emicizumab-kxwh 300 mg/2 mL (150 mg/mL) subcutaneous solution

Generic name:
Emicizumab - subcutaneous injection

Pronunciation
(EM-i-SIZ-ue-mab)

Brand name(s)
Hemlibra

This medication has rarely caused serious blood clots (including thrombotic microangiopathy) when used along with another product used to treat or prevent bleeding (activated prothrombin complex concentrate-aPCC). The risk is higher when aPCC has been used for 24 hours or longer and the dose has reached a certain amount. This interaction with aPCC may last up to 6 months after stopping emicizumab. Get medical help right away if you develop symptoms of serious blood clots, such as unusual decrease in the amount of urine, swelling ankles/feet, shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

This medication is used by people with a certain inherited bleeding problem (hemophilia A) to help prevent or lessen how often you have bleeding problems. Emicizumab belongs to a class of medications known as monoclonal antibodies. It works by helping your blood to clot normally, which helps prevent bleeding due to hemophilia A. Preventing bleeding can lessen symptoms such as painful swellings, joint pain, pain with movement, and difficulty walking far.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once a week for the first 4 weeks, followed by a maintenance dose on a regular schedule as prescribed. The injection is given in the thighs, upper arm, or abdomen (at least 2 inches from your belly button). The dosage is based on your medical condition, weight, and response to treatment.

Stop the prophylactic use of bypassing agents the day before starting emicizumab prophylaxis. You may continue prophylaxis with Factor VIII for the first week of emicizumab prophylaxis. Ask your healthcare professional for more information about the use of these other products and what to do if you have breakthrough bleeding.

Take the medication out of the refrigerator 15 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, or skin that is tender, bruised, red, or hard. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. Mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Redness, warmth, itching, or pain at the injection site may occur. Headache or muscle/joint pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using emicizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Women of childbearing age should ask about reliable forms of birth control while using this medication. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as blood clotting tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood clotting tests) must be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. Do not give two doses on the same day to make up for a missed dose.

Store in the refrigerator. Do not shake or freeze. Keep the medication in the original package to protect from light. Unopened vials may be taken out of the refrigerator and put back in the refrigerator if needed. The total time out of the refrigerator should not be more than 7 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.