to hydroxyurea. It reduces hematocrit and spleen size while improving symptoms. In clinical trials, ruxolitinib provided durable control of hematocrit without phlebotomy and significantly reduced spleen volume compared to best available therapies. The most common side effects were mild and included headache, diarrhea, and fatigue.
Flagyl is used to treat bacterial infections of the vagina, stomach, skin, joints, and respiratory tract. This medication will not treat a vaginal yeast infection.
Metronidazole 500mg tablets smpc taj pharmaceuticalsTaj Pharma
This document provides information on Metronidazole 500mg Tablets, including:
- Indications for use in treating various anaerobic bacterial and protozoal infections
- Posology details for different conditions and populations (adults, children, hepatic impairment etc.)
- Contraindications such as pregnancy in first trimester and known hypersensitivity
- Warnings regarding interactions with alcohol, lithium, anticoagulants and potential side effects
- Extensive dosing guidelines for multiple therapeutic areas and populations
Metronidazole ( Treatment for Trichomoniasis )Sufi Zukiya
This document discusses the drug metronidazole, including its structure, mechanism of action, indications, side effects, dosing, and drug interactions. Metronidazole is an antibacterial and antiprotozoal medication commonly used to treat anaerobic bacterial infections and parasites. It works by inhibiting nucleic acid synthesis in anaerobic cells. Common uses include treating bacterial vaginosis, trichomoniasis, C. difficile infections, and giardiasis. Side effects include nausea, vomiting, and neurological effects. Care should be taken with alcohol and other drug interactions.
In this presentation, mainly I concentrated on Metronidazole, which is an anti-biotic; and talking about it's pharmacokinetics, drug indication, contraindication, adverse drug reactions and taking the drug during pregnancy and lactation, finally I hope you enjoy it as much as I DID, SALAAM.
Laboratory offering TDM for Immunosuppressive Drugs needs to understands their pharmacodynamics & clinical applications so that the results value add in the patient care
Metronidazole is an antibiotic used to treat various anaerobic bacterial and protozoal infections. It works by disrupting the DNA of anaerobic bacteria and protozoa. Common uses include treating Clostridium difficile infections, bacterial vaginosis, amebiasis, giardiasis, and certain anaerobic bacterial infections. Common side effects include nausea, vomiting, and metallic taste. It should not be taken with alcohol.
This study aimed to evaluate the efficacy of oral montelukast in acute asthma exacerbation. It was a randomized, double-blind, placebo-controlled trial conducted in a tertiary care hospital over 2 years. Patients presenting with acute asthma exacerbation were randomized to receive standard therapy with either montelukast or placebo. The primary outcomes of lung function, duration of hospital stay, and secondary outcomes showed no significant differences between the montelukast and placebo groups. The study concluded that montelukast provided no added benefit over standard therapy alone for acute asthma exacerbation. Larger multicenter trials are still needed.
Ustekinumab therapy efficacy in psoriasis patients previously treated with bi...wolass
This document summarizes a study on the efficacy of ustekinumab therapy in psoriasis patients previously treated with biologic drugs. It provides details on 39 patients treated with ustekinumab, including their demographics, comorbidities, PASI scores over time, and adverse events. The results showed that ustekinumab effectively reduced PASI scores and achieved therapeutic goals for most patients. Adverse events were generally mild. Patients who had previously used other biologics had lower PASI reduction initially but still saw benefits from ustekinumab over time.
Apremilast is a small molecule inhibitor of phosphodiesterase 4 approved for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. It works by downregulating inflammatory immune mediators. Pharmacokinetically, it has good oral bioavailability and undergoes extensive metabolism. Clinical trials showed apremilast improved signs and symptoms of psoriasis and psoriatic arthritis over both short and long term use. The most common side effects are diarrhea, upper respiratory tract infection, and nausea. Apremilast is approved in Europe and the US for patients with psoriasis or psoriatic arthritis with inadequate response or intolerance to other systemic therapies.
