Dosing and uses of Ornidyl (eflornithine)
Adult dosage forms and strengths
injectable solution
- 200mg/mL
Trypanosomiasis
400 mg/kg/day divided QID IV x14 days, THEn
300 mg/kg/day PO x3-4 weeks
Orphan drug in United States
Orphan Designations
Anaplastic glioma
Familial adenomatous polyposis
Gastric cancer
Neuroblastoma
Sponsors
- Cancer Prevention Pharmaceuticals; 1760 E. River Road #250; Tucson, AZ 85718
- VBL Pharmaceuticals, Inc; 216 Robin Way; Menlo Park, CA 94025
Pediatric dosage forms and strengths
Not recommended
Ornidyl (eflornithine) adverse (side) effects
>10%
Anemia (55%)
Leukopenia (37%)
Thrombocytopenia (14%)
1-10%
Seizures (may be due to the disease) (8%)
Dizziness
Alopecia
Vomiting, diarrhea
Eosinophilia
Hearing impairment
<1%
Abdominal pain
Anorexia
Facial edema
Headache
Weakness
Warnings
Contraindications
Hypersensitivity to eflornithine or any ingredient in the formulation
Cautions
Only available from WHO; supply very limited
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ornidyl (eflornithine)
Half-life elimination: IV: 3-3.5 hr
Excretion: primarily urine (as unchanged drug)
Mechanism of action
Inhibits ornithine decarboxylase, necessary enzyme for cell division & differentiation
Administration
IV Administration
Must be diluted before use
Storage
Use within 24 hr of preparation
