Approved Use
What is ADAKVEO® (crizanlizumab-tmca)?
ADAKVEO is a prescription medicine used in people 16 years of age and older who have sickle cell disease to help reduce how often painful crises happen.
It is not known if ADAKVEO is safe and effective in children under 16 years of age.
Important Safety Information
What is the most important information I should know about ADAKVEO?
ADAKVEO may cause serious side effects, including infusion-related reactions.
Infusion-related reactions. Infusion-related reactions may happen during or within 24 hours of receiving an infusion of ADAKVEO. Your health care provider may slow down, temporarily stop, or completely stop your infusion with ADAKVEO if you have an infusion-related reaction. You may continue to receive ADAKVEO at a slower infusion rate, and your health care provider may give you certain medicines before your infusion to lower your risk of getting an infusion-related reaction. Your health care provider should monitor you for signs and symptoms of infusion-related reactions and treat your symptoms as needed. Tell your health care provider right away if you get any of the following signs and symptoms of an infusion-related reaction:
- pain in various locations
- headache
- fever
- chills or shivering
- nausea
- vomiting
- diarrhea
- tiredness
- dizziness
- sweating
- hives
- itching
- shortness of breath or wheezing
- pain in various locations
- headache
- fever
- chills or shivering
- nausea
- vomiting
- diarrhea
- tiredness
- dizziness
- sweating
- hives
- itching
- shortness of breath or wheezing
ADAKVEO may interfere with a blood test.
Tell your health care provider that you are receiving ADAKVEO before having any blood tests. ADAKVEO may interfere with a laboratory test to measure your platelet counts.
Before receiving ADAKVEO, tell your health care provider about all of your medical conditions, including if you
- are pregnant or plan to become pregnant. ADAKVEO may harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if ADAKVEO passes into your breast milk. You and your health care provider should decide the best way to feed your baby during treatment with ADAKVEO
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of ADAKVEO include:
- nausea
- joint pain
- back pain
- stomach-area (abdominal) pain or tenderness
- fever
- nausea
- joint pain
- back pain
- stomach-area (abdominal) pain or tenderness
- fever
These are not all of the possible side effects of ADAKVEO. For more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
