Elevation in portal blood pressure may occur following intraportal islet infusion but is usually temporary. During clinical trials with LANTIDRA, the median peak portal blood pressure increase from baseline was 3 mmHg (range -3 to 18 mmHg). Elevated portal pressures ≥ 22 mmHg were reported during procedures for two subjects requiring cessation of the procedure, and incomplete delivery of LANTIDRA for one subject. Monitor portal pressure and halt islet infusion if portal pressure rises above 22 mmHg.

Of the 30 subjects who received LANTIDRA, 28 subjects had panel reactive antibody (PRA) data. Overall, 6 of 28 (21%) had a transition from baseline Class I PRA < 20% to ≥ 20% after infusion. These included 1 of 9 (11%) who received one infusion, 3 of 12 (25%) who received two infusions, and 2 of 7 (29%) who received three infusions.

Common adverse reactions (occurring in ≥20% but ≤ 90% of subjects) independent of severity observed between initial infusion and 1 year following final infusion include:

Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, mouth ulceration, nausea, stomatitis, vomiting

General disorders and administration site conditions: asthenia, chills, edema peripheral, fatigue, feeling cold, thirst

Hepatobiliary disorders: hepatic steatosis, hyperbilirubinemia

Infections and infestations: herpes zoster, pneumonia, sinusitis, upper respiratory tract infection, urinary tract infection

Injury, poisoning and procedural complications: contusion

Investigations: aspartate aminotransferase increased, blood bicarbonate decreased, blood cholesterol increased, hemoglobin decreased, low density lipoprotein increased, transaminases increased

Metabolism and nutrition disorders: abnormal loss of weight, anorexia and bulimia syndrome, appetite disorder, decreased appetite, hypercholesterolemia, hyperkalemia, hypoalbuminemia, hypocalcemia, hypomagnesemia, hyponatremia

Musculoskeletal and connective tissue disorders: arthralgia, muscle spasms, musculoskeletal stiffness, myalgia, pain in extremity

Neoplasms benign, malignant and unspecified (including cysts and polyps): thyroid neoplasm

Nervous system disorders: disturbance in attention, dizziness, headache, hypoesthesia, tremor

Psychiatric disorders: anhedonia, anxiety, depressed mood, depression, insomnia, nervousness

Renal and urinary disorders: hematuria, hypertonic bladder, nocturia, pollakiuria, urinary incontinence

Reproductive system and breast disorders: menstruation irregular

Respiratory, thoracic and mediastinal disorders: cough, dysphonia, dyspnea, nasal congestion, oropharyngeal pain, sinus disorder

Skin and subcutaneous tissue disorders: acne, dry skin, onychoclasis, pruritus, rash

Vascular disorders: hypertension

Less common adverse reactions (occurring in ≥5% but <20% of subjects) observed between initial infusion and 1 year following final infusion include:

Blood and lymphatic system disorders: increased tendency to bruise, lymphadenopathy, neutropenia, thrombocytopenia

Eye disorders: cataract, conjunctival hemorrhage, eye edema, eye pruritus

Gastrointestinal disorders: Barrett's esophagus, bowel movement irregularity, colitis, constipation, dyspepsia, gastroesophageal reflux disease, oral pain, toothache

General disorders and administration site conditions: catheter site pain, chest pain, feeling of body temperature change, gait disturbance, influenza like illness, injection site extravasation, mucosal inflammation, pain, pyrexia

Infections and infestations: bacterial vaginosis, cellulitis, cytomegalovirus infection, ear infection, Epstein-Barr infection, eye infection, fungal infection, gastroenteritis, gastroenteritis viral, localized infection, nail infection, nasopharyngitis, onychomycosis, oral candidiasis, oral herpes, osteomyelitis, rhinitis, tooth infection, vaginal infection, viral upper respiratory tract infection, vulvovaginal mycotic infection

Injury, poisoning and procedural complications: hepatic hematoma, limb injury, meniscus injury

Investigations: alanine aminotransferase increased, blood alkaline phosphatase increased, blood creatinine increased, glomerular filtration rate decreased, neutrophil count decreased, urine albumin/creatinine ratio, urine protein/creatinine ratio increased, weight decreased, weight increased

Metabolism and nutrition disorders: dehydration, hyperchloremia, hyperlipidemia, hypertriglyceridemia, hypokalemia, hypophosphatemia

Musculoskeletal and connective tissue disorders: arthritis, back pain, intervertebral disc protrusion, joint stiffness, joint swelling, muscular weakness, musculoskeletal pain, neck pain, osteoarthritis, osteopenia, osteoporosis

Neoplasms benign, malignant and unspecified (including cysts and polyps): basal cell carcinoma, squamous cell carcinoma

Nervous system disorders: carpal tunnel syndrome, cognitive disorder, dysgeusia, dyskinesia, head titubation, migraine, neuropathy peripheral, paresthesia, poor quality sleep, sinus headache, syncope

Psychiatric disorders: agitation, decreased interest, libido decreased

Renal and urinary disorders: hemoglobinuria, hydronephrosis, proteinuria, urine flow decreased

Reproductive system and breast disorders: erectile dysfunction, menorrhagia, vaginal hemorrhage

Respiratory, thoracic and mediastinal disorders: dyspnea exertional, epistaxis, pleural effusion, rhinorrhea, wheezing

Skin and subcutaneous tissue disorders: alopecia, dermatitis, erythema, hidradenitis, nail disorder, night sweats, rash pruritic, rosacea, skin exfoliation, skin lesion