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
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.
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*:
Call 1-866-748-2339 to speak with a Case Coordinator about ADAKVEO Connect and how to enroll.
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:
If a patient has not yet been prescribed ADAKVEO, they may enroll in the Warrior Way program for educational email support.
• Under 18 years of age‡
• Needing reimbursement support†
• Having difficultly with self-enrollment
A brochure detailing available support for your patients and caregivers available through ADAKVEO Support at PANO.
A brochure taking a deeper look at the ADAKVEO Connect program offerings and how to enroll.
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.
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.
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.
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.