This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Itolizumab is an immunomodulatory monoclonal antibody (protein which attaches to a specific target) which was approved for its medical use on January 2013.

Mechanism of Action of undefined

Itolizumab Injection is a biological agent that belongs to the category of medications called monoclonal antibodies. Itolizumab specifically targets and binds to the domain 1 of the human CD6 cells, resulting in significant decrease in the inflammatory mediators. Itolizumab inhibits the availability of T cells without depleting them and eventually lowers the inflammation.

Uses of undefined

Itolizumab Injection has been developed to treat moderate to severe plaque psoriasis, psoriatic arthritis and rheumatoid arthritis. It is also increasingly used to reduce inflammation and cytokine release in COVID-19 patients.

undefined Drug administaration and Dosage available

In case of plaque psoriasis and cytokine release syndrome, initial dose is 1.6mg/kg indicated as an intravenous infusion. For plaque psoriasis, a dose of 1.6mg/kg in administered every 2 weeks for 12 weeks, followed by 1.6mg/kg every 4 weeks up to 24 weeks. Approximately 50ml will be administered in the first hour, followed by the remaining dose within the next hour. 

For patients with cytokine release syndrome, the first infusion of 1.6mg/kg will be initiated at the rate of 25ml/hr in the first hour, followed by 50ml/hr for the next 5-6 hours if well tolerated. Itolizumab is available as single dose vial of injection, intended for IV infusion with each vial containing 100mg Itolizumab (rDNA origin).

Warnings, Precautions and Side Effects of undefined


Contact your physician immediately if you experience severe rash, allergic reactions, or any signs of new infection. Itolizumab is not recommended if you are allergic to any of its ingredients. During this treatment your physician may monitor your vitals to prevent serious complications. Exercise caution while receiving Itolizumab Injection if you have been diagnosed with HIV, active or latent tuberculosis, hepatitis B or C. Inform your health care provider if you are about to undergo any dental or surgical procedures while on treatment with Itolizumab Injection.


Itolizumab can affect the fertility of males and females. Ask your health care provider for advice if you are pregnant, think you might be pregnant, planning to have a baby, or breastfeeding your baby. Itolizumab is probably unsafe during pregnancy it has the ability to cross the placental barrier and harm an unborn baby. It is mostly unsafe to breastfeed while on treatment with Itolizumab. Discuss with your healthcare provider and either discontinue the treatment with Itolizumab or discontinue breastfeeding while on treatment with Itolizumab. Discuss effective contraceptive methods with your healthcare provider and consider using them for at least 5 months after the last dose of Itolizumab.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Itolizumab Injection are injection site reactions, respiratory tract infections, diarrhoea, pruritus, and fever. If you experience sickness, infection or allergies during this treatment, report to your doctor immediately.

Word Of Advice

Check with your health care provider before receiving any vaccines and inform them if you are taking any other medications or herbal supplements.

Frequently Asked Question


  1. Biocon Ltd., U.S. Food and Drug Administration, [Revised on June 2020] [Accessed on 20th Sep 2022],
  2. S. Kumar et al., A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19, Expert Opinion on Biological Therapy, 2021, [Accessed on 20th Sep 2022],


The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.