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About NATALIZUMAB

NATALIZUMAB belongs to the class of monoclonal antibodies. It is used in the treatment of multiple sclerosis (a condition in which the immune system attacks the protective covering of the nerves called myelin, causing disrupted communication between the brain and body) and moderately to severe Crohn’s disease (a chronic bowel disease that affects any part of the gastrointestinal tract, mainly small and large intestine) in patients who are unable to tolerate conventional Crohn’s disease therapy and inhibitors of TNF-α.

NATALIZUMAB consists of Natalizumab, which belongs to the class of integrin receptor antagonists. It works by binding to the chemical substance called α4β7 integrin (present on the surface of the WBC that enters the gut), which is responsible for inflammation.

NATALIZUMAB may cause certain side effects, such as nausea, headache, fever, joint pain, upper respiratory tract infections, abdominal discomfort, diarrhoea, tiredness, back pain, itching, depression, and injection site reactions. Most of these side effects do not require medical attention. However, if these side effects persist, please consult your doctor. NATALIZUMAB will be administered by a trained healthcare doctor. Hence, do not self-administer. 

NATALIZUMAB should be avoided if you are allergic to any of its components.  Inform your doctor if you have any history of serious infections, tuberculosis, liver or kidney diseases, or a weak immune system, as it can worsen your health condition. NATALIZUMAB is contraindicated in patients with Progressive Multifocal Leukoencephalopathy (PML), as it can cause serious adverse effects. Consult the doctor if you are pregnant or breastfeeding.

Uses of NATALIZUMAB

Multiple sclerosis, Crohn’s disease.

Medicinal Benefits

NATALIZUMAB consists of Natalizumab, which belongs to the class of integrin receptor antagonists. It works by binding to the chemical substance called α4β7 integrin (present on the surface of the WBC that enters the gut), which is responsible for inflammation. This causes inhibition and alters the gene expression of blood monocytes and thus helps reduce inflammation of the bowel disease. It is used in the treatment of moderately to severe Crohn’s disease and multiple sclerosis.

Directions for Use

NATALIZUMAB will be administered by a healthcare professional. Do not self-administer.

Storage

Store in a cool and dry place away from sunlight

Side Effects of NATALIZUMAB

  • Injection site reactions
  • Headache
  • Nausea
  • Upper respiratory tract infections.
  • Joint pain
  • Tiredness
  • Cough
  • Back pain
  • Itching
  • Diarrhoea
  • Depression

In-Depth Precautions and Warning

Drug Warnings

Inform your doctor if you have any history of serious infections, tuberculosis, liver, or kidney diseases, or a weak immune system, as it can worsen your health condition. This medicine is contraindicated in patients with leukemia or lymphoma, or an organ transplant as it can cause life-threatening conditions. NATALIZUMAB may cause serious reactions including infusion-related or allergic reactions. This medicine may also increase the risk of serious infections and hypersensitivity reactions in some patients. Hence, patients should be carefully monitored for any changes during and after the treatment course. NATALIZUMAB is not recommended for use in children below 18 years of age as safety and efficacy are not established. This medicine can cause Progressive Multifocal Leukoencephalopathy (PML) in most patients with compromised immune system. The chance of getting PML is more if the patient is exposed to John Cunningham Virus, if received NATALIZUMAB for longer than 2 years or treated with other medicine that weakens your immune system. Hence it is important to inform your doctor about your complete medication history and previous medical history before receiving NATALIZUMAB.

Drug Interactions

Drug-Drug Interactions: NATALIZUMAB may interact with immunosuppressants (infliximab, etanercept, adalimumab, golimumab, cyclosporine, glatiramer, interferon beta), anti-cancer drugs (doxorubicin, epirubicin, idarubicin, mercaptopurine), steroid medicines (methylprednisolone, prednisolone, dexamethasone, prednisone), etc.

Drug-Food Interactions: Avoid alcohol consumption and smoking.

Drug-Disease Interactions: NATALIZUMAB should be used with caution in patients with liver or kidney disease, weak immune system, and serious infections.

