Tabelecleucel interacts in the following cases:
For patients receiving chronic corticosteroid therapy, the dose of these drugs should be reduced as much as is clinically safe and appropriate; recommended no greater than 1 mg/kg per day of prednisone or equivalent. Tabelecleucel has not been evaluated in patients receiving corticosteroid doses greater than 1 mg/kg per day of prednisone or equivalent.
Certain concomitant or recently administered medicinal products including chemotherapy (systemic or intrathecal), anti-T-cell antibody-based therapies, extracorporeal photopheresis or brentuximab vedotin could potentially impact the efficacy of tabelecleucel. Tabelecleucel should only be administered after an adequate washout period of such agents.
There are no available data with tabelecleucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with tabelecleucel. It is not known if tabelecleucel has the potential to be transferred to the foetus or can cause foetal harm when administered to a pregnant woman. Tabelecleucel is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on potential risks for the foetus.
There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with tabelecleucel.
It is unknown whether tabelecleucel is excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding women should be advised of potential risks to the breast-fed child. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tabelecleucel therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
There are no data on the effect of tabelecleucel on fertility.
Tabelecleucel has minor influence on the ability to drive and use machines, e.g. dizziness, fatigue.
The most common adverse reactions were pyrexia (31.1%), diarrhoea (26.2%), fatigue (23.3%), nausea (18.4%), anaemia (16.5%), decreased appetite (15.5%), hyponatraemia (15.5%), abdominal pain (14.6%), neutrophil count decreased (14.6%), white blood cell count decreased (14.6%), aspartate aminotransferase increased (13.6%), constipation (12.6%), alanine aminotransferase increased (11.7%), blood alkaline phosphatase increased (11.7%), hypoxia (11.7%), dehydration (10.7%), hypotension (10.7%), nasal congestion (10.7%) and rash (10.7%). The most serious adverse reactions were tumour flare reaction (1%) and graft-versus-host disease (4.9%).
The safety database is comprised of data from 340 patients (EBV+ PTLD and other EBV-associated diseases) from clinical studies, an expanded access protocol, and compassionate use requests. Frequencies of adverse reactions were calculated in 103 patients from the ALLELE study and Study EBV-CTL-201 for which all events (serious and non-serious) were collected. In the rest of the clinical development program, only serious events were collected. Adverse reactions reported from clinical trials are presented below in the following table. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Adverse reactions identified with tabelecleucel:
| System organ class (SOC) | Adverse reaction | Frequency |
|---|---|---|
| Infections and infestations | Upper respiratory tract infection Skin infection | Common Common |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Tumour pain Tumour flare reaction | Common Common |
| Blood and lymphatic system disorders | Anaemia Febrile neutropenia | Very common Common |
| Immune system disorders | Graft-versus-host diseasea | Common |
| Metabolism and nutrition disorders | Decreased appetite Hyponatraemia Dehydration Hypomagnesaemia Hypokalaemia Hypocalcaemia | Very common Very common Very common Common Common Common |
| Psychiatric disorders | Confusional state Delirium Disorientation | Common Common Common |
| Nervous system disorders | Dizziness Headache Depressed level of consciousness Somnolence Peripheral sensory neuropathy | Common Common Common Common Common |
| Cardiac disorders | Tachycardia | Common |
| Vascular disorders | Hypotension Hot flush Cyanosis | Very common Common Common |
| Respiratory, thoracic and mediastinal disorders | Hypoxia Nasal congestion Wheezing Pneumonitis Upper-airway cough syndrome Pulmonary haemorrhage | Very common Very common Common Common Common Common |
| Gastrointestinal disorders | Diarrhoea Nausea Abdominal painb Constipation Colitis Abdominal distension Flatulence Dyschezia | Very common Very common Very common Very common Common Common Common Common |
| Skin and subcutaneous tissue disorders | Rashc Pruritus Skin ulcer Skin hypopigmentation | Very common Common Common Common |
| Musculoskeletal and connective tissue disorders | Muscular weakness Arthralgia Back pain Myalgia Arthritis Joint Stiffness Soft tissue necrosis | Common Common Common Common Common Common Common |
| General disorders and administration site conditions | Pyrexia Fatigue Chills Chest paind Pain Localised oedema General physical health deterioration | Very common Very common Common Common Common Common Common |
| Investigations | Neutrophil count decreased White blood cell count decreased Aspartate aminotransferase increased Alanine aminotransferase increased Blood alkaline phosphatase increased Lymphocyte count decreased Blood creatinine increased Blood lactate dehydrogenase increased Platelet count decreased Blood fibrinogen decreased | Very common Very common Very common Very common Very common Common Common Common Common Common |
| Injury, poisoning and procedural complications | Post procedural oedema | Common |
a Graft-versus-host disease (GvHD) includes GvHD in gastrointestinal tract, GvHD in liver, rash maculo-papular (skin GvHD)
b Abdominal pain includes abdominal pain, abdominal discomfort, abdominal pain lower
c Rash includes rash, rash erythematous, rash maculo-papular, rash pustular
d Chest pain includes musculoskeletal chest pain, non-cardiac chest pain
TFR was reported in 1 patient (1%). The event was Grade 3 and the patient recovered. The onset was on the day of dosing and the duration was 60 days.
GvHD was reported in 5 (4.9%) patients. Two (40%) patients had Grade 1, 1 patient (20%) had Grade 2, 1 patient (20%) had Grade 3, and 1 (20%) patient had Grade 4 events. No fatal events were reported. Four (80%) patients recovered from GvHD. The median time to onset was 42 days (range: 8 to 44 days). The median duration was 35 days (range: 7 to 133 days).
There is potential for immunogenicity with tabelecleucel. There is currently no information indicating that potential immunogenicity to tabelecleucel impacts safety or efficacy.
There are limited data in paediatric patients. Eight patients were ≥2 to <6 years of age, 16 patients were ≥6 to <12 years of age, 17 patients were ≥12 to <18 years of age. Frequency, type and severity of adverse reactions in children were similar to adults. The adverse reactions of alanine aminotransferase increased, aspartate aminotransferase increased and osteomyelitis were reported as serious only in paediatric patients.
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