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
ADAKVEO may be given with or without hydroxyurea. Do not mix or coadminister with other drugs through the same IV line.
ADAKVEO is meant to be a long-term treatment.1 Adherence is crucial. Stress the importance of remaining on treatment and making it to each infusion1
Download this resource designed to guide you through dosing and administering ADAKVEO.
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. |
USE ASEPTIC TECHNIQUE TO PREPARE THE SOLUTION FOR INFUSION.
ADAKVEO SHOULD BE PREPARED AND ADMINISTERED BY A HEALTH CARE PROFESSIONAL
Important Reminder:
|
REMEMBER, THE DILUTED ADAKVEO SOLUTION SHOULD BE ADMINISTERED AS SOON AS POSSIBLE
Important Reminder:
|
Prophylaxis is not required. Exercise caution with corticosteroids in patients with SCD unless clinically indicated (eg, treatment of anaphylaxis)1
With monoclonal antibodies such as ADAKVEO, there is the potential for IRRs.
These are not all the potential signs and symptoms of IRRs.
2. If an IRR occurs, manage medically:
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/WITHIN 24 HOURS OF THE INFUSION
For additional ADAKVEO Safety Information, click here
Reference: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.
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.
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.