Lantidra (donislecel-jujn)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For infusion into the hepatic portal vein only.

*Do not irradiate.

*Do not use leukodepleting filters.

*Do not use if product time exceeds 48-hours post product release or if temperature is not maintained between 15 and 25degrees C.

*To be prepared and administered only by medical professionals experienced inislet cell transplantation.

*Provide pre-procedural induction immunosuppression 30-360 minutes prior to infusion.

*The recommended minimum dose is 5,000 equivalent islet number (EIN) per kg patient body weight for initial infusion (transplant) and 4,500 EIN/kg for subsequent infusions (same recipient). A second infusion may be performed if the patient does not achieve independence from exogenous insulin within one year of infusion or within one year after losing independence from exogenous insulin after a previous infusion. A third infusion may be performed using the same criteria as for the second infusion. There are no data regarding the effectiveness or safety for patients receiving more than 3 infusions.

*Use donislecel-jujn as supplied and without further dilution. See Full Prescribing information for detailed instructions on administration and preparation. Failure to follow the manufacturer's directions may result in damage and decreased viability of the islets.

*Administer cells through the hepatic portal vein using a 5 or 6 Frenchangiographic catheter indicated for infusion of donislecel-jujn. The estimated tissue volume should not exceed 10 mL per transplant infusion.

*Do not administer donislecel-jujn (islet cell product and rinse bag) through IV lines that contain any other medications or infusates other than physiological saline.

*Monitor portal pressure and blood glucose levels during infusion; also monitor for signs and symptoms of portal vein branch thrombosis. Monitor patient in the hospital for a minimum of 24 hours after the infusion.

*Continue long-term medications for immunosuppression to prevent islet graft rejection.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Donislecel-jujn is contraindicated in patients for whom immunosuppression is contraindicated.

There are no contraindication contraindications for this drug.

• Anemia
• Infection
• Malignancy
• Portal vein thrombosis

There are no moderate contraindications for this drug.

Ninety percent (90%) of subjects had at least one serious adverse reaction. The major causes are attributed to the infusion procedure or immunosuppression:

* Liver laceration/hematoma, hemorrhage, and intra-abdominal bleeding (13%)

*Elevation of portal pressure (7%)

*Infection (87%)

*Malignancy (37%)

More Frequent

• Hemorrhage
• Infection
• Malignancy
• Pneumonia
• Portal hypertension
• Retroperitoneal hemorrhage
• Sepsis
• Upper respiratory infection

Less Frequent

• Cellulitis
• Myocardial ischemia

More Frequent

• Abnormal hepatic function tests
• Acne vulgaris
• Acute abdominal pain
• Anemia
• Anorexia
• Bladder hyperactivity
• Blurred vision
• Chills
• Cough
• Depression
• Diarrhea
• Disturbance of attention
• Dizziness
• Dry skin
• Dyspnea
• Earache
• Fatigue
• General weakness
• Headache disorder
• Hematuria
• Herpes zoster
• Hyperbilirubinemia
• Hypercholesterolemia
• Hyperkalemia
• Hyperlipoproteinemia
• Hypertension
• Hypoalbuminemia
• Hypocalcemia
• Hypoesthesia
• Hypomagnesemia
• Hyponatremia
• Insomnia
• Irregular menstrual periods
• Leukopenia
• Menstrual disorder
• Muscle spasm
• Myalgia
• Nasal congestion
• Nausea
• Nervousness
• Nocturia
• Ocular pain
• Onychoclasis
• Pain in oropharynx
• Palpitations
• Peripheral edema
• Polydipsia
• Pruritus of skin
• Sensation of cold
• Sinusitis
• Skin rash
• Steatosis of liver
• Stomatitis
• Tinnitus
• Tremor
• Urinary incontinence
• Urinary tract infection
• Voice change
• Vomiting
• Xerostomia

Less Frequent

• Abnormal vaginal bleeding
• Acute cognitive impairment
• Agitation
• Alopecia
• Arthralgia
• Bacterial vaginosis
• Barrett's esophagus
• Biliary calculus
• Bruising
• Cataracts
• Chest pain
• Colitis
• Conjunctival hemorrhage
• Constipation
• Dehydration
• Dysgeusia
• Dyspepsia
• Erectile dysfunction
• Extravasation injury
• Gastroenteritis
• Gastroesophageal reflux disease
• Hyperlipidemia
• Hypertriglyceridemia
• Hypoglycemic disorder
• Hypophosphatemia
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Libido changes
• Lymphadenopathy
• Menorrhagia
• Nail disorders
• Neutropenic disorder
• Ocular itching
• Osteopenia
• Periorbital edema
• Skin inflammation
• Symptoms of anxiety
• Thrombocytopenic disorder
• Toothache
• Vertigo

No enhanced messaging available.

The safety and effectiveness of donislecel-jujn have not been established in pediatric patients with type 1 diabetes.

Pregnancy 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.

The 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.

The 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.