Daratumumab
Daratumumab is a monoclonal antibody that targets CD38, a protein found on the surface of plasma cells. It is used to treat multiple myeloma and light chain (AL) amyloidosis by killing cancer cells through multiple immune-mediated mechanisms. The medication can be used alone or in combination with other therapies for patients with these hematologic malignancies.
Daratumumab is a targeted monoclonal antibody that treats multiple myeloma and AL amyloidosis by binding to CD38 on cancer cells and triggering their destruction.
Key facts at a glance
- ATC
- L01FC01
- RxNorm
- 1721947
- Generic
- Daratumumab
- Class
- atc-l01
- Brands
- Darzalex, Darzalex Faspro
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
6 groupspregnancy
all trimestersavoid if possible
avoid use during pregnancy unless benefits outweigh risks; discontinue therapy if pregnancy occurs
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 3 months after last dose due to potential excretion in milk
monitor infant for immune suppression
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot established
not indicated for use in pediatric patients; safety and efficacy not established in patients under 18 years
not applicable
geriatric
elderly 65 and olderno initial dose adjustment required
no dose adjustment needed based on age alone; monitor for increased susceptibility to infections and infusion-related reactions
regular monitoring of blood counts and for signs of infection
renal_impairment
severe renal impairmentno dose adjustment required
no dose adjustment needed for mild, moderate, or severe renal impairment including patients on hemodialysis; administer after dialysis
monitor renal function regularly
hepatic_impairment
moderate hepatic impairmentno dose adjustment required
no dose adjustment needed for mild to moderate hepatic impairment; limited data for severe hepatic impairment use with caution
monitor liver function tests regularly
Statistics and clinical data
Drug class
CD38-directed cytolytic antibody
FDA approval year
Initial FDA approval date for Daratumumab
Primary indication
Approved therapeutic indication
Mechanism of action
Primary pharmacological mechanism
Treatment of multiple myeloma (as monotherapy or in combination with other agents) in patients who have received at least one prior therapy, and in newly diagnosed patients who are transplant ineligible. Also indicated for AL (light chain) amyloidosis.
Daratumumab binds to the CD38 glycoprotein on the surface of plasma cells, marking them for destruction by the immune system through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct apoptosis. It also may reduce CD38 enzymatic activity.
Administered as intravenous infusion; infusion-related reactions are common, especially with the first dose. May cause cytopenias and increase infection risk. Blood type testing is recommended prior to treatment due to interference with certain lab tests. Patients should be monitored for disease progression and side effects throughout therapy.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy