emicizumab-kxwh 105 mg/0.7 mL subcutaneous solution

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Medication name

Generic name:
Emicizumab-kxwh - subcutaneous injection

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

Brand name(s)
Hemlibra

Warning

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. 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.

Uses

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-kxwh 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.

How to use

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. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under your 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-kxwh prophylaxis. You may continue prophylaxis with Factor VIII for the first week of emicizumab-kxwh prophylaxis. Ask your healthcare professional for more information about the use of these other products and what to do if you have breakthrough bleeding.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Wash your hands before using this medication. Remove the medication from the refrigerator 15 minutes before you inject it so it can reach room temperature. Do not warm up this medication any other way such as by heating in the microwave, placing in hot water, or leaving it in direct sunlight. Do not shake the medication. The medication should be colorless to slightly yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean 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. It may help to mark your calendar with a reminder.

Side effects

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 your doctor has prescribed this medication because he or she 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.

Precautions

Before using emicizumab-kxwh, 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 breast-feeding.

Drug interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

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.

Missed dose

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.

Storage

Store in the original package in the refrigerator away from light and moisture. Do not shake or freeze. Unopened vials may be briefly left at room temperature and put back in the refrigerator if not used. The total time out of the refrigerator should be no longer 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.

Medical alert

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).

Important note

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.

Information last revised October 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.