Crizanlizumab is used in people with sickle cell disease to reduce how often certain episodes (vaso-occlusive crises) occur.

Crizanlizumab is for use in adults and children at least 16 years old.

Crizanlizumab may also be used for purposes not listed in this medication guide.

Some side effects may occur within 24 hours after you receive this medicine. Tell your caregiver if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath.

Crizanlizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 30 minutes to complete.

Your doctor may prescribe other treatments while using crizanlizumab.

Crizanlizumab is usually given once every 2 to 4 weeks. Follow your doctor's dosing instructions very carefully.

Do not stop using this medicine without your doctor´s advice.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using crizanlizumab.

Usual Adult Dose for Sickle Cell Anemia:

Initial dose: 5 mg/kg via IV infusion every 2 weeks for 2 doses, then
Maintenance dose: 5 mg/kg via IV infusion every 4 weeks

Comments:
-This drug may be given with or without hydroxyurea.
-Use patient's actual body weight for dose calculation.

Use: To reduce the frequency of vasoocclusive crises in patients 16 years or older with sickle cell disease.

Usual Pediatric Dose for Sickle Cell Anemia:

16 years or older:
Initial dose: 5 mg/kg via IV infusion every 2 weeks for 2 doses, then
Maintenance dose: 5 mg/kg via IV infusion every 4 weeks

Comments:
-This drug may be given with or without hydroxyurea.
-Use patient's actual body weight for dose calculation.

Use: To reduce the frequency of vasoocclusive crises in patients 16 years or older with sickle cell disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having sickle cell disease during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating sickle cell disease may outweigh any risks to the baby.

Ask a doctor if it is safe to breastfeed while using crizanlizumab.

Call your doctor for instructions if you miss an appointment for your crizanlizumab injection.

Since crizanlizumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur within 24 hours after you receive crizanlizumab. Call your doctor if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath.

Common side effects of crizanlizumab may include:

• stomach pain or tenderness;

• nausea;

• fever;

• joint pain; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect crizanlizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.