Emicizumab

What is emicizumab?

Emicizumab (also called Hemlibra®)  is a medicine that acts like FVIII (factor 8) in the body to help your blood to clot. This medicine is used to prevent bleeding in patients with FVIII deficiency (hemophilia A). It is a colorless to pale yellow liquid that is injected under the skin.

This medicine is available in the following strengths:

• 30 mg/1 ml (this is a different concentration than the other vials)
• 60 mg/0.4 ml
• 105 mg/0.7 ml
• 150 mg/1 ml

Possible side effects of emicizumab

• Injection site reactions: redness, swelling, warmth, pain
• Fever
• Headache
• Joint or muscle pain
• Diarrhea
• Call the doctor right away if you have any of the following side effects:
  • Symptoms of a blood clot
    • Arms, legs, face: swelling, redness, pain
    • Numbness, weakness, changes in awareness, facial drooping or drooling, visual changes, severe headache
    • Short of breath, chest pain, trouble breathing, or coughing up blood
  • Symptoms of TMA (thrombotic microangiopathy)—a condition where small clots can form in organs, commonly the kidneys and brain
    • Feeling fatigued, dizzy, short of breath
    • Bruises, gum or nose bleeds, minor cuts that bleed a lot
    • Confusion, seizures, sleepiness
    • Decreased urine, swollen legs, high blood pressure

These are the most common or serious side effects, but there may be more. Report all side effects to your medical team.

In case of a severe side effect or reaction, call the doctor, nurse, or pharmacist at 901-595-3300. If you are outside the Memphis area, dial toll-free 1-866-2STJUDE (1-866-278-5833).

Special instructions for emicizumab

• Store emicizumab in the refrigerator in the original package to protect from light.
  • Emicizumab may be stored at room temperature for up to 7 days, but refrigeration is preferred.
  • Do not shake this medicine.
• This medicine is offered in many strengths. Always check to be sure that you receive the same strength of medicine each time you pick up a new supply.
  • If the strength is different, the amount of medicine you need to take may also change.
  • If you receive a different strength of emicizumab and this change has not been discussed with you, call your clinic or the pharmacy.
• Each vial may only be used for one (1) dose, throw away any unused medicine after each injection or at the expiration date.

How to give emicizumab

• Emicizumab is given as an injection (shot) into the skin on a regular schedule (one time a week or one time every 2 weeks). This injection (shot) is given into the fatty areas of the body called “injection sites.”
• Dosing
  • For the first 4 weeks, doses will be given one (1) time each week. During this time, your nurse will teach you how to give the medicine while at the hospital.
    • Dose Number_____ Date______  __Dose________Injection Site___________________
    • Dose Number_____ Date______  __Dose________Injection Site___________________
    • Dose Number_____ Date_____  ___Dose________Injection Site___________________
    • Dose Number_____ Date___  _____Dose________Injection Site___________________
  • For doses after the first 4 weeks, a maintenance dose will be given on a regular schedule (one time a week or one time every 2 weeks). You should keep a log of all doses given .

Using emicizumab with other medicines

• Medicines that affect how your blood clots must be used very cautiously with emicizumab.
  • The preferred treatment of an acute bleed while on this medicine is rFVIIa (Novoseven®) or FVIII (factor 8).  The staff will give you a treatment plan including instructions for using these medicines.
  • Do not give FEIBA® with this medicine for any reason unless directly supervised by your medical team. FEIBA is also called aPCC or activated prothrombin complex concentrate.
  • If you are unsure if it is safe to take a medicine while on emicizumab, contact your medical team right away.

Possible antibody to emicizumab

• It is possible that your body may develop an inhibitor, also called an antibody, to this medicine. This could cause the medicine to not work like it should.
• When this occurs, you may need to switch to a different type of medicine to prevent bleeding. In some cases, a factor product that you have used in the past might work.
• An inhibitor to emicizumab is not the same as an inhibitor to FVIII (factor 8). Your medical team can help you understand the difference.

Please refer to Do you know…. “How to give subcutaneous injections” and “Withdrawing medicine from a vial.”