Anti protozoal and anti malarial drugsThiru Vinoth
Metronidazole is the prototype nitroimidazole anti-protozoal drug used to treat amoebiasis and other anaerobic bacterial infections. It is well absorbed orally and widely distributed throughout the body, with an elimination half-life of around 8 hours. Metronidazole's mechanism of action involves reduction of its nitro group by redox proteins in anaerobic organisms, which disrupts their energy metabolism. It is generally well tolerated but can cause adverse effects like nausea, metallic taste, and peripheral neuropathy with prolonged use. Metronidazole interacts with alcohol and some other drugs due to its metabolism.
Use of biologicals in rheumatoid arthritisILHAR HASHIM
- Biologicals are the newest class of drugs for treating rheumatoid arthritis (RA), developed using biotechnology. They target specific components of the immune system like cytokines such as tumor necrosis factor (TNF) and interleukins.
- RA is a chronic autoimmune disease that causes inflammation in the joints. While the exact causes are unknown, biologicals have become an important therapy when other disease-modifying antirheumatic drugs (DMARDs) like methotrexate fail. They can help reduce symptoms, slow joint damage, and improve quality of life.
- Major biological drugs for RA target TNF like adalimumab, etanercept, infliximab; IL-6 like
Adverse drug reactions attributed to genetic differences Ayesha Younas
Genetic differences between individuals can lead to variability in responses to drugs and adverse drug reactions. Some key points:
- About 30% of adverse drug reactions may be due to genetic polymorphisms affecting drug metabolism. Enzymes like CYP2D6 play an important role.
- Genes can impact how the body processes and breaks down drugs (pharmacokinetics) and how drugs interact with receptors (pharmacodynamics).
- Single nucleotide polymorphisms are variations in DNA sequences that can alter protein structure and drug responses. They have been linked to prolonged muscle relaxation after cholinergic drugs and hemolytic anemia from antimalarial drugs.
Pharmacogenomics aims to tailor drug therapy based on an individual's genetic makeup. Variations in genes encoding drug-metabolizing enzymes and transporters can impact drug response. This can increase risks of toxicities in poor metabolizers or reduce efficacy in ultra-rapid metabolizers. Regulatory agencies now provide dosing guidelines based on pharmacogenomic biomarkers. Understanding these genetic factors enhances drug development and allows for safer, more effective personalized medication.
Rachmat Gunadi Wachjudi was born in Garut, Indonesia in 1955. He received his medical education in Indonesia, obtaining degrees in general medicine, internal medicine, and rheumatology. He has worked as a rheumatology staff member at Dr. Hasan Sadikin Hospital. He is a member of several Indonesian medical organizations. The document provides biographical information about Rachmat Gunadi Wachjudi's education, career, and professional affiliations.
This document discusses tuberculosis categories, treatment, and diagnostic testing. It describes four categories of TB based on smear and x-ray results, HIV status, and other factors. Treatment involves multiple drug therapy including isoniazid, rifampin, pyrazinamide, and ethambutol over 2-4 months depending on the category. Diagnostics include sputum smear, culture, chest x-ray, and PPD skin test. Signs and symptoms, transmission, and other aspects of TB management are also covered.
Otezla is a drug created by Celgene Corporation to treat moderate to severe plaque psoriasis and psoriatic arthritis. It works by inhibiting the phosphodiesterase 4 enzyme, which reduces inflammation. Clinical studies showed patients experienced a reduction in symptoms and improvement in their conditions. Common side effects include diarrhea, nausea, and headache. Otezla provides an oral treatment option for these autoimmune disorders.
1) Remicade, Humira, Tysabri, and Cimzia are the main biologics approved for treating Crohn's disease.
2) Remicade and Humira have the longest history and largest safety databases, while Tysabri carries a risk of rare but serious side effects like PML.
