Pharmacology of Chronic Disease Assignment

Running head: PHARMACOLOGY
PHARMACOLOGY
Name of the student:
Name of the university:
Author note:

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Introduction:
With the global burden of chronic disease, cancer has emerged as contributing factor
behind premature death around the globe, the United States is no exception to it. In the United
States, approximately 1.6 million individuals with lung cancer are identified every year,
accounting for 1.4 million premature deaths annually (Sundar et al., 2016). While advancement
in the chemotherapy has improved outcome for the patients suffering from lungs cancer, survival
rate remain low with 5-year overall survival. However, the recent advancement of
immunotherapy for treating non-small cell lung cancer has changed the scenery of treatment of
the disease. Nivolumab is one such newly manufactured drug used in the immunotherapy that
offers a prolonged response and survival to the patient experiencing from non-small cell lung
cancer (Spigel et al, 2016). Nivolumab/MDX-1106/BMS-936558/ONO-4538 is a human
immunoglobulinG4 (IgG4) monoclonal antibody specific for treating patients from non-small
cell lung cancer (Sundar et al., 2016). However, recently this drug has been used in treating other
cancers for gaining prolonged responses. These papers aim to provide a detailed review of the
drug by using a case study focused on cancer. This paper aims to provide a detail of the new drug
in terms of drug generic and trade names, FDA approval, mechanism of action, Pharmacokinetic
and pharmacodynamics, usual route and dosing, the common and serious side effects, education
regarding the drug, cost of drug and other drugs and discussion with a pharmaceutical
representative in following paragraphs.
Case study:
Mr A, a 46 years old man presented at the nearest emergency department (ED) in
distress, shortness of breath and feeling tired and weak. He was experiencing difficulties to
communicate with the professionals. He had been diagnosed with non-small cell lung cancer a

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year ago. He had been under chemotherapy for the past 8 months and exhibited improved
symptoms. However, recently he had been exhibiting chest pain, coughing with blood and loss of
appetite. while documenting clinical history, his wife suggested that he was also experiencing
severe back pain and cough which does not go away. His medical history suggested that he used
work in a manufacturing company where he had been continuously exposed to radon, dust and
he used to smoke 10 packets a day. After an in-depth assessment, GP suggested that it might be
the case that the chemotherapy is not effective enough considering the severity of cancer. After a
detailed assessment, oncology suggested that he must be supported immediately with nivolumab
as immunotherapy for improving responses.
Discussion:
Drug generic and trade names:
Nivolumab/MDX-1106/BMS-936558/ONO-4538 is a human immunoglobulinG4 (IgG4)
monoclonal antibody specific for treating patients from non-small cell lung cancer. It is sold
under the brand name Opdivo. It is generally used for treating metastatic melanoma. It is
considered as a second-line treatment after failure of platinum-based drugs and anti-angiogenic
drugs.
Therapeutic and pharmacologic classes:
It is a class of immunoglobulinG4 (IgG4) monoclonal antibodies belong to
immunotherapy (Protein Based Therapies). It is a genetically engineered fully human antibody
that works by slowing down the rapid growth of cancer cells. The kingdom is organic acid
whereas class is

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Carboxylic Acids and Derivatives. The superclass of the drug is Organic Acids. ATC code for
the drug is L01XC17 (WHO) and the accession number is DB09035 (DB06132). The general
function is signal transducer activity.
FDA approval:-
FDA approved this OPDIVO (nivolumab for intravenous administration in 2014 and its
indication was approved depending on the duration of response and response rate as a second-
line cancer drug. It was approved for treating melanoma in 2014 but the FDA approved the drug
for treating non-small cell lung cancer in 2015 (Www.accessdata.fda.gov. 2020). The indication
of the drug is it has been used for treating a range of different cancers such as liver cancer, neck
cancer, Hodgkin lymphoma and renal cell carcinoma. This drug is also effective for individuals
suffering from brain metastases. The FDA also approved the application of this drug for the
patients suffering from autoimmune disease 2015 (Www.accessdata.fda.gov. 2020). However,
the contraindications for the drug are Immune-mediated pneumonitis, Immune-mediated
hepatitis and Immune-mediated endocrinopathies.
Mechanism of action:
This IgG4 isotype was developed to avoid antibody-dependent cellular cytotoxicity
(ADCC) unlike most of the monoclonal antibodies with IgG1 isotype that has ADCC activity. In
the case of non-small cell lung cancer, programmed cell death-ligand 1 (CD274) has emerged as
an immune checkpoint that enables anti-tumor suppression of the immune pathway. It is the
protein that stops T cells from diminishing cancer cells as well as inflamed tissue (Lee et al.,
2018). This IgG4 isotype attaches to PD-1 with greater affinity and hinder PD-1 inhibitory
signaling for T-cells, especially blocks collaboration with B7-DC as well as B7-H1. Guo, Zhang
and Chen (2017), suggested that it contains a mutation at a hinge region (S228P), this mutation