Important Safety Information

 

Infusion-Related Reactions (IRRs)

In the SUSTAIN clinical trial, IRRs (occurring during/within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO

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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.

Education Center

VOCalizer—Patient Communication Simulator

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HCP Resources

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VOCalizer Communication Skills Brochure

Familiarize yourself with the TIPS framework of patient-centered communication and how it can be applied to your conversations about ADAKVEO.

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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 dosing schedule, dosing calculation, and administration process for ADAKVEO.

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A Nurse’s Guide to the ADAKVEO Infusion Experience

A pocket guide of the need-to-know information to help infusion nurses initiate treatment, answer questions, and engage their patients.

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Logistics for ADAKVEO Infusion Appointments

Watch this video for firsthand tips from nurse practitioner, Dr Artangela Henry, on managing and explaining the logistics of ADAKVEO infusion appointments.

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3 Things to Remind Your Patients About Their Treatment Journey

Watch this video for a short overview of 3 important things to remind your patients about ADAKVEO. Featuring nurse practitioner, Dr Artangela Henry.

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Patient Services Brochure for ADAKVEO

A brochure detailing available support for your patients and caregivers available through ADAKVEO Support at PANO.

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HCP Co-pay Guide

An overview of how patients can enroll in the Novartis Universal Co-pay Program and how your practice can help coordinate support.

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Visit the Reimbursement and Support page for coding and reimbursement resources

 

Visit the Video Library for an immersive education on ADAKVEO

Patient Resources

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Patient Brochure

A downloadable brochure to help your patients with sickle cell disease navigate treatment with ADAKVEO.

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Patient Brochure (Spanish)

The Patient Brochure is available in Spanish.

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Doctor Discussion Guide

A tool to help patients remember everything they want to say about how they are feeling, how treatment is going, and ask any questions they may have.

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Understanding Treatment With ADAKVEO

A video that provides patients with helpful tips for discussing sickle cell disease and ADAKVEO with their doctor.

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ADAKVEO Mechanism of Action

A video created to educate patients on how ADAKVEO works in the body.

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ADAKVEO Connect Brochure

A brochure taking a deeper look at the ADAKVEO Connect program offerings and how to enroll.

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Warrior Way Program

A program offering helpful resources for your patients taking ADAKVEO. After registering, they will receive tips and information to help support them on their treatment journey.

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Patient Co-pay Flashcard

A guide for patients on the Novartis Universal Co-pay Program, including enrollment and options for coordinating support.

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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.

Important Safety Information

Infusion-Related Reactions (IRRs)

In the SUSTAIN clinical trial, IRRs (occurring during/within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Postmarketing cases of IRRs, including severe pain events requiring hospitalizations, have been reported. The majority of these IRRs occurred during the first and second infusions. The management of pain events included acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, antihistamines, intravenous fluids, and/or oxygen therapy. Some patients have also experienced subsequent complications such as acute chest syndrome and fat embolism, particularly those treated with steroids.

Monitor patients for signs and symptoms of IRRs, which may include pain in various locations, headache, fever, chills, nausea, vomiting, diarrhea, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing.

For severe IRRs, discontinue infusion, institute appropriate medical care, and consider permanent discontinuation of ADAKVEO. For mild or moderate IRRs, temporarily interrupt or slow the rate of infusion and initiate symptomatic treatment. For subsequent infusions, consider premedication and/or reduce the infusion rate.

Exercise caution with corticosteroids in patients with sickle cell disease unless clinically indicated (eg, treatment of anaphylaxis).

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%), abdominal pain (12%), 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, 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 accompanying full Prescribing Information.