Development of Biotechnology based on the Cloning Technology (Omalizumab). Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin-E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE on the surface of mIgE-expressing B-lymphocytes.

1. Development of Biotechnology based on the Cloning
Technology
(Omalizumab)
Department of Pharmacy
Daffodil International University

2. Omalizumab; what is it?
• It has been used to try to control severe allergic asthma, which does not respond
to high doses of corticosteroids and less widely for chronic spontaneous urticaria.
• Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal
antibody that specifically binds to free human immunoglobulin-E (IgE) in the
blood and interstitial fluid and to membrane-bound form of IgE on the surface of
mIgE-expressing B-lymphocytes.
• Omalizumab is a medication originally designed to reduce sensitivity to allergens.

3. Generic: Omalizumab
Brands : Fahadzumab(Demo Name)
Company: AP Pharmaceuticals
Description: Omalizumab is a recombinant DNA-derived humanized IgG1τ
monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
The antibody has a molecular weight of approximately 149 kiloDaltons.
Used For/Prescribed for: Omalizumab is used to treat moderate to severe
asthma that is caused by allergies, and chronic idiopathic urticaria (a form of
chronic hives) in adults and children who are at least 12 years old.

4. Formulation :
 It is formulated in a single use vial that is reconstituted with Sterile Water for
Injection (SWFI), USP, and administered as a subcutaneous (SC) injection.
 Each 202.5 mg vial of omalizumab also contains L-histidine (1.8 mg), L-
histidine hydrochloride monohydrate (2.8 mg), polysorbate 20 (0.5 mg) and
sucrose (145.5 mg) and is designed to deliver 150 mg of omalizumab in 1.2
mL after reconstitution with 1.4 mL SWFI, USP.
Form : sterile, white, preservative free, lyophilized powder
Route of administration : subcutaneous injection

5. Dosage
 Administer omalizumab 150 to 375 mg by subcutaneous injection every 2 or 4
weeks.
 Determine doses (mg) and dosing frequency by serum total IgE level (IU/mL),
measured before the start of treatment, and body weight (kg) as if serum IgE is
less than 30-100 IU/ml.
 Then 50 mg of drug is for people having 30-60 Kg of body weight and similarl
amount for 60-90 kg of weight but for people having weight between 90-150
Kg, dose is recommended as 300 mg.

6. How does work it?

8. Metabolism :
Most likely removed by opsonization via the reticuloendothelial system.
Route of elimation :
Liver elimination of IgG includes degradation in the liver reticuloendothelial
system (RES) and endothelial cells. Intact IgG is also excreted in bile.
Volume of Distribution :
78 ± 32 mL/kg
Half life :
26 Days

9. Side effects
wheezing, tightness in your chest, trouble breathing; hives or skin
rash;
feeling anxious or light-headed, fainting;
warmth or tingling under your skin;
swelling of the face, headache joint or muscle pain;
dizziness; ear pain; hair loss;
mild itching or skin rash; sore throat or cold symptoms, tired feeling;