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 within 24 hours of receiving an infusion of Adakveo. 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

Your healthcare provider may monitor you for signs and symptoms of infusion reactions.

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.

• 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.

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

• are pregnant or plan to become pregnant. It is not known if 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 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

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.