Ornidyl

Dosage Forms & 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

Pancreatic cancer

Neuroblastoma

Sponsors

• Cancer Prevention Pharmaceuticals; 1760 E. River Road #250; Tucson, AZ 85718
• VBL Pharmaceuticals, Inc; 216 Robin Way; Menlo Park, CA 94025

Not recommended

>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

Contraindications

Hypersensitivity to eflornithine or any ingredient in the formulation

Cautions

Only available from WHO; supply very limited

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.

IV Administration

Must be diluted before use

Storage

Use within 24 hr of preparation