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About ITOLIZUMAB

ITOLIZUMAB belongs to the class of 'immunomodulators', primarily used to treat psoriasis. Psoriasis is a skin disorder in which skin cells multiply and form bumpy (uneven) red patches covered with white scales. ITOLIZUMAB may also be used to treat autoimmune conditions like rheumatoid arthritis and multiple sclerosis. ITOLIZUMAB is currently being used and trialled to treat cytokine storm (excessive immune response) in COVID-19 (Corona Virus Disease-19) patients. 

ITOLIZUMAB consists of 'Itolizumab' that is a humanized recombinant IgG1 (Immunoglobulin G1) monoclonal antibody (that serve as a substitute antibody). It works by reducing the synthesis of cytokine, a substance released by the body that initiates an inflammatory response. Lately, ITOLIZUMAB is also being used in COVID-19 infection to reduce the severity of inflammation and damage in the lungs. It is thought to decrease the cytokine storm, an excessive immune response in the lungs of a COVID-19 infected person.

Your doctor will decide the dose and duration based on the medical condition. Common side effects of ITOLIZUMAB include pain and swelling at the injection site, upper respiratory tract infection, fever, itching, dizziness, and diarrhoea. These side effects are not familiar to everyone and vary individually. However, if the side effects are persistent, please reach out to your doctor.

Before starting ITOLIZUMAB, inform your doctor if you have any liver, heart or kidney diseases, bone marrow suppression, weak immune system (HIV), tuberculosis, hepatitis B, and active infections. Let your doctor know if you are pregnant or breastfeeding before starting ITOLIZUMAB. ITOLIZUMAB may cause dizziness, so drive only if you are alert and focused. ITOLIZUMAB should not be given to children and adolescents under 18 years of age as safety has not been established. Avoid consuming alcohol along with ITOLIZUMAB as it could lead to increased dizziness. 

Uses of ITOLIZUMAB

Psoriasis, Rheumatoid arthritis, and COVID-19

Medicinal Benefits

ITOLIZUMAB treats inflammation in patients with psoriasis and rheumatoid arthritis. It contains 'Itolizumab,' which is a humanized recombinant IgG1 (Immunoglobulin G1) monoclonal antibody. It works by reducing the synthesis of cytokine, a substance released by the body that initiates an inflammatory response. Lately, ITOLIZUMAB is also being used in COVID-19 infection to reduce breathing complications, the severity of inflammation, and damage in the lungs. It is being used to decrease the cytokine storm, an excessive immune response that occurs in the lungs of a COVID-19-infected person. 

Directions for Use

A healthcare professional will administer it. Do not self-administer.

Storage

Store in a cool and dry place away from sunlight

Side Effects of ITOLIZUMAB

  • Pain and swelling at the injection site
  • Upper respiratory tract infection
  • Fever
  • Itching
  • Dizziness
  • Diarrhoea 

In-Depth Precautions and Warning

Drug Warnings

Inform your doctor if you have any liver, heart or kidney diseases, bone marrow suppression, low blood cell count, weak immune system (HIV), neutropenia (low levels of neutrophils), lymphopenia (low levels of lymphocytes), tuberculosis, hepatitis B, C, and active infections before starting ITOLIZUMAB. Avoid close contact with people who have infections like chickenpox, measles, tuberculosis, and flu that can be easily spread. Thoroughly wash your hands to prevent the spread of infection. Do not take live vaccines while being treated with ITOLIZUMAB to prevent any serious consequences. ITOLIZUMAB may cause dizziness, so drive only if you are alert and focused. Avoid consuming alcohol along with ITOLIZUMAB as it could lead to increased dizziness. ITOLIZUMAB is not recommended in children and adolescents younger than 18 years of age as safety and efficacy is not established. Store ITOLIZUMAB at temperatures of 2°C to 8°C. Do not freeze the vial.

Drug Interactions

Drug-Drug Interaction: ITOLIZUMAB may interact with live vaccines. Let your doctor know if you use any prescription and over the counter medicines, including vitamins and herbal supplements, before starting ITOLIZUMAB.

Drug-Food Interaction: Avoid alcohol consumption while being treated with ITOLIZUMAB. 

Drug-Disease Interaction: ITOLIZUMAB should be used with caution in cases of liver, heart or kidney diseases, bone marrow suppression, low blood cell count, weak immune system (HIV), neutropenia, lymphopenia, tuberculosis, hepatitis B, C, and active infections.

Drug-Drug Interactions Checker List:

Safety Advice

  • Safety Warning

    Alcohol

    caution

    You are recommended to avoid alcohol consumption while taking ITOLIZUMAB. Alcohol intake, along with ITOLIZUMAB, may cause increased dizziness.

  • Safety Warning

    Pregnancy

    unsafe

    ITOLIZUMAB is not recommended during pregnancy since it may have harmful effects on the developing baby. Your doctor will prescribe ITOLIZUMAB only if the benefit outweighs the risk.

  • Safety Warning

    Breast Feeding

    caution

    It is not known if ITOLIZUMAB passes into the breastmilk when used by breastfeeding mother. Your doctor will prescribe ITOLIZUMAB only if the benefit outweighs the risk.

