EMICIZUMAB
Background and Date of Approval
Emicizumab is a medication that belongs to the class of bispecific monoclonal antibodies. The FDA approved this medicine for medical use on October 4, 2018.
Uses
Emicizumab is an intravenously administered drug. It is used to treat patients with r hemophilia A who have developed factor VIII inhibitors. It is also indicated to treat severe hemophilia A who have not developed factor VIII inhibitors (the FVIII blood level is less than 1%).
How is it administered?
Emicizumab will be given by injection under the skin (subcutaneous). Your doctor or nurse or other healthcare professional will show you how to inject the medicine. Do not try to administer the medicine if you are well-trained. Your physician will decide the dose of the injection based on your disease condition and severity. The recommended places to give an injection are the front of the waist (lower abdomen), upper outer arms, or the front of the thighs. Use only recommended places for injection. Use a different area of the body for each injection than the one you used last time.
Side Effects
The common side effects of Emicizumab are injection site reactions, joint pain, and headache. Other serious side effects are heart problems, muscle pain and cramps, blood clots, bleeding, and destruction of RBC.
Warnings
Emicizumab may increase the risk of blood clots. Before beginning therapy, discussing any history of blood clots or risk factors with your healthcare physician is critical. Rare incidences of hypersensitivity events such as rash, itching, swelling, or difficulty breathing have been observed. If any allergy symptoms appear, seek quick medical assistance.
Precautions
Do not take Emicizumab if you are allergic to Emicizumab or any other ingredients. Before you start using this medicine, it is very important to talk to your doctor about using any other medications. Inform your physician immediately if bleeding occurs after taking this medicine. This medicine is used in all age groups. Do not give this injection where the skin is red, bruised, tender, or hard, or in areas with moles or scars. Regular laboratory monitoring may be necessary, including activated partial thromboplastin time (aPTT) and factor VIII activity. Inform your healthcare provider about all your medicines, including prescription, over-the-counter, nutritional, supplements, and herbal products. Certain medications interact with Emicizumab and reduce its effectiveness by causing undesirable side effects.
Word of Advice
This medicine is administered as a subcutaneous injection. It is typically injected into the upper outer arms, thighs, or abdomen. Use a different body site each time you self-administer an injection. Maintain a record of injection sites to ensure proper rotation of body areas. Do not inject into skin areas that are tender, red, bruised, hardened, or compromised, or into areas with moles or scars. Use a new needle and syringe for each injection. Women should use an effective form of contraception to prevent pregnancy. Inform your doctor immediately if you believe you have become pregnant. Your doctor will perform laboratory tests at regular visits to monitor the effects of this medicine. Attend all scheduled appointments.
References
Hemlibra 150 mg/mL Solution for Injection - Summary of Product Characteristics (SmPC) - (emc). www.medicines.org.uk. Published September 2022. Accessed May 10, 2023. http://www.medicines.org.uk/emc/product/9043/smpc Emicizumab Injection, Highlights of Prescribing Information, Revised 2017. Accessed May 10, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf H.G. Watson, J.I.O. Craig, L.M. Manson, Blood disease, Davidsonâs Principles and Practice of Medicine, 22nd Edition, 2014, 989-1056. Le Quellec, Clinical Evidence and Safety Profile of Emicizumab for the Management of Children with Hemophilia A, Drug Design, Development and Therapy, 2020:14, https://www.dovepress.com/getfile.php?fileID=55818
Frequently Asked Questions
Can Emicizumab be self-administered at home?
Yes, Emicizumab can be self-administered at home after proper training and instructions from a healthcare professional. However, the decision to self-administer should be made in consultation with the healthcare team.
Can Emicizumab be used in pediatric patients with hemophilia?
Yes, Emicizumab is approved for use in pediatric patients with hemophilia A. The dosage and administration may vary depending on the age and weight of the child, and it should be prescribed and monitored by a healthcare professional.
Is Emicizumab suitable for all types of hemophilia?
Emicizumab is specifically designed to treat hemophilia A, which is caused by a deficiency of clotting factor VIII. It is not intended for other types of hemophilia, such as hemophilia B.
How is Emicizumab administered?
Emicizumab is administered as a subcutaneous injection, generally, it is given once a week, every two weeks, or every four weeks, depending on the treatment plan determined by the healthcare provider. The frequency of the administration depends on your disease condition and other factors.
What should I inform the physician before starting the treatment with Emicizumab?
Before you use Emicizumab, talk to your doctor and carefully follow their instructions on when to use a bypassing agent and the dose and schedule you should use. It increases the ability of your blood to clot. Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.