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XOSPATA (gilteritinib fumarate)
- Acute myeloid leukemia with FLt3 mutation
40 mg tablet
- 3 tablets (120 mg) by oral route once daily
Acute myeloid leukemia with FLt3 mutation
- 2 tablets (80 mg) by oral route once daily
- 3 tablets (120 mg) by oral route once daily
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactating mother
Contraindicated
- Congenital long QT syndrome
- Hypokalemia
- Hypomagnesemia
- Pancreatitis
- Posterior reversible encephalopathy syndrome
- Pregnancy
- Prolonged QT interval
Severe
Moderate
- None
XOSPATA (gilteritinib fumarate)
- Acute myeloid leukemia with FLt3 mutation
- Abnormal hepatic function tests
- Pneumonia
- Arthralgias
- Cough
- Diarrhea
- Dizziness
- Dyspnea
- Edema
- Fatigue
- Fever
- Headache disorder
- Hypotension
- Malaise
- Myalgias
- Nausea
- Skin rash
- Stomatitis
- Vomiting
More Frequent
Severe
Less Severe
- Differentiation syndrome
- Heart failure
- Hypertension
- Kidney disease with reduction in GFR
- Pancreatitis
- Pericardial effusion
- Pericarditis
- Prolonged QT interval
- Sepsis
- Acute abdominal pain
- Anorexia
- Hyperbilirubinemia
- Hyperglycemia
- Hypertriglyceridemia
- Insomnia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Anaphylaxis
- Posterior reversible encephalopathy syndrome
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Gilteritinib
Safety and effectiveness not established in pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established in pediatric patients.
Gilteritinib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
Gilteritinib
Avoid breastfeeding during treatment and for 2 months after last dose
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Avoid breastfeeding during treatment and for 2 months after last dose |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Acute myeloid leukemia with FLt3 mutation | |
| C92.0 | Acute myeloblastic leukemia |
| C92.00 | Acute myeloblastic leukemia, not having achieved remission |
| C92.02 | Acute myeloblastic leukemia, in relapse |
| 0-9 | A-Z |
|---|---|
| C92.0 | Acute myeloblastic leukemia |
| C92.00 | Acute myeloblastic leukemia, not having achieved remission |
| C92.02 | Acute myeloblastic leukemia, in relapse |
Formulary Reference Tool