3) The document provides brief summaries of each drug's mechanism of action, clinical trial results demonstrating efficacy in Crohn's, and safety profiles.
Humira es un medicamento biológico comúnmente recetado para el tratamiento de la psoriasis moderada a grave. Si bien puede ser efectivo, Humira también conlleva riesgos significativos como infecciones graves e incrementos en ciertos tipos de cáncer. El documento también discute alternativas de tratamiento como la terapia PUVA que pueden presentar un mejor balance de riesgos y beneficios para algunos pacientes.
3d Stock Charts - Life 2.0 Data Visualization PanelMelanie Swan
So far virtual worlds have been used mainly for architectural builds and interaction. The next obvious step is making them alive with data, streaming in data and representing it visually. Data visualization in Second Life is growing rapidly.
Wiki: http://sldataviz.pbwiki.com/
Conference link: http://www.life20.net
O Humira foi aprovado para tratamento de artrite reumatóide, artrite idiopática juvenil, artrite psoriática, espondilite anquilosante, doença de Crohn e psoríase. Estudos mostraram que o Humira, contendo o anticorpo monoclonal adalimumab, é mais eficaz do que placebo ao reduzir sintomas destas doenças inflamatórias. Os riscos incluem infecções e deve ser usado com cuidado em pacientes com tuberculose.
Questo è il nostro lavoro sull'apparato digerente e il morbo di Crohn. Purtroppo qui le GIF non funzionano, se vuole vederle può aprire la presentazione su Google Presentazioni.
Patologie gastrointestinali e contraccezioneGynevra.it
La presenza di patologie infiammatorie croniche intestinali (sindrome dell’intestino irritabile, colite ulcerosa e malattia di Crohn) A cura di Alessandra Graziottin
Direttore del Centro di Ginecologia e Sessuologia Medica dell'Ospedale San Raffaele Resnati di Milano
The document discusses transient receptor potential (TRP) channels as therapeutic drug targets. It begins by explaining that TRP channels are appealing drug targets because they do not share homology with voltage-gated sodium and calcium channels, allowing for subtype-selective compounds. It also notes that TRP channels integrate several signaling systems and mutations can cause human diseases. The document then focuses on TRP channels in pain pathways, respiratory systems, and other pathophysiological processes. It highlights clinical trials of TRPV1 and TRPV3 antagonists for pain and discusses how TRPV1 antagonists affect heat perception in humans.
This document provides information on Humira (adalimumab), including:
- It is a fully human monoclonal antibody that binds to tumor necrosis factor alpha (TNFα) to reduce inflammation.
- It is used to treat conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis.
- It is administered via subcutaneous injection usually every other week. Common side effects include infections and allergic reactions.
Infliximab is a chimeric monoclonal antibody used to treat various autoimmune diseases by binding to and inhibiting tumor necrosis factor-alpha (TNF-α), a key part of the autoimmune response. It was originally developed as a mouse antibody but was modified to contain mostly human antibody sequences. Infliximab is administered via intravenous infusion every 6-8 weeks and is approved by the FDA to treat Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis.
The document discusses the impact of single-use disposable equipment on biopharma plant design. It notes that single-use equipment allows for more compact facility footprints due to reduced cleaning requirements. Specific impacts include smaller cleanroom sizes due to more compact equipment, reduced water and utilities usage from eliminating cleaning-in-place systems, and potentially lower capital costs compared to traditional stainless steel equipment. The document also outlines some implementation considerations for single-use equipment such as bag design standards, material selection, and procurement strategies.
This document summarizes a new drug called Umeclidinium (trade name Incruse Ellipta), which is a long-acting anticholinergic agent approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Key details include that it works by blocking acetylcholine receptors, is dosed once daily at 62.5mcg via an elliptical inhaler, and was found in clinical trials to significantly improve lung function for up to 28 hours compared to placebo. The drug was generally well tolerated with the most common side effect being headaches.
