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SKYSONA (elivaldogene autotemcel)
- x-linked adrenoleukodystrophy
4x to 30x10exp6 cell/mL intravenous suspension
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Severe infection
Severe
Moderate
- None
SKYSONA (elivaldogene autotemcel)
- x-linked adrenoleukodystrophy
- Anemia
- Hypokalemia
- Leukopenia
- Lymphopenia
- Neutropenic disorder
- Thrombocytopenic disorder
- Acute abdominal pain
- Alopecia
- Anorexia
- Constipation
- Diarrhea
- Fever
- Headache disorder
- Nausea
- Skin rash
- Stomatitis
- Vomiting
More Frequent
Severe
Less Severe
- Hypertension
- Infection
- Blurred vision
- Cough
- Epistaxis
- Pain in oropharynx
- Pruritus of skin
- Skin pigmentation enhancement
- Symptoms of anxiety
- Tachycardia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Hematologic malignancy
- Hypersensitivity drug reaction
- Myelodysplastic syndrome
- Pancytopenia
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Elivaldogene autotemcel
No safety and efficacy established in children age < 4 years.
Monitor appropriate hematologic assessments to detect malignancy including myelodysplastic syndrome.
- 1 Day – 4 Years
- No safety and efficacy established in children age < 4 years.
- Monitor appropriate hematologic assessments to detect malignancy including myelodysplastic syndrome.
- 4 Years – 18 Years
- No safety and efficacy established in children age < 4 years.
- Monitor appropriate hematologic assessments to detect malignancy including myelodysplastic syndrome.
Elivaldogene Autotemcel
- Severity Level:
2
- Additional Notes: Insufficient human data on developmental toxicity risk
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Elivaldogene Autotemcel
Insufficient human data
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- This product may rarely increase your risk of developing blood cancer. Your doctor should do regular blood tests for at least 15 years to monitor for any changes to your blood. Tell your doctor right away if you develop symptoms of blood cancer, such as unusual tiredness, easy bruising/bleeding, or swollen glands.
| X-linked adrenoleukodystrophy | |
| E71.52 | X-linked adrenoleukodystrophy |
| E71.520 | Childhood cerebral x-linked adrenoleukodystrophy |
| E71.521 | Adolescent x-linked adrenoleukodystrophy |
| E71.528 | Other x-linked adrenoleukodystrophy |
| E71.529 | X-linked adrenoleukodystrophy, unspecified type |
| 0-9 | A-Z |
|---|---|
| E71.52 | X-linked adrenoleukodystrophy |
| E71.520 | Childhood cerebral x-linked adrenoleukodystrophy |
| E71.521 | Adolescent x-linked adrenoleukodystrophy |
| E71.528 | Other x-linked adrenoleukodystrophy |
| E71.529 | X-linked adrenoleukodystrophy, unspecified type |
Formulary Reference Tool