Elivaldogene autotemcel interacts in the following cases:
Elivaldogene autotemcel has not been studied in patients with hepatic impairment. Patients should be assessed for hepatic impairment to ensure elivaldogene autotemcel therapy is appropriate. No dose adjustment is required.
Elivaldogene autotemcel has not been studied in patients with renal impairment. Patients should be assessed for renal impairment to ensure elivaldogene autotemcel therapy is appropriate. No dose adjustment is required.
There are no data on the effects of elivaldogene autotemcel on human fertility. Effects on male and female fertility have not been evaluated in animal studies.
Data are available on the risk of infertility with conditioning. It is therefore advised to consider cryopreservation of semen or ova before treatment.
No clinical data on exposed pregnancies are available.
Reproductive and developmental toxicity studies with elivaldogene autotemcel were not performed. Elivaldogene autotemcel must not be used during pregnancy because of conditioning. It is unknown whether elivaldogene autotemcel transduced cells have the potential to be transferred in utero to a foetus. Pregnancy after treatment with elivaldogene autotemcel should be discussed with the treating physician.
There is no opportunity for germline transmission of the LVV that encodes an ABCD1 cDNA for human ALDP after treatment with elivaldogene autotemcel, therefore the likelihood that an offspring would have general somatic expression of the lentiviral vector that encodes an ABCD1 cDNA for human ALDP is considered negligible.
It is unknown whether elivaldogene autotemcel is excreted in human milk. The effect of administration of elivaldogene autotemcel to mothers on their breast-fed children has not been studied.
Elivaldogene autotemcel must not be administered to women who are breast-feeding.
There are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with elivaldogene autotemcel. Women of childbearing potential and men capable of fathering a child and their female partners must use an effective method of contraception (intrauterine device or combination of hormonal and barrier contraception) from start of mobilisation through at least 6 months after administration of elivaldogene autotemcel. The SmPC of the conditioning agents should be consulted for information on the need for effective contraception in patients who undergo conditioning.
A negative serum pregnancy test in women of childbearing potential must be confirmed prior to the start of mobilisation and re-confirmed prior to conditioning procedures and before medicinal product administration.
There are no data on the effects of elivaldogene autotemcel on human fertility. Effects on male and female fertility have not been evaluated in animal studies.
Data are available on the risk of infertility with conditioning. It is therefore advised to consider cryopreservation of semen or ova before treatment.
Elivaldogene autotemcel has no influence on the ability to drive or use machines.
The effect of the mobilisation agents and the conditioning agents on the ability to drive or use machines, or engage in activities such as cycling or skateboarding, must be considered.
The safety of elivaldogene autotemcel was evaluated in 51 patients with CALD in Studies ALD-102, ALD-104, and LTF-304. The most serious adverse reaction attributed to elivaldogene autotemcel was pancytopenia (3.9%). Given the small patient population and size of cohorts, adverse reactions in the table below do not provide a complete perspective on the nature and frequency of these events. Information related to safety endpoints used in the studies is provided in section 5.1.
Adverse reactions are listed by MedDRA body system organ class and by frequency. Frequencies are defined as: very common (≥1/10) and common (≥1/100 and <1/10). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Tables 1, 2, and 3 are lists of adverse reactions attributed to mobilisation/apheresis, conditioning, and elivaldogene autotemcel, respectively, experienced by patients with CALD in clinical studies with elivaldogene autotemcel.