The document discusses a clinical trial comparing the monoclonal antibodies obinutuzumab and rituximab for treating diffuse large B-cell lymphoma. Obinutuzumab is a glycoengineered, humanized antibody that clusters the CD20 antigen more effectively than rituximab. In a phase III trial, obinutuzumab plus chemotherapy did not significantly improve progression-free survival over rituximab plus chemotherapy. However, obinutuzumab's glycoengineering may enhance its antibody-dependent cellular cytotoxicity and direct cell death mechanisms relative to rituximab.
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. The document discusses the definition, origins, need and applications of pharmacoepidemiology. Specifically, it notes that pharmacoepidemiology applies epidemiological techniques to study drug use and effects in populations. It also discusses limitations of pre-marketing drug trials that pharmacoepidemiology aims to address through post-marketing surveillance and other techniques.
This document outlines Ghana's national anti-malaria drug policy. It notes that malaria is a major public health problem in Ghana, especially among children and pregnant women. The policy aims to provide prompt, safe, and effective treatment for all cases of malaria. It endorses the "TEST, TREAT, AND TRACK" initiative to diagnose and treat malaria based on testing rather than presumptively. The policy recommends artemisinin-based combination therapies as first-line treatment and identifies appropriate medications for uncomplicated malaria, severe malaria, and malaria in pregnancy based on the latest evidence and WHO guidelines. It also provides guidance on intermittent preventive treatment in pregnancy.
1) A pregnant woman presented with reactivated tuberculosis and was treated with a first-line anti-tuberculosis regimen for 6 months while closely monitored.
2) For breastfeeding, first-line anti-tuberculosis treatment is not contraindicated but precautions should be taken, and the infant may require pyridoxine supplementation.
3) An infant born to a mother with active pulmonary tuberculosis near delivery would receive preventative treatment and be evaluated for tuberculosis infection, with BCG vaccination postponed until cleared.
Medical complications in pregnancy cmt april 2010NESSlideShare
This document discusses three cases related to medical complications in pregnancy. Case 1 describes a woman who died of an undiagnosed pulmonary embolism during pregnancy. Case 2 involves a woman admitted with renal problems during pregnancy. The document then discusses prescribing medications during pregnancy, including the risks of certain anti-epileptic drugs. Case 3 presents a woman with epilepsy who is now pregnant.
This document discusses three cases related to medical complications in pregnancy. Case 1 describes a woman who died of an undiagnosed pulmonary embolism during pregnancy. Case 2 involves a woman admitted with renal problems during pregnancy. The document then discusses prescribing medications during pregnancy, highlighting lessons from thalidomide, and concludes with management considerations for epilepsy in pregnancy.
Delamanid for multidrug resistant pulmonary tuberculosisHaroon Rashid
Delamanid is a new drug that inhibits mycolic acid synthesis in Mycobacterium tuberculosis. This randomized controlled trial evaluated the safety and efficacy of Delamanid (100 mg or 200 mg twice daily) plus background regimen compared to placebo plus background regimen in 481 patients with multidrug-resistant pulmonary tuberculosis over 2 months. Patients receiving Delamanid had higher rates of sputum culture conversion at 2 months compared to placebo, indicating Delamanid enhances treatment options for multidrug-resistant tuberculosis. However, the short 2-month treatment period was a limitation.
This document summarizes information on chronic urticaria, including its prevalence, causes, impact on quality of life, and treatment options. It notes that chronic urticaria affects approximately 1% of people with acute urticaria and has a significant negative impact on quality of life. First-line treatment includes non-sedating antihistamines, sometimes at higher off-label doses. If patients do not respond sufficiently to antihistamines alone, second-line options include doxepin, leukotriene antagonists, short-term corticosteroids, dapsone, sulfasalazine, and narrowband UVB phototherapy. The document reviews evidence on the efficacy and safety of these second-
List of New Anti-cancer Drugs Approved By FDA In The First Half of 2023.pdfDoriaFang
What are the new anti-cancer drugs approved in the first half of the year? The new drugs approved covered a variety of solid tumors and blood tumor types.
