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.

Resources

HCP Resources

Supporting Patient Access for ADAKVEO

Billing & Coding Guide

Educational information for physician offices and hospital outpatient clinics, including a list of relevant codes, basic coverage information, and sample appeals and letters of medical necessity, for support during the miscellaneous J-code period.

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Sample Annotated CMS-1500

Sample annotated CMS claim form for physician offices (CMS-1500) with suggestions for each box for miscellaneous billing and coding.

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Sample Annotated UB-04

Sample annotated CMS claim form for hospital outpatient (CMS-1450/UB-04) with suggestions for each box for miscellaneous billing and coding.

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HCP Novartis Oncology Service Request Form (SRF)

The Novartis Oncology Service Request Form is used to assess patient eligibility for Novartis Oncology programs, including financial assistance and free trial offers.

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  • * Novartis Pharmaceuticals Corporation does not guarantee success in obtaining reimbursement or financial assistance. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved.

Patient Resources

 

Patient Video: Understanding Treatment With ADAKVEO

Watch for helpful tips on having a conversation with your doctor...

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Patient Brochure

Downloadable brochure to help your patients with sickle cell disease understand their ADAKVEO treatment

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ADAKVEO Patient Starter Kit

This program has been designed to help guide your patients who have been prescribed ADAKVEO through their treatment. To request an ADAKVEO Patient Starter Kit, please contact a sales rep or Network Manager or call 1-877-232-5830.

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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

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.