FDA approved drug in 2020

1. HUMIRA
ADALIMUMAB
Made by Priyansha Singh
Roll no.- 1738
Submitted to Dr. Anurag Kuhad (Asst. Prof
Pharmacology)

2. Structure of Adalimumab

3. Introduction
– HUMIRA stands for: human monoclonal anti-body in rheumatoid arthritis .
– Human monoclonal antibody against TNF alpha.
– C6428H9912N1694O1987S46.
– It binds to (TNFα), which normally binds to TNFα receptors, leading to the
inflammatory response of autoimmune diseases. By binding to TNFα,
adalimumab reduces this inflammatory response.
– Humira costs approximately $3,100 per month, From 2012 to US patent expiry
in 2016, Humira led the list of top-selling pharmaceutical products, and in 2016,
it had $16 billion of global sales.

4. Introduction continued……
– Adalimumab was the first fully human monoclonal antibody approved by the
U.S. Food and Drug administration.
– Engineered through guided selection techniques phage display and was
discovered through a collaboration between BASF Bioresearch Corporation and
Cambridge Antibody Technology.
– Initially named D2E7.

5. Mechanism of action
• Directly binding to TNF- α molecules in the blood and diseased tissue.
• Blocks its interaction with the p55 and p75 cell surface TNF receptors.
• Lyses surface TNF expressing cells in vitro.
• Does not bind or inactivate lymphotoxin (TNF b).
• Adalimumab helps to stop the inflammatory cycle of psoriatic disease and
prevent from causing the inflammation that result in psoriasis plaques.

6. Uses
– Rheumatoid arthritis: Adalimumab has been shown to reduce the signs and symptoms of
moderate to severe rheumatoid arthritis (RA) in adults. it has been approved for use alone, or
with methotrexate or similar medicines, in the U.S. since 2002.
– Psoriatic arthritis: In 2003, Adalimumab began undergoing trials for use in treating psoriasis
and psoriatic arthritis.
– Ankylosing spondylitis: Adalimumab has been shown to reduce the signs and symptoms and
is approved for treatment of, ankylosing spondylitis in adults.
– Crohn’s disease: Adalimumab has been shown to reduce the signs and symptoms of moderate
to severe Crohn's disease. It has been approved for that use in the UK since 2009.
– Ulcerative colitis: Adalimumab may be effective and well tolerated in ulcerative colitis. It has
been approved by the FDA for treatment of moderate to severe cases in adults.

7. Uses continued……
– Plaque psoriasis: Adalimumab has been shown to treat moderate to severe chronic
plaque psoriasis in adults who have the condition in many areas of their body
Adalimumab has been shown to be effective therapy when used either continuously
or intermittently in patients with moderate to severe psoriasis.
– Juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated
for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from
the age of 2 years who have had an inadequate response to one or more disease
modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in
case of intolerance to methotrexate or when continued treatment with
methotrexate is inappropriate it has-been shown to reduce the signs and symptoms
of moderate to severe polyarticular juvenile idiopathic arthritis in children 4 and
older.

8. Side Effects & Overdose
– SIDE EFFECTS:-
• back pain, headache, redness or swelling at injection site
• mild stomach pain, nausea or runny nose
• rash, itching, difficulty in breathing, swelling of lips or tongue, blood in urine, burning,
numbness, chest pain, fainting, blistered, peeling skin, swelling of ankles, diarrhea or
vomit.
– OVERDOSE:-
• still unclear
• does not show toxic effects in clinical trials

9. Prescription, pharmacodynamics
& pharmacokinetics
• prescribed by either itself or in combination with methotrexate
• given after other medications has failed in treatment
• safe to take it with topical treatments or pain relievers
• Adult – decrease acute inflammation, C-reactive protein (CRP), erythrocyte
sedimentation rate (ESR), and serum cytokines (IL-6)
• maximized with the maximum serum concentration
• Tmax were 4.7 ± 1.6 µg/mL and 131 ± 56 hours
• linear over the dose range of 0.5 to 10.0 mg/kg following a single intravenous
dose