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ZOLGENSMA (onasemnogene abeparvovec-xioi)
- Spinal muscular atrophy
2 x 10exp13 vg/mL intravenous suspension, kit
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Abnormal hepatic function tests
- Cardiac disease
- Hyperbilirubinemia
- Severe hepatic disease
- Thrombocytopenic disorder
Severe
Moderate
- None
ZOLGENSMA (onasemnogene abeparvovec-xioi)
- Spinal muscular atrophy
- Increased alanine transaminase
- Increased aspartate transaminase
- Vomiting
More Frequent
Severe
Less Severe
- Increased troponin-I level
- None
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute respiratory insufficiency
- Leukoencephalopathy
- Thrombocytopenic disorder
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Onasemnogene abeparvovec-xioi
For premature infants, delay use until full-term gestational age is reached; concomitant corticosteroids may adversely affect neurological development prior to full-term gestational age.
Not indicated for age > 2 years.
- 1 Day – 119 Days
- For premature infants, delay use until full-term gestational age is reached; concomitant corticosteroids may adversely affect neurological development prior to full-term gestational age.
- Not indicated for age > 2 years.
- 2 Years – 18 Years
- For premature infants, delay use until full-term gestational age is reached; concomitant corticosteroids may adversely affect neurological development prior to full-term gestational age.
- Not indicated for age > 2 years.
Onasemnogene Abeparvovec-xioi
- Severity Level:
2
- Additional Notes: Not indicated in pregnancy; no human or animal data available.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
Onasemnogene Abeparvovec-xioi
No info available; drug indicated for pts younger than 2 yrs of age.
| General | Excretion Potential | Effect on Infant | Notes |
| No known risks; does not adversely affect lactation | Unknown | Not known; no or inclusive data | No info available; drug indicated for pts younger than 2 yrs of age. |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Spinal muscular atrophy | |
| G12.0 | Infantile spinal muscular atrophy, type I [werdnig-hoffman] |
| G12.1 | Other inherited spinal muscular atrophy |
| G12.25 | Progressive spinal muscle atrophy |
| G12.9 | Spinal muscular atrophy, unspecified |
| 0-9 | A-Z |
|---|---|
| G12.0 | Infantile spinal muscular atrophy, type I [werdnig-hoffman] |
| G12.1 | Other inherited spinal muscular atrophy |
| G12.25 | Progressive spinal muscle atrophy |
| G12.9 | Spinal muscular atrophy, unspecified |
Formulary Reference Tool