ADAKVEO®
(ah dak vee oh)
Crizanlizumab-tmca
ADAKVEO® is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
ADAKVEO®
(ah dak vee oh)
Crizanlizumab-tmca
ADAKVEO® is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
What is ADAKVEO®
ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
ADAKVEO is used:
- in people 16 years of age and older who have sickle cell disease
- to help reduce how often certain episodes (crises) happen.
It is not known if ADAKVEO is safe and effective in children under 16 years of age
How will I receive ADAKVEO?
- Your healthcare provider will give you ADAKVEO as an infusion into your vein through an intravenous (IV) line over 30 minutes.
- You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.
- Your healthcare provider may also prescribe other treatments for you to take during treatment with ADAKVEO.
- Do not stop receiving ADAKVEO unless your healthcare provider tells you to.
- If you miss an appointment for infusion, call your healthcare provider as soon as possible to reschedule.
What are the possible side effects of ADAKVEO?
ADAKVEO may cause serious side effects. See "What is the most important information I should know about ADAKVEO?"
- The most common side effects of ADAKVEO include:
- nausea
- back pain
- joint pain
- Fiver
These are not all of the possible side effects of ADAKVEO. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before receiving ADAKVEO, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if ADAKVEO may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ADAKVEO passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment with ADAKVEO.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.
Important Safety Information
- 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.
General information about the safe and effective use of ADAKVEO.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for more information about ADAKVEO.
What are the ingredients in ADAKVEO?
Other ingredient: citric acid, polysorbate 80, sodium citrate, and water for injection
Please see full Prescribing Information for additional Important Safety Information.