Adakveo
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
Adakveo is a Monoclonal Antibody that is FDA approved for the prophylaxis of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.. Common adverse reactions include Nausea, Arthralgia (joint pain), Back pain, and Pyrexia (fever)..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
5 mg/kg administered by intravenous infusion over 30 minutes
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Adakveo in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Adakveo in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
5 mg/kg administered intravenously over 30 minutes
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Adakveo in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Adakveo in pediatric patients.
Contraindications
There is limited information regarding Adakveo Contraindications in the drug label.
Warnings
Infusion-Related Reactions:
Serious reactions may occur within 24 hours of administration.
Symptoms may include fever, chills, nausea, vomiting, fatigue, dizziness, sweating, hives, itching, shortness of breath, and wheezing.
Monitor patients during the infusion and for at least 30 minutes after completion.
If a severe reaction occurs, discontinue Adakveo permanently.
Interference with Platelet Counts:
Adakveo may interfere with automated hematology analyzers, leading to falsely decreased platelet counts.
Inform laboratories of Adakveo use to ensure accurate interpretation of platelet counts.
Adverse Reactions
Clinical Trials Experience
Nausea, Arthralgia (joint pain), Back pain, and Pyrexia (fever).
Postmarketing Experience
There is limited information regarding Adakveo Postmarketing Experience in the drug label.
Drug Interactions
Efgartigimod Alfa: Combining Adakveo with efgartigimod alfa may require careful monitoring due to potential additive effects on the immune system.
Exagamglogene Autotemcel: Co-administration with Adakveo has not been extensively studied; consult healthcare providers for personalized advice.
Lovotibeglogene Autotemcel: Potential interactions with Adakveo are not well-documented; professional medical guidance is recommended.
Rozanolixizumab: Using Adakveo alongside rozanolixizumab may necessitate monitoring for enhanced immunosuppressive effects.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Adakveo in women who are pregnant.
Pregnancy Category (AUS): B1
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Adakveo in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Adakveo during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Adakveo in women who are nursing.
Pediatric Use
The safety and effectiveness of Adakveo have been established in pediatric patients aged 16 years and older for the reduction of vaso-occlusive crises (VOCs) in sickle cell disease. Safety and effectiveness in patients younger than 16 years have not been established.
Geriatic Use
There is no FDA guidance on the use of Adakveo in geriatric settings.
Gender
There is no FDA guidance on the use of Adakveo with respect to specific gender populations.
Race
There is no FDA guidance on the use of Adakveo with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Adakveo in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Adakveo in patients with hepatic impairment.
Females of Reproductive Potential and Males
Females of reproductive potential should use effective contraception during treatment with Adakveo and for at least 3 months after the last dose due to the potential for fetal harm.
Immunocompromised Patients
There is no FDA guidance one the use of Adakveo in patients who are immunocompromised.
Administration and Monitoring
Administration
Dosage: Administer 5 mg/kg via intravenous infusion over 30 minutes.
Dosing Schedule:
Initial dose: Week 0
Second dose: Week 2
Then: Every 4 weeks thereafter
Preparation:
Bring vials to room temperature (up to 4 hours before use).
Dilute in 0.9% Sodium Chloride or 5% Dextrose to a total volume of 100 mL.
Use a 0.2-micron in-line filter during infusion.
Monitoring
Infusion-Related Reactions:
Monitor patients during and for at least 30 minutes after infusion for signs of infusion reactions (e.g., fever, chills, nausea, rash, wheezing).
If severe reactions occur, discontinue Adakveo permanently.
Laboratory Test Interference:
Be aware that Adakveo may cause falsely low platelet counts when measured by some automated analyzers.
Inform laboratory personnel to ensure accurate interpretation of results.
IV Compatibility
Administer as an IV infusion over 30 minutes.
Do not co-administer with other drugs through the same IV line.
Use immediately or store refrigerated for up to 24 hours.
Overdosage
There is limited information regarding Adakveo overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Adakveo Pharmacology in the drug label.
Mechanism of Action
Crizanlizumab is a humanized monoclonal antibody (IgG2-kappa) that binds to P-selectin, a cell adhesion molecule expressed on activated endothelial cells and platelets.
By blocking P-selectin, Adakveo inhibits the interactions between endothelial cells, platelets, red blood cells, and leukocytes, which play a central role in the pathophysiology of vaso-occlusion in sickle cell disease.
Structure
There is limited information regarding Adakveo Structure in the drug label.
Pharmacodynamics
Crizanlizumab-tmca inhibits the binding of P-selectin to its ligand PSGL-1.
The drug leads to a reduction in the frequency of vaso-occlusive crises (VOCs) in patients with sickle cell disease.
The maximum inhibition of P-selectin binding was observed within 30 minutes of infusion and maintained throughout the dosing interval.
Pharmacokinetics
Absorption: Not applicable (administered IV).
Distribution:
Steady-state volume of distribution: approximately 5.2 L.
Elimination:
Mean terminal half-life: 7.6 days.
Clearance: approximately 0.102 L/day.
Follows linear pharmacokinetics over a dose range of 5–20 mg/kg.
Accumulation: AUC increased by approximately 2.5-fold after multiple doses compared to the first dose.
Nonclinical Toxicology
There is limited information regarding Adakveo Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Adakveo Clinical Studies in the drug label.
How Supplied
Adakveo is supplied as a single-dose vial containing: ➤ 100 mg/10 mL (10 mg/mL) solution for intravenous infusion.
Each carton contains one sterile, preservative-free vial.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Keep vials in the original carton to protect from light.
Do not freeze or shake.
After dilution, the solution may be stored:
Up to 4 hours at room temperature, or
Up to 24 hours refrigerated (2°C to 8°C), protected from light.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Adakveo Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Adakveo interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Adakveo® is the only approved brand name for crizanlizumab-tmca.
Look-Alike Drug Names
There is limited information regarding Adakveo Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.