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.

Reimbursement and Support

Enroll Your Patient for Access Support

Learn More About ADAKVEO Support at PANO

ADAKVEO Support at Patient Assistance Now Oncology (PANO) brings support services for your patient in one place, including co-pay assistance, benefits investigation, access to free medication, disease management support, and disease state education. We can also help direct callers to additional support programs that best fit their needs.

Work with your patients to submit a Service Request Form (SRF) to ADAKVEO Support at PANO to get started with the benefits investigation process and identify eligibility for other support programs. Note: One half of SRF is completed by your patient and the other by your practice. Once your patient completes their part of the SRF, you'll need their confirmation number, so you can fill out your part. 

Visit the Novartis Patient Assistance Now Oncology (PANO) site to learn more about the patient support process.

Universal Co-pay Program

We recognize access to financial support may be important to your patients. With the Universal Co-pay Program, patients with private/commercial insurance may be eligible for co-pay savings for ADAKVEO® (crizanlizumab-tmca).

Your practice can help coordinate co-pay assistance. Work with your patient to complete and submit the Optional Co-pay Assistance Authorization form.

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, please visit Copay.NovartisOncology.com or call 1-877-577-7756.

Service Request Form is not required.

Coding and Reimbursement Resources

Novartis is committed to helping you get your patients started on ADAKVEO. For patient access support, an ADAKVEO Reimbursement Team member may be able to assist in addition to PANO. For immediate help, download the resources below.

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.

Download

Patient Co-pay Flashcard

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

Download

Billing & Coding Guide

Educational information for physician offices and hospital outpatient clinics, including a list of relevant codes and sample letters of appeal and medical necessity.

Download

For questions or more information on access and reimbursement, financial assistance, or additional support, please call ADAKVEO Support at PANO at 1-877-577-7756

 

 

 

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.