ADAKVEO (crizanlizumab-tmca) for Sickle cell Disease

ADAKVEO is an injection available as a prescription used to treat sickle cell disease in people 16 years of age and older to help reduce how often painful crises happen.

It is not known if ADAKVEO is safe to use in children under 16 years of age.

None.

Before receiving ADAKVEO, tell your doctor about all of your medical conditions, including if you:

• are pregnant or planning to become pregnant. ADAKVEO may harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known if ADAKVEO can pass into your breast milk.
• Tell your doctor about all of the medicines, over-the-counter medicines, prescriptions, vitamins, and herbal supplements you take.

• Your doctor will give you ADAKVEO as an infusion into your vein through an intravenous (IV) line over 30 minutes.

• You will receive your first infusion from your doctor, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.

• Your doctor may also prescribe other treatments for you to take during treatment with ADAKVEO.

• Do not stop receiving ADAKVEO unless your doctor tells you to.

• If you miss an appointment for infusion, call your doctor as soon as possible to reschedule.

The most common side effects of ADAKVEO include:

• nausea
• stomach-area (abdominal) pain or tenderness
• joint pain
• back pain
• fever

• Infusion-related reactions: Infusion-related reactions may happen during or within 24 hours of receiving an infusion of ADAKVEO. Your doctor 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 doctor may give you certain medicines before your infusion to lower your risk of getting an infusion-related reaction. Your doctor should monitor you for signs and symptoms of infusion-related reactions and treat your symptoms as needed. Tell your doctor right away if you get any of the following signs or 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

• ADAKVEO may interfere with a certain blood test: Tell your doctor that you are receiving ADAKVEO before having any blood tests. ADAKVEO may interfere with a laboratory test to measure your platelet counts.

• Store and transport refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not shake and do not freeze.

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