• Emicizumab is a modified humanized monoclonal antibody approved by the US FDA in November 2017.
• It is used in certain patients patients with hemophilia A.
Emicizumab is a modified humanized monoclonal antibody which is prescribed to prevent or minimize the frequency of bleeding episodes in adults and children suffering from congenital factor VIII deficiency (known as hemophilia A), who have developed factor VIII inhibitors.
Patients with hemophilia A have a missing clotting factor (factor VIII). These individuals are administered the factor VIII as an injection. Unfortunately, some individuals develop factor VIII inhibitors, which does not allow factor VIII to act.
Emicizumab links the clotting factors activated IXA and X and thus replaces the function of the factor VIII, and ensures the normal clotting of the blood.
• Emicizumab should not be used in patients allergic to emicizumab.
• The recommended adult and pediatric dose is 3mg/kg body weight taken once in a week for the first 4 weeks.
• After 4 weeks of duration, the dose is followed by 1.5mg/kg body weight once a week.
• If a dose is missed, take the missed dose as early as possible before the day of the next scheduled dose. This can be followed by the usual weekly dose.
• Do not double the dose to make up the missed dose.
• Emicizumab comes as an injection which has to be administered subcutaneously or just under the skin.
• Self-administration should be done only after proper training. However, self-administration is not recommended for children under 7 years of age.
• Before injecting, the vial should be checked for any discoloration of the liquid or presence of particulate matter and should be discarded if present.
• Patients should be monitored for thrombotic microangiopathy and related thrombotic events (clot formation in the blood that obstructs blood flow) especially when activated prothrombin complex concentrate is also administered. Activated prothrombin complex concentrate contains some clotting factors and is used for certain clotting problems.
• The treatment should be discontinued immediately once clinical symptoms or laboratory tests show strong association with thromboembolic events.
• Women of childbearing age should use effective birth-control contraceptives to avoid pregnancy. The effect on pregnancy of this medication is currently not known.
• Emicizumab should not be injected into the scars, moles, hard, inflamed or bruised skin. The site of injection should be changed for successive injections.
• Common: Pain, itching or swelling at the injection site, headache, pain in the joints, fever
• Gastrointestinal: Diarrhea, vomiting, stomach pain
• Cardiovascular: Clot formation within blood vessels that can result in chest pain, thrombophlebitis (inflammation of veins), swelling of the arms or feet
• Central Nervous system: Confusion, light-headedness, weakness
• Respiratory: Coughing up blood, difficulty in breathing
• Skin: Skin necrosis
• Others: Vision problems, swelling or pain around eyes, back pain, reduced urination, numbness in the face, muscle pain
• Emicizumab may interfere with some laboratory tests. Test results should be confirmed with other diagnostic procedures or with clinical examination.
• The dose should be prepared only prior to administration.
• Do not shake the vial.
• Rotate the injection sites with no more than two injections at the same site to avoid burning sensation or irritation.
• Use a separate needle for injecting into the skin and avoid using the same needle which is used to draw the medicine from the vial.
• The risk of thrombosis is significantly increased when emicizumab is taken with activated Prothrombin complex concentrate.
• Possibility of hypercoagulation is reported when emicizumab is taken along with antihemophilic factor and should be avoided.
• Store emicizumab in the original container, kept in a refrigerator at 2°C to 8°C.
• Unopened emicizumab vials can be stored at room temperature for a duration of 1 week and should be replaced into the refrigerator immediately. If the vials kept out for more than 7 days, they should be discarded.
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