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
ADAKVEO may be given with or without hydroxyurea. Do not mix or coadminister with other drugs through the same IV line.
ADAKVEO gives you the confidence of knowing your patients are receiving their once-monthly treatment with each infusion
If a dose is missed, administer ADAKVEO as soon as possible1
Please refer to full Prescribing Information for additional dosage and administration instructions.
Important Reminder:
Before preparation, ADAKVEO vials should be stored and transported:
Do not shake or freeze the vials. |
Important Reminder:
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REMEMBER, THE DILUTED ADAKVEO SOLUTION SHOULD BE ADMINISTERED AS SOON AS POSSIBLE
Important Reminder:
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CLINICAL TRIAL PROTOCOLS FOR ADAKVEO DID NOT RECOMMEND PROPHYLAXIS FOR IRRS. USE YOUR CLINICAL JUDGMENT.2 CAUTION IS RECOMMENDED WHEN CONSIDERING CORTICOSTEROIDS3
With monoclonal antibodies such as ADAKVEO, there is the potential for IRRs.
These are not all the potential signs and symptoms of IRRs.
For additional safety information, including most common adverse reactions (ARs) and management considerations, see Safety.
ADVISE YOUR PATIENTS TO CONTACT THEIR HEALTH CARE PROVIDER IMMEDIATELY IF THEY EXPERIENCE ANY OF THE ABOVE SIGNS OR SYMPTOMS OF IRRs DURING AND WITHIN 24 HOURS OF THE INFUSION
Download this resource designed to guide you through dosing and administering ADAKVEO
Watch this video for more information about the ADAKVEO dosing schedule, dosing calculation, and administration process
Brochure that provides suggested strategies for engaging with patients at their ADAKVEO infusion appointments and details safety considerations, including management considerations for infusion-related reactions and the most common adverse reactions.
Watch this video for firsthand tips from nurse practitioner, Dr. Artangela Henry, on managing and explaining the logistics of ADAKVEO infusion appointments.
Watch this video for a short overview of 3 important things to remind your patients receiving treatment with ADAKVEO. Featuring nurse practitioner, Dr. Artangela Henry.
For additional ADAKVEO Safety Information, click here
IRR, infusion-related reaction.
References: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Data on file. CSEG101A2202 Clinical Trial Protocol. Novartis Pharmaceuticals Corp; 2017. 3. Brandow AM, Carroll CP, Creary S, et al. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020;4(12):2656-2701.
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
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.