Antiemetic Prophylaxis in Major Gynaecological Surgery With Intravenous Grani...inventionjournals
In a randomized double-blind study, researchers compared the efficacy of granisetron versus metoclopramide for preventing postoperative nausea and vomiting (PONV) in 50 female patients undergoing major gynecological surgery. Patients received either granisetron 40mcg/kg or metoclopramide 0.15mg/kg before surgery. Incidence of PONV was assessed over 24 hours. While both drugs effectively prevented PONV in the first 4 hours, granisetron was more effective over the next 20 hours, with a 12% incidence of PONV versus 48% for metoclopramide. Nausea scores were also significantly lower in the granisetron group
Antiemetic Prophylaxis in Major Gynaecological Surgery With Intravenous Grani...inventionjournals
In a randomized double-blind study, researchers compared the efficacy of granisetron versus metoclopramide for preventing postoperative nausea and vomiting (PONV) in 50 female patients undergoing major gynecological surgery. Patients received either granisetron 40mcg/kg or metoclopramide 0.15mg/kg before surgery. Incidence of PONV was assessed over 24 hours. While both drugs effectively prevented PONV in the first 4 hours, granisetron was more effective over the next 20 hours, with a 12% incidence of PONV versus 48% for metoclopramide. Nausea scores were also significantly lower in the granisetron group
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Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
1. Humira (adalimumab)
in Pediatric Crohn’s Disease
By Payam Javanmardi
Academy of Applied Pharmaceutical Sciences
Canada, Toronto, October 2014
1
2. Table contents
Introduction
Clinical Pharmacology
Pharmacodynamics
Pharmacokinetics
Warning and Precautions
Drug Interactions
Use in specific populations
New approved indication
Clinical trial design and conduct
References
2
3. Humira has already received several FDA approvals
for treatment:
Rhematoid Arthritis Dec. 31, 2002
Psoriatic Arthritis Oct. 2005
Ankylosing Spondylitis July 31, 2006
Crohn’s Disease Feb. 27, 2006
Plaque Psoriasis Jan. 22, 2008
Polyarticular Juvenile Idiopathic Arthritis
Feb. 22, 2008
Ulcerative Colitis Sep. 28, 2012
3
4. Adalimumab (Humira) is a recombinant human IgG1
monoclonal antibody specific for human Tumor
Necrosis Factor (TNF-α). It consists of 1330 amino acids
and has a molecular weight of approximately 148KDa.
4
5. Adalimumab (Humira) is supplied as either a single
use, prefilled pen/prefilled glass syringe or a single
use institutional use vial.
The solution of Humira is clear and colorless, with a
pH of 5.2 .
5
6. Clinical Pharmacology
Mechanism of action
TNF-α is a naturally occurring cytokine that
is involved in normal inflammatory and
immune responses.
Adalimumab (Humira) binds specifically to
TNF-α and block cell surface TNF receptors.
6
7. Adalimumab (Humira) modulates biological
responses that are induced or regulated by TNF-α,
inducing changes in the levels of adhesion
molecules responsible for Leukocyte migration
(ELAM-1, VCAM-1, and ICAM-1).
7
9. Clinical Pharmacology
Pharmacodynamics
After treatment with Adalimumab (Humira), a decrease in
levels of CRP, ESR, and Il-6 was observed comparing to
baseline in patients with RA.
A decrease in CRP levels was also observed in patients with
Crohn’s disease and Ulcerative Colitis.
Serum levels of MMP-1 and MMP-3 that produce tissue
remodeling responsible for cartilage destruction were also
decreased after Humira administration.
