1. Research and select a pharmacologic agent that utilizes genetic engineering in its manufacturing process. List the name brand and generic name (if a generic is available). You may not use the insulin example in the Learning Point.
2. What condition(s) is this drug utilized to treat?
3. Is it FDA approved?
4. How is this medication typically dosed and how often (one example will suffice)?
5. List the manufacturer(s) and estimated cost per month without insurance. (Good Rx is a website to quickly give cost example).
6. Briefly explain the genetic process of how this medication is engineered (1 paragraph).  How does this allow it to work in the human body/benefits of using this medication?  How does it target or alter the immune response (1 paragraph)?
7. List any major risks or side effects to this medication.
8. Cite 2 scholarly resources

ANSWER

Pharmacologic Agent Utilizing Genetic Engineering

Name Brand: Humira
Generic Name: Adalimumab

Condition(s) Treated: Humira is used to treat various autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

FDA Approved: Yes, Humira is FDA approved for the mentioned conditions.

Dosage and Frequency: For rheumatoid arthritis, the typical starting dose is 40 mg injected subcutaneously every other week. After the initial dose, the patient may receive 40 mg every week.

Manufacturer and Estimated Cost: Manufactured by AbbVie Inc. Estimated cost per month without insurance can vary, but as of the time of writing, it is around $5,000 according to GoodRx.

Genetic Engineering Process and Benefits

Humira is a monoclonal antibody that targets and inhibits tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine implicated in autoimmune diseases. The medication is produced by genetically engineering cells to produce a monoclonal antibody against TNF-alpha. This allows Humira to specifically bind to TNF-alpha and inhibit its activity, which in turn helps reduce inflammation and immune response. By targeting TNF-alpha, Humira addresses the underlying cause of autoimmune diseases, providing relief to patients and helping to manage their conditions.

Immune Response Alteration

Humira alters the immune response by binding to TNF-alpha and preventing it from interacting with its receptors. This reduces the inflammatory cascade triggered by TNF-alpha, which is overactive in autoimmune diseases. By inhibiting TNF-alpha, Humira helps modulate the immune response, reducing inflammation and its associated symptoms.

Major Risks or Side Effects

Common side effects of Humira include injection site reactions, upper respiratory infections, headache, and rash. However, there are more serious risks associated with Humira, including an increased risk of infections (some severe), reactivation of latent tuberculosis, and an increased risk of certain types of cancer.