Important Safety Information

 

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated

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Indication


ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.

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Dosing and Administration

 

Dosing Schedule

ADAKVEO® (crizanlizumab-tmca) 5 mg/kg is administered by IV infusion over 30 minutes at Weeks 0 and 2, then every 4 weeks.

For more information about ADAKVEO dosing, please see Dosing and Administration.

 

Guidance for Missed Doses of ADAKVEO

If a dose is missed, administer ADAKVEO as soon as possible.

  • If ADAKVEO is administered within 2 weeks of the missed dose, continue dosing according to the patient's original schedule
  • If ADAKVEO is administered more than 2 weeks after the missed dose, continue dosing every 4 weeks thereafter

For additional information, please see Guidance for missed doses of ADAKVEO.

 

Preparation and Administration

ADAKVEO should be prepared and administered by a health care professional.

For additional information about the preparation and administration of ADAKVEO, including: dose calculation, dilution, storage conditions of the diluted solution, and administration, please see Dosing and Administration.

Please refer to full Prescribing Information for additional dosing and administration instructions.

 

Monitoring for Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg.

Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, shortness of breath or wheezing.

Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Dosing and Administration Resources

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Dosing and Administration Guide

Download this resource designed to guide you through dosing and administering ADAKVEO

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Dosing and Administration Video

Watch this video for more information about the ADAKVEO dosing schedule, dosing calculation, and administration process

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For more information, please see the Dosing and Administration section.

Patient Resources

Resources for your patient

For information and downloadable resources for patients, please see the Patient Resources section.

Access

For information on access and patient assistance, please see the Access section.

Indication

ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.

Important Safety Information

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Laboratory Test Interference: Platelet Counts

Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.

Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

Pregnancy

Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).

Other Clinically Important Adverse Reactions

Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

Please see full Prescribing Information.