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

See More
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.

Patient Support Programs

ADAKVEO Connect and Warrior Way Programs

Patients with SCD face many different barriers throughout their treatment journey1,2

  • Living with SCD can carry an emotional toll as well, caused by feelings of frustration, anxiety, helplessness, and worry about the future1
  • Patients may appreciate an extra layer of support 

Patients for whom ADAKVEO® (crizanlizumab-tmca) is prescribed can enroll in both the ADAKVEO Connect and the Warrior Way programs for personalized, multifaceted support. See below for how to enroll.

 
 
 

ADAKVEO Connect

 

One-on-one personalized support

Dedicated Case Coordinators have the time, commitment, and motivation to help patients during treatment with ADAKVEO.

Areas of help include*:

  • Providing information about ADAKVEO treatment, the typical insurance process, and navigating the health care system
  • Sending reminders about upcoming infusion appointments via text
  • Identifying and sharing resources that may assist with individualized needs or concerns, including food, transportation, and more
  • Offering support via phone, text, email, and/or mail
 

Call 1-866-748-2339 to speak with a Case Coordinator about ADAKVEO Connect and how to enroll.

ADAKVEO Connect Patient Program quote from Jennifer, a Case Coordinator: “As a Case Coordinator, I’m a listening ear, your sounding board, and partner as you start a long-term treatment, which we know can be challenging.

 

Warrior Way

 

Helpful infusion readiness materials

The Warrior Way program sends infusion readiness materials to patients at key times to align with their ADAKVEO treatment journey.

Areas of help include:

  • Helping patients prepare for their infusion appointments
  • Providing a journal to track their pain crises and infusion appointments
  • Sending materials via mail and email

If a patient has not yet been prescribed ADAKVEO, they may enroll in the Warrior Way program for educational email support.

 
 
Warrior’s Way: A kit to help you begin ADAKVEO treatment
 
 

Helping Your Patients Enroll

  1. You can help your patients enroll in ADAKVEO Connect

    • Under 18 years of age

    • Needing reimbursement support

    • Having difficultly with self-enrollment

    Enroll in the ADAKVEO Connect program

 

 

Find financial support and resources for your patients

  • Help your patients access their medication with PANO
  • Help eligible patients with private insurance save with the Universal Co-pay Card

 

Resources

test 

Patient Services Brochure for ADAKVEO

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

Download

ADAKVEO Connect Brochure

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

Download

PANO, Patient Assistance Now Oncology; SCD, sickle cell disease.

*Case Coordinators do not provide medical advice and refer patients to their HCPs for such questions.

When a Benefits Investigation is in process via PANO, patients may be able to receive updates on the status of their personal insurance approval.

Patients who are under 18 years of age will need to be enrolled by their parent/guardian via the Service Request Form.

References: 1. Osunkwo I, Andemariam B, Minniti CP, et al. Impact of sickle cell disease on patientsʼ daily lives, symptoms reported, and disease management strategies: results from the international Sickle Cell World Assessment Survey (SWAY). Am J Hematol. 2021;96:404-417. 2. Hodges JR, Phillips SM, Norell S, et al. Intentional and unintentional nonadherence to hydroxyurea among people with sickle cell disease: a qualitative study. Blood Adv. 2020;4(18):4463-4473.

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.