Eflornithine Dosage

Medically reviewed by Drugs.com. Last updated on Feb 13, 2024.

Usual Adult Dose for Neuroblastoma

Body Surface Area (BSA)
BSA greater than 1.5 m2: 768 mg (four tablets) orally twice a day
BSA 0.75 to 1.5 m2: 576 mg (three tablets) orally twice a day
BSA 0.5 to less than 0.75 m2: 384 mg (two tablets) orally twice a day
BSA 0.25 to less than 0.5 m2: 192 mg (one tablet) orally twice a day

Duration: For 2 years or until recurrence of disease or unacceptable toxicity.

Comments:

• Before initiating this drug, a complete blood count, liver function tests, and baseline audiogram tests should be performed.
• Recalculate BSA dosage every 3 months during treatment.

Use: To reduce the risk of relapse in patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy

Usual Pediatric Dose for Neuroblastoma

Body Surface Area (BSA)
BSA greater than 1.5 m2: 768 mg (four tablets) orally twice a day
BSA 0.75 to 1.5 m2: 576 mg (three tablets) orally twice a day
BSA 0.5 to less than 0.75 m2: 384 mg (two tablets) orally twice a day
BSA 0.25 to less than 0.5 m2: 192 mg (one tablet) orally twice a day

Duration: For 2 years or until recurrence of disease or unacceptable toxicity.

Comments:

• Before initiating this drug, a complete blood count, liver function tests, and baseline audiogram tests should be performed.
• Recalculate BSA dosage every 3 months during treatment.

Use: To reduce the risk of relapse in patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Recommended dose reductions for toxicity management:
Current dose: 768 mg (four tablets) orally twice a day
Recommended reduced dose: 576 mg (three tablets) orally twice a day

Current dose: 576 mg (three tablets) orally twice a day
Recommended reduced dose: 384 mg (two tablets) orally twice a day

Current dose: 384 mg (two tablets) orally twice a day
Recommended reduced dose: 192 mg (one tablet) orally twice a day

Current dose: 192 mg (one tablet) orally twice a day
Recommended reduced dose: 192 mg (one tablet) orally once daily

• If subsequent adverse reactions occur, dose reduction should be continued until the minimum dose of one 192 mg tablet once per day.
• If the patient is unable to tolerate the minimum dose of 192 mg once daily, then this drug should be permanently discontinued.

Recommended dosage modifications for the management of adverse reactions:
Myelosuppression:
Neutrophil count less than 500/mm3:

• Withhold therapy until neutrophil counts are more than or equal to 500/mm3.
• If recovered within 7 days, resume therapy at the same dose.
• If recovered after 7 days, resume therapy at the next reduced dose level.

Platelet count less than 25,000/mm3:

• Withhold therapy until platelet counts are more than or equal to 25,000/mm3.
• If recovered within 7 days, resume therapy at the same dose.
• If recovered between 7 and 14 days, resume therapy at the next reduced dose level.
• If not recovered within 14 days, permanently discontinue this drug.

Anemia (less than 8g/dL):

• Withhold therapy until recovery to more than or equal 8g/dL.
• Resume this drug at the same dose.
• If anemia recurs (less than 8g/dL):
• Withhold therapy until recovery to more than or equal 8g/dL.
• Resume this drug at the next reduced dose level.

Hepatotoxicity:
AST or ALT increased:

• Withhold therapy until recovery to less than 10*ULN.
• If recovered within 7 days, resume this drug at the same dose.
• If recovered after 7 days, resume this drug at the next reduced dose level.

Hearing loss:

• Continue dosing and repeat the audiogram in 3 weeks.
• If improved, continue therapy at the same dose.
• If clinically concerning changes persist, hold this drug for up to 30 days and repeat the audiogram.
• If stable or improved, resume therapy at the next reduced dose level.

Other adverse reactions:

• Nausea, vomiting, or diarrhea:

Grade 3:

• If symptoms respond to supportive treatment (e.g., anti-emetic, anti-diarrheal), continue dosing with this drug at the same dose.
• If symptoms do not respond to treatment,
• Withhold therapy until recovery to grade 2 or less.
• Resume therapy at the next reduced dose level.

• Other adverse reactions:

Grades 3 or 4:

• Withhold this drug until recovery to grade 2 or less.
• Resume therapy at the next reduced dose level.

Recurrent grade 4:

• Permanently discontinue this drug.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The BSA-based dosage should be recalculated every 3 months during treatment.
• Administer this drug with or without food.
• Tablets can be swallowed whole, chewed, or crushed.
• For patients who have difficulty swallowing tablets, this drug can be chewed or crushed, then mixed with 2 tablespoons of soft food or liquid.
• Visually confirm the entire contents are consumed.
• Crushed tablet preparation should be discarded after 1 hour.
• If a dose is missed, it should be administered as soon as possible. If the next dose is due within 7 hours, the missed dose should be skipped.
• If vomiting occurs after taking this drug, an additional dose should not be administered. Continue with the next scheduled dose.

Storage requirements:

• Store at room temperature, 20C to 25C (68F to 77F), excursions are permitted between 15C to 30C (59F to 86F).

Monitoring:
Hematologic: Blood cell counts
Hepatic: Liver function
Others: Hearing loss

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Bone marrow suppression may occur; patients should immediately report any signs or symptoms of thrombocytopenia, anemia, or infection.
• Hepatotoxicity may occur, patients should immediately report any signs or symptoms of hepatotoxicity.
• Hearing loss may occur; patients should immediately report any signs or symptoms of new or worsening hearing loss.
• This drug can harm a developing fetus.
• Breastfeeding is not recommended during treatment and for 1 week after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer