Adakveo

Adakveo is used:

• in people 16 years of age and older who have sickle cell disease
• to help reduce how often certain episodes (crises) happen.

It is not known if Adakveo is safe and effective in children under 16 years of age.

Adakveo may cause serious side effects, including: Infusion reactions. Infusion reactions may happen during or within 24 hours of receiving an infusion of Adakveo. Infusion-related reactions may cause pain in different areas of your body. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infusion reaction:

• fever
• chills or shivering
• nausea
• vomiting
• tiredness
• dizziness
• sweating
• hives
• itching
• shortness of breath or wheezing
• diarrhea
• headache
• pain in different areas of your body

Your healthcare 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 healthcare provider may give you certain medicines before your infusion to lower your risk of getting an infusion-related reaction. Your healthcare provider should monitor you for signs and symptoms of infusion-related reactions and treat your symptoms as needed.

Adakveo may interfere with a certain blood test. Tell your healthcare providers that you are receiving Adakveo before having any blood tests. Adakveo may interfere with a laboratory test to measure your platelet counts. See Adakveo side effects for more information about side effects.

Before you receive Adakveo, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. Adakveo may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take Adakveo during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Adakveo passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

Adakveo may cause serious side effects. See Important information. The most common side effects include:

• nausea
• back pain
• joint pain
• fever
• headache
• fatigue
• stomach pain
• diarrhea
• vomiting
• throat pain

These are not all of the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for more information.

• Your healthcare provider will give you Adakveo as an infusion into your vein through an intravenous (IV) line over 30 minutes.
• You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.
• Your healthcare provider may also prescribe other treatments for you to take during treatment.
• Do not stop receiving this medicine unless your healthcare provider tells you to.
• If you miss an appointment for infusion, call your healthcare provider as soon as possible to reschedule.

Active ingredient: crizanlizumab-tmca Inactive ingredients: citric acid, polysorbate 80, sodium citrate, sucrose, and water for injection