Select a medication above to begin.
Skysona
elivaldogene autotemcel
Black Box Warnings .
Hematologic Malignancy
including life-threatening myelodysplastic syndrome, acute myeloid leukemia have occurred; patients diagnosed 14mo-10y after administration; weigh risk/benefit and consider hematology consult before treatment start; monitor closely with CBC at least q3mo and assessments for evidence of clonal expansion or predominance 2x in 1st year, then annually; consider bone marrow evaluations as clinically indicated
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-833-666-2583 or www.skysona.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic regimens, and dosing
cerebral adrenoleukodystrophy, male
- [4-17 yo]
- Dose: 5x10^6 CD34+ cells/kg/dose IV x1; Start: >48h after myeloablative and lymphodepleting conditioning; Info: for patients with early, active disease without human leukocyte antigen-matched donor for allogeneic HSCT; do not start myeloablative and lymphodepleting conditioning until confirming elivaldogene autotemcel infusion bag(s) at treatment facility and back-up collection of CD34+ cells available; consider premed with antiemetic, antipyretic, and/or antihistamine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- HIV status, positive or unknown
- infection, active
- antiretroviral use within at least 1mo before mobilization and until apheresis completed
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- avoid: PCR-based HIV testing after elivaldogene autotemcel tx
- caution: hypersensitivity to DMSO
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
elivaldogene autotemcel
gene therapy
- gene therapy
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- myelodysplastic syndrome
- AML
- lentiviral vector-mediated insertional oncogenesis
- infection, severe
- febrile neutropenia
- pancytopenia, including prolonged
- thrombocytopenia, including prolonged
- neutropenia, including prolonged
- lymphopenia, including prolonged
- Plt engraftment delay
- neutrophil engraftment failure risk
- hypersensitivity reaction
- anaphylaxis
- seizures
Common Reactions
- leukopenia
- lymphopenia
- thrombocytopenia
- neutropenia
- mucositis
- nausea
- anemia
- vomiting
- febrile neutropenia
- alopecia
- appetite decr.
- abdominal pain
- constipation
- hypokalemia
- fever
- headache
- diarrhea
- rash
- infection, severe
- pruritus
- epistaxis
- skin hyperpigmentation
- oropharyngeal pain
- anxiety
- tachycardia
- hematologic malignancy
- HTN
- blurred vision
- cough
- infusion reaction
Safety/Monitoring .
Monitoring Parameters
screening for HBV, HCV, HTLV-1/HTLV-2, HIV-1/HIV-2 before apheresis; CBC with diff frequently until normalization, then at least q3mo x15y; integration site analysis 2x/y x1y, then annually x15y; see pkg insert for additional hematologic malignancy monitoring considerations; signs/symptoms of infection, bleeding before and after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; drug unlikely to be used during pregnancy based on indication
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception (IUD or combined hormonal and barrier contraceptive methods) from start of mobilization through at least 6mo after elivaldogene autotemcel tx in male patients and partners of childbearing potential; avoid semen donation indefinitely
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: for elivaldogene autotemcel: other; CYP450: unknown
Excretion: for elivaldogene autotemcel: unknown; Half-life: unknown
Subclass: Inherited Metabolic Disorders ; Leukodystrophy
Mechanism of Action
for elivaldogene autotemcel: adds functional copies of ABCD1 cDNA into hematopoietic stem cells via autologous CD34+ cells transduced with Lenti-D lentiviral vector, promoting production of functional ALDP, leading to degradation of very long chain fatty acids, which slows or possibly prevents further inflammation and demyelination
Formulary .
No Formulary Selected
Join Now to View Patient Handouts!
Create a FREE epocrates Online account to access patient medication instructions. Your patients and caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Each handout addresses common concerns such as how to take the medication, and possible side effects.
Current Members: Sign In.
Pill Pictures
Join Now to View Pill Pictures!
Create a FREE epocrates Online account to access full-color images of medications within the drug monograph.
Current Members: Sign In.