  • Safety Warning

    Driving

    unsafe

    ITOLIZUMAB may make you feel dizzy. Do not drive or operate machinery if you experience dizziness.

  • Safety Warning

    Liver

    caution

    Please consult your doctor since ITOLIZUMAB should be used with caution in patients with liver impairment/liver disease. Dose adjustment may be needed in patients with liver impairment. However, ITOLIZUMAB is not recommended in patients with active liver diseases.

  • Safety Warning

    Kidney

    caution

    Please consult your doctor since ITOLIZUMAB should be used with caution in patients with kidney impairment/kidney disease. Dose adjustment may be required.

  • Safety Warning

    Children

    unsafe

    ITOLIZUMAB is not recommended in children and adolescents younger than 18 years of age.

Habit Forming

No

Diet & Lifestyle Advise

  • Maintain proper weight by following a healthy and well-balanced diet.
  • Avoid smoking and alcohol consumption.
  • Try to avoid stress by practising meditation or yoga.
  • Try including selenium-rich food sources like Brazil nuts, yellowfin tuna, rice, beans, whole-wheat bread, dairy products, ham, chicken, turkey, beef, eggs, pork, baked beans, mushrooms, oatmeal, and spinach.
  • Include zinc-rich sources like meat, shellfish, legumes, hemp seeds, nuts, eggs, dairy products, whole grains, potatoes, kale, and dark chocolate in your diet.
  • Cut down on sugar, salt and processed foods.
  • Drink plenty of water.

Special Advise

  • It is advised to closely monitor the patient for infections like active tuberculosis during and after the treatment though the patient gets a negative tuberculin test.
  • It is essential to inform your doctor if you have any active viral, bacterial, and fungal infections before starting ITOLIZUMAB.

Patients Concern

Disease/Condition Glossary

Psoriasis: It is a skin disorder in which skin cells multiply and form bumpy (uneven) red patches covered with white scales. These red patches can commonly appear on the scalp, elbows, knees, and lower back. Psoriasis is a noncontagious (not spread by contact), chronic immune condition with no cure. It can be mild, moderate, and severe based on the patches coverage on the skin.

Rheumatoid arthritis: It is an autoimmune disease (the body's immune system attacks its tissue), leading to joint pain and damage. Symptoms of rheumatoid arthritis include pain, swelling, stiffness, deformities, and loss of joint function. 

COVID-19: It is a disease caused by SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2). It mainly affects the respiratory system and is spread through droplets generated when an infected person coughs, sneezes, or exhales. Common symptoms include fever, dry cough, tiredness, body aches, sore throat, loss of taste and smell, and conjunctivitis. With the severity of the disease, symptoms like dropping oxygen saturation levels, shortness of breath, chest pain, high fever, and severe weakness are also noticed. The coronavirus can further lead to complications like pneumonia, respiratory failure, heart problems, liver problems, septic shock, and death.

FAQs

How does ITOLIZUMAB work?

ITOLIZUMAB contains Itolizumab, an immunomodulator. It reduces the synthesis of pro-inflammatory markers called cytokines. Thus, it helps in decreasing inflammation in various diseases like psoriasis, rheumatoid arthritis, and multiple sclerosis.

How does ITOLIZUMAB work on COVID-19 infection?

When a person is infected with the coronavirus, his/her immune system responds in such a way that it sends useful immune chemicals to the affected areas of the lungs to fight the infection. However, in some people, this release of immune chemicals is overactive, resulting in a cytokine storm, an excessive immune response in the lungs. This can further lead to severe breathing complications in an infected person. ITOLIZUMAB reduces this cytokine storm and further prevents the inflammation and damage in the lungs of a COVID-19 infected person.

Is ITOLIZUMAB effective in treating COVID-19 infection?

ITOLIZUMAB is currently being used to decrease the negative outcome of the cytokine storm in critically, severely and moderately ill COVID-19 patients.

Can any COVID-19 infected person take ITOLIZUMAB?

ITOLIZUMAB is not recommended for every person infected with the coronavirus. ITOLIZUMAB is only prescribed by doctors in patients with severe and critical COVID infection.

Are there any specific precautions while using ITOLIZUMAB?

ITOLIZUMAB is to be carefully administered with caution in patients under doctor's supervision only. The safety of ITOLIZUMAB is not yet evaluated in conditions like neutropenia (low levels of neutrophils), lymphopenia (low levels of lymphocytes), AIDS, tuberculosis, hepatitis B and C.

What happens if there is no improvement after taking ITOLIZUMAB during COVID-19 infection?

Even if there is no improvement after administering ITOLIZUMAB, your doctor may suggest an alternate course. Please note that ITOLIZUMAB does not reverse the damage caused due to coronavirus infection, but it will further prevent the inflammation of the lungs. It is also advised to medically examine for other lung and heart related dysfunctions even the patient suffers breathlessness after ITOLIZUMAB administration.

Can I undergo vaccination while using ITOLIZUMAB?

It is not recommended to get live attenuated vaccines while being treated with ITOLIZUMAB. This may lead to serious conditions. Please consult a doctor before you start ITOLIZUMAB if you are undergoing any vaccinations.

Available Medicines for

ITOLIZUMAB