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About IDARUCIZUMAB

IDARUCIZUMAB belongs to the group of medicines called anticoagulant reversal agents used during a medical emergency to treat severe or uncontrolled bleeding that has been caused by taking dabigatran (a medicine used to prevent blood clots).

IDARUCIZUMAB contains Idarucizumab, a humanised monoclonal antibody fragment (Fab) which rapidly traps dabigatran in order to inactivate its effect.

IDARUCIZUMAB will be administered by a healthcare professional; do not self-administer. In some cases, IDARUCIZUMAB may cause headaches, constipation, fever, low potassium levels, and confusion. Do not be reluctant to talk with your doctor if any of the side effects persist or worsen.

Consult the doctor if you are pregnant or breastfeeding. The safety and effectiveness of IDARUCIZUMAB in children have not been established. Keep the doctor informed about your health condition and medications to rule out any side effects/interactions.

Uses of IDARUCIZUMAB

To treat severe or uncontrolled bleeding that has been caused by taking dabigatran (a medicine used to prevent blood clots).

Medicinal Benefits

IDARUCIZUMAB belongs to the group of medicines called anticoagulant reversal agents indicated in patients treated with dabigatran (a medicine used to prevent blood clots) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures, in life-threatening conditions or uncontrolled bleeding. IDARUCIZUMAB contains Idarucizumab, a humanised monoclonal antibody fragment (Fab) which rapidly traps dabigatran in order to inactivate its effect.

Directions for Use

IDARUCIZUMAB 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 IDARUCIZUMAB

  • Headache
  • Constipation
  • Fever
  • Hypokalaemia (low potassium levels)
  • Confusion

In-Depth Precautions and Warning

Drug Warnings

Inform the doctor if you are allergic to any of the components in IDARUCIZUMAB, if you have hereditary fructose intolerance or if you are on a sodium-restricted diet. Consult the doctor if you are pregnant or breastfeeding. Let the doctor know if you are taking any other medicines, including supplements and herbal products.

Drug Interactions

Drug-Drug Interactions: Inform the doctor if you are taking monoclonal antibodies (rozanolixizumab, efgartigimod alfa).

Drug-Food Interactions: No interactions found.

Drug-Disease Interactions: Inform the doctor if you have fructose intolerance or liver impairment.

Drug-Drug Interactions Checker List:

  • ROZANOLIXIZUMAB
  • EFGARTIGIMOD ALFA
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is not known if alcohol affects IDARUCIZUMAB. Please consult your doctor.

    • Safety Warning

      Pregnancy

      caution

      IDARUCIZUMAB should be given to pregnant women only if clearly needed. Inform the doctor if you are pregnant or think you may be pregnant.

    • Safety Warning

      Breast Feeding

      caution

      Caution is advised while administering IDARUCIZUMAB to a nursing woman.

    • Safety Warning

      Driving

      not applicable

      This medicine is for hospital use only.

    • Safety Warning

      Liver

      consult your doctor

      If you have a history of liver disease, inform your doctor before receiving IDARUCIZUMAB.

    • Safety Warning

      Kidney

      consult your doctor

      If you have a history of kidney disease, inform your doctor before receiving IDARUCIZUMAB.

    • Safety Warning

      Children

      caution

      The safety and effectiveness of IDARUCIZUMAB in children have not been established.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Eat a healthy diet and exercise regularly to maintain proper weight.
    • Avoid smoking and alcohol consumption.
    • Avoid fast food, fried food, processed meats, refined carbs and added sugar.
    • Get optimal sleep; rest well.

    Patients Concern

    Disease/Condition Glossary

    Bleeding: Bleeding is the loss of blood inside or outside the body. It is the main risk associated with dabigatran treatment. Severe or uncontrolled bleeding requires immediate medical attention to prevent loss of blood. Anticoagulant reversal agents such as IDARUCIZUMAB are used to treat severe and uncontrolled bleeding.

    FAQs

    How does IDARUCIZUMAB work?

    IDARUCIZUMAB rapidly traps dabigatran in order to inactivate its effect.

    Can people with hereditary fructose intolerance receive IDARUCIZUMAB?

    IDARUCIZUMAB may contain sorbitol, which can cause serious or life-threatening metabolic problems in people with hereditary fructose intolerance (a genetic disorder). Therefore, inform the doctor if you have hereditary fructose intolerance.

    Does IDARUCIZUMAB remove other anti-coagulant medicines from the body?

    IDARUCIZUMAB does not remove other medicines used to prevent the formation of blood clots. It will only remove dabigatran from your body.

    Available Medicines for

    IDARUCIZUMAB