Table 1. Adverse reactions attributed to mobilisation/apheresis:
| System Organ Class (SOC) | Very common | Common |
|---|---|---|
| Blood and lymphatic system disorders | Thrombocytopenia, Anaemia | |
| Metabolism and nutrition disorders | Hypokalaemia | Hypomagnesaemia |
| Nervous system disorders | Headache | |
| Vascular disorders | Hypertension | |
| Gastrointestinal disorders | Vomiting, Nausea, Paraesthesia oral | |
| Skin and subcutaneous tissue disorders | Pruritus | |
| Musculoskeletal and connective tissue disorders | Bone pain, Pain in extremity | |
| Investigations | Haemoglobin decreased |
Table 2. Adverse reactions attributed to conditioning:
| System Organ Class (SOC) | Very common | Common |
|---|---|---|
| Infections and infestations | Pseudomonal bacteraemia, Bacteraemia, Streptococcal bacteraemia, Pneumonia, Bacterial infection, Device related infection, Enterocolitis infectious, Gastroenteritis viral, Oral candidiasis, Otitis media, Pharyngitis streptococcal, Respiratory syncytial virus infection, Rhinovirus infection, Sinusitis, Skin infection, Upper respiratory tract infection bacterial, Viral upper respiratory tract infection, Folliculitis, Anal candidiasis | |
| Blood and lymphatic system disorders | Febrile neutropenia, Neutropenia, Thrombocytopenia, Anaemia, Leukopenia, Lymphopenia | Lymph node pain |
| Endocrine disorders | Adrenal insufficiency, Inappropriate antidiuretic hormone secretion | |
| Metabolism and nutrition disorders | Hypokalaemia, Hypomagnesaemia, Decreased appetite, Hypophosphataemia | Hypoglycaemia, Fluid retention, Hyponatraemia |
| Psychiatric disorders | Aversion, Insomnia | |
| Nervous system disorders | Headache | Sensory loss, Tremor, Hyporeflexia |
| Eye disorders | Conjunctival haemorrhage | |
| Cardiac disorders | Bradycardia, Sinus tachycardia, Tachycardia | |
| Vascular disorders | Hypertension | Petechiae |
| Respiratory, thoracic and mediastinal disorders | Epistaxis | Hypoxia, Tachypnoea, Cough, Oropharyngeal pain, Rhinorrhoea |
| Gastrointestinal disorders | Stomatitis, Vomiting, Diarrhoea, Abdominal pain, Constipation, Nausea | Gastritis, Gastrointestinal inflammation, Anal fissure, Proctitis, Anal pruritis, Dyspepsia, Oral pain, Proctalgia |
| Skin and subcutaneous tissue disorders | Alopecia, Skin hyperpigmentation | Rash pustular, Skin exfoliation, Dermatitis diaper, Drug eruption, Dry skin, Hyperhidrosis, Pruritis, Rash, Rash maculo-papular |
| Renal and urinary disorders | Haematuria, Incontinence, Urinary incontinence, Dysuria, Urinary tract pain | |
| Reproductive system and breast disorders | Penile pain, Scrotal ulcer | |
| General disorders and administration site conditions | Pyrexia | Face oedema, Mucosal inflammation, Fatigue |
| Investigations | Alanine aminotransferase increased, Aspartate aminotransferase increased | Occult blood positive, Adenovirus test positive, International normalised ratio increased, Blood alkaline phosphatase increased, Blood immunoglobulin G decreased, Blood lactate dehydrogenase increased, C-reactive protein increased, Weight decreased, Weight increased |
| Injury, poisoning and procedural complications | Allergic transfusion reaction |
Table 3. Adverse reactions attributed to elivaldogene autotemcel:
| System Organ Class (SOC) | Very common | Common |
|---|---|---|
| Infections and infestations | Cystitis viral | |
| Blood and lymphatic system disorders | Pancytopenia | |
| Gastrointestinal disorders | Vomiting |
Two serious reactions of pancytopenia occurred in two patients, with onset following neutrophil engraftment. Both patients had delayed hematopoietic reconstitution requiring prolonged support with blood and platelet transfusions as well as growth factors (G-CSF and eltrombopag). One patient had intercurrent parvovirus. Both events were ongoing at least 18 months after elivaldogene autotemcel infusion.
Vomiting occurred in two patients on the day of infusion, potentially related to the cryopreservation agent. Premedication may be utilized at physician discretion.
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