Donislecel
Donislecel is a human pancreatic islet cell therapy for type 1 diabetes, improving hypoglycemia awareness and managing severe hypoglycemia in patients.
Donislecel is a cell-based therapy using donor pancreatic islet cells to help manage blood sugar in type 1 diabetes patients with severe hypoglycemia problems.
Key facts at a glance
- ATC
- A10XX02
- RxNorm
- 2642217
- Generic
- Donislecel
- Class
- atc-a10
- Brands
- Lantidra
- 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
- individualized based on islet mass and clinical response
- Maximum
- consult physician
- Frequency
- as needed per transplant protocol
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established for pediatric use
- Maximum
- consult physician
- Frequency
- N/A
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid unless benefits outweigh risks
use only if clearly needed - consult with specialist
regular prenatal monitoring
pregnancy
second trimesteravoid unless benefits outweigh risks
use only if clearly needed - consult with specialist
regular prenatal monitoring
pregnancy
third trimesteravoid unless benefits outweigh risks
use only if clearly needed - consult with specialist
regular prenatal monitoring
lactation
breastfeedingnot recommended
breastfeeding should be discontinued during treatment and for some time after - consult prescribing information
none established
pediatric_age
adolescents 12 17individualize based on clinical response
use in pediatric patients only if benefits outweigh potential risks - limited clinical trial data in this age group
close monitoring of glycemic control and immune response
Use with caution and monitor for adverse effects.
geriatric
elderly over 65individualize dosing carefully
use with caution due to potential reduced immune function and increased infection risk
regular monitoring of renal function and infection markers
Use with caution and monitor for adverse effects.
renal_impairment
mildno specific dose adjustment needed
monitor renal function regularly - important in diabetic patients with potential nephropathy
baseline and periodic renal function monitoring
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severeuse with caution
assess benefit-risk carefully - patients may be more susceptible to infections
close monitoring of renal function and for signs of infection
Use with caution and monitor for adverse effects.
hepatic_impairment
milduse with caution
limited data in hepatic impairment - assess benefits vs risks
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeuse with caution
limited clinical data - consider risks carefully
close monitoring of liver function
Statistics and clinical data
FDA approval year
First FDA approval date for Donislecel (Lantidra)
Therapeutic class
Cell therapy product classification
Primary indication
Approved therapeutic indication
Administration route
Method of delivery
Donislecel is indicated for the treatment of type 1 diabetes in adults with hypoglycemia unawareness or recurrent severe hypoglycemia who have failed to achieve adequate glycemic control despite intensive diabetes management.
Donislecel consists of processed pancreatic islet cells that contain hormone-secreting endocrine cells. These islet cells regulate blood glucose by releasing insulin, glucagon, and other hormones in response to blood glucose changes, thereby restoring glucose regulation in patients whose own islet cells have been destroyed.
Donislecel requires infusion into the portal vein and necessitates immunosuppression to prevent rejection. Patients should be monitored for liver function, bleeding complications, and signs of immune rejection. This is a specialized treatment typically administered at accredited transplant centers.
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