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

• Mild and Moderate Renal Dysfunction: Data not available
• Severe Renal Dysfunction (estimated GFR less than 30 mL/min): Reduce the recommended dose by 50% based on BSA:
• BSA greater than 1.5 m2: 384 mg (two tablets) orally twice a day
• BSA 0.75 to 1.5 m2: 384 mg (two tablets) in the morning and 192 mg (one tablet) in the evening
• BSA 0.5 to less than 0.75 m2: 192 mg (one tablet) orally twice a day
• BSA 0.25 to less than 0.5 m2: 192 mg (one tablet) orally once a day

Liver Dose Adjustments

Liver dysfunction: Data not available; pharmacokinetic (PK) analyses report no clinical meaningful effects in patients with mild liver dysfunction. No PK data is available for patients with moderate or severe liver dysfunction.

Hepatotoxicity (AST or ALT 10 times ULN or greater):

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

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 8 g/dL):

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

Hearing loss (clinically concerning new or worsening hearing loss compared to baseline audiogram):

• 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.

• Nausea, vomiting, or diarrhea:

Grade 3:

• If symptoms respond to supportive treatment (e.g., anti-emetic, anti-diarrheal), continue 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 before and during treatment
Hepatic: Liver function tests before and during treatment
Other: Hearing loss: Audiogram before and during treatment

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