Donislecel-jujn (Systemic)
Brand names: Lantidra
Drug class:
Antineoplastic Agents
Usage of Donislecel-jujn (Systemic)
Donislecel-jujn has the following uses:
Donislecel-jujn is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
Donislecel-jujn is used in conjunction with immunosuppression. Immunosuppressive therapy should be initiated before the procedure and continued long-term to prevent islet graft rejection. When considering the risks associated with the infusion procedure and long-term immunosuppression, there is no evidence to show a benefit of administration of donislecel-jujn in patients whose diabetes is well-controlled with insulin therapy or patients with hypoglycemic unawareness who are able to prevent current repeated severe hypoglycemic events (neuroglycopenia requiring active intervention from a third party) using intensive diabetes management (including insulin, devices, and education).
Repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis, unless the thrombosis was limited to second- or third-order portal vein branches.
There is no evidence to support the safe and effective use of donislecel-jujn in patients with liver disease, renal failure, or who have received a renal transplant.
Efficacy and safety of donislecel-jujn were evaluated in 2 prospective, open-label, single-arm studies in a total of 30 patients with type 1 diabetes mellitus and hypoglycemic unawareness. Patients received 1–3 infusions. Results showed that 25 subjects achieved insulin independence; among these patients, 4 (13.3%) were insulin independent for less than 1 year, 12 (36.7%) were insulin independent for 1 to 5 years, and 9 (33.3%) were insulin independent for greater than 5 years. The remaining 5 patients had no days of insulin independence.
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How to use Donislecel-jujn (Systemic)
General
Donislecel-jujn is available in the following dosage form(s) and strength(s):
The dosage form is a suspension of islet cells for infusion through the hepatic portal vein. Dosage strength depends on the total number of islets packaged for infusion, which is reported on the container label and associated documents. One lot of donislecel-jujn consists of islets manufactured from the pancreas of a single deceased donor. Each dose of donislecel-jujn is provided as two (2) infusion bags connected to each other via sterile connector. One bag contains donislecel-jujn up to a maximum of 1 × 106 equivalent islet number (EIN) in 400 mL of transplant media and the second bag (Rinse Bag) contains transplant media used to rinse the bag and the infusion line.
Dosage
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Adults
Dosage and AdministrationFor infusion into the hepatic portal vein only.
Warnings
Contraindications
Donislecel-jujn is contraindicated in patients for whom immunosuppression is contraindicated.
Warnings/Precautions
Risks from Concomitant Immunosuppression
Concomitant use of immunosuppression is required to maintain islet cell viability. The use of immunosuppression in patients receiving donislecel-jujn increases the risk of serious and potentially fatal adverse reactions.
Patients receiving immunosuppressants are at increased risk of bacterial, viral, fungal, and parasitic infections, including opportunistic infections; lymphomas and other malignancies, particularly of the skin; and severe anemia, sometimes requiring transfusion.
To mitigate the risk of infection, patients should receive recommended immunizations prior to treatment. After treatment, administer Pneumocystis jirovecii pneumonia (PCP) and cytomegalovirus (CMV) prophylaxis following administration of donislecel-jujn. Avoid live vaccination while receiving immunosuppression. Monitor for fever and other signs of infection; initiate appropriate treatment early. Clinically monitor for malignancy, including skin cancer. Monitor hemoglobin/hematocrit and give blood products as indicated.
Consider discontinuation of immunosuppression in the following situations:
Procedural Complications
Liver laceration, hemorrhage and intra-abdominal bleeding have occurred with portal administration of donislecel-jujn. Manage hemostasis in the catheter track using standard practices following infusion of donislecel-jujn to reduce the risk of bleeding. Monitor for bleeding clinically and with laboratory assessments. Blood transfusions have been required.
Elevation in portal blood pressure has occurred during and following intraportal islet infusion. Monitor portal pressure; pause infusion if portal pressure rises above 22 mmHg and do not resume until it falls below 18 mmHg. Terminate infusion if portal pressure remains above 22 mmHg for longer than 10 minutes.
Portal vein branch thrombosis may occur following infusion of donislecel-jujn. Repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis unless the thrombosis was limited to second- or third-order portal vein branches.
Increased Risk of Islet Graft Rejection
Patients with a positive T- and B-cell crossmatch between recipient serum and donor lymphocytes may immediately reject the islet cells. The T- and B-cell crossmatch assay is binary. T- and B-cell both need to be negative.
Transmission of Donor-derived Infections
There is a risk of communicable disease transmission from donor to recipient that exists for donislecel-jujn. Monitor patients for signs of active infection following donislecel-jujn infusion and treat appropriately if infection is suspected.
Panel Reactive Antibodies (PRA)
Product administration may elevate PRA and negatively impact candidacy for renal transplant. Consider benefit-risk of administering donislecel-jujn to a patient who may require a renal transplant in the future.
Specific Populations
PregnancyPregnancy risk has not been assessed for donislecel-jujn. No animal reproductive and development toxicity studies have been conducted with donislecel-jujn. However, there is a risk of fetal malformations associated with certain immunosuppression medications that may be used following donislecel-jujn administration. Additionally, the risks to the patient and fetus from the procedure for donislecel-jujn infusion in pregnant women has not been assessed.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
LactationThe risk of exposing a child to donislecel-jujn components during breastfeeding has not been assessed. However, some required concomitant medications, including immunosuppressants, may be excreted in milk at least in trace amounts. Because of this, a decision should be made about whether to discontinue breastfeeding in patients who will receive a donislecel-jujn infusion.
Females and Males of Reproductive PotentialDue to the risk of fetal malformations associated with required concomitant medications, including immunosuppressants, females of reproductive potential should have a confirmed negative pregnancy test prior to donislecel-jujn infusion.
Female patients of reproductive potential should be counseled to contact their transplant team immediately if they become pregnant.
Because long-term immunosuppression is required following donislecel-jujn administration, women of childbearing potential should be informed of the potential risks that these medications pose during pregnancy and should be told to use effective contraception prior to initiation of immunosuppression and thereafter for as long as they retain reproductive potential.
Male and female fertility may be compromised by certain medications used for maintenance immunosuppression following donislecel-jujn administration.
For male patients, review the concomitant medications and determine if there is a potential for production of abnormal sperm.
Pediatric UseThe safety and effectiveness of donislecel-jujn have not been established in pediatric patients with type 1 diabetes.
Geriatric UseThe safety and effectiveness of donislecel-jujn have not been established in geriatric patients with type 1 diabetes and hypoglycemic unawareness. Clinical studies of donislecel-jujn did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently than younger patients.
Common Adverse Effects
Ninety percent (90%) of subjects had at least one serious adverse reaction. The major causes are attributed to the infusion procedure or immunosuppression:
What other drugs will affect Donislecel-jujn (Systemic)
Specific Drugs
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Please see product labeling for drug interaction information.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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