Isatuximab
Isatuximab is a monoclonal antibody therapy that targets CD38, a protein expressed on the surface of multiple myeloma cells and other hematopoietic cells. It treats multiple myeloma by directly inducing cancer cell death and activating the immune system to attack tumor cells.
Isatuximab is a targeted antibody treatment for relapsed or refractory multiple myeloma that works by binding to CD38 on cancer cells and triggering their destruction through immune mechanisms.
Key facts at a glance
- ATC
- L01FC02
- RxNorm
- 2282018
- Generic
- Isatuximab
- Class
- atc-l01
- Brands
- Sarclisa
- 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
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use in third trimester due to potential for fetal exposure
fetal monitoring and assessment of neonatal health
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
discontinue breastfeeding during treatment and for at least 5 months after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children under 18not established
not approved for use in pediatric patients; safety and efficacy not established
not applicable
geriatric
elderly 65 years and olderno specific dose adjustment required
use with caution; monitor for adverse reactions; no dose adjustment needed but closely monitor for infections
regular monitoring for signs of infection and adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno dose adjustment needed
no dose adjustment required for patients with any degree of renal impairment including end-stage renal disease
monitor renal function periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentno dose adjustment needed
no dose adjustment required for mild to moderate hepatic impairment; limited data for severe hepatic impairment
monitor hepatic function
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for multiple myeloma treatment
Drug class
Classification as anti-CD38 monoclonal antibody
Primary indication
Approved indication for adult patients with multiple myeloma
Mechanism of action
Binds to CD38 on myeloma cells leading to cell death
Isatuximab is used to treat adult patients with relapsed or refractory multiple myeloma, typically administered in combination with other anti-myeloma therapies for those who have received at least two prior lines of treatment.
As an IgG1-derived monoclonal antibody, isatuximab binds specifically to CD38 on multiple myeloma cells, inducing apoptosis (programmed cell death) and activating immune effector mechanisms including antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
Isatuximab is given as an intravenous infusion, with premedications often recommended to reduce infusion reaction risk. Common adverse effects include infusion reactions, neutropenia, anemia, and upper respiratory infections. Close monitoring is required during and after infusion administration.
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