Eflornithine Tablets

Eflornithine is a prescription medication used to treat second-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense, with involvement of the central nervous system to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

• Eflornithine is available under the following different brand names: Iwilfin, Ornidyl.

Common side effects of Eflornithine include:

• ear infection 
• red and swollen eyes (pink eye)
• diarrhea 
• vomiting
• cough 
• stuffy, runny, itchy nose or sneezing (allergic rhinitis)
• sinus infection 
• fever
• pneumonia 
• skin infection
• upper respiratory tract infection 
• urinary tract infection

Serious side effects of Eflornithine include:

• low blood cell counts symptoms include fever (temperature 100.4°f or higher), feeling unusually tired or weak, easy bruising or bleeding, shortness of breath, blood in your urine or stools, chills or shivering
• liver problems
• new or worsening hearing loss

Rare side effects of Eflornithine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet (Iwilfin)

• 192 mg

Injectable solution (Ornidyl)

• 200 mg/mL

Trypanosomiasis

Adult dosage

• Ornidyl only
  • 400 mg/kg/day divided four times a day IV for 14 days, then
  • 300 mg/kg/day orally for 3-4 weeks
  • Available from the Centers for Disease Control and Prevention
  • Although the manufacturer, Aventis, maintains its US licensure, Ornidyl (Eflornithine) is not commercially available in the United States

Neuroblastoma

Adult and Pediatric dosage

• Iwilfin only
  • Recalculate body surface area (BSA) dosage every 3 months during treatment
  • BSA 0.75-1.5 m2: 576 mg orally two times a day
  • BSA more than 1.5 m2: 768 mg orally two times a day
  • Continue for 2 years or until recurrence of disease or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Eflornithine has no noted severe interactions with any other drugs
• Eflornithine has no noted serious interactions with any other drugs
• Eflornithine has no noted moderate interactions with any other drugs
• Eflornithine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Ornidyl: Hypersensitivity to eflornithine or any ingredient in the formulation
• Iwilfin: None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Eflornithine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Eflornithine?”

Cautions

• Ornidyl: The World Health Organization supplies the CDC with a drug when used for African Trypanosomiasis
• Iwilfin
  • New or worsening hearing loss may occur; monitor hearing before and during treatment, withhold, reduce dose, or permanently discontinue based on severity
  • Can cause fetal harm
  • Myelosuppression
    • Myelosuppression reported
    • Perform blood counts including neutrophil count, platelet count, and hemoglobin level before administering and periodically during treatment
  • Hepatotoxicity
    • May cause hepatotoxicity
    • Perform liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], and total bilirubin) before initiating, every month for the first 6 months, then once every 3 months or as clinically indicated
    • Monitor more frequently in patients who develop transaminase or bilirubin elevations

Pregnancy and Lactation

• Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to pregnant women
• Verify pregnancy status in women of reproductive potential before initiating
• There are no available data on its use in pregnant women
• Inform pregnant women and women of the reproductive potential of fetal risk
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose
• Lactation
  • There are no data on the presence of eflornithine in human milk, its effects on breastfed children, or milk production
  • Advise women not to breastfeed during treatment and for 1 week after the last dose