9
10. Clinical Pharmacology
Pharmacokinetics
The maximum serum concentration (Cmax)
and the time to reach the maximum
concentration (Tmax) were 4.7± 1.6 μg/ml
and 131± 56 hours respectively, following a
single 40mg subcutaneous administration of
Humira to healthy adult subjects.
10
11. Clinical Pharmacology
Pharmacokinetics
The average absolute bioavailability of
adalimumab estimated from 3 studies
following a single 40mg subcutaneous dose
was 64%.
The Pharmacokinetics of adalimumab were
linear over the dose range of 0.5 to 10mg/kg
following a single IV dose.
11
12. Clinical Pharmacology
Warning And Precautions
Patients treated with Humira are at
increased risk for developing serious
infections involving organ systems and sites
that may lead to hospitalization or death.
Aspergilosis, Blastomycosis, candidiasis,
Coccidomycosis, Histoplasmosis, Legionellosis,
Lysteriosis, Pneumocytosis, and Tuberculosis
12
13. Clinical Pharmacology
Warning And Precautions
The risks and benefits of TNF-blocker
treatment including Humira should be
considered prior to initiating therapy in
patients with a known malignancy.
13
14. Clinical Pharmacology
Warning And Precautions
Anaphylaxis and Angioneurotic edema have
been reported following Humira
administration.
Use of TNF blockers including Humira, may
increase the risk of reactivation of hepatitis
B Virus in patients who are chronic carriers
of this virus.
14
15. Clinical Pharmacology
Warning And Precautions
Some cases of neurologic and
hematological reactions have been found
being associated with TNF blocking agents
including Humira.
Cases of worsening congestive heart failure
and new onset of CHF has been reported
with TNF blockers.
15
16. Clinical Pharmacology
Warning And Precautions
Treatment with Humira may result in the
formation of autoantibodies and, rarely, in
the development of a lupus-like syndrome.
There have been reports of severe hepatic
reactions including liver failure in patients
receiving TNF-blockers.
16
17. Clinical Pharmacology
Drug Interactions
Concomitant administration of Humira with
other biologic DMARDS (e.g., anakinra and
abatacept) or other TNF blockers is not
recommended based upon the possible
increased risk for infections and other
potential pharmacological interactions.
The use of live vaccines with Humira must
be avoided.
17
18. Clinical Pharmacology
Use in specific populations
Pregnancy
Adequate and well controlled studies with
Humira have not been conducted in
pregnant women.
Adalimumab is an IgG1 Mab and IgG1 is
actively transferred across the placenta
during the third trimester of pregnancy.
18
19. Clinical Pharmacology
Use in specific populations
Pregnancy
No fetal harm was observed in reproductive
studies performed in cynomolgus monkeys.
Because reproductive studies are not
always predictive of human response, this
drug should be used during pregnancy only
if clearly needed.
19
20. Clinical Pharmacology
Use in specific populations
Nursing Mothers
Limited data from published literature
indicate that adalimumab is present in low
levels in human milk and is not likely to be
absorbed by a breastfed infant.
However, caution should be exercised when
Humira is administered to a nursing woman.
20
21. Clinical Pharmacology
Use in specific populations
Pediatrics
Humira administered during pregnancy
could affect immune response in the in
utero- exposed newborn and infant.
The clinical significance of elevated
adalimumab levels in infants is unknown.
21
22. Clinical Pharmacology
Use in specific populations
Pediatrics
Post-marketing cases of lymphoma,
including hepatosplenic T-cell lymphoma
and other malignancies, some fatal, have
been reported among children,
adolescents, and young adults who received
treatment with TNF blockers including
Humira.
22
23. Clinical Pharmacology
Use in specific populations
Geriatrics
The frequency of serious infection and
malignancy among Humira treated patients
over 65 years of age was higher than for
those under 65 years of age in clinical
studies.
23
24. Humira a new indication for Pediatric
Crohn’s Disease
In the United States, there are an estimated
38.000 children and teens with Crohn’s
disease.
