Adakveo 10 mg/mL intravenous solution

Generic name:
Crizanlizumab - injection

Pronunciation
(KRIZ-an-LIZ-ue-mab)

Brand name(s)
Adakveo

Crizanlizumab is used by people with sickle cell disease to reduce the number of painful crises caused by the disease. It works by attaching to a certain substance in your body (P-selectin) and preventing blood cells from sticking together. Crizanlizumab belongs to a class of drugs known as monoclonal antibodies.

Read the Patient Information Leaflet if available from your pharmacist before you start using crizanlizumab and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is given as directed by your doctor on a treatment schedule. It is injected slowly into a vein usually over 30 minutes. The first 2 infusions are usually given 2 weeks apart. After that, an infusion is usually given every 4 weeks. Follow your doctor's treatment schedule.

Infusion reactions may happen during the infusion of this drug and for up to 24 hours afterward. Your doctor may prescribe other medications (such as acetaminophen, nonsteroidal anti-inflammatory drugs-NSAIDs, antihistamines) before each treatment to help prevent these side effects. Tell your doctor right away if you have symptoms of infusion reactions such as pain, headache, dizziness, fever, chills, shivering, nausea, vomiting, diarrhea, itching, or trouble breathing. Your doctor may slow down or stop your treatment for some time.

The dosage and treatment schedule are based on your medical condition, weight, and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also How to Use section.

Nausea, stomach pain, fever, or joint/back pain may 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 crizanlizumab, 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).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using crizanlizumab. Crizanlizumab may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

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 platelet counts), 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.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

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.