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How May ADAKVEO Help?

Study results with ADAKVEO^® (crizanlizumab-tmca)

IMPORTANT SAFETY INFORMATION:

What is the most important information I should know about ADAKVEO?

ADAKVEO may cause serious side effects, including infusion reactions.

Infusion reactions. Infusion reactions may happen within 24 hours of receiving an infusion of ADAKVEO. Tell your health care 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 doctor or health care provider may monitor you for signs and symptoms of infusion reactions.

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. 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 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
fever

These are not all of the possible side effects of ADAKVEO. For more information, ask your health care provider or pharmacist.

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.

Approved Use:

ADAKVEO^® (crizanlizumab-tmca) 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.

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Prescribing Info Including Patient Info

Get helpful resources for your treatment journey

IMPORTANT SAFETY INFORMATION:

What is the most important information I should know about ADAKVEO?

ADAKVEO may cause serious side effects, including infusion reactions.

Infusion reactions. Infusion reactions may happen...

See More

Approved Use:

See More

IMPORTANT SAFETY INFORMATION:

What is the most important information I should know about ADAKVEO?

ADAKVEO may cause serious side effects, including infusion reactions.

fever
Chills or shivering
nausea
vomiting
tiredness
dizziness
sweating
hives
itching
shortness of breath or wheezing

Your doctor or health care provider may monitor you for signs and symptoms of infusion reactions.

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. 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 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
fever

These are not all of the possible side effects of ADAKVEO. For more information, ask your health care provider or pharmacist.

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.

Approved Use:

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Learn about the study results with ADAKVEO

How was ADAKVEO studied?

The safety and effectiveness of ADAKVEO were studied in 198 people with sickle cell disease.

67 people received ADAKVEO, and 65 people received placebo at study centers primarily across the United States.

In the 1-year study, pain crises were defined as painful episodes that led to a health care visit (ER, clinic, hospital, or local physician visit). Your doctor or health care provider may refer to pain crises as "vaso-occlusive crises" [vey-soh uh-kloo-siv] or VOCs. The following health conditions were also considered pain crises if they led to a health care visit:

Respiratory issues, or acute chest syndrome
Reduced blood flow or cell trapping in the liver, or hepatic sequestration
Reduced blood flow or cell trapping in the spleen, or splenic sequestration
Prolonged erections, or priapism

Who received ADAKVEO in the study?

The clinical study of ADAKVEO included people:

Across all genotypes of sickle cell disease, including HbSS, HbSC, HbSß⁰-thalassemia, HbSß⁺-thalassemia, and others

Who were of African, Hispanic, Caucasian, and other ancestries

Who had either 2-4 or 5-10 painful episodes (crises) in the last 12 months

Who were also on hydroxyurea, and people who were not

What were the results of the ADAKVEO study?

ADAKVEO reduced the number of pain crises by nearly half (45%) vs. placebo in a 1-year study

67 people receiving ADAKVEO experienced a median annual rate of 1.63 pain crises compared with 2.98 pain crises in 65 people taking placebo—a 45% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study.

ADAKVEO reduced the number of pain crises people had regardless of sickle cell disease genotype and whether or not they were taking hydroxyurea.

People treated with ADAKVEO spent fewer days in the hospital (vs. placebo)

67 people taking ADAKVEO experienced a median annual rate of 4.0 days in the hospital vs 6.87 days for 65 people taking placebo—a 42% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study. The annual number of days a patient was hospitalized included those days related to pain crises.

More than one-third of people had no pain crises with ADAKVEO in the clinical study

36% of people taking ADAKVEO had no pain crises compared with 17% for people taking placebo

A total of 24 out of 67 people taking ADAKVEO had no pain crises compared with 11 out of 65 people taking placebo. These results include some people who did not complete the study.