Since there is no known cure for Crohn’s
disease, one of the treatment goals of
Pediatric Crohn’s disease is to induce and
maintain clinical remission.
24
25. In 2012, the European Commission approved
Humira for the treatment of Pediatric 6-17 years of
age with severe active Crohn’s disease who failed,
are intolerant to, or have contraindications to
conventional therapy.
25
26. In September 25, 2014 FDA approved Humira for
the treatment of Pediatric patients with moderately
to severely active Crohn’s disease for whom certain
other treatments have not worked well enough.
26
27. IMAgINE 1 study (NCT00409682)
In April 2007, a multicenter, randomized,
double-blind, parallel group 52-week clinical
phase 3 study was launched:
To evaluate the safety, efficacy, and
pharmacokinetics of the Human ANTI-TNF
monoclonal Antibody Adalimumab in
pediatric subjects with moderate to severe
Crohn’s disease.
27
28. Enrolled patients had over the previous two year
period an inadequate response to corticosteroids
or an immunomodulator (e.g., azathioprine, 6-
mercaptopurine, or methotrexate).
Patients who had previously received a TNF
blocker were allowed to enroll if they had
previously had loss of response or intolerance to
that TNF blocker.
28
29. 192 pediatric patients (6 t0 17 years of age) with
PCDAI >30 were planned to to be entered into the
study at approximately 55 sites in the US, Canada,
and Europe.
29
30. The duration of the study was to be up to 65 weeks,
which included:
1-to-3-week screening period
An induction period
A maintenance period
and a 70-day follow-up call for all subjects that
either terminated early from the study or did not
rollover into extension study.
30
31. Patients received open-label induction therapy at a dose
based on their body weight (≥ 40 Kg and <
40 Kg).
Patients ≥ 40 Kg
Week 0
160 mg
Week 2
80 mg
Patients < 40 Kg
Week 0
80 mg
Week 2
40 mg
31
34. Out of total 192 patients:
188 completed 4-week Induction Period
At week 4, 28% (52/188) of patients were in clinical
remission.
152 completed 26-week Treatment
At week 26, 33.5% (63/188) of patients were in clinical
remission.
52 completed 52-week Treatment
34
35. At both weeks 26 and 52, the proportion of patients
in clinical remission and clinical response was
numerically higher in the high dose group
compared to the low dose group.
LMD, 20/10 mg
eow
N=95
HMD, 40/20 mg eow
N=93
Week 26
Clinical Remission 28% 39%
Clinical Response 48% 59%
Week 52
Clinical Remission 23% 33%
Clinical Response 28% 42% 35
Humira is supplied as a sterile, preventative free solution of adalimumab for subcutaneous administrations.
It is the first biologic approved in the U.S. to be administered at home.
At baseline, 38% of patients were receiving corticosteroid, and 62% of patients were receiving an immunomodulator.Forty-four percent (44%) of patients had previously lost response or were intolerant to a TNF blocker.
The primary end-point was clinical remission as defined by PCDAI scores ≤ 10 at week 26.
PCD Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn’s disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, ESR, albumin, weight, height, perirectal disease, and extra intestinal manifestations. It ranges from 0 to 100. higher scores indicate more active disease.
Extension study aimed to evaluate long term maintenance and drug tolerability
HMD: High Dose Maintenance
LMD: Low Dose Maintenance
Every other week for 48 weeks
At week 12, patients who experienced a disease flare or who were non-responders were allowed to dose escalate (i.e., switch from blinded every other week dosing to blinded every week dosing). Patients who dose-escalated were considered treatment failures.
Clinical remission: defined as PCDA≤ 10
Clinical response: defined as reduction in PCDAI of at least 15 points from baseline ; The difference between the two groups was not statistically significant.
The recommended maintenance regimen is 20 mg every other week for patients weighing < 40 Kg and 40 mg every other week for patients weighing ≥ 40 Kg