Drug-Drug Interactions Checker List:

  • INFLIXIMAB
  • ETANERCEPT
  • ADALIMUMAB
  • GOLIMUMAB
  • GLATIRAMER
  • INTERFERON BETA 1A
  • DOXORUBICIN
  • EPIRUBICIN
  • MERCAPTOPURINE
  • METHYLPREDNISOLONE
  • DEXAMETHASONE
  • PREDNISOLONE
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is unknown whether alcohol interacts with NATALIZUMAB. Consult your doctor for any concerns regarding this.

    • Safety Warning

      Pregnancy

      caution

      If you are pregnant or planning pregnancy, inform your doctor before receiving NATALIZUMAB. Your doctor may prescribe this medicine if the benefits outweigh the risks.

    • Safety Warning

      Breast Feeding

      caution

      NATALIZUMAB is known to pass in the breastmilk. Hence, if you are breastfeeding, inform your doctor before receiving NATALIZUMAB. Your doctor may administer this medicine only if the benefits outweigh the risks.

    • Safety Warning

      Driving

      not applicable

      -

    • Safety Warning

      Liver

      caution

      NATALIZUMAB is known to cause hepatotoxicity in some patients. Hence, caution should be exercised. Inform your doctor if you observe any symptoms of tiredness, loss of appetite, dark urine, yellowing of the skin and eyes, or pain in the abdomen. Dose adjustment may be needed in patients with liver impairment.

    • Safety Warning

      Kidney

      caution

      NATALIZUMAB should be used with caution if you have kidney disease. Dose adjustment may be needed in patients with liver impairment.

    • Safety Warning

      Children

      unsafe

      NATALIZUMAB is not recommended in children below 18 years of age as the safety and efficacy are not established.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Maintain a low-fat diet and eat foods rich in vitamin C, such as bell peppers, spinach, parsley and berries, which help heal faster.
    • Eat more fibre-rich foods such as fruits and vegetables.
    • Eat smaller meals all day and drink small amounts of water throughout the day.
    • If you are intolerant to lactose, lower your intake of milk.
    • Avoid foods high in sugar, fat, and processed foods, as these may cause inflammation.
    • Try to avoid alcohol as it can affect your stomach and intestine and also limits the absorption of the important nutrients required by your body.
    • Try to stay active. Choose moderate exercises.
    • Prevent stress by doing meditation or yoga.

    Special Advise

    • It is advised to closely monitor the patient for infections like active tuberculosis, and HIV infection during and after the treatment.
    • It is essential to inform your doctor if you have any active viral, bacterial, and fungal infections before starting NATALIZUMAB.
    • NATALIZUMAB is used to treat the condition but does not cure it.
    • This medicine is administered only once every four weeks by a trained oncologist.
    • NATALIZUMAB will be only given to patients who have enrolled in to TOUCH program.

    Patients Concern

    Disease/Condition Glossary

    Multiple sclerosis: Multiple sclerosis is a condition that affects the brain and spinal cord. The immune system attacks the protective covering of the nerves (myelin) and causes disrupted communication between the brain and body due to nerve damage.  This causes symptoms such as problems with sensation, balance, vision, pain, impaired coordination, and fatigue.

    Crohn’s disease: Crohn’s disease is a type of chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract, from mouth to anus. But mostly occurs in the small intestine and large intestine. The symptoms include blood in stools, stomach cramps, tiredness, diarrhoea, fever, weight loss, or loss of appetite.

    FAQs

    How does NATALIZUMAB work?

    NATALIZUMAB works by binding to the chemical substance called α4β7 integrin (present on the surface of the WBC that enters the gut), which is responsible for inflammation. This alters the gene expression of blood monocytes and thus helps reduce inflammation.

    Before receiving NATALIZUMAB, what should be informed to my healthcare provider?

    Inform your doctor about your complete medical and medication history especially, if you have any history of serious infections, tuberculosis, liver or kidney diseases, or a weak immune system, as it can worsen your health condition.

    Available Medicines for

    NATALIZUMAB