Emicizumab

Generic name: Emicizumab
Dosage form: subcutaneous solution (kxwh 150 mg/mL; kxwh 30 mg/mL)
Drug class: Miscellaneous coagulation modifiers

Usage of Emicizumab

Emicizumab functions in place of a natural blood-clotting factor that is missing in people with hemophilia A. Emicizumab works as a "bridge" between other clotting factors to replace missing factor VIII.

Emicizumab is for adults and children with hemophilia A, with or without factor VIII inhibitors. Emicizumab is used to help prevent bleeding episodes or make them occur less often.

Emicizumab will not stop a bleeding episode that has already begun.

Emicizumab may also be used for purposes not listed in this medication guide.

Emicizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you also use a bypassing agent, call your doctor right away if you have any of these side effects:

headache, weakness, confusion;

feeling light-headed or unusually sick;

back pain, little or no urination;

stomach pain, vomiting;

chest pain, feeling short of breath, coughing up blood;

swelling or redness in your arms or legs;

eye pain or swelling, vision problems;

numbness in your face; or

yellowing of your skin or eyes.

Common side effects of emicizumab may include:

headache;

joint pain; or

pain, swelling, burning, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Emicizumab

You should not use emicizumab if you are allergic to it.

Tell your doctor if you use factor VIII or a bypassing agent such as FEIBA (or "aPCC"; activated prothrombin complex concentrate). Emicizumab can cause unwanted blood clots when used together with aPCC. These blood clots can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

You will most likely need to stop using bypassing agents the day before you begin using emicizumab. But you may keep using factor VIII for the first week of using emicizumab.

if your doctor tells you to keep using a bypassing agent, you may need to limit your emicizumab dose to more than 100 units/kilogram per 24 hours. Follow all instructions carefully.

Follow your doctor's instructions about using emicizumab if you are pregnant. It is not known whether emicizumab will harm an unborn baby. Control of bleeding episodes is very important during pregnancy. The benefit of preventing these episodes may outweigh any risks to the baby.

If you are not pregnant, use effective birth control to prevent pregnancy while using this medicine.

It is not known whether emicizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Relate drugs

How to use Emicizumab

Usual Adult Dose for Hemophilia A with Inhibitors:

Loading dose: 3 mg/kg suBCutaneously once a week for the first 4 weeksMaintenance dose: 1.5 mg/kg subcutaneously once a week, or 3 mg/kg subcutaneously once every two weeks, or 6 mg/kg subcutaneously once every four weeksComments:-Discontinue prophylactic use of bypassing agents the day before starting this drug; prophylactic use of factor VIII (FVIII) products may be continued during the first week of prophylaxis with this drug.-Maintenance dose selection should be based on provider preference with consideration given to patient adherence.Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Usual Pediatric Dose for Hemophilia A with Inhibitors:

Newborn or Older:Loading dose: 3 mg/kg subcutaneously once a week for the first 4 weeksMaintenance dose: 1.5 mg/kg subcutaneously once a week, or 3 mg/kg subcutaneously once every two weeks, or 6 mg/kg subcutaneously once every four weeksComments:-Discontinue prophylactic use of bypassing agents the day before starting this drug; prophylactic use of factor VIII (FVIII) products may be continued during the first week of prophylaxis with this drug.-Maintenance dose selection should be based on provider preference with consideration given to patient adherence.Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in newborn or older pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Warnings

Emicizumab can cause unwanted blood clots when used together with a bypassing agent such as FEIBA. This can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

Tell your doctor if you use a bypassing agent or factor VIII. You will most likely need to stop using it the day before you begin using emicizumab.

If you use emicizumab and a bypassing agent together, call your doctor at once if you have any of these symptoms: weakness, confusion, stomach or back pain, vomiting, decreased urination, chest pain, trouble breathing, coughing up blood, swelling or redness in your arms or legs, eye pain, or vision problems.

What other drugs will affect Emicizumab

Other drugs may affect emicizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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